Kaplan J L, Marx J A
Emergency Medical Services, Temple University Hospital, Philadelphia, Pennsylvania.
Ann Emerg Med. 1993 Feb;22(2):187-90. doi: 10.1016/s0196-0644(05)80200-8.
To evaluate the efficacy and safety of nalmefene, an investigational narcotic antagonist that has potential advantages over naloxone because of its four- to eight-hour half-life, in emergency department patients with possible narcotic overdose.
Multi-institutional, prospective, phase II, open-label study.
Complete data were available for 53 cases from two teaching hospitals. Men 18 years old or older who would otherwise receive naloxone were eligible (two women were enrolled inadvertently).
Over four hours, one to ten boluses (median, one) of 0.5 or 1.0 mg nalmefene IV were given as often as every two minutes based on clinical need. Respirations, blood pressure, pulse, pupil size, and overall clinical response were monitored. Overall clinical response (1, no change; 2, partial response; 3, complete response), first assessed at two minutes, was analyzed by the Mann-Whitney U test.
Fifteen of 25 (0.5 mg) and nine of 28 (1.0 mg) cases were opiate positive. Twelve of 15 (0.5 mg) and six of nine (1.0 mg) opiate-positive cases had a rapid complete response. Coincident causes of depressed sensorium were identified in the remaining six opiate-positive cases. No difference in initial overall clinical response was seen between 0.5-mg and 1.0-mg opiate-positive cases (P = .59). No deterioration requiring repeat nalmefene occurred in opiate-positive cases, even if methadone (four), codeine (two), or pentazocine (one) was found. No serious adverse events were judged to be related to nalmefene.
Nalmefene is effective in the reversal of opiate overdose and appears to be safe in the management of patients with altered sensorium.
评估纳美芬的疗效和安全性。纳美芬是一种研究中的麻醉拮抗剂，因其4至8小时的半衰期，相对于纳洛酮具有潜在优势，用于可能存在麻醉药物过量的急诊科患者。
多机构、前瞻性、II期、开放标签研究。
来自两家教学医院的53例患者有完整数据。18岁及以上、原本会接受纳洛酮治疗的男性符合条件（两名女性为意外纳入）。
在4小时内，根据临床需要，每两分钟静脉注射0.5或1.0毫克纳美芬，每次1至10次推注（中位数为1次）。监测呼吸、血压、脉搏、瞳孔大小和总体临床反应。总体临床反应（1，无变化；2，部分反应；3，完全反应）在两分钟时首次评估，采用曼-惠特尼U检验进行分析。
25例接受0.5毫克剂量的患者中有15例、28例接受1.0毫克剂量的患者中有9例阿片类药物检测呈阳性。接受0.5毫克剂量的阿片类药物阳性患者中有12例、接受1.0毫克剂量的患者中有6例迅速完全反应。其余6例阿片类药物阳性患者中发现了导致意识障碍的合并原因。0.5毫克和1.0毫克阿片类药物阳性患者的初始总体临床反应无差异（P = 0.59）。即使发现了美沙酮（4例）、可待因（2例）或喷他佐辛（1例），阿片类药物阳性患者也未出现需要重复使用纳美芬的病情恶化。未判定有严重不良事件与纳美芬相关。
纳美芬在逆转阿片类药物过量方面有效，且在治疗意识改变的患者时似乎安全。
