Rocca W A, Dorsey F C, Grigoletto F, Gent M, Roberts R S, Walker M D, Easton J D, Bruno R, Carolei A, Sancesario G
Epidemiology and Clinical Research, Verona, Italy.
Stroke. 1992 Apr;23(4):519-26. doi: 10.1161/01.str.23.4.519.
The Early Stroke Trial is a randomized, placebo-controlled, double-masked, multicenter study to assess the safety and efficacy of monosialoganglioside in patients who have suffered an ischemic stroke of the cerebral hemispheres.
Only patients who could be evaluated and treated within 5 hours after the onset of stroke were considered; within each center, subjects were stratified by age, sex, and clinical severity. Patients were randomly allocated to receive a specified sequence of intravenous and intramuscular doses of either monosialoganglioside or identical-appearing placebo for 21 days. Patients were followed up for 4 months after randomization. Neurological status was measured primarily by using the Canadian Neurological Scale. After assessing the effect of treatment on survival, the principal measure of efficacy will be the change in neurological status between baseline and the 4-month follow-up among survivors.
Sixteen clinical centers, 15 in Europe and one in North America, entered a total of 792 eligible patients during a 36-month recruitment period (from May 1987 to April 1990). In our series there were more men than women, and the relative frequency of patients increased with advancing age. The most frequently associated cardiovascular conditions were hypertension, atrial fibrillation, and peripheral vascular disease. Approximately 46% of the patients were admitted to a hospital within 1 hour and 81%, within 2 hours after the onset of stroke. About 22% first received the study treatment within 3 hours and 57%, within 4 hours.
This study demonstrates the feasibility of large-scale trials with the onset of treatment within 5 hours after an ischemic stroke.
早期卒中试验是一项随机、安慰剂对照、双盲、多中心研究，旨在评估单唾液酸神经节苷脂对大脑半球缺血性卒中患者的安全性和有效性。
仅纳入发病5小时内可进行评估和治疗的患者；在每个中心，受试者按年龄、性别和临床严重程度分层。患者被随机分配接受单唾液酸神经节苷脂或外观相同的安慰剂的特定静脉和肌肉注射剂量序列，持续21天。随机分组后对患者进行4个月的随访。主要通过加拿大神经功能量表测量神经功能状态。在评估治疗对生存的影响后，疗效的主要衡量指标将是幸存者基线与4个月随访之间神经功能状态的变化。
16个临床中心，欧洲15个，北美1个，在36个月的招募期（1987年5月至1990年4月）共纳入792例符合条件的患者。在我们的系列研究中，男性多于女性，患者相对频率随年龄增长而增加。最常合并的心血管疾病是高血压、心房颤动和外周血管疾病。约46%的患者在卒中发病后1小时内入院，81%在2小时内入院。约22%的患者在3小时内首次接受研究治疗，57%在4小时内。
本研究证明了在缺血性卒中发病5小时内开始治疗的大规模试验的可行性。
