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尼莫地平对创伤性蛛网膜下腔出血患者预后的影响:一项系统评价。

Effect of nimodipine on outcome in patients with traumatic subarachnoid haemorrhage: a systematic review.

作者信息

Vergouwen Mervyn D I, Vermeulen Marinus, Roos Yvo B W E M

机构信息

Department of Neurology, Academic Medical Centre, Meibergdreef 9, Amsterdam, Netherlands.

出版信息

Lancet Neurol. 2006 Dec;5(12):1029-32. doi: 10.1016/S1474-4422(06)70582-8.

Abstract

BACKGROUND

Despite several randomised controlled trials, there is still much debate whether nimodipine improves outcome in patients with traumatic subarachnoid haemorrhage. A 2003 Cochrane review reported improved outcome with nimodipine in these patients; however, because the results of Head Injury Trial (HIT) 4 were only partly presented there is still discussion whether patients with traumatic subarachnoid haemorrhage should be treated with this drug. Here, we present data from all head-injury trials, including previously unpublished results from HIT 4.

METHODS

We systematically searched PubMed and EMBASE databases using the following combinations of variables: "nimodipine" or "calcium antagonist" with "traumatic subarachnoid haemorrhage", "head injury", "head trauma", "brain injury", or "brain trauma". Bayer AG and all principal investigators or corresponding authors of the identified studies were contacted for additional information.

FINDINGS

Five manuscripts were identified, describing the results of four trials. We obtained additional data from HIT 1, 2, and 4. In total, 1074 patients with traumatic subarachnoid haemorrhage were included. The occurrence of poor outcome was similar in patients treated with nimodipine (39%) and those treated with placebo (40%); odds ratio was 0.88 (95% CI 0.51-1.54). Mortality rates did not differ between nimodipine (26%) and placebo (27%) treated patients (odds ratio 0.95; 95% CI 0.71-1.26).

INTERPRETATION

Our results do not lend support to the finding of a beneficial effect of nimodipine on outcome in patients with traumatic subarachnoid haemorrhage as reported in an earlier Cochrane review.

摘要

背景

尽管有多项随机对照试验,但关于尼莫地平是否能改善创伤性蛛网膜下腔出血患者的预后仍存在诸多争议。2003年Cochrane综述报道尼莫地平可改善这些患者的预后;然而,由于颅脑损伤试验(HIT)4的结果仅部分公布,对于创伤性蛛网膜下腔出血患者是否应使用该药仍存在讨论。在此,我们展示了所有颅脑损伤试验的数据,包括HIT 4之前未发表的结果。

方法

我们使用以下变量组合系统检索了PubMed和EMBASE数据库:“尼莫地平”或“钙拮抗剂”与“创伤性蛛网膜下腔出血”、“颅脑损伤”、“头部创伤”、“脑损伤”或“脑创伤”。我们联系了拜耳公司以及所有已识别研究的主要研究者或通讯作者以获取更多信息。

结果

识别出五篇手稿,描述了四项试验的结果。我们从HIT 1、2和4获得了额外数据。总共纳入了1074例创伤性蛛网膜下腔出血患者。接受尼莫地平治疗的患者(39%)和接受安慰剂治疗的患者(40%)出现不良预后的情况相似;比值比为0.88(95%可信区间0.51 - 1.54)。尼莫地平治疗组(26%)和安慰剂治疗组(27%)患者的死亡率无差异(比值比0.95;95%可信区间0.71 - 1.26)。

解读

我们的结果不支持早期Cochrane综述中报道的尼莫地平对创伤性蛛网膜下腔出血患者预后有有益影响的结论。

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