目的 探讨细辛脑注射剂不良反应(adverse reactions,ADR)发生的规律及特点,为临床合理用药提供参考。方法 通过检索国内有关数据库,对细辛脑注射剂ADR病例报告进行文献汇总,统计患者的基本信息、用药情况、ADR等信息,并将危及生命的严重ADR归为本次研究的重点。结果 纳入研究的85例中,重型ADR 41例,构成比48.23%;年龄小于6岁的患者54例(63.41%),发生重型ADR 28例,构成比68.29%; 90.58%ADR出现在用药10 min内,80.48%的重型ADR发生时间小于5 min;ADR累及循环系统156例次,占34.51%;呼吸系统116例次,占25.66%。有2例经治疗无效死亡,1例经治疗13 d后失视,其余82例均经治疗后症状好转。结论 细辛脑注射剂引起的ADR以过敏反应为主,其发生与多种因素有关,发生重型ADR如不及时救治可导致死亡,建议临床要做好ADR的监测与防范。

Objective To study the patterns and characteristics of adverse reactions induced by asarone injection and to provide reference for rational use of drug by clinician.Methods By retrieving data from domestic databases, we collected literature about cases of ADRs and information about the patients and medication. Life-threatening cases of ADRs were chosen as the severe ADR in this study.Results Among the eighty-five cases of adverse reactions in this study, there were forty-one cases of severe ADRs, accounting for 48.23%. Fifty-four of the patients were under six years old (63.41%), twenty-eight of whom were severe cases of ADRs, making up 68.29%. 90.58% of the adverse reactions occurred within 10 minutes of administration and 80.48% of the cases of severe ADRs took place in less than 5 minutes. The circulation system was damaged by adverse reactions 156 times, accounting for 34.51%, while the respiratory system was impaired 116 times, accounting for 25.66%. Two patients died from futile treatment, one patient lost eyesight after 13 days of treatment, and the remaining eighty-two patients improved after treatment.Conclusions Adverse reactions caused by asarone injection are mainly allergic reactions and related to multiple factors. Severe ADRs can lead to death unless dealt with without delay. Hence, it is recommended that clinicians should monitor and prevent adverse reactions induced by asarone injection.