中药治疗糖尿病肾病随机对照试验的结局指标现状分析:基于核心指标集视角OA

[Objective]To systematically analyze the reporting status of outcome indicators in randomized controlled trials(RCTs)of traditional Chinese medicine(TCM)for diabetic nephropathy(DN),clarify the frequency of use,distribution characteristics and main existing problems of various outcome indicators in current RCTs of TCM for DN,and provide evidence reference for the construction of a core outcome set(COS).[Methods]RCTs of TCM for DN published or registered from January 1,2020 to December 31,2024 were retrieved from CNKI,Wanfang Database,VIP,SinoMed,PubMed,Cochrane Library,Embase,ChiCTR and ClinicalTrials.gov.The Cochrane Risk of Bias Assessment Tool(RoB 1)was used to evaluate the methodological quality,and the outcome indicators were classified and descriptive statistics were performed.[Results]A total of 218 RCTs were included.RoB 1 assessment showed that the proportions of low bias risk in the dimensions of random sequence generation,allocation concealment,outcome assessor blinding,participant blinding,completeness of outcome data,selective reporting and other biases were 70.64%,1.38%,27.06%,1.38%,93.58%,99.08%and 0.92%,respectively,indicating that the implementation of allocation concealment and blinding was particularly insufficient.A total of 88 types of outcome indicators were involved,with a cumulative application of 3 160 times,including 3 014 times(95.38%)for physicochemical detection indicators,78 times(2.47%)for safety indicators,46 times(1.46%)for TCM symptom/syndrome indicators,10 times(0.32%)each for symptom and sign indicators and quality of life indicators,and only 2 times(0.06%)for long-term prognosis indicators.[Conclusion]At present,the selection and reporting of outcome indicators in RCTs of TCM for DN lack unified standards.In the future,it is necessary to construct a core outcome set to improve the quality of protocol prespecification and reporting.