中医药临床试验核心指标集研制技术规范

研制核心指标集是解决中医药临床试验疗效评价指标不一致、不规范、不公认、随意性等问题的重要途径.为了引导各个专科病种能规范、高效地建立中医临床试验核心结局指标,进一步提升中医临床研究的质量,需要建立中医药临床研究核心指标集研制规范.本课题组结合中医特点和国际核心指标集最新研究成果,构建了结局指标条目产生方法、指标域确定方...     

Guidelines for randomised controlled trials investigating Chinese herbal medicine

Ethnographic relevance

Clinical trials investigating Chinese herbal medicine (CHM) have been frequently criticised for their lack of scientific rigour. As part of the GP-TCM project a team of experienced clinical researchers and CHM practitioners have developed clinical trial guidelines for CHM that combine an appreciation for traditional methods of practice with detailed and practical advice on research methodology.

Materials and methods

This paper presents an executive summary of this work. It introduces the practice of CHM and the key considerations that need to be addressed whilst researching this traditional medical system.

Results

These guidelines emphasise the importance of identifying best practice, and then developing and applying appropriate and rigorous research methodologies to investigate CHM as a whole system.

Conclusions

It is hoped that this will encourage a thoughtful and meticulous process of investigation that will clarify the contribution that CHM can make to our future healthcare. Innovative new approaches are considered including the application of the new “omic” technologies and systems biology as a way of enhancing our understanding of traditional practice     

中药配方颗粒与传统中药饮片临床疗效比较

目的:观察中药配方颗粒与传统中药饮片在临床治疗中的疗效分析。方法:选取聊城市中医医院收治的100例盗汗患者,将50例采用传统中药饮片进行治疗的患者作为对照组;将50例采用中药配方颗粒进行治疗的患者作为研究组;对比两组患者治疗的临床效果。结果:治疗后,在肺卫不固型患者中,研究组患者临床治疗的总有效率显著高于对照组;且在阴虚火旺型患者中,研究组患者临床治疗的总有效率同样高于对照组(P <0.05)。结论:中药配方颗粒在盗汗患者中具有良好的临床效果,能够有效提高患者的治疗效果,值得推广。     

An integrative approach of linking traditional Chinese medicine pattern classification and biomedicine diagnosis

Traditional Chinese medicine (TCM) is a medical system with over 3000 years of continuous practice experience and refinement through treatment observations. The TCM pattern classification (also defined as Syndrome or Zheng differentiation) and treatment of ill health is the basis and the key concept of the TCM theory. All diagnostic and therapeutic methods in TCM are based on the differentiation of TCM pattern. TCM pattern can be considered as the TCM theoretical interpretation of the symptom profiles. Pattern classification is often used as a guideline in disease classification in TCM practice and has been recently incorporated with biomedical diagnosis, resulting in the increasing research interest of TCM pattern among various disciplines of integrative medicine. This paper describes the historical evolution on the integration of the TCM pattern classification and disease diagnosis in biomedicine, the methodology of pattern classification for diseases, efficacy of TCM practice with integration of TCM pattern classification and biomedical disease diagnosis, and the biological basis of TCM pattern. TCM pattern classification, which may lead to new findings in biological sciences, was also discussed.     

浅谈中药药理的临床应用

中药功效是对中药治疗作用的高度概括,中药药理作用是在中医药理论指导下,用现代科技手段研究中药与机体相互作用和作用的机制.大部分中药功效与药理作用一致.中药药理作用的临床应用,必须在整体观念和辨证论治等理论指导下,与中药功效及配伍原则进行有机结合,才能发挥更大的治疗作用.     

Progress in clinical research on the integration of Chinese and Western medicines for treating primary liver cancer

Primary liver cancer (PLC) is one of the most common malignant tumors in China. PLC is characterized by insidious onset, rapid progress, poor quality of life, and short survival time. Notably, current treatment strategies remain unsatisfactory. Traditional Chinese medicines (TCM) have been used to treat a variety of diseases, including liver diseases, for more than 2000 years. In this study, we performed a review of the use frequency and clinical efficacy of TCM in treating PLC. Relevant literature from January 1, 2009, to January 1, 2021 was retrieved from network databases of China National Knowledge Infrastructure (CNKI), Chongqing VIP, Wanfang, PubMed, and SinoMed. The most frequently used TCM and their efficacy in PLC treatment were summarized. Based on the inclusion and exclusion criteria, 33 articles were selected. Overall, the efficacy of the combination of TCM and Western medicines in the treatment of PLC was higher than that in the control groups (i.e. treatment with Western medicines alone) (65.11% vs. 44.31%, P < .05). Among the 33 selected articles, 11 were investigated for TCM preparation (marketed drugs) and 22 for TCM formulas. In total, 102 types of TCM (single herbs) were used to treat PLC. The top five most frequently used TCM were Poria (14.71%), Astragali radix (13.73%), Atractylodis Macrocephalae Rhizoma (12.75%), Bupleuri radix (12.75%), and Glycyrrhizae radix et Rhizoma (11.76%). Of the 102 types of TCM, tonics were the most frequently used categories, followed by heat-clearing medicines, blood-invigorating medicines, and stasis-resolving medicines. Of 207 papers, 174 (84.06%) could not be subjected to statistical analysis due to research quality. Further high-quality research on herb sources, formula components and dosage, toxicology, and ethics of TCM is necessary. In conclusion, TCM play a promising role in the treatment and management of PLC, although further investigations are warranted.     

再论“队列研究”在中医药临床疗效评价中的应用

文章简要介绍了队列研究的方法及其在中医药疗效评价中应用的可行性;比较详尽地介绍了作为疗效评价的队列研究其证据的等级、方法学的优点和局限性,并讨论了队列研究用于中医药临床疗效评价的方法学要点,如中医药暴露水平划分、结局指标的选择、起始暴露的确定以及最终暴露组的划归、队列迁移的控制、盲法以及安慰剂的使用、随访及统计分析过程中可能会遇到的问题。希望对中医药疗效评价研究采用队列研究设计提供参考。     

中医药治疗手足口病临床研究概述

中医药治疗手足口病方法较多,在迅速缓解病情、缩短病程,从而防止严重并发症发生上疗效突出,且无明显毒副作用。本文概括了近年来中医各家对该病病因病机的不同认识,尤其从中医内治、外治、重症治疗几方面就各医家对该病的临床研究进行归纳总结,旨在体现中医药治疗手足口病的优势;同时指出了目前临床研究中存在着疗效评价标准不统一,对作用机理和途径的研究不够深入,缺乏前瞻性、大样本、多中心性的研究等问题。并建议充分挖掘中医在手足口病重症治疗、外治和采取多种措施增强体质等方面的潜力。     

The necessity for integrating traditional,complementary, and alternative medicine into medical education curricula in Iran

BackgroundThe use of traditional and complementary medicine (T&CM) is increasing in both developed and developing countries. The school of Persian medicine (PM) in Iran is a comprehensive medical school that is rich in history and has its own special principles, elements, philosophy, and diagnostic and treatment options. Many complementary therapy modalities are also popular and in demand among patients and physicians. The aim of this paper is to provide logic for the policymakers in Iranian medical education to make changes in medical education curricula, particularly on integrating T&CM.MethodsWe reviewed the global experience in teaching T&CM to medical students, and highlighting the strengths of PM, described why it is necessary to integrate T&CM into general medicine curricula in Iran.ResultsPM is a traditional system of medicine that dates back about 7000 years. Although there are few studies about the safety and effectiveness of PM, research into it has recently been accelerated. There is a suitable opportunity for integrating T&CM with conventional medicine. Physicians should be familiar with T&CM to avoid any contraindications, interactions, and unwanted effects.ConclusionTraditional medicine is part of Iran’s heritage and, thus, needs special attention. Familiarization of physicians with T&CM can help them choose the best treatment options for their patients. To integrate T&CM into the medical education curricula of Iran, a two-credit course has been proposed for implementation across the country.     

Progress in the design and quality control of placeboes for clinical trials of traditional Chinese medicine

In recent years, new preparations of traditional Chinese medicines(TCMs) have been developed, increasing the need for their clinical trials. Using placeboes rather than control drugs is increasingly popular in clinical trials of TCMs, as the therapeutic effects of the tested TCMs can be more properly judged. The basic attributes of TCM placeboes include similarity, safety, applicability and controllability. In particular,it is necessary to have similarities in appearance, color, smell and taste ...     

19世纪以来中医药在日本的传播发展

中医药在日本有近百年的复兴史,为更好地促进中日医学交流,本文应用文献学和史学的调查研究方法,分析有关记录中医药在日本的日文刊行物。明治维新后,日本政府引进了西方医学,实施医药卫生的制度化,并废止汉方医学。但从20世纪50年代开始,汉方医学在学团组建、刊物发行、学校教育、社会教育、药物研发等方面得到发展。中日建交后,中日医学交流进一步深化并促进了中医药在日本的发展。     

中医学专业临床一体化教学管理工作的实践与探索

传统中医学专业本科教育以课堂理论教学及少量实践课程相结合,面对愈发严峻的医疗环境和就业情况,显示出其相对局限的弊端。南京中医药大学近年来积极探索医学教育的新方法、新思路,逐步开展中医学专业本科教育临床一体化教学改革,依托附属医院优势,将理论课程授课地点拓展至附属医院,使理论教学与临床实践充分结合,取得有益效果。结合我院开展情况,积极探索临床一体化教学模式,讨论实施规范,力求使临床一体化教学成效最大化。     

中药治疗高血压病的临床效果观察

摘要：目的：观察分析中药治疗高血压病的临床效果观察。方法：选取我院收治的确诊为高血压性患者72例,分为中药治疗组与西药治疗组,观察治疗前后效果及使用降压药情况。结果：两组患者8周后在临床症状、血压值等方面比较有明显差异（P〈O．05）。结论：枸杞与野菊花可以显著改善早期肝肾阴虚、肝热阳亢型高血压患者症状及预后,提高治疗效果、减少并发症的发生。     

中西医结合治疗神经性尿频症临床疗效分析

目的:探讨用中西医结合方法治疗神经性尿频症的临床疗效.方法:将60例小儿神经性尿频症病儿随机分为三组,每组各20例,自拟中西药组(缩泉饮合硝苯吡啶)治疗,并设中药组(缩泉饮)及西药组(硝苯吡啶)作对照,比较三组的疗效及不良反应.7天为一疗程.结果:三组总有效率分别为95%、85%和75%,中西药组较其它两组效果好(P＜0.05);中西药组及西药组起效快,中药组远期效果与上两组无差异;不良反应中西药组2例,西药组1例.结论:缩泉饮合硝苯吡啶治疗小儿神经性尿频症疗效较单纯缩泉饮或硝苯吡啶效果好,且不良反应少.     

0期临床试验与中药注射剂上市后临床安全性再评价

中药注射剂不良反应时有发生,临床安全性问题亟待解决,需要进行上市后临床安全性再评价,过敏反应是不良反应评价的主要内容之一.对含有毒药材的中成药、有安全问题的中药注射剂需要开展0期临床试验,0期临床试验使用“微剂量”研究周期内收集必要的药物安全性及药代动力学试验数据,微剂量可以反映中药注射剂的致敏情况.0期临床试验为上市后中药注射剂的安全性再评价提供了新的方法,是否进行0期临床试验,应依据品种是否有安全性问题而定,中药注射剂初始剂量以及样本含量的确定是研究设计的关键问题.     

臭氧加中医药治疗膝关节骨关节炎的临床研究

目的：臭氧加自拟中药方内服外用治疗膝关节骨关节炎的临床研究. 方法：86例患者被随机分为治疗组43例和对照组43例.治疗组采用臭氧加中药内服外用治疗,对照组采用氨糖美辛治疗,观察两组临床疗效和不良反应.结果：治疗组总有效率为93.02%,与对照组的62.79%比较,差异有显著性（P〈0.05）.治疗组未见不良反应,对照组有4例出现轻度消化道不适症状.结论：臭氧加自拟中药方内服外用治疗膝关节骨关节炎,取得较好疗效,安全可靠,值得临床推广.     

中药炮制与中医临床疗效的关系分析

中药炮制是在我国传统医疗的基础之上逐渐形成和发展起来的,是我国传统医学的重要组成部分,对于有效保证我国临床用药的安全以及提高我国的临床医疗效果具有十分重要的意义和作用。中药炮制的药材大多选自自然界,根据气味等可以划分为不同的种类,如果能够有效综合各类药物的不同药效并加以有针对性的炮制,则势必会最大程度的发挥药物的作用,有效使得药性偏者趋纯,烈者趋缓,中和某些过强或者过弱的药性,进而适应临床医学的各种需求,以更好的发挥其医疗作用。     

树立科学的评价观,努力促进中医药学的发展

中医药学对民族的繁衍昌盛、人民的医疗保健做出了巨大的贡献,然而由于认识的偏差和评价体系的不完善,影响了对中医药学理论体系的正确评价,进而影响了中医药学的健康发展。临床是促进中医药学发展的动力,疗效是中医药研究的中心,科学的评价体系是中医药学健康发展的保障。因此,要以临床为中心,以增强防治疾病的能力为重点,加强疑难病症的临床研究,满足社会对中医药的需求;加强危重急症的临床研究,提升中医药在医疗事业中的地位;加强功能性疾病的临床研究,展现中医药的特色优势;建立客观科学的评价体系,反映中医药特色,确立中医药优势地位,全面、正确地认识中医药;并以此为契机,带动理论的突破和基础研究的深化,促进中医药事业全面、健康地发展。     

中医药治疗纤维肌痛综合征的临床研究进展

本文归纳近年中医治疗纤维肌痛综合征的临床研究进展,概括了不同中医疗法治疗本病的现状和特色,为进一步研究纤维肌痛综合征的中医治疗提供依据,并指出目前临床研究所存在的问题和今后的研究方向。     

龙江传统医药文化特质及对中华医药文化的贡献

通过查阅古籍文献、实地考察和访问民间老中医等途径,了解龙江传统医药文化的特质。龙江医家根据当地气候环境、风土人情,以民族文化为基础,具有兼收中原文化精华,博采众长,以用为主,喜用鲜活药材、方小药猛、善治地方杂症、注重情志养生和非药物治疗、行医重医德的鲜明地方特色。龙江传统医药文化丰富、充实了中华医药文化内涵,促进了民族医药文化交融互进。