北京地区2003-2013年舒血宁注射液致不良反应回顾性分析  

Retrospective Analysis of ADR Induced by Shuxuening Injection in Beijing Area during 2003-2013

作　　者：朱盛[1] 邢百倩[2] 梅丹[1] 冯雷[1] 张晓[3] 

机构地区：[1]中国医学科学院北京协和医院药剂科,北京100730 [2]首都医科大学电力教学医院药剂科,北京100073 [3]北京市药品不良反应监测中心,北京100054

出　　处：《中国药房》2017年第26期3643-3646,共4页China Pharmacy

基　　金：国家临床重点专科建设项目

摘　　要：目的:调查北京地区舒血宁注射液致药品不良反应(ADR)发生情况,为临床合理用药提供参考。方法:对北京地区2003-2013年舒血宁致ADR上报信息进行统计归类,对发生人群、ADR累及器官/系统及临床表现、发生时间、合并用药和预后情况等进行回顾性分析。结果:在1 648例ADR报告中,老年患者的ADR发生率高于青壮年患者,女性患者发生率(60.92%)高于男性患者(39.08%)。ADR累及多个器官/系统,前3位的是神经系统(422例,21.33%)、皮肤及其附件(411例,20.78%)和其他(305例,15.42%)。临床表现主要为皮疹、瘙痒,头晕和心慌、心悸、心律失常等。ADR多发生在给药后5~30 min(27.10%)。ADR报告中存在舒血宁注射液与多种药物联合使用的情况,其中联合前列地尔注射液最为常见(61例,占联合用药患者的23.46%)。在1 648例ADR中,622例痊愈,1 039例好转,4例未好转,3例有后遗症,1例死亡。结论:临床使用舒血宁注射液应严格遵循说明书适应证,按照规定的剂量、溶剂、输注方式等使用;还应加强处方审核和用药后的监护观察,尤其对老年等特殊人群的使用要尤为关注,以减少和避免ADR的发生。OBJECTIVE： To investigate the occurrence of ADR induced by Shuxuening injection in Beijing area, and to pro- vide reference for rational drug use in clinic. METHODS： ADR induced by Shuxuening injection in Beijing area during 2003-2013 was classified statistically in respects of population, organs/systems involved in ADR, clinical manifestations, occurrence time, drug combination and prognosis. RESULTS： Of 1 648 ADR cases, the incidence of ADR in the elderly patients was higher than young patients, and that of female patients （60.92%） was higher than that of male patients （39.14%）. Multiple organs/systems were involved in Shuxuening injection-induced ADR, and top 3 were nervous system （422 cases, 21.33% ）, skin and its appen- dants （411 cases, 20.78% ） and others （305 cases, 15.42% ）. Clinical manifestations were skin rash, itching, dizziness and ner- vousness, palpitation, arrhythmia, etc. ADR mostly occurred within 5-30 min after medication. In ADR reports, there were a vari- ety of drugs combined with Shuxuening injection. Shuxuening injection combined with Alprostadil injection was most common （61 cases, accounting for 23.46% of drug combination）. Among 1 648 ADR cases, there were 622 cured cases and 1 039 cases im- proved, 4 cases were not improved, 3 cases had sequelae and 1 case died. CONCLUSIONS： Clinical application of Shuxuening in- jection should strictly follow the indications of drug package inserts; differentiation of symptoms and signs is based on specific dos- age, solvent, route of administration, etc. It is necessary to strengthen the prescription check, and strengthen the observation after medication especially for the elderly and other special groups so as to reduce and avoid ADR.

关 键 词：舒血宁注射液 不良反应 分析 合理用药 

分 类 号：R969.3[医药卫生—药理学]