布洛芬口服制剂致不良反应/事件监测数据分析

目的分析布洛芬口服制剂致不良反应/事件的特点及可能原因,为临床合理用药提供参考。方法整理2012年山东省药品不良反应监测系统收集的布洛芬口服制剂不良反应/事件监测数据,分别从患者年龄、性别、原患疾病与过敏史、用法用量、不良反应表现和合并用药等方面分析。结果布洛芬致不良反应在各个年龄段均有发生,男性(57.66%)略多于女性(42.34%);临床使用时主要用于清热、解毒、镇痛等,无超适应证用药情况;布洛芬不良反应数据中超剂量使用估计占4.43%,长期使用估计占2.85%;不良反应主要累及胃肠系统,严重不良反应表现为胃肠道出血、过敏性休克等;视觉损害不良反应占所有不良反应的1.18%。结论布洛芬疗效是确切的,但要关注布洛芬导致的严重胃肠道损害、过敏性休克和视觉损害等反应。

Analysis of 1 332 cases adverse reactions/events induced by oral preparations of ibuprofen

Objective To provide some references for clinical rational drug use by analysis the influence factors of ad- verse drug reactions induced by the oral preparations of ibuprofen. Methods Retrieval the data induced by ibuprofen in Shandong adverse drug reaction monitoring system received from Jan. 2012 to Dec. 2012. And analysis of the patients＇ age, gender, original disease, allergy, usage, dosage, clinical manifestations, and the drug combination, etc. Results The adverse drug reactions occurred at all ages. The male patients were more than female slightly. Clinical use was mainly used to clear heat, dctoxification and analgesia. There were no super indications medications. The overdose in adverse drug reaction data was estimated to 4. 43%. The long - term use was estimated to 2. 85%. Adverse reactions mainly involved the gastrointesti- nal system. The serious adverse reactions were gastrointestinal bleeding,anaphylactic shock, etc. Visual impairment adverse reactions accounted for 1.18% of all adverse reactions. Conclusion Although the ibuprofen＇s curative effect was exact, more attention was needed to focus on severe gastrointestinal reactions, anaphylactic shock and visual impairment.