Wu Xiao-Lei, Qiang Xiao-Yu, Ji Zhao-Chen, Hu Hai-Yin, Feng Chao-Nan, Wang Dan-Lei, Peng De-Hui, Cao Lu-Jia, Zhang Jun-Hua
Center for Evidence-based Medicine, Tianjin University of Traditional Chinese Medicine Tianjin 301617, China.
Zhongguo Zhong Yao Za Zhi. 2022 May;47(9):2322-2329. doi: 10.19540/j.cnki.cjcmm.20220210.501.
The present study systematically collected, analyzed, and evaluated randomized controlled trial(RCT) of Chinese patent medicine in the treatment of heart failure to provide references for follow-up clinical research design, guideline update, and policy formulation, and promote the improvement of clinical evidence quality. On the basis of the collection in the Traditional Chinese Medicine(TCM) Clinical Evidence Database System(EVDS), CNKI, VIP, Wanfang, SinoMed, PubMed, and Web of Science were searched for RCTs of Chinese patent medicine in the treatment of heart failure from database inception to December 31, 2020. The di-sease type, publication time, sample size, intervention/control setting, course of treatment, evaluation indexes, and methodological quality were analyzed and evaluated. A total of 1 631 RCTs were included, including 1 622 in Chinese and 9 in English. It was first published in 1995, with the largest number of publications in 2016. There were only 56 RCTs(3.43%) with a sample size≥200. Seventy-eight types of Chinese patent medicines were involved, including 49 types of oral drugs and 29 types of injections. There were 34 intervention/control protocols, which were dominated by Chinese patent medicine+conventional treatment vs conventional treatment, accounting for 28.51%(n=465). About 94.0% of RCTs reported the course of treatment, mainly 14-56 days. The evaluation indexes were mainly physical and chemical tests and symptoms/signs, and left ventricular ejection fraction(LVEF) was the most frequently used measurement index. In enumeration indexes, clinical efficacy(response rate) was used the most frequently. Methodologically, 92.0% of the research subjects were rated as high risk of blindness. There were only 13 RCTs(0.80%) reporting registered information. It is necessary to further standardize the design, implementation, and quality control of clinical studies in order to improve the quality of evidence and avoid research waste.
本研究系统收集、分析和评价了中成药治疗心力衰竭的随机对照试验（RCT），为后续临床研究设计、指南更新及政策制定提供参考，促进临床证据质量的提高。在中医药临床证据数据库系统（EVDS）收集的基础上，检索中国知网、维普、万方、中国生物医学文献数据库、PubMed及Web of Science中自建库至2020年12月31日关于中成药治疗心力衰竭的RCT。对疾病类型、发表时间、样本量、干预/对照设置、疗程、评价指标及方法学质量进行分析评价。共纳入1631项RCT，其中中文1622项，英文9项。首次发表于1995年，2016年发表数量最多。样本量≥200的RCT仅56项（3.43%）。涉及78种中成药，其中口服药49种，注射剂29种。有34种干预/对照方案，以中成药+常规治疗对比常规治疗为主，占28.51%（n = 465）。约94.0%的RCT报告了疗程，主要为14 - 56天。评价指标主要为理化检查和症状/体征，左心室射血分数（LVEF）是最常用的测量指标。在计数指标中，临床疗效（有效率）使用最为频繁。方法学上，92.0%的研究对象被评为高盲法风险。仅13项RCT（0.80%）报告了注册信息。有必要进一步规范临床研究的设计、实施及质量控制，以提高证据质量，避免研究浪费。
