医院2008—2019年皮肤药物不良反应回顾性分析

Retrospective Analysis of Cutaneous Adverse Drug Reactions in Hospital from 2008 to 2019

关键词:  皮肤  药物不良反应  儿童  安全用药

Key words:  cutaneous  adverse drug reactions  children  safe drug use

摘要:

目的 探讨南京医科大学附属儿童医院皮肤药物不良反应（cutaneous adverse drug reactions，CADRs）发生的特点及规律，为儿童安全用药提供参考。方法 通过国家药品不良反应监测系统导出2008年1月—2019年12月医院上报的1 290例CADRs病例报告，收集这些患儿发生CADRs的临床表现、类别、涉及的药物及患儿治疗病程等信息并建立数据库。结果 1 290例CADRs病例报告中，男性患儿802例，占比62.17%，其CADRs病例报告明显高于女性患儿，同时本研究发现幼儿期（1~6岁）儿童CADRs发生率最高；共涉及药品137种，主要类型为抗菌药物和中药及其提取物，涉及的药品剂型以注射剂为主，给药途径以静脉滴注为主，最为常见的皮肤黏膜损害为斑丘疹（694例，54.56%）。CADRs中罕见的严重皮肤黏膜损害有18例，涉及的主要药物类型为抗癫痫药物及抗感染药物，皮肤黏膜损害以重症多形红斑以及抗癫痫药物高敏综合征为主，绝大部分严重皮肤药品不良反应经对症治疗后好转，但有1例患儿死亡。结论 根据CADRs发生的规律和特点，临床医师要及时观察CADRs的发生以减少药源性不良反应的发生，同时重点监护特殊人群用药，保障患者安全用药。

Abstract:

OBJECTIVE To explore the characteristics and regularity of the occurrence of cutaneous adverse drug reactions(CADRs) in the Children's Hospital of Nanjing Medical University and provide reference for clinical safety and rational use of drugs tor children. METHODS The 1 290 CADRs cases reported by the hospital where the author work in from January 2008 to December 2019 were derived through the National Adverse Drug Reaction Monitoring System, and the information on the clinical manifestations, categories, medications involved, and treatment history of CADRs in these children were collected to establish a database. RESULTS Among the 1 290 CADRs cases, 802 cases were male, accounting for 62.17%, and the CADRs cases were significantly higher than those of female children. Meanwhile, the incidence of CADRs was highest in young children(1-6 years old). There were 137 kinds of drugs involved. The main types were antibacterial drugs and traditional Chinese medicines. The dosage forms involved were mainly injectable, and the drug delivery route was mainly intravenous infusion. The most common skin mucosal damage was maculopapular rash(694 cases, 54.56%). There were 18 cases of rare severe skin and mucosal damage in CADRs, and the main types of drugs involved were anti-epileptic drugs and anti-infective drugs. The skin and mucous membrane damage was dominated by severe multitype erythema and anti-epileptic drug hypersensitivity syndrome. Most of the severe skin adverse reactions were improved after symptomatic treatment, but one pediatric patient died. CONCLUSION According to the regularity and characteristics of CADRs, clinicians should observe the occurrence of CADRs so as in time to reduce the occurrence of drug-induced adverse reactions. At the same time, clinicians should also focus on monitoring the use of drugs for special populations to ensure the safety of drug use.