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.

Clinical Effect of Integrated Traditional Chinese and Western Medicine on Diabetic Peripheral Neuropathy

Objective:Patients with diabetic peripheral neuropathy were treated with integrated traditional Chinese and western medicine,and the final results were observed.Methods:70 patients with such symptoms were randomly divided into two groups.The number of people is the same,and the treatment methods are different.The control group uses western medicine,while the observation group uses traditional Chinese medicine to evaluate the treatment effect.Results:After treatment,the effective rate of the observation group was(P<0.05),indicating that the treatment effect was significantly better.Conclusion:Patients with clinical diabetic peripheral neuropathy treated with routine nutrition and nerve repair,and with Chinese medicine,the effect is more satisfactory,and the effect is positive,so as to promote the optimization of their health.

Property theory of Chinese materia medica: Clinical pharmacodynamics of traditional Chinese medicine

The property theory of Chinese materia medica is one of the foundations of traditional Chinese medicine.The property of Chinese materia medica(PCMM)is a multi-dimensional expression of the effect of Chinese materia medica(CMM),and it is related to the clinical prescription that fully reflects the clinical effect evaluation of CMM in a holistic,systematic,and scientific way.This paper discusses the source,development,and application of the PCMM by considering not only the five dimensions that constitute the PCMM but also the recognition of the human body and disease as given in traditional Chinese medicine.This paper aims to provide theoretical guidance for the rational use and development of CMM.

Therapeutic Effect of Oral Administration and External Therapy of Traditional Chinese Medicine on Cervical Tuberculous Lymphadenopathy

Objective:To analyze the clinical effect and value of oral administration and external therapy of traditional Chinese medicine for treatment of cervical tuberculous lymphadenopathy.Methods:A total of 56 patients with cervical tuberculous lymphadenopathy admitted to our hospital from January 1 to January 2018 were recruited.By using double-blind method,the patients were divided into control group(n=28)and experimental group(n=28).Control group comprised of patients with conventional anti-tuberculosis treatment,while the experimental group comprised of patients treated with oral administration and external therapy of traditional Chinese medicine.Total effective rate,incidence of complication and level of T lymphocyte subsets were compared between the two groups of cervical tuberculous lymphadenopathy patients.Results:Post-treatment data of total effective rate,complication rate,CD3+,CD4+,CD8+,CD4+/CD8+of the experimental group were compared with the control group.P<0.05;statistical analysis showed statistical significance.Post-treatment data of CD3+,CD4+,CD8+,CD4+/CD8+of both control and experimental groups were compared with pre-treatment data.P<0.05;statistical analysis showed statistical significance.Conclusion:Oral administration and external therapy of traditional Chinese medicine possesses significant effect in treatment of cervical tuberculous lymphadenopathy.

Clinical observation of traditional Chinese medicine nursing on recovery of gastrointestinal function in patients after abdominal operation

Objective: To observe the clinical effect of traditional Chinese medicine nursing on the recovery of gastrointestinal function after abdominal operation. Methods: A total of 148 patients undergoing abdominal surgery from June 2013 to June 2014 in our hospital were randomly divided into observation group and control group, 74 cases in each group. The control group received routine nursing and the observation group was treated with the pointer, acupuncture and external application of abdominal treatment on the basis of routine nursing, which is 2 times a day,7 days for a course of treatment. Results: The recovery time of bowel sound, the first anal exhaust defecation time the in the observation group and the hospital day was less than the control group. With the comparison of two groups, the difference between the two groups was statistically significant (P < 0.05). The incidence of abdominal pain, abdominal distension, nausea, vomiting and constipation in the observation group was significantly lower than that in the control group (P < 0.05). Conclusion: On the basis of routine nursing, the implementation of traditional Chinese medicine characteristic nursing can effectively promote the recovery of gastrointestinal function, reduce the occurrence of complications, shorten the length of stay and improve the clinical effect.

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.

Effect of Western medicine therapy assisted by Ginkgo biloba tablet on vascular cognitive impairment of none dementia

Objective:To discuss the clinical effects of Western medicine therapy assisted by Ginkgo biloba tablet(GBT) on patients with vascular cognitive impairment of none dementia(VCIND).Methods: A total of 80 patients with VCIND were divided into two groups randomly:Conventional treatment group(control group) and combined treatment group.Conventional treatment group was given conventional treatment with anti-platelet aggregation.In this group,75 mg aspirin was given three times a day for 3 months.While in combined treatment group,19.2 mg CRT was given three times a day for 3 months together with conventional treatment(anti-platelet aggregation drugs). Montreal cognitive assessment(MoCA) and transcranial Doppler(TCD) were used to observe changes of cognitive ability and cerebral blood flow in VCIND patients before and after treatment in both groups.Then the clinical data were analyzed so as to compare the efficacy in two groups. Results:After 3 month-treatment in combined treatment group,the scores of executive ability, attention,abstract,delayed memory,orientation in the MoCA were significantly increased compared with those before treatment and those in control group after treatment.Besides,blood flow velocity of anterior cerebral artery increased significandy than that before treatment and that in control group after treatment.Conclusions:CBT tablet can improve the therapeutic efficacy as well improve cognitive ability and cerebral blood flow supply of patients with VCIND.

A comprehensive review of research progress in Chinese medicines for primary liver cancer treatment

Primary liver cancer seriously threatens human health,affects the quality of life,and has a high mortality rate.Traditional Chinese medicine(TCM)has long been used in the prevention,treatment,and adjuvant treatment of primary liver cancer.Clinical trials were conducted in recent years to evaluate the efficacy and safety of TCM.The mechanism of action of TCM in primary liver cancer treatment also received extensive attention.This study summarizes the common monomial Chinese herbal medicines and their components,formulae,and the proprietary Chinese medicines used to treat primary liver cancer.Common medicines include Chansu(Bufonis venenum),Kushen(Sophorae flavescentis radix),Renshen(Ginseng radix et rhizoma),and Jianghuang(Curcumae longae rhizoma).This study also reviewed the literature on liver cancer treatment using TCM.The results confirmed the safety and efficacy of TCM in liver cancer treatment.The possible mechanisms involved are also listed,including influencing the cell cycle,inducing cancer cell apoptosis and autophagy,inhibiting cancer cell angiogenesis and metastasis,regenerating the microenvironment and DNA methylation,and regulating the innate immune response.For primary liver cancer patients who often have a long disease course,Chinese herbal medicine often plays a role in protecting and conditioning the body.Research aimed at finding more traditional Chinese herbal medicines and their mechanisms of action should be promoted.This study aimed to provide a scientific reference for further research and the rational clinical application of TCM for primary liver cancer treatment.

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.

Some Reflections on the Evaluation of Clinical Effectiveness of Chinese Medicine in China

The randomized controlled trial （RCT） as applied to medicine started in the mid last century（1） and is now deemed as the most rigorous scientific method for evaluating the clinical effectiveness of medical interventions. The earliest RCTs in Chinese medicine （CM） appeared in the early 1980s. In the past 30 years, RCT was seen to have gradually infiltrated into and have been accepted reluctantly by CM.

Analysis of the Curative Effect of Cold-Dampness Epidemic Prescription(寒湿疫方)on the Main Symptoms of Quarantined People in Community

Objective:To evaluate the curative effect of"Cold-Dampness Epidemic Prescription(寒湿疫方)"on the main symptoms of quarantined people in community based on real-world research data,and to provide scientific basis for Chinese medicine to fight Coronavirus disease 2019 under the"Wuchang Model".Methods:From February 4,2020 to March 5,2020,the data of community quarantined people who only took"Cold-Dampness Epidemic Prescription(寒湿疫方)"under the management of"Wuchang Model"were collected,and the demographic characteristics,basic diseases,distribution of sick people,treatment process,disappearance time of eight clinical symptoms,adverse reactions and clinical outcomes of patients were statistically analyzed.Results:A total of 951 quarantined people in COVID-19 community were included,including 440 males(46.27%)and 511 females(53.73%),the oldest was 89 years old,the youngest was 2 years old,and the average age was 43.34 years old;Among the quarantined population in the community,there were 141 cases diagnosed by CDC(14.83%),CDC excluded 810 cases(85.17%);106 cases of CDC were diagnosed as COVID-19,accounting for 47.96%of the self-reported cases,and 311 cases(32.70%)had previous medical history;696(73.19%)had no obvious symptoms,and 255(26.81%)developed fever,fatigue,cough,sputum,shortness of breath,loss of appetite,diarrhea and mood,of which 187(19.66%)had cough symptoms,followed by sputum coughing(14.30%)and fever(13.56%).Conclusion:"Cold-Dampness Epidemic Prescription(寒湿疫方)"is effective in treating the clinical symptoms of COVID-19 without obvious adverse reactions.

Could We Use Clinical Benefit to Evaluate the Effects of Chinese Medicine on the Treatment of Cancer?

The patients, who cannot endure the chemotherapy anymore, or internal disease or present drug resistance, normally use CM for improving their physical conditions and inhibiting tumor. CM has got excellent reputation because of the effects. Nonetheless, few clinical articles of CM to treat cancer are published on major international journals up to now.

Quantitative Evaluation of the Compatibility Effects of Aidi Injection on the Treatment of Hepatocellular Carcinoma Using Targeted Metabolomics:A New Strategy on the Mechanism Study of an Anticancer Compound in Traditional Chinese Medicine

Objective:Compound traditional Chinese medicine(CTCM)with the application of compatibility from multiple active ingredients with multiple-specific targets can achieve a synergistic effect on cancer therapy.This study is aimed to observe the compatibility effects of Aidi injection on the treatment of hepatocellular carcinoma and to explore the mechanism of CTCM.Methods:Aidi injection is a clinical compound prescription containing Mylabris,Ginseng,Astragalus,and Acanthopanax,which can inhibit tumor growth and induce apoptosis.In this study,the anticancer activity of Aidi injection,as well as its disassembled and combined compositions,had been evaluated by varying levels of polyamine biomarkers on human hepatoma Hep-G2 cells detected using ultrahigh-performance liquid chromatography-tandem mass spectrometry.Results:According to the different variations in polyamine levels,it was revealed that Mylabris and Ginseng had an antitumor effect,while Astragalus acted as an assistant and Acanthopanax had weak anticancer activity.The increased level of polyamines in Hep-G2 cells had been found in HL-7702 cells.On combining Mylabris and Ginseng,polyamine levels went close to the normal level,which was even more marked when Astragalus was added.Aidi injection acted like the combination of Mylabris,Ginseng,and Astragalus.Conclusions:This study established a quantitative evaluation of the compatibility effects of Aidi injection based on polyamine biomarkers and evaluated the consistency of its anticancer effect,providing a manner to research the efficacy evaluation of CTCM.Moreover,the correlation between polyamine metabolism and anticancer activity can be used in anticancer drug screening.

The Application of Assessment of the Quality of Life in the Clinical Efficacy Evaluation System and the Selection of Questionnaires of Chinese Medicine Treating Tumors

In China, CM has been applied to treat almost every cancer patient, especially during the observation period after surgery, routine radiotherapy and chemotherapy. Several decades of CM treatment results have shown that CM treatment could be helpful in improving patients＇ physical rehabilitation, relieving symptoms and strengthening immunity. CM also could aid in the decline of rates of recurrence and metastasis, prolong the survival time, and especially, have significant effects on relieving symptoms such as relieving fatigue, improving syndromes caused by conventional therapies （surgery, radiotherapy, chemotherapy and biological treatment）, and indescribable discomforts caused by the unknown reason. It has been found in several studies that conventional medical treatment combined with CM could significantly improve QOL, and reduce treatment-related and disease-related symptoms. Patients treated with CM and Western medicine have higher scores in the fields of psychology, society,

经皮肝癌射频消融术联合中药灌肠治疗的临床观察

目的分析对原发性肝癌患者实施经皮肝癌射频消融术联合中药灌肠治疗的效果。方法抽取2022年12月至2023年12月济南市第三人民医院收治的原发性肝癌患者168例,以随机信封法分成两组,两组均接受经皮肤癌射频消融术治疗,对照组仅接受此方案治疗,共84例,观察组在此基础上增加应用中药灌肠治疗,共84例。对比中医证候积分、免疫功能指标及血清生长因子指标水平变化情况及治疗有效率。结果治疗后,观察组中医证候积分、CD8^(+)、碱性成纤维细胞生长因子、血管内皮生长因子及重组转化生长因子β_(1)水平均明显下降且低于对照组(P<0.05);CD4^(+)、CD4^(+)/CD8^(+)均明显上升且高于对照组,此外,该组治疗有效率也比对照组高(P<0.05)。结论治疗原发性肝癌时,在经皮肝癌射频消融术治疗的基础上增加使用中药灌肠治疗可显著改善患者临床症状、提高机体免疫力、抑制肿瘤转移、提升临床疗效。

中成药治疗眩晕随机对照试验的证据总结与评价

[目的]通过收集、整理各数据库建库以来中成药治疗眩晕的临床随机对照试验(RCT),系统评价、分析,为后续研究开展提供参考,帮助提高临床证据质量,并为制定相关指南提供依据。[方法]基于中医药循证研究证据库系统(EVDS)旗下中成药临床证据数据库(AICED-CPM)收录的文献,结合检索中国知网(CNKI)、万方数据知识服务平台(Wanfang Database)等中英文数据库中中成药治疗眩晕的RCT,进行统计分析,采用RoB和CONSORT对纳入文献进行评价。[结果]检索得到符合纳排标准的RCTs 242篇,其中纳入患者样本量300例及以上的RCTs 7篇,包含8种中成药;所有文献涉及中成药共有97种(口服中成药65种,中药注射剂32种),发文量最多的中成药为天麻素注射液(75篇,30.99%);干预/对照设计27种,其中“中成药+西药vs.西药”为最常用设计(66篇,27.27%);疗程以7~28 d为主(164篇,67.77%);评价指标中,共出现9种计数指标(331次),46种计量指标(599次);方法学质量方面,分配隐藏及其他偏倚均为中高风险,报告质量方面,方法、随机方法、讨论中部分小条目报告情况较差。[结论]中成药治疗眩晕RCT的方法学质量和报告质量较低,偏倚风险过高,试验设计不够严谨。后续研究开展应遵循CONSORT声明规范研究方案设计,在研究过程中加强质量控制,重视试验注册,为指南制定提供更高级别证据支持,为未来研究的开展提供有价值的参考。

加味逍遥丸化学成分、药理作用及临床应用进展

加味逍遥丸可用于疏肝解郁、清热调经。本文就近年来加味逍遥丸组方中各组分的化学成分、药理作用及临床用药现状等研究进行综述,为深入研究加味逍遥丸药理机制提供思路,为临床合理用药及扩大用药范围提供参考。

基于多维谱效关系的中药质量控制与安全性评价的研究进展

中药为宝贵的传统医学资源,但由于中药发挥药效成分不明确、中药安全性评价体系以及质量控制不够完善限制了其临床应用价值。中药不同于西药,其成分复杂、作用靶点多,一种药效的体现往往是多种成分协同作用的结果,且中药药效易受采收时节、炮制方法、不同产地以及不同配伍等的影响,所以中药的安全性评价和质量控制一直以来备受关注。本文对基于多维谱效的中药安全性评价以及质量控制进行整理,为中药安全性评价和质量控制的进一步研究提供理论支持。

Chemical Composition, Pharmacological Effects and Clinical Applications of Cinobufacini

Chinese medicine cinobufacini is an extract from the dried skin of Bufo bufo gargarizans Cantor,with active ingredients of bufadienolides and indole alkaloids.With further research and clinical applications,it is found that cinobufacini alone or in combination with other therapeutic methods can play an anti-tumor role by controlling proliferation of tumor cells,promoting apoptosis,inhibiting formation of tumor neovascularization,reversing multidrug resistance,and regulating immune response;it also has the functions of relieving cancer pain and regulating immune function.In this paper,the chemical composition,pharmacological effects,clinical applications,and adverse reactions of cinobufacini are summarized.However,the extraction of monomer components of cinobufacini,the relationship between different mechanisms,and the causes of adverse reactions need to be further studied.Also,high-quality clinical studies should be conducted.