Xie Kai, Guan Sheng-Nan, Jing Hui, Zhang Chen-Xi, Wang Hai-Feng
the First Affiliated Hospital of Henan University of Chinese Medicine Zhengzhou 450000, China Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases Co-constructed by Henan Province &Education Ministry of China, Henan University of Chinese Medicine Zhengzhou 450000, China.
Zhongguo Zhong Yao Za Zhi. 2022 Oct;47(20):5642-5653. doi: 10.19540/j.cnki.cjcmm.20220523.501.
This study analyzed the outcome indicators in randomized controlled trial(RCT) on Chinese medicine as adjuvant therapy for severe pneumonia in the past years, laying a foundation for the design of clinical trials on and construction of core outcome set(COS) for severe pneumonia. To be specific, related RCT was retrieved from CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, Cochrane Library, Web of Science, Chinese Clinical Trial Registry, and ClinicalTrials.gov(from January 1,2011 to April 9,2022). Then data in the trials were extracted, and the quality of included RCT was assessed according to Cochrane handbook, followed by descriptive analysis of the use of outcome indicators. A total of 11 833 articles were screened out, and finally 34 RCTs were included(2 were protocols). The included trials involved 109 outcome indicators with emergence frequency of 320, which were mainly classified into 9 categories: physicochemical indicators(54, frequency 167), time to achieve the efficacy(15, frequency 38), clinical effective rate(10, frequency 36), quality of life(11, frequency 35), symptoms and signs(7, frequency 18), traditional Chinese medicine(TCM) syndrome(4, frequency 13), safety(3, frequency 8), economic evaluation(1, frequency 1), other indicators(4, frequency 4). The indicators with high frequency followed the order: total effective rate, arterial oxygen partial pressure, C-reactive protein, white blood cell count, arterial blood carbon dioxide partial pressure. A total of 5 articles(14.71%) reported the main outcome indicators and 11 articles(32.35%) adopted the efficacy on TCM syndromes as the outcome indicator. There are many problems in the selection of outcome indicators in RCT on the treatment of severe pneumonia with Chinese medicine, mainly manifested as the disregard of clinical endpoint indicators, the inappropriate selection of surrogate indicators, and the non-standard evaluation criteria for the efficacy on TCM syndrome. It is suggested that the evaluation system for the efficacy of Chinese medicine on severe pneumonia should be established in accordance with the method for international COS to improve the quality of clinical trials.
本研究分析了近年来中医药辅助治疗重症肺炎的随机对照试验（RCT）中的结局指标，为重症肺炎临床试验设计及核心结局集（COS）构建奠定基础。具体而言，从中国知网、万方、维普、中国生物医学文献数据库、PubMed、EMbase、Cochrane图书馆、Web of Science、中国临床试验注册中心及ClinicalTrials.gov检索相关RCT（检索时间为2011年1月1日至2022年4月9日）。然后提取试验中的数据，依据Cochrane手册评估纳入RCT的质量，随后对结局指标的使用情况进行描述性分析。共筛选出11833篇文章，最终纳入34项RCT（2项为试验方案）。纳入的试验涉及109个结局指标，出现频次为320次，主要分为9类：理化指标（54个，频次167）、起效时间（15个，频次38）、临床有效率（10个，频次36）、生活质量（11个，频次35）、症状体征（7个，频次18）、中医证候（4个，频次13）、安全性（3个，频次8）、经济学评价（1个，频次1）、其他指标（4个，频次4）。高频指标依次为总有效率、动脉血氧分压、C反应蛋白、白细胞计数、动脉血二氧化碳分压。共有5篇文章（14.71%）报告了主要结局指标，11篇文章（32.35%）采用中医证候疗效作为结局指标。中医药治疗重症肺炎的RCT结局指标选择存在诸多问题，主要表现为忽视临床终点指标、替代指标选择不当、中医证候疗效评价标准不规范。建议按照国际COS方法建立中医药治疗重症肺炎的疗效评价体系，以提高临床试验质量。
