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蛛网膜下腔出血时动脉瘤手术的时机——荷兰的一项观察性研究

Timing of aneurysm surgery in subarachnoid haemorrhage--an observational study in The Netherlands.

作者信息

Nieuwkamp D J, de Gans K, Algra A, Albrecht K W, Boomstra S, Brouwers P J A M, Groen R J M, Metzemaekers J D M, Nijssen P C G, Roos Y B W E M, Tulleken C A F, Vandertop W P, van Gijn J, Vos P E, Rinkel G J E

机构信息

Department of Neurology, University Medical Centre, Utrecht, Utrecht, The Netherlands.

出版信息

Acta Neurochir (Wien). 2005 Aug;147(8):815-21. doi: 10.1007/s00701-005-0536-0. Epub 2005 Jun 16.

Abstract

BACKGROUND

There is still lack of evidence on the optimal timing of surgery in patients with aneurysmal subarachnoid haemorrhage. Only one randomised clinical trial has been done, which showed no difference between early and late surgery. Other studies were observational in nature and most had methodological drawbacks that preclude clinically meaningful conclusions. We performed a retrospective observational study on the timing of aneurysm surgery in The Netherlands over a two-year period.

METHOD

In eight hospitals we identified 1,500 patients with an aneurysmal subarachnoid haemorrhage. They were subjected to predefined inclusion criteria. We included all patients who were admitted and were conscious at any one time between admission and the end of the third day after the haemorrhage. We categorised the clinical condition on admission according the World Federation of Neurological Surgeons (WFNS) grading scale. Early aneurysm surgery was defined as operation performed within three days after onset of subarachnoid haemorrhage; intermediate surgery as performed on days four to seven, and late surgery as performed after day seven. Outcome was classified as the proportion of patients with poor outcome (death or dependent) two to four months after onset of subarachnoid haemorrhage. We calculated crude odds ratios with late surgery as reference. We distinguished between management results (reconstructed intention to treat analysis) and surgical results (on treatment analysis). The results were adjusted for the major prognosticators for outcome after subarachnoid haemorrhage.

FINDINGS

We included 411 patients. There were 276 patients in the early surgery group, 36 in the intermediate surgery group and 99 in the late surgery group. On admission 78% were in good neurological condition (WFNS I-III). MANAGEMENT RESULTS: Overall, 93 patients (34%) operated on early had a poor outcome, 13 (36%) of those with intermediate surgery and 37 (37%) in the late surgery group had a poor outcome. For patients in good clinical condition on admission and planned for early surgery the adjusted odds ratio (OR) was 1.3 (95% CI 0.5 to 3.0). The adjusted OR for patients admitted in poor neurologicalcondition (WFNS IV-V) and planned for early surgery was 0.1 (95% CI 0.0 to 0.6). SURGICAL RESULTS: For patients in good clinical condition on admission who underwent early operation the adjusted OR was 1.1 (95% CI 0.4 to 3.2); it was 0.2 (95% CI 0.0 to 0.9) for patients admitted in poor clinical condition.

CONCLUSIONS

In this observational study we found no significant difference in outcome between early and late operation for patients in good clinical condition on admission. For patients in poor clinical condition on admission outcome was significantly better after early surgery. The optimal timing of surgery is not yet settled. Ideally, evidence on this issue should come from a randomised clinical trial. However, such a trial or even a prospective study are unlikely to be ever performed because of the rapid development of endovascular coiling.

摘要

背景

关于动脉瘤性蛛网膜下腔出血患者的最佳手术时机,目前仍缺乏证据。仅进行过一项随机临床试验,结果显示早期手术和晚期手术之间没有差异。其他研究本质上是观察性的,且大多数存在方法学缺陷,无法得出具有临床意义的结论。我们对荷兰两年内动脉瘤手术的时机进行了一项回顾性观察研究。

方法

在八家医院,我们确定了1500例动脉瘤性蛛网膜下腔出血患者。他们需符合预先设定的纳入标准。我们纳入了所有在出血后入院至第三天末任何时间入院且神志清醒的患者。根据世界神经外科联合会(WFNS)分级量表对入院时的临床状况进行分类。早期动脉瘤手术定义为在蛛网膜下腔出血发作后三天内进行的手术;中期手术为在第四天至第七天进行,晚期手术为在第七天之后进行。结局分类为蛛网膜下腔出血发作后两至四个月时预后不良(死亡或依赖他人)的患者比例。我们以晚期手术为参照计算粗比值比。我们区分了管理结果(重建意向性治疗分析)和手术结果(治疗分析)。结果针对蛛网膜下腔出血后结局的主要预后因素进行了调整。

结果

我们纳入了411例患者。早期手术组有276例患者,中期手术组有36例,晚期手术组有99例。入院时78%的患者神经状况良好(WFNS I - III级)。管理结果:总体而言,早期手术的93例患者(34%)预后不良,中期手术的患者中有13例(36%),晚期手术组中有37例(37%)预后不良。对于入院时临床状况良好且计划进行早期手术的患者,调整后的比值比(OR)为1.3(95%可信区间0.5至3.0)。对于入院时神经状况不佳(WFNS IV - V级)且计划进行早期手术的患者,调整后的OR为0.1(95%可信区间0.0至0.6)。手术结果:对于入院时临床状况良好且接受早期手术的患者,调整后的OR为1.1(95%可信区间0.4至3.2);对于入院时临床状况不佳的患者,该值为0.2(95%可信区间0.0至0.9)。

结论

在这项观察性研究中,我们发现入院时临床状况良好的患者早期手术和晚期手术的结局没有显著差异。对于入院时临床状况不佳的患者,早期手术后的结局明显更好。手术的最佳时机尚未确定。理想情况下,关于这个问题的证据应该来自随机临床试验。然而,由于血管内栓塞术的快速发展,这样的试验甚至前瞻性研究都不太可能进行。

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