摘要目的 使用处方序列对称分析(PSSA)对他汀类药物的肝脏安全性进行探究,验证该信号检测方法在国内医疗保险数据库应用的可行性.方法 以2013年我国城镇职工和居民基本医疗保险数据库中使用他汀类药物且同时使用保肝类药物的人群为研究对象,使用PSSA分析他汀类药物的肝脏安全性,确定洗脱期等研究参数,计算各他汀类药物的调整序列比(ASR).结果 在符合纳入标准的5 649人中,洗脱期设定为1个月,间隔期设定为60 d.他汀类药物总体的ASR为1.471(95％CI:1.395 ～ 1.550),阿托伐他汀的ASR为1.419(95％CI:1.335～ 1.508),辛伐他汀的ASR为1.307(95％CI:1.164 ～ 1.467).用药间隔30d内的信号较强.结论 经过PSSA,他汀类药物和肝脏损害可能存在潜在关联,尤其是阿托伐他汀和辛伐他汀.验证了PSSA作为一种快速、有效的药品安全性信号检测方法在我国医疗保险数据库运用的可行性.

abstractsObjective To study the association between statins use and liver-injury through prescription sequence symmetry analysis (PSSA) and evaluate the feasibility of the method to be used in Chinese Medical Insurance Database.Methods The data of the patients who prescribed both statins and liver-proactive drugs in Chinese Basic Medical Insurance Database in 2013 were selected as study subjects to calculate the adjusted sequence ratio (ASR) with signal detection methods to determine the study parameters and investigate the potential association between statins use and liver-injury.Results In 5 649 individuals which met the inclusion criteria,the washout period was set as one month and interval period was set as 60 days.The overall ASR of statins was 1.471(95％CI:1.395-1.550),the ASR of atorvastatin was 1.419 (95％CI:1.335-1.508),the ASR of simvastatin was 1.307 (95％CI:1.164-1.467).The positive signal was strong in 30 days interval period.Conclusions PSSA indicated that there might be potential association between statins use and liver-injury,especially the uses of atorvastatin and simvastatin.This signal detection method may be a fast and effective method in drug safety evaluation and can be used in Chinese Medical Insurance Database.