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尼莫地平预防性治疗动脉瘤性蛛网膜下腔出血有效性和安全性的荟萃分析。

Meta-analysis of the effectiveness and safety of prophylactic use of nimodipine in patients with an aneurysmal subarachnoid haemorrhage.

机构信息

Department of Neurology, Taihe Hospital Affiliated to Hubei University of Medicine, Shiyan City, Hubei Province, China.

出版信息

CNS Neurol Disord Drug Targets. 2011 Nov;10(7):834-44. doi: 10.2174/187152711798072383.

Abstract

BACKGROUND AND OBJECTIVES

Cerebral vasospasm is an important cause of poor outcomes in subarachnoid haemorrhage patients. This study was designed to assess the effectiveness and safety of nimodipine in the prevention of cerebral vasospasm in aneurysmal subarachnoid haemorrhage patients.

METHODS

We searched Pubmed, OVID, Embase, the Cochrane library, the stroke clinical trial registry, and the National Science and Technology Library database and collected prospective, randomised, controlled clinical trials of the prophylactic use of nimodipine for aneurismal subarachnoid haemorrhage patients. A meta-analysis was performed on the studies that met the criteria for inclusion.

RESULTS

Eight studies met the inclusion criteria, and 1514 patients finished trial observation for the different indicators. Compared with the placebo group, fully recovered (all cases) patients increased 64% in the nimodipine group (P = 0.0002, OR = 1.64, 95 percent CI 1.26 - 2.13, NNT=-1.048), fully recovered or moderately disabled (all cases) patients increased 79 percent (P = 0.0007, OR = 1.79, 95% CI 1.28 - 2.51, NNT = -5.889), patient death (in cerebral vasospasm cases) decreased 74% (P = 0.008, OR = 0.26, 95% CI 0.09 - 0.71, NNT = 2.298), the incidence of symptomatic cerebral vasospasm decreased 46% (P < 0.00001, OR = 0.54, 95% CI 0.42 - 0.69, NNT = 1.952), the incidence of delayed neurological function deficits (all cases) decreased 38% (P < 0.0001, OR = 0.62, 95% CI 0.50 - 0.78, NNT = 1.078), the occurrence of cerebral infarction (on CT scan) decreased 58% (P = 0.001, OR = 0.58, 95% CI 0.42 - 0.81, NNT = 3.314), the occurrence of cerebral infarction (in cerebral vasospasm cases) decreased 65% (P = 0.003, OR = 0.35, 95% CI 0.17 - 0.69, NNT = 3.688), the occurrence of cerebral infarction (all cases) decreased 48% (P < 0.00001, OR = 0.52, 95% CI 0.41 - 0.66, NNT = 1.196), and the difference in recurrent haemorrhage and adverse reactions between the nimodipine and placebo groups was not statistically significant (nimodipine group versus placebo group, recurrent haemorrhage P = 0.15, OR = 0.75, 95% CI 0.50 - 1.11; adverse reaction P = 0.59, OR = 1.13, 95% CI 0.71 - 1.81).

CONCLUSION

Compared with placebo, nimodipine can significantly improve clinical outcomes, as assessed by self-formulated standards and Glasgow outcome scores, and it can significantly reduce the occurrence of symptomatic cerebral vasospasm and delayed neurological function deficits (all cases), as well as cerebral infarction, although the incidence rate of recurrent haemorrhage and adverse reactions is not significantly reduced by nimodipine.

摘要

背景与目的

脑血管痉挛是蛛网膜下腔出血患者预后不良的一个重要原因。本研究旨在评估尼莫地平预防蛛网膜下腔出血患者脑血管痉挛的有效性和安全性。

方法

我们检索了 Pubmed、OVID、Embase、Cochrane 图书馆、中风临床试验注册处和国家科技图书馆数据库,收集了尼莫地平预防治疗颅内动脉瘤性蛛网膜下腔出血患者的前瞻性、随机、对照临床试验。对符合纳入标准的研究进行了荟萃分析。

结果

有 8 项研究符合纳入标准,1514 例患者完成了不同指标的试验观察。与安慰剂组相比,尼莫地平组完全康复(所有病例)的患者增加了 64%(P=0.0002,OR=1.64,95%CI 1.26-2.13,NNT=-1.048),完全康复或中度残疾(所有病例)的患者增加了 79%(P=0.0007,OR=1.79,95%CI 1.28-2.51,NNT=-5.889),患者死亡(在脑血管痉挛病例中)减少了 74%(P=0.008,OR=0.26,95%CI 0.09-0.71,NNT=2.298),症状性脑血管痉挛的发生率降低了 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)的发生率降低了 38%(P<0.0001,OR=0.62,95%CI 0.50-0.78,NNT=1.078),脑梗死(CT 扫描)的发生率降低了 58%(P=0.001,OR=0.58,95%CI 0.42-0.81,NNT=3.314),脑血管痉挛病例中脑梗死的发生率降低了 65%(P=0.003,OR=0.35,95%CI 0.17-0.69,NNT=3.688),所有病例中脑梗死的发生率降低了 48%(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的再出血和不良反应发生率差异无统计学意义(尼莫地平组与安慰剂组比较,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

与安慰剂相比,尼莫地平可显著改善临床结局,采用自订标准和 Glasgow 预后评分评估,尼莫地平还可显著降低症状性脑血管痉挛和迟发性神经功能缺损(所有病例)的发生,以及脑梗死的发生,尽管尼莫地平不能显著降低再出血和不良反应的发生率。

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