门诊沙利度胺超说明书使用的评价及管理

Evaluation and Management of Off-label Use of Thalidomide in the Outpatients

关键词:  沙利度胺  超说明书  循证医学  分级管理  安全用药

Key words:  thalidomide  off-label  evidence-based medicine  hierarchical management  safe medication

摘要:

目的 通过循证医学的方法评价和规范沙利度胺的合理化用药。方法 回顾性调取2017年沙利度胺片处方122张，对超说明书用药的处方进行分类统计，并寻找中外数据库、典籍、指南等循证依据，依照证据质量提出超说明书用药的推荐强度和干预措施。结果 沙利度胺片超说明书使用的主要类型为超适应证，发生率最高的前3位科室分别为血液科、风湿免疫科和口腔科，发生率最高的前3位临床疾病分别为多发性骨髓瘤、原发性骨髓纤维化和复发性阿弗他溃疡。根据超说明书用药分级管理制度，对超说明书用法进行循证分析，同意使用的有1种，限制使用的有5种，特殊使用的有5种，不同意使用的有0种。结论 沙利度胺片超说明书用药现象普遍存在，应严格执行超说明用药制度，促进临床用药安全。

Abstract:

OBJECTIVE To evaluate the clinical use and standardize rational drug use of thalidomide through evidence-based medicine. METHODS A retrospective survey of 122 prescriptions for thalidomide tablets in 2017 was conducted. The prescriptions in which thalidomide was used off-label were categorized, and evidence of Chinese or foreign databases, classics, and guidelines was provided. According to the quality of evidence, proposed recommended strengths and take interventions. RESULTS The main type of off-label use of thalidomide tablets was superindicated. The top three departments with the highest incidence were Hematology, Rheumatology and Immunology, and Stomatology. The top three clinical diagnoses were multiple myeloma, primary myelofibrosis, and recurrent aphthous ulcers. According to the off-label beyond-instructions classification management system, analyzing evidence-based medical evidence, one type was agreed to use, five types were limited used, five typies were specially used, and no type was not agreed to use.CONCLUSION There is a widespread phenomenon of the off-label use of thalidomide tablets. It must be strictly implement off-label management system to promote safe medication.