1128张免疫抑制剂处方超说明书用药情况及其不良反应风险分析

Analysis of Off-Label Drug Use of 1 128 Immunosuppressants Prescriptions and its Risks of Adverse Drug Reactions

目的:了解某三级甲等医院(以下简称“该院”)免疫抑制剂超说明书用药情况,探讨超说明书用药的风险,促进合理用药。方法:抽取2016年7月至2018年6月该院门诊所有含免疫抑制剂的处方,筛查出全部超说明书用药处方进行统计分析。依据国内外文献报道、指南及Micromedex工具,分析超说明书用药的依据;应用风险矩阵法,评估超说明书用药的不良反应发生风险水平。结果:统计区间内,该院免疫抑制剂超说明书用药处方共1128张,类型主要为超适应证用药。证据类型包括国外指南(94张,占8.3%)、国内指南(396张,占35.1%)、专家共识(596张,占52.8%)及其他文献(42张,占3.7%);25项免疫抑制剂超说明书用法中,11项(占44.0%)已被Micromedex数据库收录。环孢素的肾毒性,吗替麦考酚酯的呼吸障碍、淋巴瘤及非黑色素瘤和他克莫司的肾毒性、呼吸窘迫综合征等不良反应风险级别为E级,为极严重风险。结论:该院门诊免疫抑制剂超说明书用药均有相关证据支持,但证据质量有差异,存在严重不良反应风险。在实际应用中,建议医院建立超说明书用药评价小组,尽快形成院内专家共识,尽量规避医疗风险,促进合理用药。

OBJECTIVE: To investigate the current status of off-label drug use of immunosuppressants prescriptions in a grade Ⅲ level A hospital(hereinafter referred to as "the hospital"), so as to probe into the risk of off-label drug use and promote the rational drug use. METHODS: Immunosuppressants prescriptions from the outpatient department of the hospital from Jul. 2016 to Jun. 2018 were selected, and all off-label drug use prescriptions were screened for statistical analysis. The basis of off-label drug use was analyzed according to domestic and foreign literature reports, guidelines and Micromedex tools. Risk matrix method was used to evaluate the risk level of adverse drug reactions of off-label drug use. RESULTS: Within the statistical interval, there were 1 128 off-label drug use of immunosuppressants prescriptions in the hospital, and the main types were drugs with off-label indications. Evidence types were respectively foreign guidelines(94 prescriptions, 8.3%), domestic guidelines(396 prescriptions, 35.1%), expert consensus(596 prescriptions, 52.8%) and other literature(42 prescriptions, 3.7%). Among the 25 off-label drug use of immunosuppressants, 11(44.0%) off-label drug use had been included by Micromedex. The risk of renal toxicity of cyclosporine, respiratory disorders of mycophenolate mofetil, renal toxicity of lymphoma, non-melanoma and tacrolimus, respiratory distress syndrome and other adverse drug reactions were rated as grade E, which was considered as the severe risk. CONCLUSIONS: The off-label use of immunosuppressants in the outpatient department of the hospital is supported by relevant evidence, but the quality of the evidence is different and there is a risk of severe adverse drug reactions. In clinical practice, it is suggested that the hospital should establish the off-label drug use evaluation group to form consensus among experts in the hospital as soon as possible,so as to avoid medical risks as far as possible and promote the rational drug use.