32203例注射用尖吻蝮蛇血凝酶相关变态反应自动监测研究

Incidence and risk factors of allergic reaction related by haemocoagulase agkistrodon for injection among 32203 patients by automatic surveillance

目的分析注射用尖吻蝮蛇血凝酶大样本人群中相关变态反应的发生率、发生特征及影响因素。方法依托"医疗机构药物不良事件主动监测与智能评估警示系统"(ADE-ASAS),对2016年7月至2018年7月间使用注射用尖吻蝮蛇血凝酶的住院患者进行自动监测。对报警的药品不良反应/事件(ADR/ADE)疑似病例辅以人工评价后,最终获得其致皮肤损害、过敏性休克和过敏样反应的发生率、发生特征及相关影响因素。结果32203例用药人群的系统自动监测用时约2 h;最终皮肤损害发生率为1.00‰;过敏样反应发生率为0.09‰,未监测到过敏性休克病例。用药天数是注射用尖吻蝮蛇血凝酶致皮肤损害的影响因素。结论注射用尖吻蝮蛇血凝酶致皮肤损害和过敏样反应的合计发生率为1.09‰,属于偶见。用药天数每增加1天,患者出现皮肤损害的风险在发生率1.00‰的基础上增加26.60%,提示在临床用药中应严格掌握适应证和用药时间。

Objective gic reaction related by haemocoagulase agkistrodon for injection.Methods The data of inpatients from July in 2016 to July in 2018 was analyzed retrospectively with active surveillance and assessment system of adverse drug events(ADE-ASAS).After re-evaluation by clinical pharmacists,the incidence and risk factors of skin lesion,anaphylactic shock and anaphylactoid reaction related by haemocoagulase agkistrodon were analyzed.Results A total of 32203 cases using haemocoagulase agkistrodon were automatically surveilled,and the running time of this system was about 2 hours.The incidence of adverse skin reaction was 1.00‰.The incidence of anaphylactoid reaction was 0.09‰.No cases of anaphylactic shock were surveilled.The duration of drug was associated with haemocoagulase agkistrodon-related adverse skin reactions.Conclusion The incidence of adverse skin reaction and anaphylactic shock was1.09‰at anoccasional level.With the increase of duration of drug,the risk of adverse skin reaction increases by 26.60%.It is suggested that the indications and medication time should be strictly ordered in clinical medication.