Kong Xin-Xin, Xie Kai, Huang Xia-Jin, Li Zhen, Yin Wen-Jing, Wang Hai-Feng
Department of Respiratory and Critical Care Medicine, the First Affiliated Hospital of Henan University of Chinese Medicine Zhengzhou 450000, China the First School of Clinical Medicine, Henan University of Chinese Medicine Zhengzhou 450000, China.
Department of Respiratory and Critical Care Medicine, the First Affiliated Hospital of Henan University of Chinese Medicine Zhengzhou 450000, China the First School of Clinical Medicine, 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. 2024 Oct;49(19):5343-5353. doi: 10.19540/j.cnki.cjcmm.20240526.501.
To analyze the outcome indicators of randomized controlled trial(RCT) of traditional Chinese medicine(TCM) in the treatment of non-severe community-acquired pneumonia(NSCAP), and to provide a basis for the design of NSCAP clinical trials and the construction of core outcome set. CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, Cochrane Library, and Web of Science were systematically searched from establishment to August 31, 2023. Two reviewers independently screened the literature, extracted data, and evaluated the risk of bias in the included studies. Qualitative analysis was used to describe the outcome indicators of the included studies. A total of 42 903 articles were preliminarily obtained, and 47 articles were finally included(4 articles in English and 43 articles in Chinese core). Seventy-nine outcome indicators were extracted, with 434 times. They were mainly divided into 9 categories: physical and chemical indicators(23 kinds, 96 times) [including inflammatory indicators(16 kinds, 78 times), arterial blood gas analysis(4 kinds, 8 times), and immune indicators(3 kinds, 10 times)], symptoms and signs(7 kinds, 86 times), clinical efficacy time(15 kinds, 83 times), clinical efficacy rate(12 kinds, 69 times), safety events(3 kinds, 50 times), TCM syndrome efficacy(4 kinds, 26 times), rating scales(13 kinds, 22 times), economic indicators(1 kind, 1 time), and other indicators(1 kind, 1 time). Numerous issues with the selection of outcome indicators of RCT in TCM treatment of NSCAP existed. These issues primarily showed up as unclear distinctions between primary and secondary outcome indicators, non-standard end point selection and TCM syndrome efficacy indicator evaluation criteria, and insufficiently used quality of life scales and health economics indicators. It is suggested to refer to the establishment method of the international core outcome set, improve the standardized TCM clinical efficacy evaluation system for NSCAP under the doctor-patient co-construction mode, and improve the quality of clinical trial.
分析中医药治疗非重症社区获得性肺炎（NSCAP）随机对照试验（RCT）的结局指标，为NSCAP临床试验设计及核心结局集构建提供依据。系统检索中国知网、万方、维普、中国生物医学文献数据库、PubMed、EMbase、Cochrane图书馆及Web of Science，检索时间从建库至2023年8月31日。两名研究者独立筛选文献、提取数据并评估纳入研究的偏倚风险。采用定性分析描述纳入研究的结局指标。初步获得42903篇文献，最终纳入47篇（英文4篇，中文核心43篇）。提取79个结局指标，共出现434次。主要分为9类：理化指标（23种，96次）[包括炎症指标（16种，78次）、动脉血气分析（4种，8次）、免疫指标（3种，10次）]、症状体征（7种，86次）、临床疗效时间（15种，83次）、临床有效率（12种，69次）、安全事件（3种，50次）、中医证候疗效（4种，26次）、评定量表（13种，22次）、经济指标（1种，1次）、其他指标（1种，1次）。中医药治疗NSCAP的RCT结局指标选择存在诸多问题。这些问题主要表现为主要结局指标与次要结局指标区分不清、终点选择不规范、中医证候疗效指标评价标准不规范、生活质量量表及卫生经济学指标使用不足。建议参考国际核心结局集制定方法，在医患共建模式下完善NSCAP中医药临床疗效评价体系，提高临床试验质量。
