壳聚糖膜剂致眼结膜充血不良事件分析

摘要

目的 通过研究2008年8月14日～9月1日期间某院33例术后患者眼结膜充血的突发性群体不良事件,探讨突发性群体不良事件的用药关联性分析方法.方法 调查分析该事件中的患者所使用的药品和药械制品,并进行归纳与分析.结果 排除药品与术后患者眼结膜充血的可能性,而医疗器械产品"医用可降解防术后粘连壳聚糖膜剂"与眼结膜充血存在明显关联性.结论 该眼结膜充血突发性群体不良事件为壳聚糖膜剂所致.%Objective By studying the 33 cases of abrupt group adverse events of conjunctival hyperemia after surgery in a hospital from August 14 to September 1 in 2008, investigated the analysis method for drugs relevance of the abrupt group adverse events cases. Methods The medicines and the medical device products were investigated and analysed, and an inductive analysis was made. Results The probability of the relevance between medicines and the conjunctival hyperemia of the patients after surgery was excluded, and there was significant relevance between the medical device product, medical biodegradable chitosan preventing postsurgical adhesion, and the conjunctival hyperemia. Conclusion The abrupt group adverse events of conjunctival hyperernia was caused by medical biodegradable chitosan preventing postsurgical adhesion.