近十年中医药干预脓毒症急性肾损伤临床试验结局指标分析

Analysis of the Outcome Indicators in Clinical Trials of Traditional Chinese Medicine on Sepsis-Associated Acute Kidney Injury in Recent Ten Years

目的 评价目前中医药干预脓毒症急性肾损伤(SA-AKI)临床随机对照试验(RCTs)中结局指标选择状况,为SA-AKI临床试验设计和核心结局指标集提供依据和基础。方法 通过系统检索4个中文数据库、3个英文数据库和2个临床试验注册中心,分析随机对照试验的结局指标报告情况,检索时间均从2012年1月1日至2022年9月11日。按照Cochrane进行偏倚风险评价。初步检索出1 057篇文献,最终纳入24篇RCTs。结果 提取结局指标77种,共237频次。其中有效性指标主要包括病情严重程度的APACHEⅡ评分、肌酐、血尿素氮、炎症指标(白细胞介素-6、肿瘤坏死因子-α、血清胱抑素C)、病死率及SOFA评分。安全性指标主要包括血压下降、皮肤反应等不良事件。但仅有1篇RCT区分了主要及次要结局指标,均未报告卫生经济学指标,缺乏中医特色疗效指标,且存在指标测量工具及测量时点不统一等问题。

Objective:To evaluated the current status of outcome indicators in clinical randomized controlled tri-al(RCTs)of Chinese medicine intervention on sepsis-associated acute kidney injury(SA-AKI),and to provide ba-sis and foundation for clinical trial design and core outcome indicator set of SA-AKI.Methods:By systematically searching 4 Chinese databases,3 English databases and 2 clinical trial registries,the RCTs of outcome indicators were analyzed.All searches were from Jauary 1st,2012 to September 1lth,2022.Risk of bias was assessed accord-ing to Cochrane.A total of 1057 articles were retrieved and 24 RCTs were included.Results:The results showed that 77 outcome indicators were extracted with 237 frequencies.The efficacy measures included APACHE II score,creatinine,blood urea nitrogen,inflammatory markers(IL-6,tumor necrosis factors-α,serum cystatin c),mor-tality and SOFA score.The safety indexes mainly included blood pressure drop,skin reaction and other adverse events.However,only one RCT identified the primary and secondary outcome indicators.None of the studies re-ported health economic indicators,nor has traditional Chinese medicine characteristics of efficacy indicators,and none has indicators of measurement tools and measurement time,etc.