基于循证医学方法评价普瑞巴林超适应证用药情况

Assessment of off-label indications use of pregabalin by evidence-based medicine ap‐proach

目的利用循证医学方法评价普瑞巴林超适应证用药情况,为临床合理用药提供参考。方法抽取合肥市滨湖医院2023年1月1日至6月30日的普瑞巴林门诊处方,按照最新版药品说明书筛选超适应证用药处方,以不同级别循证医学证据为基础,建立超说明书适应证的循证评价方法和流程,检索循证医学证据,并进行方法学和证据的质量评价,从而判断有无循证医学证据。结果纳入本研究的普瑞巴林超适应证处方涉及49种诊断。依据国外说明书、权威医学专著和指南、循证医学数据库,判定糖尿病周围神经病变、癫痫、耳大神经痛、肋间神经痛、三叉神经痛、神经病理性疼痛、神经性头痛、坐骨神经痛、焦虑、甲状腺术后疼痛、尿毒症伴不宁腿综合征、尿毒症性瘙痒、癌痛、腰椎术后疼痛有循证证据;其余诊断均无循证证据,建议禁止使用。结论基于循证医学方法评价普瑞巴林超适应证用药情况发现,该院普瑞巴林超适应证用药比较普遍,建议加强管理,促进普瑞巴林安全、有效、合理用药。

Objective To assess the off-label indications use of pregabalin by evidence-based medicine,and provide reference for the rationality of clinical drug use.Methods Outpatient prescriptions of pregabalin in Binhu Hospital of Hefei from January 1,2023 to June 30,2023 were extracted,and the off-label indications prescriptions were screened according to the latest version of drug instructions.The off-label indications evidence-based medicine evaluation methods and processes were established based on the evidence of different levels of evidence-based medicine,the evidence was searched and the quality of the methodology and evidence were evaluated,so as to judge whether there was evidence of evidence-based medicine.Results There were 49 kinds of diagnosis involved in the off-label indications prescription of pregabalin in this study,according to foreign instructions,authoritative medical monographs and guidelines,and evidence-based medicine database,there were evidences for diabetic peripheral neuropathy,epilepsy,great auricular neuralgia,intercostal neuralgia,trigeminal neuralgia,neuropathic pain,neuropathic headache,sciatica,anxiety,thyroid postoperative pain,uremia with restless leg syndrome,uremic pruritus,cancer pain,lumbar postoperative pain.There was no evidence-based medicine for other diagnoses,and recommended to prohibit use.Conclusion Based on assessment of off-label indications use of pregabalin by evidence-based medical approach,it was found that the off-label indications use of pregabalin was common in the hospital,and it is suggested to strengthen the management to promote the safe,effective and rational use of pregabalin.