山东省中成药致泌尿系统不良反应/不良事件报告分析和风险信号挖掘

Report Analysis and Risk Signal Mining of Adverse Reactions / Adverse Events of UrinarySystem Induced by Chinese Patent Medicines in Shandong

目的为临床安全使用中成药提供参考。方法选取山东省药品不良反应监测中心数据库2018年1月至2021年12月的中成药药品不良反应(ADR)/药品不良事件(ADE)报告57103份,提取其中致泌尿系统ADR/ADE的报告143份(涉及患者143例),对数据进行分类统计,并运用比例报告比(PRR)法、报告比值比(ROR)法和综合标准(MHRA)法挖掘ADR/ADE的风险信号,总结其特点。结果143份报告中,患者性别男多于女(58.04%比41.96%);年龄以45~89岁多见(115例,80.42%);涉及中成药种类以理血剂占比最大(37.06%),其次为清热剂(20.98%),再次为补益剂(14.69%);具体药物以注射用血塞通(冻干)、参麦注射液、仙灵骨葆胶囊、三金片、丹红注射液较多见(分别为7例、6例、6例、6例、5例);ADR/ADE发生于用药后3 min至20 d,其中24 h内最多见(60.14%);痊愈88例,好转51例,4例不详;主要ADR/ADE表现有尿频(35例)、血尿(20例)、多尿(19例)、尿色异常(17例)等。PRR法、ROR法、MHRA法分别检出风险信号6个、6个、7个,6个共有信号中有3个(多尿、尿急、小便失禁)在各自药品说明书中未提及。结论临床可根据该类ADR/ADE的发生特点有针对性地加强相应中成药的用药监测,促进其安全使用。

Objective To provide a reference for the clinical safe use of Chinese patent medicines.Methods A total of 57103 adverse drug reaction(ADR)/adverse drug event(ADE)reports of Chinese patent medicines from January 2018 to December 2021 in the Shandong Adverse Drug Reaction Monitoring Center database were selected,143 ADR/ADE reports related to urinary system of which were extracted,involving 143 patients,and the data were classified and analyzed.Proportional reporting ratio(PRR),reporting odds ratio(ROR)and comprehensive standard(MHRA)methods were used to mine the risk signals of ADRs/ADEs,and the characteristics were summarized.Results Among the 143 reports,there were more males than females(58.04%vs.41.96%),their ages were mostly in the range of 45 to 89 years(115 cases,80.42%).The most Chinese patent medicines involved were blood-regulating agents(37.06%),followed by heat-clearing agents(20.98%)and tonic agents(14.69%).The specific drugs were mostly Sanqi Panax Notoginseng for Injection,Shenmai Injection,Xianling Gubao Capsules,Sanjin Tablets and Danhong Injection(involving seven,six,six,six and five cases respectively).ADRs/ADEs occurred from 3 min to 20 d after medication,with the highest incidence in 24 h(60.14%).Among the patients,88 cases recovered,51 improved,and four were unknown.The main ADR/ADE manifestations included frequent urination(35 cases),hematuria(20 cases),polyuria(19 cases)and abnormal urine color(17 cases).Six,six and seven risk signals were detected by the PRR,ROR and MHRA methods respectively;among the six common signals,three(polyuria,urgent urination and urinary incontinence)were not mentioned in the corresponding drug instructions.Conclusion It is suggested that we should strengthen the medication monitoring of Chinese patent medicines based on the occurrence characteristics of ADRs/ADEs in clinical practice to promote their safe use.