目的 对天津市第一中心医院门诊患者氯硝西泮超说明书用药进行真实世界调研，并对超说明书用药证据情况进行循证评价，为临床提供严谨的循证证据提高临床临床合理用药。方法 通过信息系统提取天津市第一中心医院2020年1月—2024年7月门诊患者开具氯硝西泮处方的资料信息。依据氯硝西泮片原研药品说明书中批准相关适应证对判定超说明书用药情况进行统计。根据统计结果，查阅Micromedex^®系统、广东省药学会发布的《超说明书用药目录2024版》等对已收录的适应证进行超说明书用药的合理性评价。若系统中尚未收录某种超说明书用法，则针对这种超说明书用药适应证完成相关证据检索，进行循证评价。结果 研究最终纳入使用氯硝西泮的门诊患者超说明书用药处方4 340张，全部为超适应证用药，主要超适应证包括睡眠障碍、睡眠障碍合并焦虑、焦虑症等。超说明书用药的证据依据均为指南/专家共识与系统评价（SR）/荟萃分析（Meta），经质量评价后发现，虽然证据质量大部分为中到高等质量，但在推荐意见中多数作为二线治疗方案或辅助用药，因此临床应用氯硝西泮时需要谨慎评估。结论 本院门诊患者的氯硝西泮超适应证用药的比例过高，超说明书用药参考指南/专家共识以及SR/Meta时也需要谨慎的辨别证据质量的高低，综合评估患者的获益和风险，对患者谨慎用药，防止药物滥用的情况发生。

Objective The objective is to conduct a real-world survey on the off-label use of clonazepam in Tianjin First Central Hospital outpatient clinic and perform an evidence-based evaluation of such usage, aiming to provide rigorous evidence for improving clinical rational drug use. Methods The data of clonazepam prescription for outpatients in Tianjin First Central Hospital from January 2020 to July 2024 were extracted through the information system. The off-label use of clonazepam tablets was determined according to the relevant indications approved in the drug instructions. According to the statistical results, the rationality of off-label drug use was evaluated by referring to the Micromedex^® system and the “Off-label Drug Catalog 2024 edition” issued by Guangdong Pharmaceutical Society. If some off-label use is not included in the system, the relevant evidence search is completed for this indication of off-label use, and evidence-based evaluation is carried out. Results In this study, a total of 4 340 off-label drug prescriptions for outpatients using clonazepam were ultimately included, all of which pertained to indication off-label use, primarily encompassing insomnia, insomnia combined with anxiety, and anxiety. The evidence of off-label drug use was solely derived from guidelines, expert consensus, and systematic reviews/Meta-analyses. The quality evaluation indicated that while the majority of the evidence was of moderate to high quality, it should be note that most of the recommendations were primarily utilized as second-line treatment or adjuvant medications. Therefore, the clinical use of clonazepam should be carefully assessed. Conclusion The prevalence of off-label clonazepam use among outpatients in our hospital is substantial. When considering off-label drug utilization based on guidelines/expert consensus, or SR/Meta-analyses, it is crucial to meticulously assess the quality of evidence and comprehensively evaluate the benefits and risks for patients. Prescribing medications cautiously is essential in order to mitigate potential for drug abuse.

R971

天津药学中青年科研项目(TJYX2023-06)