近两年中医药干预脓毒症胃肠功能障碍临床试验结局指标的分析

Randomized controlled trial outcome indicators of traditional Chinese medicine for gastrointestinal dysfunction in sepsis in recent two years

该研究介绍了近两年中医药干预脓毒症胃肠功能障碍临床随机对照试验(RCT)结局指标的报告情况,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,分析临床试验结局指标的报告情况,并使用Cochrane协作网的ROB工具进行偏倚风险评价。经筛选最终纳入临床RCTs 55篇。结果显示,目前的脓毒症胃肠功能障碍临床研究报告了有效性与安全性指标。有效性指标主要包括病情严重程度的APACHEⅡ评分、胃肠功能障碍评分、肠鸣音评分、炎症指标(如C-反应蛋白、降钙素原)等;安全性指标主要包括胃肠反应、皮肤反应等不良事件。但所有指标均未区分主要和次要结局,两者均未报告相关的卫生经济学指标且研究方法学质量相对较差。鉴于目前中医药干预脓毒症胃肠功能障碍研究结局指标报告现状,构建中医药治疗脓毒症胃肠功能障碍的核心结局指标集,提升临床研究的方法学质量,有助于更准确地体现中医药的实际效果。

The purpose of the study is to analyze the outcomes of randomized controlled trial(RCT) of Chinese herbal medicine formula(CHMF) in the treatment of gastrointestinal dysfunction in sepsis in recent two years.We systematically searched four Chinese databases,three English databases,and two clinical trial registries to analyze the reports of outcome indicators of clinical trials,and evaluated the risk of bias by using the ROB tool of Cochrane Collaboration.After screening,55 clinical RCTs were included.The results showed that the current clinical studies of gastrointestinal dysfunction in sepsis reported the efficacy and safety indicators.The efficacy indicators included APACHE Ⅱ scores,gastrointestinal dysfunction scores,bowel sound scores,and inflammatory indicator such as C-reactive protein and procalcitonin.The safety indicators mainly include gastrointestinal reactions,skin reactions,and other adverse events and adverse reactions.However,there was no distinction between primary and secondary outcomes.The relevant indicators of health economics were not reported,and the quality of research methodology was poor.Therefore,we suggest that future researchers should be well prepared in the top-level design stage and actively construct the core outcome set,so as to improve the quality of clinical trials.