Ricci Stefano, Dinia Lavinia, Del Sette Massimo, Anzola Paolo, Mazzoli Tatiana, Cenciarelli Silvia, Gandolfo Carlo
UO Neurologia, ASL 1 dell’ Umbria, Città di Castello, Italy.
Cochrane Database Syst Rev. 2012 Jun 13(6):CD008348. doi: 10.1002/14651858.CD008348.pub2.
Sonothrombolysis is a promising but unproven tool for treating acute ischaemic stroke. There is an ongoing debate about the efficacy, safety, technical aspects of ultrasound administration and the possible potentiating effect of microbubbles.
To assess the effectiveness and safety of sonothrombolysis in patients with acute ischaemic stroke.
We searched the Cochrane Stroke Group Trials Register (last searched in November 2011), the Cochrane Controlled Trials Register (The Cochrane Library 2011, Issue 12), MEDLINE (1950 to November 2011), EMBASE (1980 to November 2011), Database of Abstract and Review of Effects (DARE) (The Cochrane Library 2011, Issue 11), Stroke Trials Registry, Clinicaltrials.gov and Current Controlled Trials. We also searched the reference lists from relevant articles and reviews, and contacted colleagues, authors and researchers active in the field. Searching was completed in November 2011.
Randomised trials of sonothrombolysis (any duration, any frequency of ultrasound, with or without microbubbles administration) started within 12 hours of symptom onset compared with intravenous tissue plasminogen activator (tPA) or conventional treatment.
Two review authors selected trials for inclusion, assessed trial quality and extracted the data independently. We contacted study authors for missing data.
We identified five eligible studies (233 patients). For the primary outcome (death or dependency at three months), five studies with a total number of 206 patients were available (four defined independence as a modified Rankin score of 0 to 2 and one used 0 to 1). Patients treated with sonothrombolysis were no more likely to be dead or disabled at three months (odds ratio (OR) 0.80, 95% confidence interval (CI) 0.45 to 1.44). For the secondary outcomes, failure to recanalise was lower in the sonothrombolysis group (230 patients) (OR 0.28, 95% CI 0.16 to 0.50), no significant difference was found in mortality (206 patients) and in cerebral haemorrhage (233 patients).
AUTHORS' CONCLUSIONS: Sonothrombolysis did not reduce death or dependency at three months, but appeared to increase recanalisation without clear hazard. A larger clinical trial is warranted.
超声溶栓是一种治疗急性缺血性卒中的有前景但尚未得到证实的工具。关于其疗效、安全性、超声给药的技术方面以及微泡可能的增效作用，目前仍存在争议。
评估超声溶栓治疗急性缺血性卒中患者的有效性和安全性。
我们检索了Cochrane卒中小组试验注册库（最后检索时间为2011年11月）、Cochrane对照试验注册库（《Cochrane图书馆》2011年第12期）、MEDLINE（1950年至2011年11月）、EMBASE（1980年至2011年11月）、效果摘要与综述数据库（DARE）（《Cochrane图书馆》2011年第11期）、卒中试验注册库、Clinicaltrials.gov以及当前对照试验。我们还检索了相关文章和综述的参考文献列表，并联系了该领域活跃的同事、作者和研究人员。检索工作于2011年11月完成。
症状发作12小时内启动的超声溶栓随机试验（任何持续时间、任何超声频率，给予或未给予微泡），与静脉注射组织型纤溶酶原激活剂（tPA）或传统治疗进行比较。
两位综述作者选择纳入试验，独立评估试验质量并提取数据。我们联系研究作者获取缺失数据。
我们确定了五项符合条件的研究（233例患者）。对于主要结局（三个月时死亡或依赖），共有206例患者的五项研究可供分析（四项将独立定义为改良Rankin评分为0至2，一项使用0至1）。接受超声溶栓治疗的患者在三个月时死亡或残疾的可能性并不更高（比值比（OR）0.80，95%置信区间（CI）0.45至1.44）。对于次要结局，超声溶栓组再通失败率较低（230例患者）（OR 0.28，95%CI 0.16至0.50），在死亡率（206例患者）和脑出血（233例患者）方面未发现显著差异。
超声溶栓在三个月时并未降低死亡或依赖，但似乎增加了再通且无明显危害。有必要进行更大规模的临床试验。
