中医药治疗HIV/AIDS相关腹泻疗效和安全性的Meta分析与GRADE证据评价

Meta-Analysis and GRADE Evaluation of Efficacy and Safety of Chinese Medicine in Treating HIV/AIDS-Related Diarrhea

目的:系统评价中医药治疗人类免疫缺陷病毒感染或获得性免疫缺陷综合征(HIV/AIDS)相关腹泻(HRD)的临床疗效和安全性,并进行GRADE证据质量评价。方法:检索中国知网(CNKI)、PubMed等中英文数据库和临床试验注册平台,检索中医药治疗HRD的随机对照试验(检索时间从各个数据库建库至2023年3月31日),由2名研究人员独立进行数据检索、数据提取、偏倚风险评价和Meta分析。结果:最终纳入31篇文献和1项临床研究,共计3474例患者,其中试验组1830例,对照组1644例。Meta分析结果显示,中医药治疗能显著提高HRD患者的临床疗效有效率,降低大便次数积分、中医症状积分、腹泻量表积分、腹痛积分,加快腹泻消失时间,增加体质量。临床疗效有效率和中医症状积分均未发现发表偏倚。GRADE证据质量评价结果显示:中医症状积分、大便次数积分、CD4+T细胞绝对数量为高级质量证据;临床疗效有效率、腹泻恢复时间、腹泻量表积分、腹痛积分、不良反应发生率和体质量为中级质量证据;中医证候临床疗效有效率为低级质量证据。结论:中医药能提高HRD患者的临床疗效有效率,改善腹泻临床症状,且安全性较好,推荐使用于HRD的治疗。但由于所纳入的研究方法质量较低和部分结局指标证据质量较低,尚需更多设计严谨的多中心随机对照试验增加证据强度。

Objective:To systematically evaluate the clinical effects and safety of Chinese Medicine in treating human immunodeficiency virus/acquired immune deficiency syndrome(HIV/AIDS)-related diarrhea(HRD),and to evaluate the quality of evidence by GRADE.Methods:Chinese and English databases such as China National Knowledge Infrastructure(CNKI)and PubMed,as well as clinical trial registration platforms,were used to search for randomized controlled trials of Chinese medicine treatment for HRD(retrieval time from the establishment date of each database to March 31,2023).Data retrieval,data extraction,bias risk assessment,and Meta-analysis were conducted by two researchers independently.Results:Ultimately,31 papers and one clinical study with 3474 patients were included,involving 1830 cases in the trial group and 1644 cases in the control group.The Meta-analysis results showed that Chinese medicine treatment can significantly improve the clinical efficacy of HRD patients,reduce the scores of stool frequency,diarrhea disappeared time,traditional Chinese medicine symptom scores,diarrhea scale scores,and abdominal pain scores,and increase body mass.No publication bias was found in the clinical effective rates and traditional Chinese medicine symptom scores.The GRADE evidence quality rating results showed that Chinese medicine symptom scores,stool frequency scores,and absolute CD4+T cell count are high-level quality evidence;the clinical effective rate,diarrhea recovery time,diarrhea scale scores,abdominal pain scores,the incidence of adverse reactions,and body mass are intermediate quality evidence;the clinical effective rates of traditional Chinese medicine syndrome is low-quality evidence.Conclusion:Chinese medicine can improve the clinical efficacy of HRD patients and alleviate clinical symptoms of diarrhea,with good safety.It is recommended for the treatment of HRD.However,due to the low quality of the research methods included and the low quality evidence of some outcome indexes,more rigorously designed multicenter randomized controlled trials are needed to increase the strength of evidence.