目的 探讨热毒宁注射液导致儿童不良反应（ADR）的一般规律及特点，促进临床合理用药。方法 对南京医科大学附属南京儿童医院2012年1月-2015年12月使用热毒宁注射液致104例ADR患者的性别、年龄、原患疾病、给药剂量、ADR发生时间、联合用药情况、ADR累及器官/系统及临床表现、转归等进行回顾性分析。结果 男性患儿发生ADR的比例相对较高，占55.77%；以单次给药剂量10 mL发生率最高，占35.24%；ADR出现时间多数在用药初期，用药30 min内发生的占66.34%；临床表现以皮肤及附件损害（38.89%）、全身性损害（30.15%）为主，经停药及对症治疗后均预后良好。结论 儿童是热毒宁注射液ADR的高发群体，临床使用应辨证施治、规范用药，加强用药监测，密切防范不良反应的发生。

Objective To investigate the adverse drug reaction (ADR) induced by Reduning Injection occurred in chlderen and to provide guidance for clinical rational drug use. Methods The age, sex, original illness, single dose, time of ADR occurrence, combinations, ADR involved organs or systems, clinical manifestations, and outcomes of 104 cases induced by Reduning Injection from January 2012 to December 2015 in Nanjing Children's Hospital Affiliated to Nanjing Medical University were statistically analyzed. Results The ADR of Reduning Injection commonly occur in children, with boys majority(55.77%), 35.24% cases were given the single dose of 10 mL, and about 66.34% cases occurred within 30 min after administration. Clinical symptoms were mainly with skin and its appendages and the whole system damage was accounting for 38.89% and 30.15% respectively. All were recovered by timely treatment. Conclusion Children are the high-risk group of this drug, and it is suggested that we should insist on treatment based on syndrome differentiation and standard medication, and strengthen supervision to reduce the incidence of ADR induced by Reduning Injection.

南京医科大学科技发展基金面上项目（2015NJMU068）