Objective To rapidly evaluate the effectiveness, safety and economy of edaravone in treating acute ischemic stroke (AIS), and to provide the evidence-based basis for clinical decision-making.
Methods PubMed, Embase, Web of Science, Cochrane Library, CNKI and WanFang Data databases and the official website of health technology assessment (HTA) agency were electronically searched to collect HTA reports, systematic reviews/Meta-analysis and pharmacoeconomic studies of edaravone in the treatment of AIS from the inception to October 1, 2024. Two reviewers independently screened the literature, extracted data, evaluated the quality, summarized the results, and qualitatively described and analyzed the results.
Results A total of 12 literature were included, involving 9 systematic reviews/Meta-analysis and 3 pharmacoeconomic studies. In terms of efficacy, edaravone alone or in combination with conventional therapy (alteplase, ozagrel) increased efficiency, improved short-term neurological deficit scores and improved patients' ability to perform activities of daily living compared with placebo or conventional therapy (alteplase, ozagrel) (P﹤0.05). There was no significant difference in the incidence of adverse reactions between edaravone and placebo, routine treatment, or other neuroprotectants (P>0.05). Combined with alteplase, it could reduce the incidence of intracranial hemorrhage compared to alteplase alone (P﹤0.05), with no statistically significant difference in all-cause mortality (P﹤0.05). Pharmacoeconomic studies showed that, edaravone does not have a cost-effectiveness advantage in the short term, but it may have a cost-effectiveness advantage from limited long-term studies.
Conclusion Edaravone is effective and safe in the treatment of AIS, but there is limited research evidence and the conclusion still needs to be confirmed by further studies and clinical trials, and the economics need to be further evaluated.
1.中华医学会神经病学分会, 中华医学会神经病学分会脑血管病学组. 中国急性缺血性卒中诊治指南2023[J]. 中华神经科杂志, 2024, 57(6): 523-559. [Chinese Society of Neurology, Chinese Stroke Society. Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2023[J]. Chinese Journal of Neurology, 2024, 57(6): 523-559.] DOI: 10.3760/cma.j.cn113694-20240410-00221.
2.国家卫生健康委员会急诊医学质控中心, 中国医师协会急诊医师分会, 世界中医药学会联合会急症专业委员会 ,等. 中国急性缺血性脑卒中急诊诊治专家共识 [J]. 中国急救医学, 2018,38(4): 281-287. DOI: 10.3760/cma.j.issn.2095-4352.2018.03.001.
3.王凯, 张学琴, 杨珍珍, 等. 神经保护剂改善急性缺血性脑卒中神经功能的网状Meta分析[J]. 中南药学, 2020, 18(4): 685-693. [Wang K, Zhang XQ, Yang ZZ, et al. Network Meta-analysis of neuroprotective agents for improving neurological function in acute cerebral infarction[J]. Central South Pharmacy, 2020, 18(4): 685-693.] DOI: CNKI:SUN:ZNYX.0.2020-04-035.
4.杜亚明, 赵志刚. 神经保护药治疗急性缺血性脑卒中的研究现状[J]. 中国临床药理学杂志, 2018, 34(6): 725-727. [Du YM, Zhao ZG. Current status of neuroprotective agents in the treatment of acute ischemic stroke[J]. The Chinese Journal of Clinical Pharmacology, 2018, 34(6): 725-727.] DOI: 10.13699/j.cnki.1001-6821.2018.06.033.
5.Yamashita T, Deguchi K, Nagotani S, et al. Vascular protection and restorative therapy in ischemic stroke[J]. Cell Transplant, 2011, 20(1): 95-97. DOI: 10.3727/096368910X532800.
6.Shinohara Y, Yamaguchi T. Outline of the Japanese Guidelines for the Management of Stroke 2004 and Subsequent Revision[J]. Int J Stroke, 2008, 3(1): 55-62. DOI: 10.1111/j.1747-4949.2008.00178.x.
7.李文萍, 邓平阳, 杨林. 右美托咪定用于ICU机械通气患者的快速卫生技术评估[J]. 药物流行病学杂志,2024, 33(4): 441-448. [Li WP, Deng PY, Yang L, et al. Dexmedetomidine for sedation in the ICU patients on mechanical ventilation: a rapid health technology assessment[J]. Chinese Journal of Pharmacoepidemiology, 2024, 33(4): 441-448.] DOI: 10.12173/j.issn.1005-0698. 202311046.
8.Hailey D. Toward transparency in health technology assessment: a checklist for HTA reports[J]. Int J Technol Assess Health Care, 2003, 19(1): 1-7. DOI: 10.1017/s0266462303000011.
9.Shea BJ, Reeves BC, Wells G, et al. AMSTAR 2: a critical appraisal tool for systematic reviews that include randomised or non-randomised studies of healthcare interventions, or both[J]. BMJ, 2017, 358: j4008. DOI: 10.1136/bmj.j4008.
10.Husereau D, Drummond M, Augustovski F, et al. Consolidated health economic evaluation reporting standards (CHEERS) 2022 explanation and elaboration: a report of the ISPOR CHEERS II good practices task force[J]. Value Health, 2022, 25(1): 10-31. DOI: 10.1016/j.jval.2021.10.008.
11.Zhao K, Li GZ, Nie LY, et al. Edaravone for acute ischemic stroke: a systematic review and meta-analysis[J]. Clin Ther, 2022, 44(12): e29-e38. DOI: 10.1016/j.clinthera.2022.11.005.
12.马爱霞, 马骏捷, 徐丹妮. 我国依达拉奉联合奥扎格雷与单用奥扎格雷治疗急性缺血性脑卒中疗效比较的Meta分析[J]. 药品评价, 2013, 10(4): 12-18. [Ma AX, Ma JJ, Xu DN. The comparison of curative effects of treating cerebral ischemic stroke on edaravone and ozagrel and on ozagrel only in China--the meta analysis[J]. Drug Evaluation, 2013, 10(4): 12-18.] DOI: 10.3969/j.issn.1672-2809.2013.04.004.
13.何建丽, 宣仙君, 蒋敏海. 依达拉奉治疗急性缺血性脑卒中有效性及安全性的荟萃分析[J]. 浙江医学, 2020, 42(2): 164-170. [He JL, Xuan XJ, Jiang MH, et al. Meta-analysis on effectiveness and safety of edaravone for acute ischemic stroke[J]. Zhejiang Medical Journal, 2020, 42(2): 164-170.] DOI: CNKI:SUN:ZJYE.0.2020-02-020.
14.张竞文, 陈頔, 赵紫楠, 等. 依达拉奉治疗糖尿病合并急性缺血性脑卒中的有效性和安全性系统评价[J]. 中国药业, 2022, 31(3): 108-114. [Zhang JW, Chen D, Zhao ZN, et al. Efficacy and safety of edaravone in the treatment of diabetes mellitus complicated with acute ischemic stroke: a systematic review[J].China Pharmaceuticals, 2022, 31(3): 108-114.] DOI: 10.3969/j.issn.1006-4931.2022.03.027.
15.Hu R, Guo Y, Lin Y, et al. Safety and efficacy of edaravone combined with alteplase for patients with acute ischemic stroke: a systematic review and meta-analysis[J]. Pharmazie, 2021, 76(2): 109-113. DOI: 10.1691/ph.2021.0949.
16.Chen C, Li M, Lin L, et al. Clinical effects and safety of edaravone in treatment of acute ischaemic stroke: a meta-analysis of randomized controlled trials[J]. J Clin Pharm Ther, 2021, 46(4): 907-917. DOI: 10.1111/jcpt.13392.
17.Yang J, Cui X, Li J, et al. Edaravone for acute stroke: meta-analyses of data from randomized controlled trials[J]. Dev Neurorehabil, 2015, 18(5): 330-335. DOI: 10.3109/17518423.2013.830153.
18.Yang B, Shi J, Chen X, et al. Efficacy and safety of therapies for acute ischemic stroke in China: a network meta-analysis of 13289 patients from 145 randomized controlled trials[J]. PLoS One, 2014, 9(2): e88440. DOI: 10.1371/journal.pone.0088440.
19.Shinohara Y, Inoue S. Cost-effectiveness analysis of the neuroprotective agent edaravone for noncardioembolic cerebral infarction[J]. J Stroke Cerebrovasc Dis, 2013, 22(5): 668-674. DOI: 10.1016/j.jstrokecerebrovasdis.2012.04.002.
20.毛玉芳. 依达拉奉和长春西汀治疗急性脑梗死的药物经济学评价[J]. 河北医学, 2014, 20(6): 946-949. [Mao YF. Pharmaco-economic Evaluation on Edaravone and Vinpocetine in Treatment of Acute Cerebral Infarction[J]. Hebei Medicine,2014, 20(6): 946-949.] DOI: 10.3969/j.issn.1006-6233.2014.06.023.
21.刘国恩, 张玉哲, 范丽亚, 等. 急性缺血性脑卒中三种常用神经保护药物成本-效果分析[J]. 中国卫生经济, 2012, 31(8): 62-65. [Liu GE, Zhang YZ, Fang LY, et al. Cost-Effectivenss of 3 Common Neuroprotective Agents for Acute Ischemic Stroke[J]. Chinese Health Economics, 2012, 31(8): 62-65.] DOI: 10.3969/j.issn.1003-0743.2012.08.021.
22.张世洪, 叶凯丽. 缺血性脑损伤神经保护剂应用现状与研究进展[J]. 内科理论与实践, 2017, 12(2): 83-87.DOI: 10.16138/j.1673-6087.2017.02.002. DOI: 10.16138/j.1673-6087.2017.02.002.
23.Sinha M, Shukla R, Garg RK, et al. A randomized controlled clinical trial to compare the safety and efficacy of edaravone in acute ischemic stroke[J]. Ann Indian Acad Neurol, 2011, 14(2): 103-106. DOI: 10.4103/0972-2327.82794.
24.母立峰, 戎佩佩, 宋金春. 依达拉奉治疗急性缺血性卒中的药物经济学研究综述[J]. 中国药师, 2019, 22(2): 318-321. [Mu LF, Rong PP, Song JC. Review of pharmacoeconomic studies on edaravone in the treatment of ischemic stroke[J]. China Pharmacist, 2019, 22(2): 318-321.] DOI: 10.3969/j.issn.1008-049X.2019.02.033.