目的 探討熱毒寧注射液導(dǎo)致兒童不良反應(yīng)（ADR）的一般規(guī)律及特點(diǎn)，促進(jìn)臨床合理用藥。方法 對南京醫(yī)科大學(xué)附屬南京兒童醫(yī)院2012年1月-2015年12月使用熱毒寧注射液致104例ADR患者的性別、年齡、原患疾病、給藥劑量、ADR發(fā)生時間、聯(lián)合用藥情況、ADR累及器官/系統(tǒng)及臨床表現(xiàn)、轉(zhuǎn)歸等進(jìn)行回顧性分析。結(jié)果 男性患兒發(fā)生ADR的比例相對較高，占55.77%；以單次給藥劑量10 mL發(fā)生率最高，占35.24%；ADR出現(xiàn)時間多數(shù)在用藥初期，用藥30 min內(nèi)發(fā)生的占66.34%；臨床表現(xiàn)以皮膚及附件損害（38.89%）、全身性損害（30.15%）為主，經(jīng)停藥及對癥治療后均預(yù)后良好。結(jié)論 兒童是熱毒寧注射液ADR的高發(fā)群體，臨床使用應(yīng)辨證施治、規(guī)范用藥，加強(qiáng)用藥監(jiān)測，密切防范不良反應(yīng)的發(fā)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.

南京醫(yī)科大學(xué)科技發(fā)展基金面上項(xiàng)目（2015NJMU068）