Department of Neurosurgery, University Hospital of Nice, Hôpital Pasteur, avenue de la voie Romaine, Nice, France.
Neurosurg Rev. 2013 Oct;36(4):523-30; discussion 530-1. doi: 10.1007/s10143-013-0469-7. Epub 2013 May 2.
The aim of this study was to assess the safety and efficacy of intraventricular fibrinolysis (IVF) for aneurysmal subarachnoid hemorrhage (aSAH) with severe intraventricular hemorrhage (IVH). In this randomized controlled trial, between 2005 and 2009, patients with aSAH and severe IVH were randomly assigned into two groups: one treated with external ventricular drainage (EVD) combined with intraventricular recombinant tissue plasminogen activator (rt-PA) and the second with EVD alone. The primary end-point was mortality rate within the first 30 days. We performed meta-analysis including all published articles that compared IVF + EVD to EVD alone in patients with aSAH IVH. Eleven patients were included in the rt-PA group, eight in the control group. At 30 days, mortality rate was lower in the rt-PA group (45.5 vs. 62.5%), but results were not statistically significant (p = 0.65). Clearance of third and fourth ventricles was obtained previously in the rt-PA group (4.25 days) compared to the control group (10.67 days) (p = 0.001). There was no statistically significant difference concerning the occurrence of complications. The meta-analysis showed a better survival rate with IVF without raised statistical significance (odds ratio = 0.32 [95% confidence interval, 0.10-1.03]). This study shows that IVF is as safe as EVD alone for aSAH with severe IVH. It accelerates blood clot resolution in the ventricular system. Mortality rate could be improved by IVF but without significant results. Because of the severity and rarity of this pathology, a multicenter study is required.
www.clinicaltrials.gov (NCT00823485).
本研究旨在评估脑室内纤维蛋白溶解（IVF）治疗伴有严重脑室内出血（IVH）的蛛网膜下腔出血（aSAH）的安全性和有效性。在这项随机对照试验中，2005 年至 2009 年间，将伴有严重 IVH 的 aSAH 患者随机分为两组：一组接受脑室外引流（EVD）联合脑室内重组组织纤溶酶原激活剂（rt-PA）治疗，另一组仅接受 EVD 治疗。主要终点为 30 天内死亡率。我们进行了荟萃分析，纳入了所有比较 IVF+EVD 与 EVD 单独治疗伴有 IVH 的 aSAH 患者的已发表文章。rt-PA 组纳入 11 例患者，对照组纳入 8 例患者。30 天时，rt-PA 组死亡率较低（45.5%比 62.5%），但无统计学意义（p=0.65）。rt-PA 组脑室第三和第四脑室的清除时间更早（4.25 天），而对照组（10.67 天）则更长（p=0.001）。并发症发生率无统计学差异。荟萃分析显示，IVF 组的生存率更好，但无统计学意义（比值比=0.32[95%置信区间，0.10-1.03]）。本研究表明，IVF 与单独 EVD 治疗伴有严重 IVH 的 aSAH 一样安全。它可加速脑室系统中血凝块的溶解。IVF 可能会提高死亡率，但结果无统计学意义。由于该疾病的严重程度和罕见性，需要进行多中心研究。
