Outcome indicators in clinical trials with traditional Chinese medicine treatment of sepsis
[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.
traditional Chinese medicinesepsisoutcome indicatorrandomized controlled trial
万方数据
维普
