雷公藤多苷超说明书用于儿童的用药分析

目的:调查雷公藤多苷在儿童中的使用情况,为该药的合理应用提供基础数据。方法:抽取广州某三甲医院2011年7月1日-2016年6月30日5年间使用雷公藤多苷住院患者的病历,收集18岁以下患儿相关资料,对其基本情况、疾病情况、用药情况等进行分析。结果:共抽出符合条件的患者584例,其中18岁以下患者66例。男性41例,女性25例。主要诊断为过敏性紫癜和肾病综合征,其余诊断包括强直性脊柱炎、系统性红斑狼疮、类风湿性关节炎等。住院主要方案为雷公藤多苷单药或联合激素,少数联合免疫抑制剂。部分患儿日剂量超过1.5 mg·kg^-1。部分病历缺少知情同意书,但签署率基本随年份增加。结论:雷公藤多苷在临床使用中存在超诊疗常规、日剂量过大,未签署知情同意书等情况,需进一步加强管理。

Analysis of off-label use of tripterygium glycosides in children

OBJECTIVE To retrospectively investigate the off-label use of tripterygium glycosides in children.METHODS Medical records of inpatients prescribed tripterygium glycosides between 1^st July 2011 and 30^th June 2016 were extracted from electronic medical records.Baseline data and information on disease and medication for patients under 18 years old were collected and analyzed.RESULTS Totally 584 medical records were extracted.Among them 66 patients were under 18 years old,including 41 males and 25 females.The main diagnoses were allergic purpura and nephrotic syndrome.Other diagnoses included spondylitis ankylopoietica,systemic lupus erythematosus,rheumatoid arthritis,etc.The main therapeutic regimens were tripterygium glycosides alone and tripterygium glycosides combined with glucocorticoids.Twenty-seven children (40.9%) were prescribed tripterygium glycosides at daily doses over 1.5 mg·kg^-1.Thirty-one medical records (47.0%) lacked informed consent forms.But this situation seemed to be improved by years.CONCLUSION In the clinical practice,tripterygium glycosides are administered beyond the routine medical standards,at over doses,without informed consent,etc.,which need to be regulated.