An ultra-robust fingerprinting method for quality assessment of traditional Chinese medicine using multiple reaction monitoring mass spectrometry

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.

Analysis of the Clinical Effect of Chinese Medicine Combined with Acupuncture and Moxibustion on Insomnia

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.

The Influence of Integrated Chinese and Western Medicine Treatment on the Quality of Life and Laboratory Indicators of Patients with Novel Coronavirus Pneumonia

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.

Nursing outcomes of traditional Chinese medicine adjunctive therapy on osteofascial compartment syndrome:a review

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.

A holistic strategy for quality and safety control of traditional Chinese medicines by the “iVarious” standard system

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.

Quality Markers of Traditional Chinese Medicine:Concept,Progress,and Perspective

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.

Development of chromatographic technologies for the quality control of Traditional Chinese Medicine in the Chinese Pharmacopoeia

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.

Multimodal integrated strategy for the discovery and identification of quality markers in traditional Chinese medicine

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.

Pharmacological intervention of traditional Chinese medicine for the quality of life in patients with colorectal cancer： a systematic review and meta-analysis

目的：评价不同中医药方法对结直肠癌患者生活质量的影响.方法：从Cochrane,Pubmed,Embase,Medline和Web of Science数据库中筛选随机对照试验来进行系统研究,并由两名评审员独立提取数据,使用软件ReviewManager5.3进行数据处理.结果：共有18个合格研究,1312名患者被纳入.实验组采用中医药结合西医治疗,或单纯中医药治疗;对照组采用西医治疗.结果显示：（1）实验组与对照组近期有效率比较,差异不具有统计学意义【P=0.06,0R=1.38,95%CI=（0.98,1.95）】.（2）实验组的KPS评分高于对照组【P〈0.001,WMD=9.60,95%CI=（5.62,13.57）】.（3）实验组与对照组毒副反应比较：实验组白细胞下降,血小板减少,恶心呕吐,腹泻,神经毒性不良反应的发生率均低于对照组【P〈0.001,OR=0.31,95%CI=（0.19,0.50）】,【P=0.003,OR=0.49,95%CI=（0.31,0.78）】,【P〈0.001,OR=0.30,95%CI=（0.16,0.54）】,【P〈0.001,OR=0.40,95%CI=（0.27,0.58）】和【P〈0.001,OR=0.43,95%CI=（0.30,0.61）】.（4）实验组与对照组免疫学检测比较：实验组的CD3,CD4,和CD4/CD8的均值均高于对照组【P〈0.001,MD=5.55,95%CI=（4.83,6.28）】,[P〈0.001,MD=6.75,95%CI=（5.25,8.26）】,[P=0.001,MD=0.26,95%CI=（0.10,0.41）】.结论：中医药对结直肠癌患者的近期临床有效率作用不显著,但可提高患者的KPS评分,缓解化疗的毒副作用,调节自身免疫,改善患者的生活质量.

Study on the Quality of Traditional Chinese Veterinary Medicine and Discussion on the Problems

In this paper,the study on the quality of traditional Chinese veterinary medicine and its existing problems are discussed,which mainly include the research techniques and research thoughts of traditional Chinese veterinary medicine,and the problems in its research progress,at the same time,the causes for the quality problems of traditional Chinese veterinary medicine are analyzed,and the solutions for the problems are put forward. The quality research of traditional Chinese veterinary medicine should refer to traditional Chinese medicine,then inherit,carry forward and innovate it based on the modern research. Solving the problems in the development of traditional Chinese veterinary medicine and putting forward the thinkings conforming to the development of traditional Chinese veterinary medicine using advanced instruments and devices as well as science and technology are urgent affairs.

Effects of Traditional Chinese Medicine Five-element Music Combined with Acupoint Application on Perioperative Sleep Quality in Patients Undergoing Joint Replacement Surgery

OBJECTIVE: To explore the effects of traditional Chinese medicine(TCM) five-element music combined with acupoint application on perioperative sleep quality in patients undergoing joint replacement surgery. METHODS: In this study, a total of 122 patients with joint replacement surgery in Beijing Jishuitan Hospital were targeted from 2015 to 2018. All patients were grouped by random number table method. Among them, 61 patients with routine nursing were included in the control group. On this basis, the other 61 patients with acupoint application and TCM five-element music therapy were included as the observation group. 2 weeks later, the Pittsburgh Sleep Quality Index(PSQI) was used to evaluate sleep quality in all patients. The sleep improvement of the 2 groups was evaluated, and the patient was assessed for anxiety and depression, and the curative efficacy was evaluated. RESULTS: After 2 weeks of nursing, the PSQI of the patients improved significantly. The PSQI of the observation group was only 6.6 ± 2.4, and the control group decreased to 9.9 ± 2.7. The observation group was better than the control group, and the difference was statistically significant(P < 0.05). Comparing the 2 groups, the anxiety score of the observation group decreased to 4.8 ± 1.6, which was significantly lower than that of 6.9 ± 2.2 in the control group. The depression score of the observation group decreased to 4.6 ± 1.3, which was significantly lower than that of 6.8 ± 2.3 in the control group. In the control group, the negative emotion scores after nursing were better than those before nursing, and the difference was statistically significant(P < 0.05). Comparing the 2 groups, the effective rate of sleep improvement in the observation group was 96.6%, and the cure rate was as high as 49.1%. The control group was 82.0%, and the cure rate was 18.0%. The observation group was better than the control group, and the difference was statistically significant(P < 0.05). CONCLUSION: The combination of TCM five-element music with acupoint application can improve the perioperative sleep quality of patients undergoing joint replacement surgery, and it can help patients to relieve negative emotions. It is worth promoting.

Discussion on the Quality Evaluation Method of Traditional Chinese Medicine Compound Preparations

As an important representative of the modernization of the Chinese medicine industry,traditional Chinese medicine(TCM)compound preparations are an indispensable part of the development of TCM.The complex ingredients and unclear action mechanism of TCM compound preparations restrict the development of TCM.In line with this problem,the modern TCM research has made extensive remarkable achievements.From the single indicator in the past to multiple indicator,the research on the combination of TCM fingerprints and pharmacodynamics also has made great progress.The introduction of quality evaluation methods such as the"quantitative analysis of multi-components by a single marker","dose-effect"indicator,"Bioactive Equivalent Combinatorial Components"(BECCs)and TCM quality markers have brought new ideas for quality control of TCM compound preparations.

Literature review and analysis of the application of health outcome assessment instruments in Chinese medicine

OBJECTIVE： To evaluate the application of health assessment instruments in Chinese medicine. METHODS： According to a pre-defined search strategy, a comprehensive literature search for all articles published in China National Knowledge Infrastructure databases was conducted. The resulting articles that met the defined inclusion and exclusion criteria were used for analysis. RESULTS： A total of 97 instruments for health outcome assessment in Chinese medicine have been used in fundamental and theoretical research, and 14 of these were also used in 29 clinical trials that were randomized controlled trials, or descriptive or cross-sectional studies. In 2 152 Chinese medicine-based studies that used instruments in their methodology, more than 150 questionnaires were identified. Among the identified questionnaires, 51 were used in more than 10 articles （0.5%）. Most of these instruments were developed in Western countries and few studies （4%） used the instrument as the primary evidence for their conclusions. CONCLUSION： Usage of instruments for health outcome assessment in Chinese medicine is increasing rapidly; however, current limitations include selection rationale, result interpretation and standardization, which must be addressed accordingly.

Literature review and analysis of the development of health outcomes assessment instruments in Chinese medicine

OBJECTIVE： To evaluate the development of health outcomes assessment instruments in Chinese medicine. METHODS： A comprehensive literature search for all published articles in China National Knowledge Infrastructure Database, Chongqing VIP Database and WANFANG Data was conducted. The studies that met the inclusion and exclusion criteria were used to extract information according to a predesigned assessment instrument. RESULTS： A total of 97 instruments for health outcome assessment in Chinese medicine were identified. Of these questionnaires, 7 were generic, 12 were condition-specific and 78 were disease-specific. All instruments were suitable for adults, children, and both men and women. These instruments aimed to evaluate the health-related quality of life, signs and symptoms as well as patient satisfaction and doctor-reported outcome. However, the descriptions were poorly constructed for some of the most basic parameters, such as the domains and items, administrative mode, response options, memory recall periods, burden evaluation, format, copyright, content validity, and other properties. CONCLUSION： The instrument development for health outcomes assessment in Chinese medicine is increasing rapidly; however, there are many limitations in current methodologies and standards, and further studies are needed.

Health technology assessment in traditional Chinese medicine in China: current status, opportunities, and challenges

Objectives:The widespread usage of traditional Chinese medicine(TCM)and the government's emphasis on TCM in China have created a positive macro-environment and great opportunities to develop and strengthen health technology assessment(HTA)in TCM.Over the past ten years,a series of policies have been issued by the government to promote the application of HTA and the development of TCM in China.This study reviews the concepts and characteristics of TCM,summarizes the current status of HTA in TCM,and analyzes the opportunities and challenges faced by HTA development in TCM with respect to deepening of healthcare reforms.Methods:Literature review and website searches were used to acquire information regarding the basic theories of TCM and the current status,opportunities,and challenges for HTA in TCM.Results:The number of articles on HTA in TCM rose substantially,especially those published in China National Knowledge Infrastructure(CNKI).With the optimistic policy environment and huge market demand for TCM,the development of HTA in TCM is expected to flourish in China.However,HTA in TCM also faces numerous challenges such as the absence of a clinical efficacy evaluation system for TCM and insufficient basic research evidence and qualified personnel.Conclusions:TCM has unique characteristic that distinguishes it from Western medicine.Currently,it is important to take all measures to address the existing main challenges and thereby take advantage of the present opportunities to develop and improve HTA in TCM.

International expert consensus on clinical application of traditional Chinese medicine formula granules

Guided by the theory of traditional Chinese medicine(TCM),TCM formula granules are made through the optimal process of extraction,concentration,drying,and granulation by combining modern new preparation technologies and pharmaceutical technologies.TCM formula granules are stable,safe,convenient,and effective.Compared with TCM decoction pieces,TCM formula granules can achieve the full process control of its industry chain from field to workshop and standardize the management of the origin of medicinal materials,processing of decoction pieces,processing technology,quality inspection,sales,and products distribution.TCM formula granules can partially replace Chinese patent medicines.Only available for around 800 common varieties of TCM,TCM formula granules cannot replace decoction pieces for many types which are not commonly used in clinical practice.A large number of formula granules are used in clinical and animal studies so that investigators no longer need to extract and control the quality of TCM decoction pieces.How to improve the production process,establish the quality standard,perfect the regulatory system,and expand the clinical application are the problems we need to solve as soon as possible for the better development of formula granules.

Hospital-based health technology assessment:The next frontier for traditional Chinese medicine hospitals

Hospital-based health technology assessment(HB-HTA)is highly valuable in the application of hospital medical technology,cost control,improvement of medical quality,and protection of medical safety,and its use is increasing daily globally.However,in China,HB-HTA is still in its infancy,and it is yet to be adopted in traditional Chinese medicine(TCM).Therefore,this article introduces the application and development of HB-HTA,as well as discusses the current situation of TCM and related future development strategies to provide ideas and references for the development of HB-HTA in TCM.We conclude and recommend that all major stakeholders,including the state,health departments,and hospital leaders,support and promote the exploration and development of HB-HTA in TCM hospitals and integrative medicine hospitals.We also suggest the utilization of existing talents and introduction of other necessary talents to promote better and faster organizational development,as well as suggest the formation of a national and internationally recognized HB-HTA guidance manual and toolkit for TCM hospitals based on both the national HTA guidelines and the evaluation of TCM hospitals pilot projects.Moreover,we recommend that HB-HTA pilot study should be executed with Chinese patent medicine as the starting point to form the implementation process and framework in the TCM arena.

Translational Chinese Medicine: A Way for Development of Traditional Chinese Medicine

Translational Chinese medicine is one of the latest developing fields in traditional Chinese medicine. In this paper, we discuss the “3 w” namely, “what is”, “why to advance”, “how to carry out” and the significance of translational Chinese medicine. To overcome the innate drawbacks of traditional Chinese medicine (TCM), the basic theory of TCM had better be refreshed. The safety and efficacy of classic formulae and therapy experience of TCM should be evaluated based on strict quality control and reaffirmed with evidence based medicine. The significance of translational Chinese medicine is to transform Chinese medicine into a balanced, personalized medicine with sound safety, good efficacy and strict quality control.

Quality Evaluation on Traditional Chinese Medicine Nursing Plan for Stroke in Acute and Recovery Phases

OBJECTIVE: To formulate the quality evaluation questionnaire of Traditional Chinese Medicine(TCM) nursing plan for stroke in acute and recovery phases, and to evaluate the quality of TCM nursing plan for stroke by clinical nurses. METHODS: The questionnaire was designed by referring to the Applicability Questionnaire of TCM Clinical Diagnosis and Treatment Guideline, and the expert consultation was used to assess the content validity. In addition, the results of the questionnaire were processed and analyzed with SPSS20.0 software. RESULTS: The content validity of the self-designed questionnaire was 0.94 for the S-CVI/Ave score. The results of the questionnaire demonstrated that the overall content of the plan was "better than the original routine nursing plan"(59.18%); the recognition degree of "common symptoms"(36.70%) and "syndrome classification"(36.70%) of the plan was the lowest. CONCLUSION: The plan is supposed to be further improved in the future in order to be coincident with clinical reality.

Research of Quality Standards for Stachydrine Hydrochloride in Chinese Medicine TJF Granule

A high-performance liquid chromatographic method was applied to the determination of stachydrine hydrochloride concentration in TJF granule (Chinese name: Tiao-Jing-Fang), using a mobile phase of methanol-acetonitrile (50:50, v/v) by the Agilent Kromasi NH2 column (250 mm × 4.6 mm, 5 μm, S/N: 22N25110). Detection wavelength was 201 nm. The result revealed good linearity of stachydrine hydrochloride and was obtained within the range of 0.20 - 1.98 μg/mL (R = 0.9995). The average recovery was 97.01%;the relative standard deviation (RSD) was 0.19%. To the best of our knowledge, this is the first report dedicated to the determination of stachydrine hydrochloride by the evaporative light scattering detector-high-performance liquid chromatographic (ELSD-HPLC) method.