苦黄注射液致不良反应/不良事件36例分析

Analysis of 36 Cases of ADR/ADE Caused by Kuhuang Injection

目的:了解苦黄注射液致不良反应/不良事件(ADR/ADE)的特点及相关因素,促进临床合理用药。方法:对某院2004-2012年收集到的36例苦黄注射液致ADR/ADE报告中患者的性别及年龄、用药剂量及溶媒、联合用药、ADR/ADE发生时间、ADR/ADE累及器官/系统及临床表现、ADR/ADE的治疗及转归等情况进行统计分析。结果:36例ADR/ADE中,男性患者较多(占58.33%),与就诊的肝病患者性别比例相符;ADR/ADE大部分发生在首次给药后,最快为用药5 min后,最慢为用药23 d后;以皮肤及其附件损害最常见(占38.46%);ADR/ADE经处理后均治愈。结论:应重视和加强苦黄注射液致ADR/ADE的监测和报告工作,严格按说明书使用,并尽量避免联合用药。

OBJECTIVE： To investigate the characteristics and relative factors of adverse drug reactions/event （ADR/ADE） of Kuhuang injection, and to promote rational use of drugs in the clinic. METHODS： 36 cases of ADR/ADE induced by Kuhuang injection during 2004 to 2012 were analyzed statistically in respects of the patients＇ gender and age, dosage, solvent, drug combination, occurrence time of ADR/ADE, organs or systems involved, clinical manifestations, treatment and outcome of ADR/ADE, ect. RESULTS： Of 36 ADR cases, male showed higher proportion （58.33%）, which was consistent with the sex ratio of the pa- tients with liver disease. Most adverse drug reactions occurred after the frist medication, the fastest 5 minutes after administration, and the slowest 23 days after medication in which. Lesion of skin and the appendants were the most common manifestations, accounting for 38.46%. Treatments of ADR/ADE were cured. CONCLUSIONS： Great importance should be attached to ADR/ADE monitoring and reporting induced by Kuhuang injection, to use Kuhuang Injection strictly according to package inserts and avoid combination.