阿立哌唑在儿童青少年中超说明书用药循证证据评价及用药分析

Evaluation of Evidence-Based Medicine Evidence and Drug Analysis of Off-Label Use of Aripiprazole in Children and Adolescents

关键词:  阿立哌唑  儿童青少年  超说明书用药  循证医学  分析评价

Key words:  aripiprazole  children and adolescents  off-label drug use  evidence-based medicine  analysis and evaluation

摘要:

目的? 对阿立哌唑在儿童及青少年精神疾病治疗中超说明书使用的循证医学证据及其临床应用进行评价,为临床合理用药提供参考。方法 收集国内外药品说明书、临床指南共识、诊疗规范、医学文献资料,筛选并采纳最高级别的循证医学证据,建立阿立哌唑在儿童青少年精神疾病中超说明书用药的循证证据评价表。抽取安徽医科大学附属亳州医院2023年1月1日—2024年10月30日接受阿立哌唑治疗的儿童青少年门诊及住院病例,根据建立的循证评价表对其临床超说明书使用情况进行分析评价。结果 共纳入超说明书适应证23种,包括“强推荐”7种,“中等强推荐”3种,“弱推荐”1种,“不推荐”12种。507例门诊住院患者中超说明书用药占比为66.86%,“中等强推荐”及以上推荐等级的占比为66.08%。结论 阿立哌唑在儿童青少年精神疾病中存在广泛的超说明书使用现象,大部分常见病种的推荐等级较高,但仍需关注循证证据不足的超说明书用药问题,同时应加强超说明书用药的管理,提高用药的安全性与合理性。

Abstract:

ABSTRACT: OBJECTIVE To evaluate the evidence-based medical evidence and clinical use of aripiprazole in treating of mental disorders in children and adolescents, and to provide a reference for clinical rational use of drugs. METHODS Through the collection of domestic and international drug instructions, clinical guidelines and consensus, diagnosis and treatment norms, medical literature materials, and screen and adopt the highest level of evidence-based medical evidence, establish an evidence-based evaluation table for the off-label drug use of aripiprazole in children and adolescents with mental disorders. Extract outpatient and inpatient cases of children and adolescents treated with aripiprazole from The Affiliated Bozhou Hospital of Anhui Medical University from January 1, 2023 to October 30, 2024, and analyze and evaluate the clinical off-label drug use in accordance with the established evidence-based evaluation table. RESULTS A total of 23 off-label indications were included, including 7 “strongly recommended”, 3 “moderately strongly recommended”, 1 “weakly recommended”, and 12 “not recommended”. Among the 507 outpatient and inpatient patients, the proportion of off-label drug use was 66.86%, and the proportion of "moderately strongly recommended" and above recommended levels is 66.08%. CONCLUSION Aripiprazole has a wide range of off-label drug use in mental diseases of children and adolescents, and most common diseases have a high recommendation grade, However, it still needs to pay attention to the problems of off-label drug use with insufficient evidence-based evidence. Simultaneously, it is necessary to strengthen the management of off-label drug use to improve the safety and rationality of medication.