Efficacy and safety of nalmefene hydrochloride for acute cerebral infarction: a meta-analysis_Chinese Journal of Evidence-Based Medicine

Authors：

ZHANG Yunzhou ¹ , LIU Qun ² , ZHAO Mingjuan ^3,4 , ZENG Xiantao ³ ,  WENG Hong ³

1. Department of Neurology, Capital Medical University Xuanwu Hospital, Beijing, 100053, P.R.China;
2. Department of Neurology, Bethune First Hospital of Jilin University, Changchun, 130012, P.R.China;
3. Center for Evidence-Based and Translational Medicine, Zhongnan Hospital of Wuhan University; Center for Evidence-Based and Translational Medicine, Wuhan University; Department of Evidence-Based Medicine and Clinical Epidemiology, The Second Clinical College, Wuhan University, Wuhan, 430071, P.R.China;
4. Department of Cardiology, the First Affiliated Hospital of Henan University, Kaifeng, 475000, P.R.China;

Corresponding author：

WENG Hong, Email: wengh92@163.com

Keywords：

Nalmefene hydrochloride; Nalmefene; Acute cerebral infarction; Acute ischemic stroke; meta-analysis; Systematic review; Randomized controlled trial

DOI：

10.7507/1672-2531.201807050

Video：

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Objectives To systematically review the efficacy and safety of nalmefene hydrochloride for acute cerebral infarction.Methods PubMed, EMbase, The Cochrane Library, CBM, CNKI, WanFang Data and VIP databases were electronically searched to collect randomized controlled trials (RCTs) on nalmefene hydrochloride for acute cerebral infarction from inception to February 21^st, 2018. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies, then, meta-analysis was performed by using RevMan 5.3 software.Results A total of 8 RCTs involving 1 038 patients were included. The results of meta-analyses showed that, compared to the routine treatment group, the nalmefene hydrochloride group was significantly associated with an increased reduction in total effective rate (RR=1.14, 95%CI 1.04 to 1.23, P=0.003), GCS (MD=1.30, 95%CI 0.66 to 1.94, P<0.0001), patient satisfaction (RR=1.26, 95%CI 1.03 to 1.55, P=0.03), cerebral blood flow (MD=5.00, 95%CI 3.81 to 6.19, P<0.05), and cerebral blood volume (MD=0.28, 95%CI 0.23 to 0.32, P<0.05). It was also significantly associated with an reduction of NIHSS, CSS, level of inflammatory factors after treatment in 14 days, level of MMP-9 and mean transit time of contrast medium (P<0.05). However, no significant association was observed between two groups in level of inflammatory factors after treatment in 20 days. For safety outcomes, no significant association was found between two groups in mortality, dizziness, and nausea and vomiting.Conclusions The current evidence indicates that the nalmefene hydrochloride can be used to treat acute cerebral infarction based on routine treatment of acute cerebral infarction, and the safety is relatively good. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusion.

Citation： ZHANG Yunzhou, LIU Qun, ZHAO Mingjuan, ZENG Xiantao, WENG Hong. Efficacy and safety of nalmefene hydrochloride for acute cerebral infarction: a meta-analysis. Chinese Journal of Evidence-Based Medicine, 2019, 19(2): 173-179. doi: 10.7507/1672-2531.201807050 Copy

1.	郝子龙, 刘鸣, 李伟, 等. 成都卒中登记方法及 3 123 例患者基本特征和功能结局. 中华神经科杂志, 2011, 44(12): 826-831.
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8.	王东, 单艳华, 李小霞, 等. 纳美芬对脑梗死患者的治疗作用及血清细胞因子的影响. 中国实用医药, 2012, 7(5): 54-56.
9.	朱沛传. 纳美芬治疗脑梗死的疗效观察. 临床合理用药杂志, 2012, 5(18): 40-41.
10.	谢成. 纳美芬对急性脑梗死神经保护作用研究. 现代诊断与治疗, 2015, (7): 1498-1499.
11.	姜国林, 毛蕾. 盐酸纳美芬治疗急性脑梗死的临床观察. 中国处方药, 2016, 14(9): 7-8.
12.	张林峰, 谢成, 杨诚. 纳美芬对急性脑梗死疗效及神经保护作用机制研究. 中国现代药物应用, 2017, 11(6): 49-51.
13.	孙晶, 李小平, 王婷婷, 等. 纳美芬改善大面积脑梗死预后: 随机对照前瞻性临床试验方案. 中国组织工程研究, 2017, 21(36): 5835-5840.
14.	廖日房, 曾转萍, 温预关. 阿片类拮抗药纳美芬注射剂的单剂量和多剂量 I 期临床药代动力学研究. 南方医科大学学报, 2008, 28(10): 1816-1819.
15.	Class PS, Jhaveri RM, Smith LR. Comparison of potency and duration of action of nalmefene and naloxone. Anesth Analg, 1994, 78(3): 536-541.
16.	章成, 黄文祥, 罗涛, 等. 盐酸纳美芬注射液药代动力学. 重庆医科大学学报, 2009, 34(9): 1250-1253.
17.	温预关, 喻凌寒, 杨梦心, 等. 盐酸纳美芬注射液在健康人体的药动学研究. 中国药学杂志, 2008, 43(13): 1015-1018.
18.	武弋, 雷鹏, 曹富裕, 等. 罕见 1 例盐酸纳美芬用药不良反应的分析报告. 中华神经外科疾病研究杂志, 2015, 14(2): 181-182.
19.	杨晓萍, 张丽萍. 静滴盐酸纳美芬注射液致大面积荨麻疹 1 例. 中国医药导刊, 2011, 13(3): 494.

1. 郝子龙, 刘鸣, 李伟, 等. 成都卒中登记方法及 3 123 例患者基本特征和功能结局. 中华神经科杂志, 2011, 44(12): 826-831.
2. Wei JW, Heeley EL, Wang JG, et al. Comparison of recovery patterns and prognostic indicators for ischemic and hemorrhagic stroke in China: the China QUEST (Quality Evaluation of Stroke Care and Treatment) registry study. Stroke, 2010, 41(9): 1877-1883.
3. 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. 中国急性缺血性脑卒中诊治指南2014. 中华神经科杂志, 2015, 48(4): 246-257.
4. Zeng X, Zhang Y, Kwong JS, et al. The methodological quality assessment tools for preclinical and clinical studies, systematic review and meta-analysis, and clinical practice guideline: a systematic review. J Evid Based Med, 2015, 8(1): 2-10.
5. Higgins JPT, Green S. Cochrane handbook for systematic reviews of interventions (version 5.1.0). The Cochrane Collaboration, 2011. Available at: http://www.cochrane-handbook.org.
6. Clark WM, Raps EC, Tong DC, et al. Cervene (Nalmefene) in acute ischemic stroke: final results of a phase III efficacy study. The Cervene Stroke Study Investigators. Stroke, 2000, 31(6): 1234-1239.
7. 赵阳. 纳美芬治疗大脑中动脉主干梗塞的临床疗效研究. 长春: 吉林大学, 2011.
8. 王东, 单艳华, 李小霞, 等. 纳美芬对脑梗死患者的治疗作用及血清细胞因子的影响. 中国实用医药, 2012, 7(5): 54-56.
9. 朱沛传. 纳美芬治疗脑梗死的疗效观察. 临床合理用药杂志, 2012, 5(18): 40-41.
10. 谢成. 纳美芬对急性脑梗死神经保护作用研究. 现代诊断与治疗, 2015, (7): 1498-1499.
11. 姜国林, 毛蕾. 盐酸纳美芬治疗急性脑梗死的临床观察. 中国处方药, 2016, 14(9): 7-8.
12. 张林峰, 谢成, 杨诚. 纳美芬对急性脑梗死疗效及神经保护作用机制研究. 中国现代药物应用, 2017, 11(6): 49-51.
13. 孙晶, 李小平, 王婷婷, 等. 纳美芬改善大面积脑梗死预后: 随机对照前瞻性临床试验方案. 中国组织工程研究, 2017, 21(36): 5835-5840.
14. 廖日房, 曾转萍, 温预关. 阿片类拮抗药纳美芬注射剂的单剂量和多剂量 I 期临床药代动力学研究. 南方医科大学学报, 2008, 28(10): 1816-1819.
15. Class PS, Jhaveri RM, Smith LR. Comparison of potency and duration of action of nalmefene and naloxone. Anesth Analg, 1994, 78(3): 536-541.
16. 章成, 黄文祥, 罗涛, 等. 盐酸纳美芬注射液药代动力学. 重庆医科大学学报, 2009, 34(9): 1250-1253.
17. 温预关, 喻凌寒, 杨梦心, 等. 盐酸纳美芬注射液在健康人体的药动学研究. 中国药学杂志, 2008, 43(13): 1015-1018.
18. 武弋, 雷鹏, 曹富裕, 等. 罕见 1 例盐酸纳美芬用药不良反应的分析报告. 中华神经外科疾病研究杂志, 2015, 14(2): 181-182.
19. 杨晓萍, 张丽萍. 静滴盐酸纳美芬注射液致大面积荨麻疹 1 例. 中国医药导刊, 2011, 13(3): 494.

Chinese Journal of Evidence-Based Medicine

Efficacy and safety of nalmefene hydrochloride for acute cerebral infarction: a meta-analysis

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