符合中药特点的安全性评价技术方法的探索

Exploration of Safety Evaluation Technology and Method in Accordance with the Characteristics of Traditional Chinese Medicine

目的:针对中医药开展临床研究在安全性评价方面的现状进行综述,并探讨进一步完善其评价技术方法。方法:检索CNKI数据库中的中医药开展临床研究的安全性评价相关文献,围绕试验设计、试验目的,安全性评价指标,统计结果方面进行系统综述;提出合并用药问题中药的预警性监测、基于微信公众号的全过程受试者管理模式的安全性评价新技术。结果:纳入文献206篇,其中加载试验占比58.74%,43篇文献(占20.67%)试验目的是为了减轻西药比如化疗药物的毒副作用,发挥中医药的减毒增效功能优势。随着疗程时间的增加,试验组的不良反应发生率低于对照组。讨论:不良反应表述总体十分不规范,提出了中药质控溯源、建立全过程的监测系统、完善因果关系判断方法等策略。

Objective: To summarize the status quo of clinical research in safety evaluation of traditional Chinese medicine and to explore the methods of further improving its evaluation technology. Methods: The relevant literatures on the safety evaluation of clinical research in Chinese medicine were retrieved in the CNKI database. The design, test purpose, safety evaluation index and statistical results were systematically reviewed. The new technology of safety evaluation of the Chinese medicine based on the WeChat official account was put forward. Results: 206 papers were included, of which 58.74% of the loading tests and 43 literatures (20.67%) were used to reduce the toxic and side effects of Western medicine such as chemotherapy drugs and give full play to the advantages of reducing toxicity and efficiency of traditional Chinese medicine. With the increase of treatment time, the incidence of adverse reactions in the experimental group was lower than that of the control group. Discussion: The expression of adverse reactions is not standardized in general, and the strategies of tracing the source of quality control of traditional Chinese medicine, establishing the monitoring system of the whole process and improving the judgment method of causal relationship are put forward.