中国循证医学杂志

中国循证医学杂志

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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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 21st, 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.

关键词: 盐酸纳美芬; 纳美芬; 急性脑梗死; 急性缺血性脑卒中; meta 分析; 系统评价; 随机对照试验

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

引用本文: 张运周, 刘群, 赵明娟, 曾宪涛, 翁鸿. 盐酸纳美芬治疗急性脑梗死有效性和安全性的 meta 分析. 中国循证医学杂志, 2019, 19(2): 173-179. doi: 10.7507/1672-2531.201807050 复制

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