As an important branch of medicine, Traditional Chinese Medicine(TCM) has been applied for the treatment of diseases for thousands of years in China and other countries in East Asia. The Chinese Pharmacopoeia(ChP) is ...As an important branch of medicine, Traditional Chinese Medicine(TCM) has been applied for the treatment of diseases for thousands of years in China and other countries in East Asia. The Chinese Pharmacopoeia(ChP) is a drug code formulated by the Chinese government, and it includes a special volume for the monographs of TCM, which plays an important role in ensuring the quality of drugs. The use of quality control technology has always been a complex and important factor in TCM. Owing to the chemical diversity of TCM, chromatography technology has been proven to be a comprehensive strategy for the assessment of the overall quality of TCM and has become the main analytical method in the ChP.This article provides an overview of the classical and modern chromatographic technologies applied in the ChP, and summarizes the advantages and disadvantages of each technique in the TCM monographs.In 2020, the new edition of the Ch P(the 2020 edition) has been implemented at the end of 2020. This paper also contains a brief introduction about the application of chromatographic technologies in the new edition of the ChP.展开更多
Chinese medicines are an important part of traditional Chinese medicines,but their'safe,effective,stable and controllable'issue still remains to be solved.The rise of metabonomics in 20th century,consistent wi...Chinese medicines are an important part of traditional Chinese medicines,but their'safe,effective,stable and controllable'issue still remains to be solved.The rise of metabonomics in 20th century,consistent with the overall adjustment concept of multi-component,multi-level,multi-target,multi-metabolic pathways of traditional Chinese medicines,is conducive to solve basic problems in their quality control.This paper systematically describes recent application and development of 1H-NMR metabonomics techniques,LC-MS metabonomics techniques and GC-MS metabonomics techniques in the quality control of traditional Chinese medicines.It provides a new reference for Chinese medicines and the identification and quality assessment of their products.展开更多
BACKGROUND Breast cancer(BC)is the second leading cause of tumor-related mortality after lung cancer.Chemotherapy resistance remains a major challenge to progress in BC treatment,warranting further exploration of feas...BACKGROUND Breast cancer(BC)is the second leading cause of tumor-related mortality after lung cancer.Chemotherapy resistance remains a major challenge to progress in BC treatment,warranting further exploration of feasible and effective alternative therapies.AIM To analyzed the quality of life(QoL)and survival of patients with BC treated with integrated traditional Chinese and Western medicine(TCM-WM).METHODS This study included 226 patients with BC admitted to the First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine between February 2018 and February 2023,including 100 who received conventional Western medicine treatment(control group)and 126 who received TCM-WM treatment(research group).The total effective rate,side effects(alopecia,nausea and vomiting,hepatorenal toxicity,and myelosuppression),QoL assessed using the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire(EORTC QLQ-C30),1-year overall survival(OS),recurrence and metastasis rates,and serum inflammatory factors[interleukin(IL)-6,IL-10,and tumor necrosis factor alpha]were comparatively analyzed.RESULTS The research group showed statistically better overall efficacy,EORTC QoL-C30 scores,and 1-year OS than the control group,with markedly lower side effects and 1-year recurrence and metastasis rates.Moreover,the posttreatment levels of serum inflammatory in the research group were significantly lower than the baseline and those in the control group.CONCLUSION Overall,TCM-WM demonstrated significantly improved therapeutic efficacy while ensuring drug safety in BC,which not only improved patients’QoL and prolonged survival,but also significantly inhibited the inflammatory response.展开更多
Background:This study uses a literature review and the Delphi expert consultation method to construct a competency evaluation model for infection control personnel in traditional Chinese medicine(TCM)hospitals.The aim...Background:This study uses a literature review and the Delphi expert consultation method to construct a competency evaluation model for infection control personnel in traditional Chinese medicine(TCM)hospitals.The aim is to strengthen infection control management in TCM hospitals,assess the competency of infection control personnel in their positions,and assist them in identifying the competencies that need improvement.Methods:Based on the literature research method and the Delphi expert consultation method,a competency model for the position was constructed through two rounds of expert consultations,analyzing the relationships between various factors and establishing a hierarchical structure model.Pairwise comparisons were made among the elements at the same level to construct a judgment matrix.Through the analytic hierarchy process,the weight coefficients of the indicators at each level in the competency model were obtained.Results:This study conducted a comprehensive assessment of various capabilities and practices related to hospital infection control.The survey results indicate that participants excelled in multiple areas,with a high overall satisfaction rate.95.28%of participants were able to develop hospital infection monitoring plans based on national infection control policies,demonstrating a good understanding and execution of these policies.94.09%of participants were familiar with high-risk populations and key departments in the hospital.91.73%of participants were able to establish monitoring scopes based on the trends of multidrug-resistant bacteria and conduct information monitoring,reflecting strong response capabilities.92.91%of participants were able to collaborate with relevant departments to conduct bacterial resistance monitoring,showing a good team spirit.94.49%of participants were able to perform targeted monitoring,including surgical site infections,indicating that they have effective monitoring strategies.91.34%of participants were able to collect and organize monitoring data and establish a systematic database,demonstrating good data management skills.90.16%of participants were able to interpret laws and regulations related to hospital infection management,indicating a high level of legal knowledge.89.37%of participants generally possessed good communication skills.92.52%of participants were able to guide medical staff on occupational safety and protective knowledge,showing an emphasis on occupational health.Participants demonstrated a strong desire to learn and innovate,with 87.01%actively participating in continuing education and research activities,reflecting a pursuit of professional development.Conclusion:Based on the results of the two rounds of expert consultations,a competency evaluation model for infection control personnel in TCM hospitals was formed.Through the analytic hierarchy process,the weight coefficients of various indicators at different levels in the model were obtained,and the research results have good scientific validity and reliability.展开更多
Objective To analyze the changing trend of average medical expenses and structure in general hospitals and traditional Chinese medicine(TCM)hospitals and the effects and differences achieved by the two kinds of hospit...Objective To analyze the changing trend of average medical expenses and structure in general hospitals and traditional Chinese medicine(TCM)hospitals and the effects and differences achieved by the two kinds of hospitals through controlling unreasonable growth of medical expenses,so as to provide reference for controlling the rapid rise of medical cost in public hospitals and optimizing the cost structure.Methods Based on the changes of related indicators of medical expense control from 2012 to 2021,the overall characteristics,changes of cost structure and trends of medical expenses in general hospitals and TCM hospitals were investigated.Results and Conclusion From 2012 to 2021,the increase of medical expenses in general hospitals and traditional Chinese medicine hospitals had slowed down,the proportion of drug revenue to medical income began to decline,and the medical service income increased.However,the proportion of inspection,test and sanitary materials income has increased instead of decreasing,but the management cost has decreased.The two kinds of hospitals have achieved certain cost control results,the structure of medical cost has changed greatly,and the technical service and labor value of medical personnel have been reflected to a certain extent.However,it is still necessary to explore a more scientific and reasonable cost control mechanism to promote the further optimization of medical cost structure.展开更多
Objective: To evaluate the efficacy of traditional Chinese medicine(TCM) for preventing acute mountain sickness(AMS).Methods: We included randomized controlled trials(RCTs) which evalueded the effect of TCM for preven...Objective: To evaluate the efficacy of traditional Chinese medicine(TCM) for preventing acute mountain sickness(AMS).Methods: We included randomized controlled trials(RCTs) which evalueded the effect of TCM for preventing AMS, compared with a placebo, no treatment or acetazolamide. The literature was searched in 6major databases. RevMan 5.4 software was used for the meta-analysis. The relative risk for discrete variables and the mean difference for continuous variables with 95% confidence intervals(CIs) were applied to express the effect size. The risk of bias in the included studies was evaluated using the Cochrane risk assessment tool 2.0(RoB 2.0), and the evidence certainty was assessed using the Grading of Recommendations Assessment and the Development and Evaluation(GRADE) approach.Results: Twenty RCTs involving 3015 participants and 16 TCM patent drugs were included. The overall risk of bias in the majority of studies(15/20) was of some concerns. In terms of the AMS incidence,Rhodiola rosea(R. rosea, Hong Jing Tian) and Ginkgo biloba(G. biloba, Yin Xing Ye) were equivalent to the placebo/no treatment [RR(95% CI): 0.66(0.43-1.01), 0.82(0.63-1.06), respectively]. The AMS incidence in the G. biloba group was higher than that in the acetazolamide group [RR(95% CI): 2.92(1.69-5.06)]. In terms of improving the AMS symptom score on days 1 and 3 in the plateau, R. rosea and G. biloba were superior to the placebo or no treatment [MD(95% CI):-0.98(-1.71,-0.25),-2.05(-3.14,-0.95), respectively]. The other 14 Chinese patent medicines were evaluated in a single trial, and the majority of the results were negative. The subgroup analysis showed that the effect of R. rosea was related to the intervention time, way of ascending, and altitude.Conclusion: R. rosea and G. biloba were effective in improving AMS symptoms but had no effect in reducing the AMS incidence. There was insufficient evidence to support the use of other TCM patent drugs to prevent AMS. More randomized double-blind placebo-controlled trials are warranted to evaluate and screen effective Chinese patent medicines for AMS prevention.展开更多
Objective:To assess outcome indicators in clinical trials and provide a reference for establishing a core outcome set to treat hyperplasia of mammary gland(HMG)with traditional Chinese medicine(TCM).Methods:Eight onli...Objective:To assess outcome indicators in clinical trials and provide a reference for establishing a core outcome set to treat hyperplasia of mammary gland(HMG)with traditional Chinese medicine(TCM).Methods:Eight online databases were searched from their inception to December 31,2022,to assess outcomes reported in randomized controlled trials(RCTs)of HMG treated with TCM.The quality of the included studies was assessed according to the Cochrane Risk of Bias Assessment Tool.All outcomes were extracted,classified,and described.Results:A total of 8249 articles were initially retrieved.Of these,70 articles were eligible and involved 10618 participants with HMG.A total of 17 outcome indicators with a frequency of 271 times were involved and were collected according to six outcome domains.Conclusions:The core outcomes of RCTs of HMG treated with TCM are large and divergent.There are problems in evaluation standards,primary and secondary outcomes,TCM characteristic indicators,long-term prognosis,and standardization of reporting.It is recommended to strengthen the trial design and actively construct the core outcome sets with TCM characteristics for HMG.展开更多
Traditional Chinese medicines(TCMs)have played an important role in the treatment of diseases for thousands of years.With the rise of the combination therapy for multi-gene diseases,TCMs attracted more attentions grad...Traditional Chinese medicines(TCMs)have played an important role in the treatment of diseases for thousands of years.With the rise of the combination therapy for multi-gene diseases,TCMs attracted more attentions gradually.However,TCMs is a complex system which could contain tens,or even hundreds of compounds.Selection of chemical markers is thus a key to the展开更多
An effective quality control system is the key to ensuring the quality, safety and efficacy of traditional Chinese medicines(TCMs). However, the current quality standard research lacks top-level design and systematic ...An effective quality control system is the key to ensuring the quality, safety and efficacy of traditional Chinese medicines(TCMs). However, the current quality standard research lacks top-level design and systematic design,mostly based on specific technologies or evaluation methods. To resolve the challenges and questions of quality control of TCMs, a brand-new quality standard system, named "iVarious", was proposed. The system comprises eight elements in a modular format. Meaning of every element was specifically illustrated via corresponding research instances. Furthermore, frankincense study was taken as an example for demonstrating standards and research process, based on the "i Various" system. This system highlighted a holistic strategy for effectiveness,security, integrity and systematization of quality and safety control standards of TCMs. The establishment of"i Various" integrates multi-disciplinary technologies and progressive methods, basis elements and key points of standard construction. The system provides a novel idea and technological demonstration for regulation establishment of TCMs quality standards.展开更多
Objective:The paper is to comprehensively summarize and analyze the basic situation and methodological quality of clinical randomized controlled trials(RCTs)of traditional Chinese patent medicines and traditional Chin...Objective:The paper is to comprehensively summarize and analyze the basic situation and methodological quality of clinical randomized controlled trials(RCTs)of traditional Chinese patent medicines and traditional Chinese classic famous prescriptions published in 2022,to provide evidence and reasonable suggestions for the advancement of clinical research and the formulation of policies and guidelines.Methods:The Evidence Database System of clinical evidence-based evaluation of traditional Chinese medicine was searched,and data from China National Knowledge Infrastructure(CNKI),PubMed,and other databases were supplemented.The search duration was from January 1,2022,to December 31,2022.RCTs of traditional Chinese patent medicines and traditional Chinese classic famous prescriptions were included as the source of clinical evidence,and published information,sample size,intervention,control measures,treatment course,methodological quality,and key link report were analyzed and evaluated.Results:A total of 1,464 RCTs of traditional Chinese patent medicines were included,which comprised 667 types of traditional Chinese patent medicines;“traditional Chinese patent medicines+Western medicine vs.Western medicine”was the most widely used intervention and control setting,involving 417 RCTs(28.48%).A total of 245 RCTs of traditional Chinese classic famous prescriptions were included,comprising 55 types of traditional Chinese classic famous prescriptions.“Decoction+conventional treatment vs.conventional treatment”was the most widely used intervention and control setting,with 87 RCTs(35.51%).Published RCTs on traditional Chinese patent medicines and traditional Chinese classic famous prescriptions were limited by the study design and implementation.Most“allocation concealment”and“blinding of patients and personnel”were rated as medium to high risk.There are insufficient reports on key research links such as experimental registration and ethical approval.Conclusions:The number of RCTs on traditional Chinese patent medicines has decreased in 2022,but there has been a slight improvement in the research quality and impact.There are relatively few studies on traditional Chinese classic famous prescriptions.Measures must be taken to improve clinical trial design,implementation,and reporting.Methodological experts should be invited to provide professional technical guidance on the trial design.In the research implementation process,attention should be paid to quality control,particularly the standardization of the randomized execution.展开更多
Inflammatory bowel disease,particularly ulcerative colitis(UC),poses significant treatment challenges due to its chronic nature and potential for severe complications.This editorial reviews a recent network meta-analy...Inflammatory bowel disease,particularly ulcerative colitis(UC),poses significant treatment challenges due to its chronic nature and potential for severe complications.This editorial reviews a recent network meta-analysis that evaluated the efficacy of and highlighted the superior outcomes achieved by combining each of five traditional Chinese medicine(TCM)formulations with mesalazine for the adjuvant treatment of UC.Clinical outcomes included enhanced mucosal healing,improved quality of life,and reduced recurrence rates.Additionally,the combination therapy resulted in a lower incidence of adverse reactions compared with mesalazine monotherapy.Despite these promising results,limitations such as variability in study quality and TCM dosage highlight the need for further highquality,large-sample,multicenter randomized controlled trials.This editorial underscores the potential of TCM in enhancing UC management and calls for more rigorous research to substantiate these findings and refine clinical guidelines.展开更多
Objective:To explore and analyze the clinical efficacy of Chinese medicine combined with acupuncture and moxibustion in the treatment of insomnia.Method:80 patients with primary insomnia were selected as the study sam...Objective:To explore and analyze the clinical efficacy of Chinese medicine combined with acupuncture and moxibustion in the treatment of insomnia.Method:80 patients with primary insomnia were selected as the study sample,with 20 cases randomly selected as the control group and the rest as the observation group.The control group was treated with ordinary western medicine,while the observation group patients were treated with traditional Chinese medicine combined with acupuncture and moxibustion based on this syndrome differentiation.The comparison items were treatment effect,sleep quality,mental health,quality of life,specific sleep indicators,cerebral blood flow and neurotransmitters.Result:The treatment effectiveness showed that the observation group had a higher treatment effectiveness rate than the control group(P<0.05);The results of sleep quality showed that after treatment,the scores of the observation group were lower than those of the control group in seven dimensions:sleep quality,sleep time,sleep onset time,sleep efficiency,sleep disorders,hypnotic drugs,and daytime dysfunc‐tion score(P<0.05);The quality of life results showed that after treatment,the observa‐tion group had higher scores than the control group in eight dimensions:physiological function,physiological function,physical pain,health status,energy,social function,emotional function,and mental health(P<0.05);The results of slow wave sleep time and fast eye movement sleep time showed that after treatment,the HAMA and HAMD scores of the physiological mechanism in the observation group were lower than those in the control group(P<0.05);The results of cerebral blood flow and neurotransmitter indica‐tors show that after treatment,glutamateγ-The peak systolic blood flow velocity of ami‐nobutyric acid,vertebral artery,and basilar artery in the observation group was higher than that in the control group(P<0.05).Conclusion:The clinical treatment of Chinese medicine combined with acupuncture and moxibustion in the treatment of insomnia patients can significantly improve the clinical treatment effect,and improve the cerebral hemorrhage and neurotransmitter status of patients,promote the improvement of their physical and mental status,can more significantly improve the quality of sleep,reduce sleep difficulties,reduce the dosage of sleeping pills,which has important clinical application value.展开更多
Objective: To investigate the influence of integrated Chinese and Western medicine treatment on the quality of life and laboratory indicators of patients with novel coronavirus pneumonia (COVID-19). Methods: A prospec...Objective: To investigate the influence of integrated Chinese and Western medicine treatment on the quality of life and laboratory indicators of patients with novel coronavirus pneumonia (COVID-19). Methods: A prospective, self-controlled study was conducted to analyze the changes in corresponding laboratory indicators and quality of life in 75 confirmed COVID-19 patients treated with integrated Chinese and Western medicine in our hospital during the early stage, middle stage, recovery period, and two weeks after discharge. The effectiveness and safety of the treatment regimen were evaluated in conjunction with the time for 2019-nCoV nucleic acid conversion, disease progression, and adverse reactions. Results: The PLT levels in the initial stage were significantly lower than those in the recovery period in 75 patients. The CRP levels in the initial stage were significantly lower than those after discharge for 2 weeks. The TBIL, IBTL, and DHIL levels in the initial stage were significantly lower than those in the middle stage. The K+ levels in the initial stage were significantly lower than those in the recovery period and after discharge for 2 weeks. The LYMGH levels in the initial stage were significantly lower than those in the recovery period and after discharge for 2 weeks. The TP and ALB levels in the initial stage were higher than those in the middle stage and the recovery period. The LDH levels, scores of daily activity limitation, scores of respiratory distress symptoms, scores of psychological emotions, CT imaging scores, and positive rate of nucleic acid were significantly lower than those in the recovery period and after discharge for 2 weeks. The AG, CK, CK-MB, and α-HBDH levels in the initial stage were significantly higher than those in the recovery period. However, the AMY level in the initial stage was significantly lower than that in the recovery period and after discharge for 2 weeks (p Conclusion: Integrated Chinese and Western medicine treatment has a significant impact on laboratory indicators such as PLT, LYMGH, CRP, TBIL, IBTL, DHIL, TP, ALB, K+, AG, LDH, CK, CK-MB, α-HBDH, AMY, CT imaging, and 2019-nCoV nucleic acid in COVID-19 patients. It has good clinical efficacy and safety, and can improve the quality of life of patients.展开更多
The rate of disability due to acute osteofascial compartment syndrome(OCS)is high,and the therapeutic effect of decompressive fasciotomy is not ideal.This paper retrospectively reviews the modern treatment of OCS,incl...The rate of disability due to acute osteofascial compartment syndrome(OCS)is high,and the therapeutic effect of decompressive fasciotomy is not ideal.This paper retrospectively reviews the modern treatment of OCS,including Western medicine and Traditional Chinese medicine(TCM),mainly in the context of the advantages of TCM in the treatment process of decompressive fasciotomy or conservative treatment to the patients who are suffering from OCS.It was found that TCM treatment reduced the levels of serum creatine kinase(CK),lactate dehydrogenase(LDH),and aspartate aminotransferase(AST);it is beneficial to the elimination of swelling and pain.TCM adjunctive therapy promotes patients’postoperative functional recovery and decreases the occurrence of fasciotomy in patients;TCM can relieve tissue hypoxia of compartments and prevent necrosis of muscle and nerve tissue.TCM treatment improves the quality of medical service and ensures the safety of OCS patients.This paper aims to summarize the function of TCM in the treatment of OCS,provide reference for the clinical treatment of OCS,and improve the nursing/medical outcomes of OCS.展开更多
Objective: This paper takes the example of a Panax notoginseng extraction workshop and designs an automated production workshop with advanced domestic capabilities. Methods: 1) Based on the small-scale Panax notoginse...Objective: This paper takes the example of a Panax notoginseng extraction workshop and designs an automated production workshop with advanced domestic capabilities. Methods: 1) Based on the small-scale Panax notoginseng extraction process, the feasibility of the workshop production process is demonstrated. 2) The workshop process design for Panax Notoginseng saponin extraction is completed, including production organization plans and the selection of key equipment. 3) For the Panax notoginseng extraction workshop process, an automated production control system is designed. Conclusion: Through optimized design of the production process and automation system, continuous and automated production of traditional Chinese medicine extraction is achieved, leading to improvements in drug quality and production efficiency.展开更多
As the most important complementary medication against a variety of diseases,traditional Chinese medicines(TCMs)have been extensively applied over thousands of years.Current quality control of herbal medicines,however...As the most important complementary medication against a variety of diseases,traditional Chinese medicines(TCMs)have been extensively applied over thousands of years.Current quality control of herbal medicines,however,is in great dispute.Unlike chemical drugs,which have clear and validated quality standards,the content of only one(or a few)compounds of many herbs and preparations is currently assessed as an indicator of quality,even though the assessed compound(s)is neither closely associated with the efficacy nor representative of the medicine as a whole.Based on the clinical use,compatibility of multiple component prescriptions,and manufacturing process of TCM,the new concept of a TCM quality marker that was proposed in previous work is discussed further here.In addition,practical technological approaches are described for the qualitative analysis and quantification of TCMs including herbs,processed products,and preparations,which lead to the discovery and identification of specific chemicals as quality markers and new quality control patterns.The progress that has been made in TCM quality control is also addressed.This work provides useful information for the quality control of herbal medicines in the future.展开更多
BACKGROUND Recent research suggests that although prokinetic agents,acid suppressors,and radical treatment for Helicobacter pylori infection may be effective in patients with functional dyspepsia(FD),a large proportio...BACKGROUND Recent research suggests that although prokinetic agents,acid suppressors,and radical treatment for Helicobacter pylori infection may be effective in patients with functional dyspepsia(FD),a large proportion of patients still fail to respond to these treatments or may suffer from severe adverse reactions.Many traditional Chinese medicinal herbs can regulate the status of the entire body and have special advantages in the treatment of functional diseases.The present study was designed to verify the efficacy of Biling Weitong Granules(BLWTG),a traditional Chinese medicinal herbal compound formula,in alleviating epigastric pain syndrome(EPS)in FD patients,in an attempt to provide an effective prescription for the clinical treatment of this disease.AIM To evaluate the clinical efficacy and safety of BLWTG in treating EPS in patients with FD.METHODS In this multicenter,stratified,randomized,double-blind,placebo-controlled,parallel group clinical trial,eligible patients were randomized into the BLWTG and placebo groups who were treated for 6 wk.Efficacy indicators including the severity and frequency of EPS and the time to pain resolution and safety indicators including adverse events were observed and compared.RESULTS The baseline demographic data and clinical characteristics,such as epigastric pain symptoms,pain intensity,and frequency of attacks,were matched between the two groups before randomization.After 6 wk of treatment and after the center effect was eliminated,the epigastric pain was significantly improved in 28.33%and 85.59%of the patients in the placebo and BLWTG groups,respectively(P<0.05).At 6 wk,the resolution rate of epigastric pain was 15%and 69.49%in the placebo and BLWTG groups,respectively(P<0.05).The differences of total FD clinical score between these two groups were significant(P<0.05)at 2,4,and 6 wk(P<0.05).The scores of each item and the total score in the Functional Digestive Disorders Quality of Life Questionnaire showed significant differences between the two groups at 6 wk after both the center and interaction effects were eliminated(P<0.05).There was no significant difference in the incidence of adverse events between the two groups,and no serious adverse event was noted during the observation.CONCLUSION Compared with placebo,BLWTG markedly improved EPS in FD patients without causing serious adverse reactions.展开更多
Chromatographic fingerprinting has been perceived as an essential tool for assessing quality and chemical equivalence of traditional Chinese medicine.However,this pattern-oriented approach still has some weak points i...Chromatographic fingerprinting has been perceived as an essential tool for assessing quality and chemical equivalence of traditional Chinese medicine.However,this pattern-oriented approach still has some weak points in terms of chemical coverage and robustness.In this work,we proposed a multiple reaction monitoring(MRM)-based fingerprinting method in which approximately 100 constituents were simultaneously detected for quality assessment.The derivative MRM approach was employed to rapidly design MRM transitions independent of chemical standards,based on which the large-scale fingerprinting method was efficiently established.This approach was exemplified on QiShenYiQi Pill(QSYQ),a traditional Chinese medicine-derived drug product,and its robustness was systematically evaluated by four indices:clustering analysis by principal component analysis,similarity analysis by the congruence coefficient,the number of separated peaks,and the peak area proportion of separated peaks.Compared with conventional ultraviolet-based fingerprints,the MRM fingerprints provided not only better discriminatory capacity for the tested normal/abnormal QSYQ samples,but also higher robustness under different chromatographic conditions(i.e.,flow rate,apparent pH,column temperature,and column).The result also showed for such large-scale fingerprints including a large number of peaks,the angle cosine measure after min-max normalization was more suitable for setting a decision criterion than the unnormalized algorithm.This proof-of-concept application gives evidence that combining MRM technique with proper similarity analysis metrices can provide a highly sensitive,robust and comprehensive analytical approach for quality assessment of traditional Chinese medicine.展开更多
With the modernization and internationalization of traditional Chinese medicine(TCM),the requirement for quality control has increased.The quality marker(Q-marker)is an important standard in this field and has been im...With the modernization and internationalization of traditional Chinese medicine(TCM),the requirement for quality control has increased.The quality marker(Q-marker)is an important standard in this field and has been implemented with remarkable success in recent years.However,the establishment of Qmarkers remains fragmented and the process lacks systematicity,resulting in inconsistent quality control and insufficient correlation with clinical efficacy and safety of TCM.This review introduces four multimodal integrated approaches that contribute to the discovery of more comprehensive and accurate Qmarkers,thus aiding in the establishment of new quality control patterns based on the characteristics and principles of TCM.These include the whole-process quality control strategy,chemical-activity-based screening method,efficacy,safety,and consistent combination strategy,and TCM theory-guided approach.Furthermore,methodologies and representative examples of these strategies are described,and important future directions and questions in this field are also proposed.展开更多
This paper discussed how to protect and control the quality of wild Chinese herbal medicine resources in nature reserves by taking Longyuwan National Forest Park within Funiu Mountain Nature Reserve as an example. Thr...This paper discussed how to protect and control the quality of wild Chinese herbal medicine resources in nature reserves by taking Longyuwan National Forest Park within Funiu Mountain Nature Reserve as an example. Through the combination of three methods including literature review, visiting and investigational studies, and field surveys, the data of investigation, collection and collation were analyzed. According to data of surveys, collection and collation, problems related to the protection of wild Chinese herbal medicine resources faced by Longyuwan Scenic Spot within Funiu Mountain Nature Reserve were also analyzed and protection strategies and quality control of wild Chinese herbal medicine resources in this nature reserve were discussed. It was expected that the results would provide important scientific references for the sustainable development, protection and quality control of wild Chinese herbal medicine resources within nature reserves.展开更多
文摘As an important branch of medicine, Traditional Chinese Medicine(TCM) has been applied for the treatment of diseases for thousands of years in China and other countries in East Asia. The Chinese Pharmacopoeia(ChP) is a drug code formulated by the Chinese government, and it includes a special volume for the monographs of TCM, which plays an important role in ensuring the quality of drugs. The use of quality control technology has always been a complex and important factor in TCM. Owing to the chemical diversity of TCM, chromatography technology has been proven to be a comprehensive strategy for the assessment of the overall quality of TCM and has become the main analytical method in the ChP.This article provides an overview of the classical and modern chromatographic technologies applied in the ChP, and summarizes the advantages and disadvantages of each technique in the TCM monographs.In 2020, the new edition of the Ch P(the 2020 edition) has been implemented at the end of 2020. This paper also contains a brief introduction about the application of chromatographic technologies in the new edition of the ChP.
文摘Chinese medicines are an important part of traditional Chinese medicines,but their'safe,effective,stable and controllable'issue still remains to be solved.The rise of metabonomics in 20th century,consistent with the overall adjustment concept of multi-component,multi-level,multi-target,multi-metabolic pathways of traditional Chinese medicines,is conducive to solve basic problems in their quality control.This paper systematically describes recent application and development of 1H-NMR metabonomics techniques,LC-MS metabonomics techniques and GC-MS metabonomics techniques in the quality control of traditional Chinese medicines.It provides a new reference for Chinese medicines and the identification and quality assessment of their products.
文摘BACKGROUND Breast cancer(BC)is the second leading cause of tumor-related mortality after lung cancer.Chemotherapy resistance remains a major challenge to progress in BC treatment,warranting further exploration of feasible and effective alternative therapies.AIM To analyzed the quality of life(QoL)and survival of patients with BC treated with integrated traditional Chinese and Western medicine(TCM-WM).METHODS This study included 226 patients with BC admitted to the First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine between February 2018 and February 2023,including 100 who received conventional Western medicine treatment(control group)and 126 who received TCM-WM treatment(research group).The total effective rate,side effects(alopecia,nausea and vomiting,hepatorenal toxicity,and myelosuppression),QoL assessed using the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire(EORTC QLQ-C30),1-year overall survival(OS),recurrence and metastasis rates,and serum inflammatory factors[interleukin(IL)-6,IL-10,and tumor necrosis factor alpha]were comparatively analyzed.RESULTS The research group showed statistically better overall efficacy,EORTC QoL-C30 scores,and 1-year OS than the control group,with markedly lower side effects and 1-year recurrence and metastasis rates.Moreover,the posttreatment levels of serum inflammatory in the research group were significantly lower than the baseline and those in the control group.CONCLUSION Overall,TCM-WM demonstrated significantly improved therapeutic efficacy while ensuring drug safety in BC,which not only improved patients’QoL and prolonged survival,but also significantly inhibited the inflammatory response.
基金supported by Weifang Science and Technology Development Plan Project(Soft Science,2022RKX054)Shenzhen Elite Talent Project(JY2024-2).
文摘Background:This study uses a literature review and the Delphi expert consultation method to construct a competency evaluation model for infection control personnel in traditional Chinese medicine(TCM)hospitals.The aim is to strengthen infection control management in TCM hospitals,assess the competency of infection control personnel in their positions,and assist them in identifying the competencies that need improvement.Methods:Based on the literature research method and the Delphi expert consultation method,a competency model for the position was constructed through two rounds of expert consultations,analyzing the relationships between various factors and establishing a hierarchical structure model.Pairwise comparisons were made among the elements at the same level to construct a judgment matrix.Through the analytic hierarchy process,the weight coefficients of the indicators at each level in the competency model were obtained.Results:This study conducted a comprehensive assessment of various capabilities and practices related to hospital infection control.The survey results indicate that participants excelled in multiple areas,with a high overall satisfaction rate.95.28%of participants were able to develop hospital infection monitoring plans based on national infection control policies,demonstrating a good understanding and execution of these policies.94.09%of participants were familiar with high-risk populations and key departments in the hospital.91.73%of participants were able to establish monitoring scopes based on the trends of multidrug-resistant bacteria and conduct information monitoring,reflecting strong response capabilities.92.91%of participants were able to collaborate with relevant departments to conduct bacterial resistance monitoring,showing a good team spirit.94.49%of participants were able to perform targeted monitoring,including surgical site infections,indicating that they have effective monitoring strategies.91.34%of participants were able to collect and organize monitoring data and establish a systematic database,demonstrating good data management skills.90.16%of participants were able to interpret laws and regulations related to hospital infection management,indicating a high level of legal knowledge.89.37%of participants generally possessed good communication skills.92.52%of participants were able to guide medical staff on occupational safety and protective knowledge,showing an emphasis on occupational health.Participants demonstrated a strong desire to learn and innovate,with 87.01%actively participating in continuing education and research activities,reflecting a pursuit of professional development.Conclusion:Based on the results of the two rounds of expert consultations,a competency evaluation model for infection control personnel in TCM hospitals was formed.Through the analytic hierarchy process,the weight coefficients of various indicators at different levels in the model were obtained,and the research results have good scientific validity and reliability.
文摘Objective To analyze the changing trend of average medical expenses and structure in general hospitals and traditional Chinese medicine(TCM)hospitals and the effects and differences achieved by the two kinds of hospitals through controlling unreasonable growth of medical expenses,so as to provide reference for controlling the rapid rise of medical cost in public hospitals and optimizing the cost structure.Methods Based on the changes of related indicators of medical expense control from 2012 to 2021,the overall characteristics,changes of cost structure and trends of medical expenses in general hospitals and TCM hospitals were investigated.Results and Conclusion From 2012 to 2021,the increase of medical expenses in general hospitals and traditional Chinese medicine hospitals had slowed down,the proportion of drug revenue to medical income began to decline,and the medical service income increased.However,the proportion of inspection,test and sanitary materials income has increased instead of decreasing,but the management cost has decreased.The two kinds of hospitals have achieved certain cost control results,the structure of medical cost has changed greatly,and the technical service and labor value of medical personnel have been reflected to a certain extent.However,it is still necessary to explore a more scientific and reasonable cost control mechanism to promote the further optimization of medical cost structure.
基金supported by the Institute Projects of China Tibetology Research Center in 2022(CTRC20226JS05).
文摘Objective: To evaluate the efficacy of traditional Chinese medicine(TCM) for preventing acute mountain sickness(AMS).Methods: We included randomized controlled trials(RCTs) which evalueded the effect of TCM for preventing AMS, compared with a placebo, no treatment or acetazolamide. The literature was searched in 6major databases. RevMan 5.4 software was used for the meta-analysis. The relative risk for discrete variables and the mean difference for continuous variables with 95% confidence intervals(CIs) were applied to express the effect size. The risk of bias in the included studies was evaluated using the Cochrane risk assessment tool 2.0(RoB 2.0), and the evidence certainty was assessed using the Grading of Recommendations Assessment and the Development and Evaluation(GRADE) approach.Results: Twenty RCTs involving 3015 participants and 16 TCM patent drugs were included. The overall risk of bias in the majority of studies(15/20) was of some concerns. In terms of the AMS incidence,Rhodiola rosea(R. rosea, Hong Jing Tian) and Ginkgo biloba(G. biloba, Yin Xing Ye) were equivalent to the placebo/no treatment [RR(95% CI): 0.66(0.43-1.01), 0.82(0.63-1.06), respectively]. The AMS incidence in the G. biloba group was higher than that in the acetazolamide group [RR(95% CI): 2.92(1.69-5.06)]. In terms of improving the AMS symptom score on days 1 and 3 in the plateau, R. rosea and G. biloba were superior to the placebo or no treatment [MD(95% CI):-0.98(-1.71,-0.25),-2.05(-3.14,-0.95), respectively]. The other 14 Chinese patent medicines were evaluated in a single trial, and the majority of the results were negative. The subgroup analysis showed that the effect of R. rosea was related to the intervention time, way of ascending, and altitude.Conclusion: R. rosea and G. biloba were effective in improving AMS symptoms but had no effect in reducing the AMS incidence. There was insufficient evidence to support the use of other TCM patent drugs to prevent AMS. More randomized double-blind placebo-controlled trials are warranted to evaluate and screen effective Chinese patent medicines for AMS prevention.
基金This study was supported by the National Administration of Traditional Chinese Medicine(SATCM-2015-BZ402).
文摘Objective:To assess outcome indicators in clinical trials and provide a reference for establishing a core outcome set to treat hyperplasia of mammary gland(HMG)with traditional Chinese medicine(TCM).Methods:Eight online databases were searched from their inception to December 31,2022,to assess outcomes reported in randomized controlled trials(RCTs)of HMG treated with TCM.The quality of the included studies was assessed according to the Cochrane Risk of Bias Assessment Tool.All outcomes were extracted,classified,and described.Results:A total of 8249 articles were initially retrieved.Of these,70 articles were eligible and involved 10618 participants with HMG.A total of 17 outcome indicators with a frequency of 271 times were involved and were collected according to six outcome domains.Conclusions:The core outcomes of RCTs of HMG treated with TCM are large and divergent.There are problems in evaluation standards,primary and secondary outcomes,TCM characteristic indicators,long-term prognosis,and standardization of reporting.It is recommended to strengthen the trial design and actively construct the core outcome sets with TCM characteristics for HMG.
文摘Traditional Chinese medicines(TCMs)have played an important role in the treatment of diseases for thousands of years.With the rise of the combination therapy for multi-gene diseases,TCMs attracted more attentions gradually.However,TCMs is a complex system which could contain tens,or even hundreds of compounds.Selection of chemical markers is thus a key to the
基金financial support from National Major Scientific and Technological Special Project for "Significant New Drugs Development" (2014ZX09304307-002)Youth Development Research Foundation of NIFDC (2013WA8)the National Natural Foundation of China (81303214)
文摘An effective quality control system is the key to ensuring the quality, safety and efficacy of traditional Chinese medicines(TCMs). However, the current quality standard research lacks top-level design and systematic design,mostly based on specific technologies or evaluation methods. To resolve the challenges and questions of quality control of TCMs, a brand-new quality standard system, named "iVarious", was proposed. The system comprises eight elements in a modular format. Meaning of every element was specifically illustrated via corresponding research instances. Furthermore, frankincense study was taken as an example for demonstrating standards and research process, based on the "i Various" system. This system highlighted a holistic strategy for effectiveness,security, integrity and systematization of quality and safety control standards of TCMs. The establishment of"i Various" integrates multi-disciplinary technologies and progressive methods, basis elements and key points of standard construction. The system provides a novel idea and technological demonstration for regulation establishment of TCMs quality standards.
基金funded by Tianjin Science and Technology Bureau-Outstanding youth program-Methodological research on Intelligent Transformation of evicence in Traditional Chinese medicine(20JCJQJC00120)Traditional Chinese Medicine Innovation Team and Talent Support Program National Traditional Chinese Medicine Multidisciplinary Interdisciplinary Innovation Team Project(ZYYCXTD-D-202204).
文摘Objective:The paper is to comprehensively summarize and analyze the basic situation and methodological quality of clinical randomized controlled trials(RCTs)of traditional Chinese patent medicines and traditional Chinese classic famous prescriptions published in 2022,to provide evidence and reasonable suggestions for the advancement of clinical research and the formulation of policies and guidelines.Methods:The Evidence Database System of clinical evidence-based evaluation of traditional Chinese medicine was searched,and data from China National Knowledge Infrastructure(CNKI),PubMed,and other databases were supplemented.The search duration was from January 1,2022,to December 31,2022.RCTs of traditional Chinese patent medicines and traditional Chinese classic famous prescriptions were included as the source of clinical evidence,and published information,sample size,intervention,control measures,treatment course,methodological quality,and key link report were analyzed and evaluated.Results:A total of 1,464 RCTs of traditional Chinese patent medicines were included,which comprised 667 types of traditional Chinese patent medicines;“traditional Chinese patent medicines+Western medicine vs.Western medicine”was the most widely used intervention and control setting,involving 417 RCTs(28.48%).A total of 245 RCTs of traditional Chinese classic famous prescriptions were included,comprising 55 types of traditional Chinese classic famous prescriptions.“Decoction+conventional treatment vs.conventional treatment”was the most widely used intervention and control setting,with 87 RCTs(35.51%).Published RCTs on traditional Chinese patent medicines and traditional Chinese classic famous prescriptions were limited by the study design and implementation.Most“allocation concealment”and“blinding of patients and personnel”were rated as medium to high risk.There are insufficient reports on key research links such as experimental registration and ethical approval.Conclusions:The number of RCTs on traditional Chinese patent medicines has decreased in 2022,but there has been a slight improvement in the research quality and impact.There are relatively few studies on traditional Chinese classic famous prescriptions.Measures must be taken to improve clinical trial design,implementation,and reporting.Methodological experts should be invited to provide professional technical guidance on the trial design.In the research implementation process,attention should be paid to quality control,particularly the standardization of the randomized execution.
文摘Inflammatory bowel disease,particularly ulcerative colitis(UC),poses significant treatment challenges due to its chronic nature and potential for severe complications.This editorial reviews a recent network meta-analysis that evaluated the efficacy of and highlighted the superior outcomes achieved by combining each of five traditional Chinese medicine(TCM)formulations with mesalazine for the adjuvant treatment of UC.Clinical outcomes included enhanced mucosal healing,improved quality of life,and reduced recurrence rates.Additionally,the combination therapy resulted in a lower incidence of adverse reactions compared with mesalazine monotherapy.Despite these promising results,limitations such as variability in study quality and TCM dosage highlight the need for further highquality,large-sample,multicenter randomized controlled trials.This editorial underscores the potential of TCM in enhancing UC management and calls for more rigorous research to substantiate these findings and refine clinical guidelines.
文摘Objective:To explore and analyze the clinical efficacy of Chinese medicine combined with acupuncture and moxibustion in the treatment of insomnia.Method:80 patients with primary insomnia were selected as the study sample,with 20 cases randomly selected as the control group and the rest as the observation group.The control group was treated with ordinary western medicine,while the observation group patients were treated with traditional Chinese medicine combined with acupuncture and moxibustion based on this syndrome differentiation.The comparison items were treatment effect,sleep quality,mental health,quality of life,specific sleep indicators,cerebral blood flow and neurotransmitters.Result:The treatment effectiveness showed that the observation group had a higher treatment effectiveness rate than the control group(P<0.05);The results of sleep quality showed that after treatment,the scores of the observation group were lower than those of the control group in seven dimensions:sleep quality,sleep time,sleep onset time,sleep efficiency,sleep disorders,hypnotic drugs,and daytime dysfunc‐tion score(P<0.05);The quality of life results showed that after treatment,the observa‐tion group had higher scores than the control group in eight dimensions:physiological function,physiological function,physical pain,health status,energy,social function,emotional function,and mental health(P<0.05);The results of slow wave sleep time and fast eye movement sleep time showed that after treatment,the HAMA and HAMD scores of the physiological mechanism in the observation group were lower than those in the control group(P<0.05);The results of cerebral blood flow and neurotransmitter indica‐tors show that after treatment,glutamateγ-The peak systolic blood flow velocity of ami‐nobutyric acid,vertebral artery,and basilar artery in the observation group was higher than that in the control group(P<0.05).Conclusion:The clinical treatment of Chinese medicine combined with acupuncture and moxibustion in the treatment of insomnia patients can significantly improve the clinical treatment effect,and improve the cerebral hemorrhage and neurotransmitter status of patients,promote the improvement of their physical and mental status,can more significantly improve the quality of sleep,reduce sleep difficulties,reduce the dosage of sleeping pills,which has important clinical application value.
文摘Objective: To investigate the influence of integrated Chinese and Western medicine treatment on the quality of life and laboratory indicators of patients with novel coronavirus pneumonia (COVID-19). Methods: A prospective, self-controlled study was conducted to analyze the changes in corresponding laboratory indicators and quality of life in 75 confirmed COVID-19 patients treated with integrated Chinese and Western medicine in our hospital during the early stage, middle stage, recovery period, and two weeks after discharge. The effectiveness and safety of the treatment regimen were evaluated in conjunction with the time for 2019-nCoV nucleic acid conversion, disease progression, and adverse reactions. Results: The PLT levels in the initial stage were significantly lower than those in the recovery period in 75 patients. The CRP levels in the initial stage were significantly lower than those after discharge for 2 weeks. The TBIL, IBTL, and DHIL levels in the initial stage were significantly lower than those in the middle stage. The K+ levels in the initial stage were significantly lower than those in the recovery period and after discharge for 2 weeks. The LYMGH levels in the initial stage were significantly lower than those in the recovery period and after discharge for 2 weeks. The TP and ALB levels in the initial stage were higher than those in the middle stage and the recovery period. The LDH levels, scores of daily activity limitation, scores of respiratory distress symptoms, scores of psychological emotions, CT imaging scores, and positive rate of nucleic acid were significantly lower than those in the recovery period and after discharge for 2 weeks. The AG, CK, CK-MB, and α-HBDH levels in the initial stage were significantly higher than those in the recovery period. However, the AMY level in the initial stage was significantly lower than that in the recovery period and after discharge for 2 weeks (p Conclusion: Integrated Chinese and Western medicine treatment has a significant impact on laboratory indicators such as PLT, LYMGH, CRP, TBIL, IBTL, DHIL, TP, ALB, K+, AG, LDH, CK, CK-MB, α-HBDH, AMY, CT imaging, and 2019-nCoV nucleic acid in COVID-19 patients. It has good clinical efficacy and safety, and can improve the quality of life of patients.
基金supported by Henan University Undergraduate Teaching Reform Research and Practice Project:Innovative Geriatric Nursing Professional Training Mode Reform and Practice(No.HDXJJG2020-09)Henan Province Higher Education Teaching Reform Research and Practice Project(No.2021SJGLX333)Henan Medical Education Research Project(No.wjlx2021046).
文摘The rate of disability due to acute osteofascial compartment syndrome(OCS)is high,and the therapeutic effect of decompressive fasciotomy is not ideal.This paper retrospectively reviews the modern treatment of OCS,including Western medicine and Traditional Chinese medicine(TCM),mainly in the context of the advantages of TCM in the treatment process of decompressive fasciotomy or conservative treatment to the patients who are suffering from OCS.It was found that TCM treatment reduced the levels of serum creatine kinase(CK),lactate dehydrogenase(LDH),and aspartate aminotransferase(AST);it is beneficial to the elimination of swelling and pain.TCM adjunctive therapy promotes patients’postoperative functional recovery and decreases the occurrence of fasciotomy in patients;TCM can relieve tissue hypoxia of compartments and prevent necrosis of muscle and nerve tissue.TCM treatment improves the quality of medical service and ensures the safety of OCS patients.This paper aims to summarize the function of TCM in the treatment of OCS,provide reference for the clinical treatment of OCS,and improve the nursing/medical outcomes of OCS.
文摘Objective: This paper takes the example of a Panax notoginseng extraction workshop and designs an automated production workshop with advanced domestic capabilities. Methods: 1) Based on the small-scale Panax notoginseng extraction process, the feasibility of the workshop production process is demonstrated. 2) The workshop process design for Panax Notoginseng saponin extraction is completed, including production organization plans and the selection of key equipment. 3) For the Panax notoginseng extraction workshop process, an automated production control system is designed. Conclusion: Through optimized design of the production process and automation system, continuous and automated production of traditional Chinese medicine extraction is achieved, leading to improvements in drug quality and production efficiency.
基金The authors are grateful for financial support from the National Key Research and Development Program of China(2016YFE0121400)the National Natural Science Foundation of China(81430096)+2 种基金the Program for Changjiang Scholars and Innovative Research Team in University(IRT_14R41)the Macao Science and Technology Development Fund,Macao SAR(006/2015/AMJ)to Y.Xiethe Tianjin Natural Science Foundation(15JCYBJC29500).
文摘As the most important complementary medication against a variety of diseases,traditional Chinese medicines(TCMs)have been extensively applied over thousands of years.Current quality control of herbal medicines,however,is in great dispute.Unlike chemical drugs,which have clear and validated quality standards,the content of only one(or a few)compounds of many herbs and preparations is currently assessed as an indicator of quality,even though the assessed compound(s)is neither closely associated with the efficacy nor representative of the medicine as a whole.Based on the clinical use,compatibility of multiple component prescriptions,and manufacturing process of TCM,the new concept of a TCM quality marker that was proposed in previous work is discussed further here.In addition,practical technological approaches are described for the qualitative analysis and quantification of TCMs including herbs,processed products,and preparations,which lead to the discovery and identification of specific chemicals as quality markers and new quality control patterns.The progress that has been made in TCM quality control is also addressed.This work provides useful information for the quality control of herbal medicines in the future.
基金National New Drug Innovation Program,No.2017ZX09304003Special Research on Modernization of Traditional Chinese Medicine in the National Key Research and Development Program in the 13th Five-Year Plan Demonstrative Research,No.2017YFC1703703.Institutional review board statement:This study was approved by the IRB of Xiyuan Hospital of China Academy of Chinese Medical Sciences(No.2016XL011).
文摘BACKGROUND Recent research suggests that although prokinetic agents,acid suppressors,and radical treatment for Helicobacter pylori infection may be effective in patients with functional dyspepsia(FD),a large proportion of patients still fail to respond to these treatments or may suffer from severe adverse reactions.Many traditional Chinese medicinal herbs can regulate the status of the entire body and have special advantages in the treatment of functional diseases.The present study was designed to verify the efficacy of Biling Weitong Granules(BLWTG),a traditional Chinese medicinal herbal compound formula,in alleviating epigastric pain syndrome(EPS)in FD patients,in an attempt to provide an effective prescription for the clinical treatment of this disease.AIM To evaluate the clinical efficacy and safety of BLWTG in treating EPS in patients with FD.METHODS In this multicenter,stratified,randomized,double-blind,placebo-controlled,parallel group clinical trial,eligible patients were randomized into the BLWTG and placebo groups who were treated for 6 wk.Efficacy indicators including the severity and frequency of EPS and the time to pain resolution and safety indicators including adverse events were observed and compared.RESULTS The baseline demographic data and clinical characteristics,such as epigastric pain symptoms,pain intensity,and frequency of attacks,were matched between the two groups before randomization.After 6 wk of treatment and after the center effect was eliminated,the epigastric pain was significantly improved in 28.33%and 85.59%of the patients in the placebo and BLWTG groups,respectively(P<0.05).At 6 wk,the resolution rate of epigastric pain was 15%and 69.49%in the placebo and BLWTG groups,respectively(P<0.05).The differences of total FD clinical score between these two groups were significant(P<0.05)at 2,4,and 6 wk(P<0.05).The scores of each item and the total score in the Functional Digestive Disorders Quality of Life Questionnaire showed significant differences between the two groups at 6 wk after both the center and interaction effects were eliminated(P<0.05).There was no significant difference in the incidence of adverse events between the two groups,and no serious adverse event was noted during the observation.CONCLUSION Compared with placebo,BLWTG markedly improved EPS in FD patients without causing serious adverse reactions.
基金financially supported by the National Natural Science Foundation of China(Grant No.81803714)the Fundamental Research Funds for the Central Universities(Grant No.2019QNA7041).
文摘Chromatographic fingerprinting has been perceived as an essential tool for assessing quality and chemical equivalence of traditional Chinese medicine.However,this pattern-oriented approach still has some weak points in terms of chemical coverage and robustness.In this work,we proposed a multiple reaction monitoring(MRM)-based fingerprinting method in which approximately 100 constituents were simultaneously detected for quality assessment.The derivative MRM approach was employed to rapidly design MRM transitions independent of chemical standards,based on which the large-scale fingerprinting method was efficiently established.This approach was exemplified on QiShenYiQi Pill(QSYQ),a traditional Chinese medicine-derived drug product,and its robustness was systematically evaluated by four indices:clustering analysis by principal component analysis,similarity analysis by the congruence coefficient,the number of separated peaks,and the peak area proportion of separated peaks.Compared with conventional ultraviolet-based fingerprints,the MRM fingerprints provided not only better discriminatory capacity for the tested normal/abnormal QSYQ samples,but also higher robustness under different chromatographic conditions(i.e.,flow rate,apparent pH,column temperature,and column).The result also showed for such large-scale fingerprints including a large number of peaks,the angle cosine measure after min-max normalization was more suitable for setting a decision criterion than the unnormalized algorithm.This proof-of-concept application gives evidence that combining MRM technique with proper similarity analysis metrices can provide a highly sensitive,robust and comprehensive analytical approach for quality assessment of traditional Chinese medicine.
基金supported by the National Natural Science Foundation of China(Grant No.:81973701)Innovation Team and Talents Cultivation Program of National Administration of Traditional Chinese Medicine(Grant No.:ZYYCXTD-D-202002)Westlake Laboratory(Westlake Laboratory of Life Sciences and Biomedicine).
文摘With the modernization and internationalization of traditional Chinese medicine(TCM),the requirement for quality control has increased.The quality marker(Q-marker)is an important standard in this field and has been implemented with remarkable success in recent years.However,the establishment of Qmarkers remains fragmented and the process lacks systematicity,resulting in inconsistent quality control and insufficient correlation with clinical efficacy and safety of TCM.This review introduces four multimodal integrated approaches that contribute to the discovery of more comprehensive and accurate Qmarkers,thus aiding in the establishment of new quality control patterns based on the characteristics and principles of TCM.These include the whole-process quality control strategy,chemical-activity-based screening method,efficacy,safety,and consistent combination strategy,and TCM theory-guided approach.Furthermore,methodologies and representative examples of these strategies are described,and important future directions and questions in this field are also proposed.
基金Supported by Funding from the State Nationalities Affairs Commission(2015-GM-178)National Training Programs of Innovation and Entrepreneurship for Undergraduates(GCYS2016110001)
文摘This paper discussed how to protect and control the quality of wild Chinese herbal medicine resources in nature reserves by taking Longyuwan National Forest Park within Funiu Mountain Nature Reserve as an example. Through the combination of three methods including literature review, visiting and investigational studies, and field surveys, the data of investigation, collection and collation were analyzed. According to data of surveys, collection and collation, problems related to the protection of wild Chinese herbal medicine resources faced by Longyuwan Scenic Spot within Funiu Mountain Nature Reserve were also analyzed and protection strategies and quality control of wild Chinese herbal medicine resources in this nature reserve were discussed. It was expected that the results would provide important scientific references for the sustainable development, protection and quality control of wild Chinese herbal medicine resources within nature reserves.