Coutinho Jonathan, de Bruijn Sebastiaan Ftm, Deveber Gabrielle, Stam Jan
Department of Neurology, Academic Medical Centre, University of Amsterdam, PO Box 22700, Amsterdam, Netherlands, 1100 DE.
Cochrane Database Syst Rev. 2011 Aug 10;2011(8):CD002005. doi: 10.1002/14651858.CD002005.pub2.
Treatment of cerebral venous sinus thrombosis with anticoagulants has been controversial. Anticoagulants may prevent new venous infarcts, neurologic deterioration and pulmonary embolism but may also promote haemorrhages.
To assess the effectiveness and safety of anticoagulant therapy in patients with confirmed cerebral venous sinus thrombosis.
We searched the Cochrane Stroke Group Trials Register (last searched August 2010), MEDLINE (1950 to August 2010), EMBASE (1980 to August 2010) and the Cochrane Central Register of Controlled Trials (The Cochrane Library, 2011 Issue 1). In an effort to identify further published, unpublished and ongoing trials we searched ongoing trials registers and reference lists of relevant articles, and contacted authors.
Unconfounded randomised controlled trials in which anticoagulant therapy was compared with placebo or open control in patients with cerebral venous sinus thrombosis (confirmed by intra-arterial contrast, or venography with magnetic resonance, or venography with computed tomography imaging).
Two review authors independently extracted outcomes for each of the two treatment groups (anticoagulant treatment and control). The outcome data for each patient were analysed in the treatment group to which the patient was originally allocated (intention-to-treat analysis). We calculated a weighted estimate of the treatment effects across trials (relative risk, absolute risk reduction).
We included two small trials involving 79 patients. One trial (20 patients) examined the efficacy of intravenous, adjusted dose unfractionated heparin. The other trial (59 patients) examined high dose, body weight adjusted, subcutaneous, low-molecular weight heparin (nadroparin). Anticoagulant therapy was associated with a pooled relative risk of death of 0.33 (95% confidence interval (CI) 0.08 to 1.21) and of death or dependency of 0.46 (95% CI 0.16 to 1.31). The absolute reduction in the risk of death or dependency was 13% (95% CI 30% to -3%). No new symptomatic intracerebral haemorrhages were observed. One major gastro-intestinal haemorrhage occurred after anticoagulant treatment. Two control patients (placebo) had a diagnosis of probable pulmonary embolism (one fatal).
AUTHORS' CONCLUSIONS: Based upon the limited evidence available, anticoagulant treatment for cerebral venous sinus thrombosis appeared to be safe and was associated with a potentially important reduction in the risk of death or dependency which did not reach statistical significance.
使用抗凝剂治疗脑静脉窦血栓形成一直存在争议。抗凝剂可能预防新的静脉梗死、神经功能恶化和肺栓塞,但也可能促使出血。
评估确诊为脑静脉窦血栓形成患者接受抗凝治疗的有效性和安全性。
我们检索了Cochrane卒中组试验注册库(最后检索时间为2010年8月)、MEDLINE(1950年至2010年8月)、EMBASE(1980年至2010年8月)以及Cochrane对照试验中央注册库(《Cochrane图书馆》,2011年第1期)。为了识别更多已发表、未发表及正在进行的试验,我们检索了正在进行的试验注册库、相关文章的参考文献列表,并联系了作者。
无混杂因素的随机对照试验,其中将脑静脉窦血栓形成患者(经动脉内造影、磁共振静脉造影或计算机断层扫描静脉造影确诊)的抗凝治疗与安慰剂或开放对照进行比较。
两位综述作者独立提取两个治疗组(抗凝治疗组和对照组)中每组的结局。对每位患者的结局数据在其最初分配的治疗组中进行分析(意向性分析)。我们计算了各试验治疗效果的加权估计值(相对危险度、绝对危险度降低)。
我们纳入了两项涉及79例患者的小型试验。一项试验(20例患者)研究了静脉注射调整剂量普通肝素的疗效。另一项试验(59例患者)研究了高剂量、根据体重调整的皮下注射低分子肝素(那屈肝素)。抗凝治疗的合并相对死亡危险度为0.33(95%置信区间(CI)0.08至1.21),死亡或依赖的合并相对危险度为0.46(95%CI 0.16至1.31)。死亡或依赖风险的绝对降低为13%(95%CI 30%至 -3%)。未观察到新的有症状的颅内出血。抗凝治疗后发生1例严重胃肠道出血。两名对照患者(安慰剂组)被诊断可能发生肺栓塞(1例死亡)。
基于现有有限证据,脑静脉窦血栓形成的抗凝治疗似乎是安全的,且与死亡或依赖风险潜在的重要降低相关,但未达到统计学显著性。