蛛网膜下腔出血患者预防性应用尼莫地平有效性和安全性的Meta分析(上)  

Efficacy and safety of prophylactic use of nimodipine in patients with aneurysmal subarachnoid hemorrhage:a meta-analysis

作　　者：刘光健[1] 王正军[2] 王云甫[1] 刘勇[1] 汪晓玲[1] 罗国君[1] 朱飞奇[3] 

机构地区：[1]湖北医药学院附属太和医院神经内科,十堰442000 [2]湖北医药学院附属太和医院药学部,十堰442000 [3]汕头大学医学院附属广东粤北人民医院神经内科

出　　处：《中国脑血管病杂志》2011年第1期28-33,46,共7页Chinese Journal of Cerebrovascular Diseases

摘　　要：目的评价尼莫地平预防动脉瘤性蛛网膜下腔出血(SAH)患者脑血管痉挛的有效性及安全性。方法检索Pubmed、OVID、EMBase、Cochrane library、卒中临床试验注册及国家科技图书文献中心数据库,检索截止时间均为2010年11月。收集尼莫地平被预防性用于动脉瘤性蛛网膜下腔出血患者的前瞻性随机临床对照试验,对符合纳入标准的研究进行Meta分析。结果有8项研究符合纳入标准,1499例患者接受了不同指标的试验观察。与安慰剂组比较,尼莫地平组(所有病例)的完全康复率增加了64%[P=0.000 2,OR=1.64,95% CI:1.26～2.13;需要治疗的患者数(NNT)=-1.048],完全康复或中等残疾率增加了79%(P=0.000 7,OR=1.79,95%CI:1.28～2.51;NNT=-5.889),死亡、严重残疾或植物状态发生率降低了38%(P=0.000 3,OR=0.62,95%CI:0.48～0.80;NNT=1.529);脑血管痉挛(CVS病例)的病死率降低了74%(P=0.008,OR=0.26,95%CI:0.09～0.71;NNT=2.298);症状性CVS的发生率降低了46%(P<0.00001,OR=0.54,95%CI:0.42～0.69;NNT=1.952);迟发性神经功能缺损(所有病例)发生率降低了38%(P<0.000 1,OR=0.62,95%CI:0.50～0.78;NN=1.078);症状性脑梗死的发生率降低了46%(P<0.00001,OR=0.54,95%CI:0.42～0.69;NNT=1.079);经CT证实的脑梗死的发生率为安慰剂组的58%(P=0.001,OR=0.58,95%CI:0.42～0.81;NNT=3.314);CVS病例脑梗死的发生率为安慰剂组的35%(P=0.003,OR=0.35,95%CI:0.17～0.69;NNT=3.688),脑梗死(所有病例)发生率为安慰剂组的52%(P<0.00001,OR=0.52,95%CI:0.41～0.66;NNT=1.196);尼莫地平组与安慰剂组再出血和不良反应发生率的差异均无统计学意义(再出血:P=0.15,OR=0.75,95%CI:0.50～1.11;不良反应:P=0.59,OR=1.13,95%CI:0.71～1.81)。结论与安慰剂比较,尼莫地平可显著改善动脉瘤性SAH患者的临床转归,可降低症状性CVS、迟发性神经功能缺损以及脑梗死的发生率,而再出血和不良反应的发生率与安慰剂相当。Objective To evaluate the efficacy and safety of nimodipine for cerebral vasospasm （CVS） in patients with aneurysmal subarachnoid hemorrhage. Methods We reviewed the database of searched Pubmed, OVID, EMBase, Coehrane library, Stroke Trials Register （U. S. Clinical Trials Registry）, and the National Science and Technology Library up to November 2010. The prospective, randomized ,controlled clinical trials about preventive application of nimodipine in patients with aneurysmal subarachnoid hemorrhage controlled clinical trials was collected. Meta-analysis was performed for the studies met the inclusion criteria. Results （1）Eight studies met the inclusion criteria. A total of 1499 patients completed the trials and observations of the different indicatois respectively. In all the patients, the complete recovery rate increased 64% in the nimodipine group compared to the plaeebo group （ P = 0. 000 2, 0R=1.64, 95%CI 1.26-2. 13; the number of patients needed to treat[NNT] = - 1.048）. The patients with complete recovery or moderate disability increased 79% （P =0. 000 7, OR = 1.79, 95% CI 1.28 -2.51 ; NNT= -5. 889） ; the rates of death, severe disability or vegetative survival decreased 38% （P = 0. 000 3, OR = 0. 62, 95% （30. 48 - 0.80 ; NNT = 1. 529） ; the mortality of the patients with CVS decreased 74% （P =0. 008, OR = 0.26, 95% CI 0. 09 - 0.71 ; NNT = 2. 298 ） ; the incidencc of symptomatic CVS decreased 46% （P 〈 0. 000 01, OR = 0.54, 95% CI 0. 42 - 0.69 ; NNT = 1. 952） ; the incidence of delayed neurologieal deficits in all patients decreased 38% （P 〈 0. 000 1 , OR = 0.62, 95% CI 0. 50 - 0.78 ; NNT = 1. 078） ; the incidence of symptomatic cerebral infarction decreased 46% （P 〈 0. 000 01, OR = 0. 54, 95% CI 0. 42- 0. 69; NNT = 1. 079 ）; the incidence of cerebral infarction confirmed by C Twas58% of the placebo group （P〈0.001, 0R=0.58, 95%C10.42-0.81; NNT=3.314）; the incidence of cerebral infarction in patients with CVS was 35% of the placebo group （ P = 0. 003, OR

关 键 词：尼莫地平 蛛网膜下腔出血 血管痉挛 颅内 随机对照试验 META分析 

分 类 号：R743.3[医药卫生—神经病学与精神病学]