Stambaugh J E, McAdams J
Clin Pharmacol Ther. 1987 Aug;42(2):210-9. doi: 10.1038/clpt.1987.134.
Sixty hospitalized subjects with chronic moderate to severe pain as a result of advanced cancer were enrolled in a randomized, parallel, double-blind trial comparing single doses and multiple doses of intramuscular dezocine (10 mg) with butorphanol (2 mg) and placebo. During the initial 6-hour efficacy evaluation, analgesia was measured using verbal and visual scriptors and vital signs, and acute toxicity information was recorded. Subjects with initial pain relief entered the 7-day multidose portion of the trial, and efficacy and toxicity data were recorded daily. After the initial dose the peak analgesia of the active agents was similar, but the duration of analgesia was longer with dezocine. After multiple doses, dezocine was superior to butorphanol in terms of length of treatment. Dezocine had less toxicity than had butorphanol after both single and repeated doses, further suggesting that dezocine may be beneficial in managing chronic cancer pain. The described study design is unique in that it compares the analgesic efficacy and toxicity of several analgesics with placebo after both single and multiple doses in the same subject. This method may prove to be an alternative pain model to evaluate chronic cancer pain.
60名因晚期癌症导致慢性中度至重度疼痛的住院患者被纳入一项随机、平行、双盲试验,该试验比较了肌肉注射单剂量和多剂量地佐辛(10毫克)与布托啡诺(2毫克)及安慰剂的效果。在最初6小时的疗效评估期间,使用语言和视觉描述以及生命体征来测量镇痛效果,并记录急性毒性信息。最初疼痛得到缓解的患者进入试验的7天多剂量阶段,每天记录疗效和毒性数据。初始剂量后,活性药物的峰值镇痛效果相似,但地佐辛的镇痛持续时间更长。多次给药后,地佐辛在治疗时长方面优于布托啡诺。单剂量和重复剂量给药后,地佐辛的毒性均低于布托啡诺,这进一步表明地佐辛可能有助于控制慢性癌痛。所描述的研究设计独特之处在于,它在同一受试者中比较了单剂量和多剂量给药后几种镇痛药与安慰剂的镇痛效果和毒性。这种方法可能被证明是评估慢性癌痛的一种替代疼痛模型。