机构地区:[1]北京医院药学部,国家老年医学中心,中国医学科学院老年医学研究院,北京市药物临床风险与个体化应用评价重点实验室(北京医院),北京100730 [2]北京市宣武中医医院审计科,北京100050
出 处:《中国医院用药评价与分析》2022年第12期1491-1495,共5页Evaluation and Analysis of Drug-use in Hospitals of China
基 金:北京市中医药科技发展资金项目(No.JJ-2020-32)。
摘 要:目的:利用循证证据,评估舒血宁注射液治疗缺血性脑卒中的有效性、安全性和经济性,为临床合理用药提供参考。方法:检索万方数据库、中国生物医学文献数据库、中国知网、PubMed、the Cochrane Library、Embase、国际卫生技术评估网络和国际卫生技术评估协会等网站,对舒血宁注射液治疗缺血性脑卒中的卫生技术评估(HTA)报告、Meta分析/系统评价和药物经济学研究等资料进行汇总分析,并对文献及其方法学进行质量评价。结果:共纳入22篇文献,10篇为Meta分析/系统评价,12篇为药物经济学研究,未检索到HTA报告。有效性研究结果显示,舒血宁注射液辅助治疗缺血性脑卒中,在提高总有效率,改善神经功能缺损评分、颅脑CT结果、实验室指标(全血黏度、血浆黏度、纤维蛋白原、红细胞聚集指数、红细胞压积)水平、美国国立卫生研究院卒中量表评分和改良爱丁堡-斯堪的纳维亚卒中量表评分等方面均具有一定优势。安全性研究结果显示,舒血宁注射液的不良反应以过敏样反应为主,大多在停药后可自行消退。药物经济学评价结果显示,与银杏内酯注射液、银杏达莫注射液、长春西汀注射液等比较,舒血宁注射液不具有经济学优势;与注射用血栓通、刺五加注射液、苦碟子注射液、依达拉奉注射液等比较,舒血宁注射液的成本-效果比更优;与血塞通注射液比较,药物经济学评价结果不一致。结论:舒血宁注射液辅助治疗缺血性脑卒中有助于提高临床疗效,改善评价指标。未来有待于进一步开展更规范的临床观察及药物经济学研究,补充更高质量的循证证据。OBJECTIVE: To evaluate the efficacy, safety and economical efficiency of Shuxuening injection in the treatment of ischemic stroke by the evidence-based evidence, so as to provide reference for clinical rational drug use.METHODS: Retrieved from Wanfang Data, CBM, CNKI, PubMed, the Cochrane Library, Embase, International Network of Agencies for Health Technology Assessment and Health Technology Assessment International and other websites, health technology assessment(HTA) reports, Meta-analysis/systematic reviews and pharmacoeconomic studies related to Shuxuening injection in the treatment of ischemic stroke were sorted and analyzed. The quality evaluation was performed on the literature and their methodology. RESULTS: A total of 22 literature were included, among which, 10 studies were conducted on Meta-analysis/systematic reviews, 12 studies were conducted on pharmacoeconomics, HTA reports were not obtained. The results of efficacy studies showed that Shuxuening injection in adjuvant treatment of ischemic stroke have certain advantages in increasing the total effective rate, improving neurological deficit score and brain CT results, laboratory indicators(whole blood viscosity, plasma viscosity, fibrinogen, erythrocyte aggregation index, hematocrit), improving National Institutes of Health Stroke Scale score and Modified Edinburgh-Scandinavian Stroke Scale score. Safety studies showed that the adverse drug reactions of Shuxuening injection were mainly allergic-like reactions, and most of them could be resolved spontaneously after drug withdrawal. Results of pharmacoeconomic evaluation showed that Shuxuening injection did not possess economic advantages compared with Ginkgolide injection, Yinxing damo injection, Vinpocetine injection, etc.;the cost-effectiveness ratio of Shuxuening injection was better compared with Xueshuantong for injection, Acanthopanax senticosus injection, Ixeris sonchifolia injection, Edaravone injection, etc.;the results of pharmacoeconomic evaluation were inconsistent compared with Xuesaito
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