喜炎平注射液文献不良事件个案报道

目的:探讨喜炎平注射液不良事件发生的规律及其影响因素。方法:采用文献计量学的研究方法,全面收集喜炎平注射液的不良事件个案及典型病例报道,参考其销售数据和HIS数据,分析性别、年龄、过敏史、原发病、给药方法、剂量、合并用药、溶媒、不良事件发生时间等的规律。结果:喜炎平注射液不良事件个案报道,14岁以下的患者占60.61%,而HIS数据中,14岁以下用药的人次占88.72%;原发病为呼吸系统感染和发热的不良事件占81.81%;合并使用维生素C注射液的不良事件个案占1/3;输液开始后30 min内发生的不良事件占总数的89.29%;2例死亡病例都有药物过敏史。结论:儿童用药风险没有超过平均水平;对喜炎平合并使用维生素C注射液的安全性,应开展进一步的研究;建议喜炎平注射液静脉滴注开始30min内加以关注;建议对其他药物过敏者应禁用喜炎平注射液。

Adverse event case reports for Xiyanping injection based on literature

Objective: To explore the influencing factors of adverse event of Xiyanping injection. Method: By use of literature metrology, we tried to collect the adverse event cases from literature, and we also obtained the sales data and HIS data of Xiyanping injection, then we made an analysis to the gender, age, allergy, disease, administration method, dosage, combined medication, solvent, time of the adverse event occur. Result: The rate of adverse event for female was larger than male.81.81% adverse events occurred while the treatment of respiratory infection and fever, 1/3 cases combined vitamin C injection, 89.29% cases occurred in 30 min after the transfusion begin, all of the 2 death cases have had drug allergies. Conclusion: The continue studies should be developed to find whether there is relationship between the adverse event and vitamin C injection, Doctors should pay attention to the patient after the transfusion begin in 30 min, the treatment with Xiyanping to patients who have drug allergies should be banned.