前瞻性、随机、开放标签的 II 期临床试验：在严重蛛网膜下腔出血后同时进行脑室内纤维蛋白溶解和低频旋转。
Prospective, randomized, open-label phase II trial on concomitant intraventricular fibrinolysis and low-frequency rotation after severe subarachnoid hemorrhage.
机构信息
Department of Neurosurgery and Institute for Diagnostic and Interventional Radiology, Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany.
出版信息
Stroke. 2013 Aug;44(8):2162-8. doi: 10.1161/STROKEAHA.113.001790. Epub 2013 Jun 4.
BACKGROUND AND PURPOSE
The goal of this randomized, open-label phase II study was to investigate the effect of concomitant low-frequency head-motion therapy and intraventricular fibrinolysis in patients after surgical or endovascular treatment for aneurysmal subarachnoid hemorrhage.
METHODS
Sixty patients experiencing subarachnoid hemorrhage were randomized into treatment with intraventricular application of recombinant tissue-type plasminogen activator and lateral rotational therapy (experimental) or treatment as usual (control). The primary end point was defined as functional outcome, measured by Glasgow Outcome Scale at discharge and at 3-month follow-up. Clot clearance rate, radiographic features of delayed cerebral ischemia, and posthemorrhagic hydrocephalus were defined as secondary end points.
RESULTS
The majority of patients (78.3%) experienced severe subarachnoid hemorrhage. Although there was a higher incidence of subgaleal hematomas in the experimental group, there was no difference in the incidence of adverse or severe adverse events between the 2 groups. Despite significantly higher clot clearance rates, there was no beneficial effect on the incidence of delayed cerebral ischemia and poor functional outcome, as well as posthemorrhagic hydrocephalus after experimental treatment.
CONCLUSIONS
Despite the ineffectiveness on reduction of delayed cerebral ischemia or poor functional outcome, intraventricular fibrinolysis and kinetic therapy seems to be a safe and effective concept for therapeutic reduction of subarachnoid clot in a patient collective experiencing predominantly severe subarachnoid hemorrhage. Therefore, future studies should investigate this treatment in a larger patient collective with a lower degree of primary brain injury and until full clot clearance on serial imaging.
CLINICAL TRIAL REGISTRATION URL
http://www.controlled-trials.com. Unique identifier: ICRCTN13230264.
背景与目的
本随机、开放标签的二期研究旨在探讨在接受手术或血管内治疗的颅内出血患者中，同时进行低频头部运动治疗和脑室内溶栓的效果。
方法
60 名蛛网膜下腔出血患者被随机分为脑室内应用重组组织型纤溶酶原激活物和侧向旋转治疗组（实验组）或常规治疗组（对照组）。主要终点定义为出院时和 3 个月随访时的格拉斯哥结局量表测定的功能结局。清除率、迟发性脑缺血的影像学特征和出血后脑积水被定义为次要终点。
结果
大多数患者（78.3%）经历了严重的蛛网膜下腔出血。尽管实验组的皮下血肿发生率较高，但两组的不良事件或严重不良事件发生率没有差异。尽管实验组的清除率明显较高，但在迟发性脑缺血和不良功能结局的发生率以及出血后脑积水方面，并没有对实验组的治疗效果产生有益影响。
结论
尽管在降低迟发性脑缺血或不良功能结局方面没有效果，但脑室内溶栓和动力学治疗似乎是一种安全有效的方法，可用于治疗主要表现为严重蛛网膜下腔出血的患者的蛛网膜下腔血肿。因此，未来的研究应该在原发性脑损伤程度较低的更大患者群体中，并在连续影像学检查中达到完全清除血肿的情况下，进一步研究这种治疗方法。
Zotero 插件