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.	郝子龍, 劉鳴, 李偉, 等. 成都卒中登記方法及 3 123 例患者基本特征和功能結局. 中華神經科雜志, 2011, 44(12): 826-831.
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8.	王東, 單艷華, 李小霞, 等. 納美芬對腦梗死患者的治療作用及血清細胞因子的影響. 中國實用醫藥, 2012, 7(5): 54-56.
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12.	張林峰, 謝成, 楊誠. 納美芬對急性腦梗死療效及神經保護作用機制研究. 中國現代藥物應用, 2017, 11(6): 49-51.
13.	孫晶, 李小平, 王婷婷, 等. 納美芬改善大面積腦梗死預后: 隨機對照前瞻性臨床試驗方案. 中國組織工程研究, 2017, 21(36): 5835-5840.
14.	廖日房, 曾轉萍, 溫預關. 阿片類拮抗藥納美芬注射劑的單劑量和多劑量 I 期臨床藥代動力學研究. 南方醫科大學學報, 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, 黃文祥, 羅濤, 等. 鹽酸納美芬注射液藥代動力學. 重慶醫科大學學報, 2009, 34(9): 1250-1253.
17.	溫預關, 喻凌寒, 楊夢心, 等. 鹽酸納美芬注射液在健康人體的藥動學研究. 中國藥學雜志, 2008, 43(13): 1015-1018.
18.	武弋, 雷鵬, 曹富裕, 等. 罕見 1 例鹽酸納美芬用藥不良反應的分析報告. 中華神經外科疾病研究雜志, 2015, 14(2): 181-182.
19.	楊曉萍, 張麗萍. 靜滴鹽酸納美芬注射液致大面積蕁麻疹 1 例. 中國醫藥導刊, 2011, 13(3): 494.

1. 郝子龍, 劉鳴, 李偉, 等. 成都卒中登記方法及 3 123 例患者基本特征和功能結局. 中華神經科雜志, 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. 中華醫學會神經病學分會中華醫學會神經病學分會腦血管病學組. 中國急性缺血性腦卒中診治指南2014. 中華神經科雜志, 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. 趙陽. 納美芬治療大腦中動脈主干梗塞的臨床療效研究. 長春: 吉林大學, 2011.
8. 王東, 單艷華, 李小霞, 等. 納美芬對腦梗死患者的治療作用及血清細胞因子的影響. 中國實用醫藥, 2012, 7(5): 54-56.
9. 朱沛傳. 納美芬治療腦梗死的療效觀察. 臨床合理用藥雜志, 2012, 5(18): 40-41.
10. 謝成. 納美芬對急性腦梗死神經保護作用研究. 現代診斷與治療, 2015, (7): 1498-1499.
11. 姜國林, 毛蕾. 鹽酸納美芬治療急性腦梗死的臨床觀察. 中國處方藥, 2016, 14(9): 7-8.
12. 張林峰, 謝成, 楊誠. 納美芬對急性腦梗死療效及神經保護作用機制研究. 中國現代藥物應用, 2017, 11(6): 49-51.
13. 孫晶, 李小平, 王婷婷, 等. 納美芬改善大面積腦梗死預后: 隨機對照前瞻性臨床試驗方案. 中國組織工程研究, 2017, 21(36): 5835-5840.
14. 廖日房, 曾轉萍, 溫預關. 阿片類拮抗藥納美芬注射劑的單劑量和多劑量 I 期臨床藥代動力學研究. 南方醫科大學學報, 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, 黃文祥, 羅濤, 等. 鹽酸納美芬注射液藥代動力學. 重慶醫科大學學報, 2009, 34(9): 1250-1253.
17. 溫預關, 喻凌寒, 楊夢心, 等. 鹽酸納美芬注射液在健康人體的藥動學研究. 中國藥學雜志, 2008, 43(13): 1015-1018.
18. 武弋, 雷鵬, 曹富裕, 等. 罕見 1 例鹽酸納美芬用藥不良反應的分析報告. 中華神經外科疾病研究雜志, 2015, 14(2): 181-182.
19. 楊曉萍, 張麗萍. 靜滴鹽酸納美芬注射液致大面積蕁麻疹 1 例. 中國醫藥導刊, 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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