四川省药品不良反应监测中心2016年11月-2017年11月妊娠期患者药品不良反应回顾性分析

Retrospective Analysis of Gestational Adverse Drug Reactions from Sichuan Center for Adverse Drug Reaction Monitoring from Nov. 2016 to Nov. 2017

目的:了解四川省妊娠期(包括围产期)患者药品不良反应(ADR)发生的特点及规律,为保障临床用药安全、有效提供依据。方法:对2016年11月-2017年11月上报至四川省药品不良反应监测中心的妊娠期患者ADR进行统计分析,包括上报来源及人员分布、患者基本情况、给药途径、药品分类及主要药品、累及系统/器官、分级及转归等。结果:共计上报1 309例(1 340例次)妊娠期患者ADR,其中医疗机构上报1 305例、经营企业上报3例、生产企业上报1例,医师上报986例、护士上报188例、药师上报133例、药品安全专员上报2例;859例为21~30岁,占比最大(65.62%);867例次由静脉给药引起(64.70%);引起ADR的药品种类以生殖系统用药(491例次,36.64%)、抗微生物药(479例次,35.75%)和血液系统药(110例次,8.21%)为主,主要药品为卡前列素氨丁三醇注射液(187例次、13.96%)、注射用头孢唑林钠(122例次,9.10%)和缩宫素注射液(105例次,7.84%);ADR主要累及皮肤及其附件(517例次,33.95%)、胃肠系统(387例次、25.41%)和全身(175例次,11.49%);在1 309例妊娠期ADR中,一般ADR有1 251例(95.57%)、严重ADR有58例(4.43%,包括14例危及生命、7例住院时间延长和37例其他),患者好转592例(45.22%)、痊愈716例(54.70%)、未好转1例(0.08%)。结论:临床应加强对妊娠期患者的用药监测,特别是监护妊娠期子宫收缩药物和抗微生物药的不良反应,谨慎用药,促进妊娠期患者临床用药安全。

OBJECTIVE:To investigate the characteristics and regularity of gestational(including perinatal period)adverse drug reactions(ADR)in Sichuan province,and to provide evidence for ensuring the safety and effectiveness of drug use in clinic.METHODS:Gestational ADR reported to Sichuan provincial ADR monitoring center from Nov.2016 to Nov.2017 were statistically analyzed in respects of report source,personnel distribution,general information of patients,route of administration,drug types and main drugs,involved system/organ,grading and outcome,etc.RESULTS:A total of 1 309 gestational ADR cases(1 3/40 case time)were collected,in which 1 305 were from medical institutions,3 from enterprises and 1 from manufacturer.There were 986 physicians,188 nurses,133 pharmacists and 2 commissioners for drug safety.859 cases(65.62%)were 21-30 years old,accounting for the largest proportion.867 case time were caused by intravenous administration(64.70%).ADR-inducing drug types mainly included reproductive system drugs(491 case time,36.64%),antimicrobial drugs(479 case time,35.75%)and blood system drugs(110 case time,8.21%).Main of them were Carboprost tromethamine injection(187 case time,13.96%),Cefazolin sodium for injection(122 case time,9.10%)and Oxytocin injection(105 case time,7.84%).ADR mainly involved skin and its appendants(517 case time,33.95%),gastrointestinal system(387 case time,25.41%),whole body(175 case time,11.49%).In 1 309 gestational ADR,1 251 cases(95.57%)were general ADR;58 cases(14.43%)were severe ADR,including 14 life-threatening cases,7 extended hospital stay and 37 others;592(45.22%)patients improved,716(54.70%)recovered and 1(0.08%)did not improve.CONCLUSIONS:In clinical practice,it is necessary to strengthen the monitoring of drug use in patients during gestational,especially monitor ADR of uterine contraction drugs and antimicrobial drugs during gestational,use drug cautiously and promote clinical medication safety in gestational patients.