中医药治疗脓毒症临床试验结局指标分析

Outcome indicators in clinical trials with traditional Chinese medicine treatment of sepsis

关键词:  中医药  脓毒症  结局指标  随机对照试验

Key words:  traditional Chinese medicine  sepsis  outcome indicator  randomized controlled trial

摘要:

[目的] 系统评价了近2年中医药治疗脓毒症的随机对照试验（RCT）的结局指标使用情况，以期为后续的核心结局指标集研究奠定基础。[方法] 检索中国知网（CNKI）、万方数据库（WanfangData）、中文科技期刊数据库（VIP）、中国生物医学文献服务系统（SinoMed）、PubMed、Embase、CochraneLibrary数据库和两个临床试验注册中心，纳入中医药治疗脓毒症RCTs，使用Cochrane风险偏倚评估工具进行文献质量评价。[结果] 共纳入47篇RCTs和6篇临床试验注册方案。53项研究共报告了569个结局指标，161种结局指标，使用频率最高的15个结局指标为急性生理与慢性健康（APACHEⅡ）评分、降钙素原、序贯器官衰竭（SOFA）评分、C反应蛋白、总有效率、28d病死率、白介素-6、平均动脉压、重症监护室（ICU）住院时间、乳酸、不良事件、肿瘤坏死因子-α、CD4、CD8、中医证候积分。[结论] 中医药治疗脓毒症相关的结局指标选取异质性较大，指标离散程度较高；忽视中医特色指标，安全性指标和经济学指标；结局指标报告不规范，结局指标类型随意转换，指标主次不分，指标存在相似交叉条目；指标测量工具及时点不统一。因此，亟需构建具有中医药特色，适合中国临床研究的脓毒症核心结局指标集。

Abstract:

[Objective] This study systematically evaluated the use of outcome indicators in the randomized controlled trials (RCT) with traditional Chinese medicine treatment of sepsis over the last 2 years,in order to lay the foundation for subsequent core outcome set (COS). [Methods] We searched China National Knowledge Network(CNKI),Wanfang Database(Wanfang),Chinese Journal of Science and Technology Database(VIP),China Biomedical Literature Service System(SinoMed),PubMed,Embase,Cochrane Library database and two clinical trial registries. RCTs related to the treatment of sepsis with traditional Chinese medicine were included,and the risk of bias were evaluated by using Cochrane risk bias assessment tool. [Results] Fifty-three studies reported a total of 569 outcome indicators and 161 kinds of outcome indicators. The 15 outcome indicators with the highest frequency of use were APACHEII score,procalcitonin, SOFA score,C-reactive protein,total efficiency rate,28-day mortality,interleukin-6,mean arterial pressure,length of ICU stay,lactic acid,adverse events,tumor necrosis factor-α,CD4,CD8,and traditional Chinese medicine syndrome score. [Conclusion] The selection of outcome indicators was heterogeneous and had a high degree of dispersion;Ignoring TCM characteristic indicators,safety indicators and economic indicators;the outcome indicators report was not standard,the outcome indicators type was arbitrarily converted,the primary and secondary indicators were not distinguishable,and there were crossovers between indicators;the measuring tool and time point is not uniform. Therefore,it is urgent to construct sepsis COS with TCM characteristics and suitable for clinical research in China.