住院患者静注人免疫球蛋白超说明书用药的循证评价

Evidence-Based Evaluation of Off-Label Administration of Intravenous Immunoglobulin in Inpatients

目的:对本院患者静注人免疫球蛋白(IVIg)超说明书用药进行调查及循证评价分析,为临床合理应用IVIg提供参考。方法:回顾性分析2018年1月~2020年12月本院住院患者应用IVIg的情况。以药品说明书为依据,点评是否有超说明书使用情况。查阅Micromedex数据库,若收录,进行证据分级;若未收录,搜索中英文循证医学文献后进行证据分级,以评价超说明书应用IVIg的合理性。结果:使用IVIg的患者共计204例;160例(78.43%)为超说明书用药,包括超适应症用药125例(78.13%)、超剂量用药17例(10.62%)、超疗程用药18例(11.25%);循证等级中低证据等级(C类)56例(35.0%)、无证据33例(20.7%)。结论:IVIg超说明书用药比例较高,且存在低证据等级或无证据的情况,应进一步研究和评价应用该药品的必要性。

Objective:In order to provide references for rational clinical application of human immunoglobulin,investigation and evidence-based evaluation of off-label application of intravenous immunoglobulin(IVIg)in our hospital were conducted.Methods:The application of intravenous human immunoglobulin in inpatients from January 2018 to December 2020 in our hospital was retrospectively analyzed.off-label uses were collected based on drug instructions.Evidence for off-label uses were classifi ed by referring to Micromedex database.If off-label use was not included in Micromedex,search Chinese and English evidence-based medical literatures and perform evidence grading to evaluate the rationality of off-label application of human immunoglobulin.Results:A total of 204 patients received intravenous injection of human immunoglobulin,160 cases(78.43%)were used off-label,including 125 cases(78.13%)for indication,17 cases(10.62%)for over-dose and 18 cases(11.25%)for over-course of treatment.There were 56 cases(35.0%)with low level of evidence(grade C)and 33 cases(20.7%)without evidence.Conclusion:The proportion of off-label drug use of human immunoglobulin is high,and some of them have low level evidence or no evidence.Further study and evaluation of the necessity of the drug use should be conducted.