Han Jin, Yuan Yue, Xu Fang-Biao, Song Yan-Bo, Sun Yong-Kang, Wang Xin-Zhi
Encephalopathy Center of the First Affiliated Hospital of Henan University of Chinese Medicine Zhengzhou 450099, China the First Clinical Medical School of Henan University of Chinese Medicine Zhengzhou 450046, China.
the First Clinical Medical School of Henan University of Chinese Medicine Zhengzhou 450046, China.
Zhongguo Zhong Yao Za Zhi. 2025 Jan;50(2):542-559. doi: 10.19540/j.cnki.cjcmm.20240826.501.
This study systematically reviewed the randomized controlled trial(RCT) of traditional Chinese medicine(TCM) treatment of post-stroke depression(PSD) and analyzed the clinical study characteristics and outcome indicators, aiming to optimize the design and establish the core outcome set in the future clinical trials of the TCM treatment of PSD. PubMed, Web of Science, Cochrane Library, EMbase, CNKI, VIP, Wanfang, and SinoMed were searched for the relevant RCT published in recent 3 years. The basic characteristics, intervention measures, and outcome indicators of the included RCT were extracted, and the descriptive analysis was carried out. A total of 76 RCTs were eventually included, with the sample size concentrated in 80-100 cases. The most frequent TCM syndromes were liver depression and Qi stagnation(15 times, 31.91%) and phlegm combined with stasis(5 times, 10.63%). The frequency of intervention methods followed a descending trend of TCM decoction(35 times, 46.05%) and TCM decoction + acupuncture(4 times, 5.26%), Chinese patent medicine(3 times, 3.94%), and the intervention mainly lasted for 1 to 3 months(43 times, 60.56%). The adverse reactions of patients were mainly digestive system reaction(150 patients, 39.37%) and nervous system reaction(112 patients, 29.39%). Most of the included studies had unclear risk of bias, involving 84 outcome indicators, which belonged to 8 indicator domains. The RCTs of TCM treatment of PSD showed a variety of problems, such as non-standard TCM syndrome differentiation, inconsistent names of TCM syndrome scores and measurement tools, low quality, unclear risk of bias, neglect of endpoint indicators, unreasonable selection of substitute indicators, lack of differentiation between primary and secondary outcome indicators, non-standard reporting of safety indicators, insufficient attention to economic indicators, and lack of long-term prognosis evaluation. It is suggested that the future research should improve the quality of methodology and build a standardized core outcome set to promote the development of high-quality clinical research in this field.
本研究系统评价了中医药治疗脑卒中后抑郁（PSD）的随机对照试验（RCT），分析其临床研究特征及结局指标，旨在优化设计并确立未来中医药治疗PSD临床试验的核心结局指标集。检索了PubMed、Web of Science、Cochrane图书馆、EMbase、中国知网（CNKI）、维普资讯（VIP）、万方数据库和中国生物医学文献数据库（SinoMed），查找近3年发表的相关RCT。提取纳入RCT的基本特征、干预措施及结局指标，并进行描述性分析。最终共纳入76项RCT，样本量集中在80～100例。最常见的中医证型为肝郁气滞（15次，31.91%）和痰瘀互结（5次，10.63%）。干预方法的使用频率呈以下降趋势：中药汤剂（35次，46.05%）、中药汤剂+针灸（4次，5.26%）、中成药（3次，3.94%），干预主要持续1～3个月（43次，60.56%）。患者的不良反应主要为消化系统反应（150例患者，39.37%）和神经系统反应（112例患者，29.39%）。纳入的研究大多偏倚风险不明确，涉及84个结局指标，分属于8个指标领域。中医药治疗PSD的RCT存在多种问题，如中医证候辨证不规范、中医证候评分及测量工具名称不一致、质量较低、偏倚风险不明确、忽视终点指标、替代指标选择不合理、主次结局指标区分不清、安全性指标报告不规范、对经济指标关注不足以及缺乏长期预后评估等。建议未来研究应提高方法学质量，构建标准化的核心结局指标集，以促进该领域高质量临床研究的发展。
