中西医结合治疗尿酸性肾病的随机对照试验中结局指标的选择

Selection of Outcome Indicators in Randomized Controlled Trials of Integrated Traditional Chinese and Western Medicine for the Treatment of Uric Acid Nephropathy

目的:对中西医结合治疗尿酸性肾病的随机对照试验的研究中结局指标的选择进行分析,为今后临床选择正确的结局指标提供参考。方法:对10个数据库进行尿酸性肾病的随机对照试验检索,提取并分析结局指标。结果:共有162篇文献79个指标纳入研究,其中肌酐、尿素氮、24 h尿蛋白定量3个指标多用于评定肾功能,血尿酸多用于评价尿酸水平。有效率判定使用率>87%,不良事件的报告率为41.3%,64个指标使用率<5%。结论:目前无统一的结局指标,大多尿酸性肾病研究使用生化指标作为结局指标,但无选择硬终点或临床重要结局;纳入文献数量较少,需要进一步讨论如何选择结局指标。

Objective:To analyze the selection of outcome indicators measured in randomized controlled trials(RCTs)of uric acid nephropathy treated with integrated traditional Chinese and western medicine,thereby providing a reference for future clinical studies to select the appropriate outcome indicators.Methods:Ten databases were searched for RCTs involving uric acid nephropathy.The outcome indicators reported were extracted and analyzed.Results:A total of 162 research articles with 79 outcome indicators were included in the study.Of these indicators,creatinine,urea nitrogen,and 24-hour urinary protein excretion were measured mainly for the evaluation of renal function,and blood uric acid was commonly used in evaluating the level of uric acid.The rate of outcome indicators utilized for determining treatment effects was higher than 87%.Adverse events were reported at a rate of 41.3%.Sixty-four indicators had a utilization rate of less than 5%.Conclusion:So far,there are no uniform outcome indicators.Most studies on uric acid nephropathy use biochemical indicators as outcome measures.However,no hard endpoints or clinically important outcomes were selected.The number of included studies is small and further discussion is needed on how to select outcome indicators.