Silver Brian, McCarthy Sharon, Lu Mei, Mitsias Panayiotis, Russman Andrew N, Katramados Angelos, Morris Daniel C, Lewandowski Christopher A, Chopp Michael
Department of Neurology, Henry Ford Hospital, Detroit, Michigan 48202, USA.
J Stroke Cerebrovasc Dis. 2009 Sep-Oct;18(5):381-3. doi: 10.1016/j.jstrokecerebrovasdis.2009.01.007.
In several animal studies of young and aged rats with ischemic stroke, treatment with sildenafil improved functional outcomes compared with placebo. We conducted a safety study of sildenafil (25 mg daily for 2 weeks) shortly after ischemic stroke onset.
We recruited patients aged 18 to 80 years with ischemic stroke, National Institutes of Health stroke scale (NIHSS) score 2 to 21, between days 2 and 9 after symptom onset. Patients were treated with sildenafil for 2 weeks (25 mg daily). The primary outcome measure was the adverse occurrence of any of the following during the treatment period: stroke worsening, new stroke, myocardial infarction, vision loss, hearing loss, or death from any cause. Secondary outcome measures were NIHSS score, Barthel indices, and modified Rankin score at 90 days.
Twelve patients were recruited. Mean age was 57 years, 5 were female, and median NIHSS score at entry was 9.5 (range 2-20). The primary outcome measure occurred in one patient (sudden death). Another patient committed suicide 2 months after study entry (and 6 weeks after treatment with sildenafil had been completed). Among the 10 survivors, at 90 days, median NIHSS score was 2 (range 0-12), median Barthel index was 95 (range 15-100), and median modified Rankin score was 1.5 (range 0-5).
Sildenafil (25 mg daily for 2 weeks) appeared to be safe in this group of patients with mild to moderately severe stroke. Further studies of higher doses will be tested.
在多项针对年轻和老年缺血性中风大鼠的动物研究中，与安慰剂相比，西地那非治疗可改善功能结局。我们在缺血性中风发作后不久进行了一项西地那非（每日25毫克，持续2周）的安全性研究。
我们招募了年龄在18至80岁之间、缺血性中风发作后第2至9天、美国国立卫生研究院卒中量表（NIHSS）评分为2至21分的患者。患者接受西地那非治疗2周（每日25毫克）。主要结局指标是治疗期间出现以下任何一种不良情况：中风恶化、新发中风、心肌梗死、视力丧失、听力丧失或任何原因导致的死亡。次要结局指标是90天时的NIHSS评分、巴氏指数和改良Rankin评分。
招募了12名患者。平均年龄为57岁，5名女性，入组时NIHSS评分中位数为9.5（范围2 - 20）。主要结局指标发生在1名患者身上（猝死）。另一名患者在研究入组后2个月（以及西地那非治疗完成6周后）自杀。在10名幸存者中，90天时，NIHSS评分中位数为2（范围0 - 12），巴氏指数中位数为95（范围15 - 100），改良Rankin评分中位数为1.5（范围0 - 5）。
西地那非（每日25毫克，持续2周）在这组轻度至中度严重中风患者中似乎是安全的。将对更高剂量进行进一步研究。
