Kantor T G, Hopper M
Clin Pharmacol Ther. 1984 Jan;35(1):46-9. doi: 10.1038/clpt.1984.7.
One hundred twenty-one patients with postpartum pain caused by uterine cramp or episiotomy pain were the subjects of a randomized, double-blind, single-dose study of oral nalbuphine (N), 15 mg (N = 39); codeine (C), 60 mg (N = 42); and placebo (N = 40) for analgesia. Observations were made over 6 hr. There were significant differences for sum of pain intensity differences and total pain relief between the active drugs and placebo but not between N and C. Time to onset of analgesia favored N (mean = 0.65 min) over C (mean = 0.74 min), but the analgetic effect of N diminished more rapidly at this dose. Results were the same for both uterine cramp and episiotomy pain. Adverse effects were of the narcotic type and of the same incidence for the two active drugs. Two new parameters for determining analgetic effect are introduced: number of dropouts per dose and number of subjects with zero analgetic effect.
121名因子宫收缩或会阴切开术疼痛而导致产后疼痛的患者参与了一项口服纳布啡(N组)、15毫克(N = 39);可待因(C组)、60毫克(N = 42);以及安慰剂(N = 40)用于镇痛的随机、双盲、单剂量研究。观察持续6小时。活性药物与安慰剂之间在疼痛强度差异总和及总疼痛缓解方面存在显著差异,但N组和C组之间无显著差异。镇痛起效时间N组(平均 = 0.65分钟)优于C组(平均 = 0.74分钟),但在此剂量下N组的镇痛效果消退更快。子宫收缩疼痛和会阴切开术疼痛的结果相同。不良反应为麻醉类,两种活性药物的发生率相同。引入了两个用于确定镇痛效果的新参数:每剂量的退出人数和镇痛效果为零的受试者人数。