盐酸纳美芬治疗急性脑梗死有效性和安全性的meta分析
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摘要
目的系统评价盐酸纳美芬治疗急性脑梗死的有效性和安全性。方法计算机检索PubMed、EMbase、The Cochrane Library、CBM、CNKI、WanFang Data和VIP数据库,搜集有关盐酸纳美芬治疗急性脑梗死的随机对照试验(RCT),检索时限均为建库至2018年2月21日。由2名研究者独立筛选文献、提取资料及评价纳入研究的风险偏倚后,采用RevMan 5.3软件进行meta分析。结果共纳入8个RCT,包括1 038例患者。meta分析结果显示:与常规治疗组相比,盐酸纳美芬+常规治疗组可显著提高总有效率[RR=1.14,95%CI(1.04,1.23),P=0.003]、GCS评分[MD=1.30,95%CI(0.66,1.94),P<0.000 1],提高患者满意度[RR=1.26,95%CI(1.03,1.55),P=0.03]、脑血流量[MD=5.00,95%CI(3.81,6.19),P<0.05]和脑血容量[MD=0.28,95%CI(0.23,0.32),P<0.05],还可显著降低患者NIHSS评分、CSS评分、治疗14天后的炎症因子水平、MMP-9水平及对比剂平均通过时间(P值均<0.05)。但两组治疗20天后的炎症因子水平差异无统计学意义。在安全性方面,两组患者死亡率、头晕、恶心呕吐发生率的差异均无统计学意义。结论目前有限的证据显示,在急性脑梗死常规治疗的基础上加用盐酸纳美芬可提高临床疗效,且安全性较好。受纳入研究数量和质量的限制,上述结论尚待更多高质量研究予以验证。
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 in20 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.
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 in20 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.
引文
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.
5Higgins 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.
15Class 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.
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.
5Higgins 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.
15Class 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.