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.

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.

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.

探讨基于核心指标集构建中医特色的射血分数保留心力衰竭1+N模式疗效评价体系

核心指标集是就某一特定研究领域达成的所有临床研究都应该测量和报告的最少的临床结局,核心指标集可以提高临床疗效评价的规范性和可比性,是循证医学发展的必然、是中医药临床疗效评价的重要抓手、是推动中医药疗效评价与国际接轨的关键。如何运用核心指标集实现临床疗效国际化、标准化的同时,又能遵循中医诊疗特点体现自身优势是中医临床疗效评价的难点。针对这一难点,项目组创新性地提出了1+N模式的射血分数保留心衰(heart failure with preserved ejection fraction, HFpEF)疗效评价体系,即通用的核心指标集“1”+个性化指标集“N”,以满足循证医学和中医学疗效评价的双重需求。本文初探HFpEF疗效评价构建模式,主张在规范化基础上体现多样化和个性化的研究目的需求。结合HFpEF临床疗效评价的现状,综合业内专家意见,探讨了HFpEF 1+N模式疗效评价构建中核心指标集“1”的取舍以及“N”体系的构建思路,以期最大程度的形成符合中医药特色的临床评价体系新范式,推动中医药国际化进程。

个体化中医证候积分与传统中医证候积分在中医临床疗效评价中的应用对比研究

目的评价个体化中医证候积分在中医临床疗效评价中的优势。方法在中药干预双心疾病的临床试验中,分别使用个体化中医证候积分和传统中医证候积分,对患者主观症状进行疗效评价。结果在评价准确性上,两种评价方法整体疗效相似,但分别计算两种评价方法与实际主观感受的符合率,则个体化中医证候积分明显高于传统中医证候积分,差异有统计学意义(P<0.05);在评价全面性上,传统中医证候积分中仅包含7个固定症状,而个体化中医证候积分中出现了74个症状,几乎没有症状群完全相同的患者,两组出现频率均>30次的症状有10个,均与肝郁气滞证及其变证相关,且单个症状疗效试验组优于对照组,差异有统计学意义(P<0.05)。结论与传统中医证候积分相比,个体化中医证候积分能够更加准确、全面地反映中医药干预前后患者主观感受的变化。

新医科背景下中医临床实践混合教学评价研究

目的:在线上与线下相融合的背景下针对多元化体系评价方式进行研究探索,以达到迭代临床实践课程教学目的 .方法:比较以融入形成性评价为核心的混合教学模式与结果导向式终结性评价的线下传统教学模式的学生成绩,同时通过问卷调查获取两种教学模式学生满意度反馈.结论:以融入形成性评价为核心的混合教学模式对学生成绩的提高与满意度反馈更具有促进作用.

中医专业临床中药炮制学课程核心能力评价指标体系构建

目的构建中医专业临床中药炮制学课程核心能力评价指标体系,以期更加客观、全面地培养和评价学生的核心能力。方法研究小组基于教学内容和教学目标,并结合文献研究,拟订调查问卷,采用德尔菲法(Delphi)进行专家函询,形成中医专业的临床中药炮制学课程核心能力评价指标体系。结果专家函询问卷回收率为100%,各级指标的变异系数为0.067~0.481,协调系数为0.223~0.330。最终确立本轮采纳的评价指标体系:一级指标2项,二级指标9项,三级指标21项。结论中医专业临床中药炮制学课程核心能力评价指标体系科学可靠,能够客观、全面地为培养和评价中医专业本科生学习该课程的效果提供量化参考依据。

基于柯氏评估模型分析中医学本科实习生中医临床思维效果研究

目的探讨应用柯氏评估模型评估中医学本科实习生中医临床思维培训的效果。方法选取福建中医药大学附属人民医院传统内科中医学本科实习生40人,随机分为对照组和实验组,各20人。对照组以传统模式培训,实验组采用“中医辨治六步程式”逐步强化的培训模式。培训2周后,应用柯氏评估模型综合评估培训的效果。结果反应层:对比两组对培训的满意度,差异有显著统计学意义(P<0.01)。学习层:比较两组培训后理论、中医临床思维与操作能力考核成绩,差异有显著统计学意义(P<0.01)。行为层:培训后比较医生对两组在实践中运用中医临床思维与操作技能的满意度,差异有显著统计学意义(P<0.01)。结果层:比较经管患者的满意度,两组差异有显著统计学意义(P<0.01);两组投诉率、事故率均为0。结论柯氏评估模型可从整体上评估中医本科实习生临床培训的效果,科学性与可行性强;“中医辨治六步程式”逐步强化的培训模式可明显提高本科实习生中医临床思维与诊疗能力。

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.

芪龙通络汤治疗不稳定型心绞痛的临床效果

目的探讨芪龙通络汤治疗不稳定型心绞痛的临床效果。方法选取2021年1月至2023年8月福建中医药大学附属第二人民医院收治的90例不稳定型心绞痛患者作为研究对象,按照随机数字表法分为研究组(45例)与对照组(45例),研究组采用芪龙通络汤、常规治疗方法,对照组采用常规治疗方法,两组均连续用药4周。比较两组的生活质量、治疗指标、治疗结果。结果治疗后,研究组患者的生活质量高于对照组,差异有统计学意义(P<0.05);治疗后,研究组舒张压、收缩压、甘油三酯(TG)、总胆固醇(TC)、低密度脂蛋白胆固醇(LDL-C)均低于对照组,研究组患者的高密度脂蛋白胆固醇(HDL-C)高于对照组,差异有统计学意义(P<0.05);研究组的总有效率高于对照组,差异有统计学意义(P<0.05)。结论芪龙通络汤能够显著降低血压、血脂等指数,稳定不稳定型心绞痛患者的体征状态,且服用后生活质量改善明显。