Clark W, Ertag W, Orecchio E, Raps E
Oregon Stroke Center, Portland, OR, USA.
J Stroke Cerebrovasc Dis. 1999 Jul-Aug;8(4):224-30. doi: 10.1016/s1052-3057(99)80071-8.
Cervene (nalmefene), an opioid antagonist with relative kappa receptor selectivity, has shown neuroprotective effects in multiple experimental central nervous system injury and ischemic models. The agent already has a well-established safety profile in various clinical indications. Results from an earlier pilot study in 44 acute stroke patients suggest that Cervene administered by 24-hour maintenance infusion was safe and tolerable. The primary and secondary objectives of the current study were to assess the dose-related safety and preliminary efficacy of Cervene in patients with acute ischemic stroke.
The present investigation was a Phase II, placebo-controlled, double-blind, randomized, dose-comparison, parallel-group study of a 24-hour administration of Cervene injection. Patients with acute ischemic stroke, onset of symptoms within 6 hours, and baseline score > or =4 on the National Institute of Health Stroke Scale (NIHSS) were randomized to 1 of 4 treatment groups: Cervene 6 mg, 20 mg, 60 mg or placebo. The primary efficacy outcome was the proportion of patients achieving a score of > or =60 on the Barthel Index and a rating of "moderate disability" or better on the Glasgow Outcome Scale at 12 weeks.
A total of 312 patients were randomized at 28 centers. All doses of Cervene were well tolerated. Overall, there was no significant difference in 3-month functional outcome for any dose of Cervene treatment compared with placebo. However, a prospective secondary analysis showed that both male and female patients less than age 70 years may have had an improved 3-month outcome.
The results of this study indicate that the competitive kappa receptor opiate antagonist Cervene can be given safely to acute stroke patients at doses up to 60 mg/24 hr. Although overall there was no significant difference in the 3-month outcome, Cervene treatment may be associated with improved outcomes for patients younger than age 70.
塞尔维恩（纳美芬）是一种对κ受体具有相对选择性的阿片类拮抗剂，已在多种实验性中枢神经系统损伤和缺血模型中显示出神经保护作用。该药物在各种临床适应症中已具有公认的安全性。一项早期针对44例急性中风患者的试点研究结果表明，通过24小时持续输注给予塞尔维恩是安全且可耐受的。本研究的主要和次要目标是评估塞尔维恩在急性缺血性中风患者中的剂量相关安全性和初步疗效。
本研究是一项II期、安慰剂对照、双盲、随机、剂量比较、平行组研究，对塞尔维恩注射液进行24小时给药。急性缺血性中风患者，症状发作在6小时内，且美国国立卫生研究院卒中量表（NIHSS）基线评分≥4分，被随机分为4个治疗组之一：塞尔维恩6毫克、20毫克、60毫克或安慰剂。主要疗效指标是在第12周时，达到巴氏指数评分≥60分且格拉斯哥预后量表评分为“中度残疾”或更好的患者比例。
共有312例患者在2…
