55例清开灵注射液不良反应文献分析

Analysis of 55 Adverse Drug Reactions Induced by Qingkailing Injection

目的:探讨清开灵注射液所致不良反应(ADR)的规律和特点,为临床安全用药提供参考。方法:对2000–2009年国内医药期刊报道的清开灵注射液所致ADR性别与年龄分布、既往过敏史、ADR出现时间、原患疾病、用药情况、主要临床表现、抢救措施及预后等进行统计分析。结果:55例ADR中,男、女患者分别占58.18%和41.82%,儿童和青壮年发生比例相对较高(63.63%),ADR大多发生在用药30min内,主要以全身性损害(61.82%)和皮肤及其附件损害(16.36%)为主。过敏性休克发生例次较多。结论:临床应当严格对清开灵注射液的使用,重视过敏性休克反应。

Objective： To discuss the general characteristics of the ADRs induced by qingkailing injection, and provide guideline for rational drug use in clinic. Methods： 55 ADR cases induced by qingkailing injection reported in domestic medical journals from 2000 to 2009 were collected and statistically analyzed in respect of the distribution of gender and age, the condition of anaphylaxis, occurrence time of ADRs, the primary diseases, utilization of drugs, main clinical manifestations, rescuing measures and prognosis. Results： Among the 55 ADR cases, the proportions of the male and female patients were 58.18% and 41.82%, and the proportions of ADR that happened to children and young were relatively high （63.63%）. Most of the ADR induced by qingkailing injection occurred within 30 minutes after medication. The disorders of the whole body and skin （61.82%） and appendants damage （16.36%） occupied mostly in ADR cases. The incidence of allergic shock was high. Conclusion： Doctor should use the medicine strictly, and pay more attention to the anaphylactic shock. The monitoring of the medicine should be emphasized to reduce the incidence of ADRs.