Feng Chao-Nan, Hu Hai-Yin, Ji Zhao-Chen, Qiang Xiao-Yu, Chen Zhe, Ou Yi, Cao Lu-Jia, Zhang Jun-Hua
Centre for Evidence-based Medicine, Tianjin University of Traditional Chinese Medicine Tianjin 301617, China.
Zhongguo Zhong Yao Za Zhi. 2022 May;47(9):2351-2357. doi: 10.19540/j.cnki.cjcmm.20210910.501.
The clinical randomized controlled trials(RCTs) of Chinese patent medicine in the treatment of chronic obstructive pulmonary disease(COPD) were reviewed and analyzed to provide references for clinical research, guideline development, policy formulation, and quality improvement of clinical evidence. On the basis of the collection in the Traditional Chinese Medicine(TCM) Clinical Evidence Database System(EVDS), CNKI, Wanfang, SinoMed, Cochrane Library, PubMed, EMbase were searched for RCTs of Chinese patent medicine for COPD as a source of clinical evidence from database inception to December 31, 2019. The publication time, sample size, intervention and control measures, course of treatment, outcome indicators, and methodological quality of the trials were analyzed and evaluated. A total of 733 RCTs of Chinese patent medicine for COPD were included, among which 228 RCTs had a sample size higher than 100, accounting for 31.1% of total RCTs. Eighty-eight Chinese patent medicines were involved, including 40 oral medicines and 48 injections. A total of 327 RCTs mentioned intervention and control measures(Chinese patent medicine + conventional treatment vs conventional treatment), accounting for 43.0%. In addition, 94.40% of the RCTs reported the course of treatment, and 53.20% of the RCTs determined 8-14 d as the intervention course. The evaluation indicators adopted were numerous, among which physicochemical indicators(70.57%) and symptoms/signs(24.35%) were the most frequently employed. The operation of allocation concealment and blinding was not standard. Registration and the procedure related to ethics were mostly missing. The results indicate that there are prominent methodological problems in the clinical trials of Chinese patent medicine in the treatment of COPD, affecting the reliability and practicability of the trials. It is necessary to further standardize the design, implementation, and quality control of clinical trials of Chinese patent medicine in the treatment of COPD, highlight the clinical value of Chinese patent medicine for COPD, and improve the quality of evidence.
对中成药治疗慢性阻塞性肺疾病（COPD）的临床随机对照试验（RCT）进行回顾与分析，为临床研究、指南制定、政策制定及临床证据质量提升提供参考。在中国中医临床证据数据库系统（EVDS）收集的基础上，检索中国知网、万方、维普、Cochrane图书馆、PubMed、EMbase中从建库至2019年12月31日关于中成药治疗COPD的RCT，作为临床证据来源。对纳入试验的发表时间、样本量、干预与对照措施、疗程、结局指标及方法学质量进行分析与评价。共纳入733项中成药治疗COPD的RCT，其中样本量大于100的RCT有228项，占RCT总数的31.1%。涉及88种中成药，其中口服制剂40种，注射剂48种。共327项RCT提及干预与对照措施（中成药+常规治疗对比常规治疗），占43.0%。此外，94.40%的RCT报告了疗程，53.20%的RCT将干预疗程确定为8 - 14天。采用的评价指标众多，其中理化指标（70.57%）和症状/体征（24.35%）最为常用。分配隐藏和盲法操作不规范。多数缺少注册及伦理相关程序。结果表明，中成药治疗COPD的临床试验存在突出的方法学问题，影响试验的可靠性和实用性。有必要进一步规范中成药治疗COPD临床试验的设计、实施及质量控制，突出中成药对COPD的临床价值，提高证据质量。
