摘要
目的：探讨舒血宁注射液所致不良反应（ ADR）的特点，为临床安全用药提供依据。方法采集北京不良反应监测中心数据库的2008年-2013年的舒血宁注射液不良反应报表，从单次剂量、给药频次、输液溶媒、ADR发生时间、ADR累及器官或系统及临床表现等进行回顾性分析。结果1205例舒血宁不良反应报告中，男477例（39.6%），女728例（60.4%），平均年龄（63.2±12.5）岁；舒血宁ADR发生时间，表现为用药后的各个时间段；不良反应累及机体多个系统/器官，其中皮肤及附件损害最多，占23.2%，其次为神经系统损害（20.2%）、循环系统损害（18.0%）等；用药剂量符合药品说明书的1120例，记录输液溶媒的290例报表中，200例未按药品说明书推荐溶媒使用。严重报表19例，表现为过敏样反应（8例）、过敏性休克（5例）、周身皮疹伴瘙痒（3例）、急性肾衰竭（1例）、肝细胞损害（1例）、血小板减少（1例）。结论舒血宁所致的不良反应可累及机体多个系统/器官，严格按照药品说明书合理用药，注意ADR监测，警惕药品不良反应发生。
Abstract
Objective To explore the characteristics of adverse reactions caused by Shuxuening In-jection and provide the basis for safety using in clinical. Methods To collect the Shuxuening Injection ad-verse reaction reports during 2008 -2013 from the database of Beijing ADR Monitoring Center and from a single dose,frequency,drug infusion solvent,ADR occurrence time,ADR involving organs or systems,as well as clinical manifestations were retrospectively analyzed. Results Among the 1205 ADR cases,477 cases (39. 6%)were male and 728 cases(60. 4%)were female,the average age of the patients was(63. 2 ± 12. 5) years old. The ADRs induced by Shuxuening injection occurred at different time after drug administration. The ADRs could involve multiple organs and systems,with the most frequent in skin and its appendages (23. 2%),followed by nervous system disorders(20. 2%),circulatory system disorders(18. 0%),etc.;In the dosage,the 1120 ADR cases were used according to the drug instructions and there are 200 cases of fail-ure to use the drug instructions recommendation solvent in 290 cases recorded. There were 19 cases of serious ADRs,with the performance of allergy-like reaction(8 cases),manifestations of allergic shock(5 cases), whole body skin rash with itching(3 cases),acute renal failure(1 case),liver cells disorders(1 case)and platelets reduction(1 case). Conclusion The ADRs caused by Shuxuening Injection could involve multiple organs and systems,we should be strictly in accordance with the drug instructions for rational drug use and pay attention to the ADR monitoring,in order to avoid adverse reactions.
国家科技期刊平台
NSTL
维普
万方数据