摘要
目的:探讨炎琥宁注射剂致不良反应/事件(ADR/ADE)发生的一般规律及特点,为临床合理使用炎琥宁注射剂提供参考。方法:对2008～2009年深圳市各单位上报的139例与炎琥宁注射剂有关的ADR/ADE报告进行分类统计、分析。结果:139例ADR/ADE涉及到6个厂家生产的产品,ADR/ADE在0～9岁人群构成比为57.14%且呈现性别差异;ADR/ADE可累及人体多个器官系统,主要累及皮肤及附件,其次为神经系统、循环系统等,严重者可出现过敏性休克。ADR/ADE多发生在30 min以内,绝大多数ADR/ADE经治疗后转归良好。低龄人群,特别是0～9岁婴幼儿、儿童给药剂量、浓度严重偏高。结论:炎琥宁注射剂可致过敏性休克等严重ADR/ADE发生,应提高合理用药水平,加强炎琥宁注射剂用药监护,以减少ADR/ADE发生,保障患者用药安全。
Objective：To investigate the essential characteristics and regularity of adverse drug reactions/events （ADR/ADE） induced by yanhuning injection to provide references for its rational clinic use. Method：A statistical analysis of 139 cases of its ADR/ADE reports was conducted from all healthcare settings from 2008 to 2009. Result：Yanhuning injection from six manufactories was involved in 139 ADR/ADE reports. 57.4% of ADR/ADE occurred in the 0-9 age＇ s population with some extent gender discrepancy. The single ADR/ADE could lead to more than one organ/system lesion and their clinical manifestations were various. The lesions of ADR/ADE were primarily involved in skin and its accessories, followed by the nerve system, circulation system, etc. The allergic shock was observed in some severe-ADR/ADE reports. The onset time of most ADRs/ADEs was within 30 min after intravenous administration and most ADR./ADE had good prognosis after withdrawal of medication and anti-allergy treatment. The dosage and concentration of yanhuning administrated to the 0-9 age＇ s population were abnormally high. Conclusion ： Yanhuning injection could lead to some deadly ADRs/ADEs, such as allergic shock. The rational use and monitoring of yanhuning injection should be improved and strengthened so as to decrease the occurrence of ADR/ADE cases and ensure the patient＇ s safety.
出处
《药物流行病学杂志》
CAS
2011年第7期340-343,共4页
Chinese Journal of Pharmacoepidemiology
