基于CHPS的利伐沙班致出血主动监测工具研究

Active Monitoring Tool for Hemorrhage Induced by Rivaroxaban Based on CHPS

目的探讨基于中国医院药物警戒系统(CHPS)的利伐沙班出血风险主动监测工具的设计思路,以及CHPS对某类或某种药品特定药品不良反应(ADR)主动监测方法的应用前景。方法抽取深圳市某安装了CHPS(2.0版本)的三级甲等医院2020年7月1日至12月31日使用利伐沙班的住院患者病历1071份。利用CHPS集成建模工具,结合药品说明书、深圳市ADR监测数据库中利伐沙班出血ADR情况、相关文献涉及的出血ADR等综合设置利伐沙班出血主动监测工具检索目标病例并验证。结果检索出487例目标病例,经去除重复病例及筛查,最终验证出47例真阳性病例,监测方案阳性预测值为10.68%;47例(56例次)出血病例中,男女比例为1∶1.04;年龄以60岁以上最多(42例,89.36%);表现以胃肠道出血最多(23例次,41.07%),其次为隐性出血(17例次,30.36%),皮下出血、泌尿系统出血(均为7例次,12.50%),死亡2例。结论老年患者使用利伐沙班发生出血的风险较高,胃肠道出血是较突出且可导致死亡的需要关注的风险。该研究所设计的主动监测工具可提高利伐沙班出血ADR/药品不良事件(ADE)的发现率,可为设计基于某种或某类药物ADR主动监测方案提供参考。

Objective To investigate the design ideas of an active monitoring tool for hemorrhage risk induced by rivaroxaban based on the China Hospital Pharmacovigilance System(CHPS),and the application prospect of active monitoring method based on CHPS for specific adverse drug reactions(ADRs)of a certain drug.Methods A total of 1071 medical records of inpatients treated with rivaroxaban in a tertiary A hospital in Shenzhen that installed CHPS(2.0 version)from July 1 to December 31,2020 were extracted.Based on the drug instructions,hemorrhage ADRs induced by rivaroxaban in the Shenzhen ADRs monitoring database and hemorrhage ADRs involved in relevant literature,an active monitoring tool for hemorrhage induced by rivaroxaban was comprehensively designed by the CHPS integrated modeling tool,and the target cases were searched and verified.Results A total of 487 target cases were searched,after removing duplicate cases and screening,47 true positive cases were finally verified,and the positive predictive value of the monitoring tool was 10.68%.Among the 47 cases(56 case times)of hemorrhage,the ratio of male to female was 1∶1.04,with most over 60 years old(42 cases,89.36%).The patients′symptoms were mostly gastrointestinal hemorrhage(23 case times,41.07%),followed by concealed hemorrhage(17 case times,30.36%),subcutaneous hemorrhage(seven case times,12.50%),urinary system hemorrhage(seven case times,12.50%),and two cases died.Conclusion Elderly patients have a higher risk of hemorrhage when using rivaroxaban,and gastrointestinal hemorrhage is a characteristic risk and can induce death,which requires attention.The designed active monitoring tool can improve the detection rate of hemorrhage ADRs/adverse drug events(ADEs)induced by rivaroxaban,and can provide a reference for designing an active monitoring scheme of ADRs induced by a certain drug.