目的 采用循證醫(yī)學(xué)方法對蕪湖市第二人民醫(yī)院來那度胺超說明書用藥情況進(jìn)行評價，為促進(jìn)臨床合理使用新型抗腫瘤藥物提供參考。方法 按照《超說明書用藥循證評價規(guī)范》與權(quán)威指南建立新型抗腫瘤藥物超說明書用藥評價標(biāo)準(zhǔn)與循證醫(yī)學(xué)評價流程。回顧性調(diào)查蕪湖市第二人民醫(yī)院2021年1月—2023年12月住院患者使用來那度胺的病例資料，統(tǒng)計來那度胺超說明書用藥情況。根據(jù)評價標(biāo)準(zhǔn)對超說明書用藥進(jìn)行循證評價。結(jié)果 共收集使用來那度胺的病例資料87例，其中超說明書用藥39例，占比44.83%，超說明書用藥類型包括適應(yīng)證、劑量與療程。39例超說明書用藥中處于復(fù)發(fā)/難治階段患者的構(gòu)成比為64.10%。評價為“建議使用”“限制使用”“特殊使用”“不建議使用”構(gòu)成比分別為15.39%、56.41%、25.64%、2.56%。結(jié)論 來那度胺超說明書用藥較常見，存在評價結(jié)果為不建議使用的超說明書用藥，醫(yī)療機(jī)構(gòu)應(yīng)加強(qiáng)超說明書用藥管理。該院利用循證醫(yī)學(xué)方法制定的評價標(biāo)準(zhǔn)為新型抗腫瘤藥物超說明書用藥評價提供參考價值。

Objective To evaluate the off-label use of lenalidomide using evidence-based medicine methods in the Second People’s Hospital of Wuhu, in order to provide reference for promoting the rational use of new anti-tumor drugs in clinical practice. Methods Establish evaluation criteria and evidence-based medical evaluation process for the off-label use of new anti-tumor drugs in accordance with Evidence-Based Evaluation Specification for Off-label Drug Use and Authoritative Guidelines. Case data from inpatients that using lenalidomide were retrospectively investigated in the Second People’s Hospital of Wuhu from January 2021 to December 2023, and the off-label drug use were statistically analyzed and reviewed by evidence-based evaluation criteria. Results A total of 87 cases using lenalidomide were collected from the hospital, of 39 cases were off-label drug use, accounting for 44.83%, the main categories of off-label drug use were indication, dosage, course of treatment. Among the off-label use of lenalidomide, 64.10% were in the stage of relapsed/refractory treatment. The proportions of “recommended use” “restricted use” “special use” and “not recommended use” were 15.39%, 56.41%, 25.64%, 2.56%, respectively. Conclusion The off-label use of lenalidomide is more common, and there are evaluation results indicating that it is not recommended to use. Medical institutions should strengthen the management of the off-label drug use. The evaluation criteria established by using evidence-based medicine methods provide reference value for evaluation of the off-label use of new anti-tumor drugs.

R979.1