中药临床试验肝肾功能指标异常值的分析与评价

Analysis and evaluation of abnormal values of liver and kidney function indexes in clinical trials of traditional Chinese medicine

目的:探讨中药临床试验肝肾功能指标的异常值。方法:收治肝肾指标异常患者3 047例,分析中药临床试验中肝肾功能指标异常与药物相关性。结果:肝功能指标异常中,ALT异常1 060例,AST异常215例,肝肾功能异常常见原因有脂肪肝、饮酒、饮食、合用他药。肝功能异常无意义患者解释原因的缺失比例高于有意义患者。结论:中药临床试验中,对安全性评价指标肝肾功能异常值的评估存在漏洞,无意义患者的原因解释不到位。

Objective:To investigate the abnormal value of liver and renal function indexes in clinical trials of traditional Chinese medicine.Methods:3047 patients with abnormal liver and kidney indexes were selected.We analyzed the correlation between abnormal liver and renal function indexes and drug in clinical trials of traditional Chinese medicine.Results:In the abnormal liver function indexes,ALT was abnormal in 1 060 cases;AST was abnormal in 215 cases.The common causes of abnormal liver and kidney function indexes were fatty liver,drinking,diet,combined with other medicine.In patients with abnormal liver function without signi ficance,the loss ratio for explaining the reasons was higher than that of patients with significant.Conclusion:In clinical trials of traditional Chinese medicine,there was loophole for evaluating the abnormal values of liver and kidney function indexes,explanation for patients without significance was not in place.