Quality of life and survival analyses of breast cancer cases treated with integrated traditional Chinese and Western medicine

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.

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.

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.

Status and Development Trend of Evaluation of Post-Marketing Traditional Chinese Medicines in China

Evaluation of traditional Chinese medicines after the market has achieved fruitful results after years of development.The real-world research concept has been first proposed by Chief Researcher Xie Yanming in 2010 and to 2020 with the approval of the National Medical Products Administration to use real-world evidence to support drug development and review in 2020.Real-world data application and transformation continue to cause heated discussions in the industry.Real-world research concepts have been added new motivation into the evaluation of Chinese medicines after they are marketed.The development of the Chinese patent medicine industry is facing unprecedented opportunities and challenges.

Enhancing ulcerative colitis treatment with traditional Chinese medicine

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.

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.

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.

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.

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

Objective： The objective of this study is to evaluate the impact of various traditional Chinese medicine （TCM）approaches on the quality of life in patients with colorectal cancer. Methods： In this study, we systematically performedthe screening of randomized controlled trials from Cochrane Library, Pubmed, Embase, Medline, and Web of Science.The data were extracted by two reviewers independently, and then risk assessment was performed. All the analyses wereconducted using Review Manager 5.3. Results： A total of 18 eligible studies containing 1312 patients were included.Experimental group were treated with TCM combined with Western medicine or TCM alone （N = 688） and controlgroup were treated with Western medicine treatment alone （N = 624）. The results showed that the recent clinicalefficiency between the two groups was not statistically significant （P = 0.06）. KPS scores of the experimental group werehigher than those in the control group [P 〈 0.001, WMD = 9.60, 95%CI = （5.62, 13.57）]. The toxicity comparisonshowed that the occurrence of toxicities, such as leucopenia, thrombocytopenia, nausea and vomiting, diarrhea, andneurotoxicity in the experimental group was lower than that in the control group [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）], and [P 〈 0.001, OR = 0.43, 95%CI = （0.30, 0.61）]. The immunological test comparisondemonstrated that the immunological parameters （CD3, CD4, and CD4/CD8） showed higher values in the experimentalgroup than those in the control group [P 〈 0.001, MD = 5.55, 95%CI = （4.83, 6.28）], [P 〈 0.0001, MD = 6.75, 95%CI =（5.25, 8.26）], and [P = 0.001, MD = 0.26, 95%CI = （0.10, 0.41）]. Conclusions： TCM did not show significant recentclinical efficiency. However, treatment with TCM showed increase in KPS scores in patients with colorectal cancer,alleviation of toxicity associated with chemotherapy, regulation of autoimmunity, and improvement in the quality of lifeof patients.

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.

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.

Systematic evaluation of traditional Chinese medicine for treating Parkinson's disease

BACKGROUND：To evaluate the quality of the literature addressing traditional Chinese medicine for treating Parkinson＇s disease.DATA SOURCE：A computer-based online search of Chinese publications from January 2001 to July 2008 was conducted in Chinese Biology Medical Disc Database and China National Knowledge Infrastructure. Search key words were Parkinson＇s disease, integrated traditional Chinese and Western medicine, traditional Chinese medicine therapy, and Chinese herb therapy.DATA SELECTION：Articles describing randomized, controlled trials and quasi-randomized, controlled trials were included. Literature quality was assessed using the criteria-Systematic evaluation of clinical literature related to treatment of Parkinson＇s disease with traditional Chinese medicine. This included methodology, interventions in the treatment/control group, evaluation criterion of outcomes, and frequency.MAIN OUTCOME MEASURES：Evaluation criterion of outcomes （various score methods and evaluation scales）, methodological quality, and frequency distribution were all measured.RESULTS：A total of 33 articles with randomized, controlled trials were included. Of these, six described a random method, and the remaining did not describe random allocation methods or random sequence generation methods. None of the studies estimated sample size. Case descriptions of withdrawal and loss to follow-up were unclear. Both the Unified Parkinson＇s Disease Rating Scale and Webster scale were used in the eligible studies as evaluation criteria.CONCLUSION：There are no high-quality studies that address traditional Chinese medicine therapy and integrated traditional Chinese and Western medicine for treating Parkinson＇s disease in China. Eligible studies were not performed in accordance with Consolidated Standards of Reporting Trials statement or Standards for Reporting Interventions in Controlled Trials of Acupuncture criteria, and the literature quality was low. The presently used criteria for evaluating therapeutic effects do not completely assess outcomes of traditional Chinese medicine for treating Parkinson＇s disease. The identification of precise outcomes should be verified using randomized, controlled studies with adequate controls and proper designs.

Prospects for the future of clinical efficacy evaluation of traditional Chinese medicine——Emphasis on original theory and clinical practice

Traditional Chinese medicine(TCM)clinical efficacy evaluation runs through the development of TCM and has been progressing so far.With the introduction of evidence-based medicine(EBM)in recent 20 years,TCM clinical efficacy evaluation has developed rapidly,accumulated research and experience,improved the quality and standardization of research,but also gradually found deep-seated deficiencies.In 2019,the China Center for Evidence-based Traditional Chinese Medicine(CCEBTCM)was established,and TCM was included in the 11th revision of the International Statistical Classification of Diseases(ICD-11).In above opportunities for TCM clinical efficacy evaluation,it is necessary to face up to the previous deficiencies,so that the TCM clinical efficacy evaluation can truly reflect the actual clinical practice characteristics,including TCM clinical problems,TCM thinking and TCM diagnosis&treatment mode.Based on the summary and analysis of past research,development concepts are proposed in this article.On the one hand,original concepts of TCM should be confidently paid more attention to the design and implementation of TCM clinical efficacy evaluation to be close to TCM clinical practice.On the other hand,it is necessary to consolidate the foundation of TCM clinical practice before evaluating efficacy.Evaluated object built on TCM ontology knowledge should be demonstrated based on clinical practice,and unknown evaluated object combined with new methods,technologies and concepts should be maturely integrated in clinical practice firstly.

Quality Control for Traditional Medicines–Chinese Patent Medicines

Ji Shen: Dr.Ma Shuangcheng,Director of Institutes for Control of Chinese Traditional Medicines and Ethnic Medicine,National Institutes for Food and Drug Control,is a long-term researcher on the quality standards of Chinese materia medica,Chairman Member of the Risk Assessment of the Pharmacopoeia of People's Republic of China ,and is also the Director Member of the Professional Committee of Drug Risk,China Pharmaceutical Association,and the Director Member of the Directors Committee of Chinese Materia Medica Quality and Safety.He has long been engaged in the control of the quality and safety of Chinese materia medica,and has also been included in the National 10000 Talent Plan.Let's invite Dr.Ma to give a report.Thank you.

Quality Control for Traditional Medicines–Chinese Crude Drugs

Distinguished guests,ladies and gentlemen,I am very happy to meet many of my old friends today.I would also like to thank Chinese Pharmaceutical Association for providing me with such a good opportunity to communicate with Chinese and European friends.The topic of my report today is the quality standard of Chinese crude drugs and the development ideas.Director Ma introduced the relevant situation of the quality standards of Chinese patent medicines.