目的 對(duì)天津市第一中心醫(yī)院門診患者氯硝西泮超說明書用藥進(jìn)行真實(shí)世界調(diào)研，并對(duì)超說明書用藥證據(jù)情況進(jìn)行循證評(píng)價(jià)，為臨床提供嚴(yán)謹(jǐn)?shù)难C證據(jù)提高臨床臨床合理用藥。方法 通過信息系統(tǒng)提取天津市第一中心醫(yī)院2020年1月—2024年7月門診患者開具氯硝西泮處方的資料信息。依據(jù)氯硝西泮片原研藥品說明書中批準(zhǔn)相關(guān)適應(yīng)證對(duì)判定超說明書用藥情況進(jìn)行統(tǒng)計(jì)。根據(jù)統(tǒng)計(jì)結(jié)果，查閱Micromedex^®系統(tǒng)、廣東省藥學(xué)會(huì)發(fā)布的《超說明書用藥目錄2024版》等對(duì)已收錄的適應(yīng)證進(jìn)行超說明書用藥的合理性評(píng)價(jià)。若系統(tǒng)中尚未收錄某種超說明書用法，則針對(duì)這種超說明書用藥適應(yīng)證完成相關(guān)證據(jù)檢索，進(jìn)行循證評(píng)價(jià)。結(jié)果 研究最終納入使用氯硝西泮的門診患者超說明書用藥處方4 340張，全部為超適應(yīng)證用藥，主要超適應(yīng)證包括睡眠障礙、睡眠障礙合并焦慮、焦慮癥等。超說明書用藥的證據(jù)依據(jù)均為指南/專家共識(shí)與系統(tǒng)評(píng)價(jià)（SR）/薈萃分析（Meta），經(jīng)質(zhì)量評(píng)價(jià)后發(fā)現(xiàn)，雖然證據(jù)質(zhì)量大部分為中到高等質(zhì)量，但在推薦意見中多數(shù)作為二線治療方案或輔助用藥，因此臨床應(yīng)用氯硝西泮時(shí)需要謹(jǐn)慎評(píng)估。結(jié)論 本院門診患者的氯硝西泮超適應(yīng)證用藥的比例過高，超說明書用藥參考指南/專家共識(shí)以及SR/Meta時(shí)也需要謹(jǐn)慎的辨別證據(jù)質(zhì)量的高低，綜合評(píng)估患者的獲益和風(fēng)險(xiǎn)，對(duì)患者謹(jǐn)慎用藥，防止藥物濫用的情況發(fā)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

天津藥學(xué)中青年科研項(xiàng)目(TJYX2023-06)