从“毒”论治急性冠脉综合征随机对照试验结局指标的文献分析

Literature Analysis of Outcome Indicators of Randomized Controlled Trials for the Treatment of Acute Coronary Syndrome from"Toxin"

目的:评价从“毒”论治急性冠脉综合征(ACS)随机对照试验(RCTs)结局指标的选择现状,以期为今后的相关研究及核心结局指标数据集的建立提供参考。方法:以“毒”和“冠心病”“急性冠脉综合征”等主题词检索中英文数据库并按照预先制定的纳入与排除标准筛选文献;利用Cochrane风险偏倚评估工具对纳入文献进行质量评价;采用定性分析及结局指标分类等方法进行统计学分析。结果:初步检索到文献4206篇,最终纳入中文文献58篇,英文文献0篇。纳入的58篇RCTs均报道了有效性结局指标。Corhrane偏倚风险评估工具显示:在随机序列的生成、分配隐藏、对研究者、受试者实施盲法方面多数评价为偏倚风险不确定,对结局评估者实施盲法方面多数评价为高偏倚风险,在结局数据的完整性、选择性报告、其他偏倚方面多数评价为低偏倚风险。58篇RCTs涉及病人5172例,平均样本量约为89例,共得到108项结局指标,总频次337次,单篇RCT结局指标最少为2个,最多达15个,平均6个;主要概括为6类,分别为临床疗效、症状体征、理化检测、生活质量、安全性、远期预后指标。结论:活血解毒中药治疗急性冠脉综合征RCTs的总体偏倚风险不明确,在结局指标的选择上数量悬殊,差异明显,主次不分,方法不同,时点不定且缺乏中医“病证结合”特色的现象。

Objective:To evaluate the selection of outcomes in randomized controlled trials(RCTs)for the treatment of acute coronary syndrome(ACS)from"toxin",to provide reference for future related studies and the establishment of core outcome indicator data sets.Methods:Keywords such as"toxicity","coronary heart disease"and"acute coronary syndrome"were used to search the Chinese and English databases,and references were screened according to the preset exclusion criteria.Cochrane risk bias assessment tool was used to evaluate the quality of the included literatures.Qualitative analysis and outcome index classification were used for statistical analysis.Results:A total of 4206 literatures were initially retrieved,with 58 were in Chinese.All 58 RCTs included reported effective outcome measures.The Corhrane bias risk assessment tool showed that the majority of generation of random sequences,allocation concealment,and blinding of researchers and subjects were assessed as unclear bias risk.The majority of terms of blinding of outcome assessors were assessed as high bias risk.The majority of terms of completeness of outcome data,selective reporting,and other biases were assessed as low bias risk.Fifty-eight RCTs involved 5172 patients,with an average sample size of about 89 cases.A total of 108 outcome indicators were obtained,with a total frequency of 337 times.The outcome indicators of a single RCT were at least 2 and up to 15,with an average of about 6,which were mainly summarized as clinical efficacy,symptoms and signs,physical and chemical detection,quality of life,safety,and long-term prognosis indicators.Conclusion:The overall bias risk of RCTs for the treatment of acute coronary syndrome with Chinese medicine for invigorating blood and resolving toxins was not clear,with a wide range of outcome indicators,obvious differences in the number of choices,lack of priority,different methods,uncertain time points and lack of traditional Chinese medicine"disease and evidence combination"features.