Bloomfield S S, Cissell G B, Peters N M, Mitchell J, Nelson E D, Barden T P
Clin Pharmacol Ther. 1987 Jul;42(1):89-95. doi: 10.1038/clpt.1987.113.
Anirolac, a new nonsteroidal anti-inflammatory drug, was evaluated for relative efficacy, safety, and time course of analgesia. In a stratified, randomized, parallel, double-blind trial, 120 hospitalized women with moderate or severe postpartum uterine pain were treated with single oral doses of anirolac, 50 or 100 mg, naproxen sodium, 550 mg, or placebo. Using verbal scales, patients rated pain intensity, pain relief, and side effects at regular intervals for 6 hours. Highest summed analgesic ratings over placebo were induced by anirolac, 100 mg (P less than or equal to 0.001), and naproxen (P less than or equal to 0.001), followed by anirolac, 50 mg (P less than or equal to 0.005). At each assessment after the first hour, anirolac, 50 and 100 mg, and naproxen induced significantly stronger analgesia than did placebo. Statistically significantly more drowsiness was reported with all three active agents than with placebo. Our results suggest that, for postpartum uterine pain, analgesia with anirolac, 50 or 100 mg, is equivalent to that with naproxen, 550 mg.
对一种新型非甾体抗炎药阿尼洛尔的镇痛相对疗效、安全性和时程进行了评估。在一项分层、随机、平行、双盲试验中,120名患有中度或重度产后子宫疼痛的住院女性分别接受单次口服50毫克或100毫克阿尼洛尔、550毫克萘普生钠或安慰剂治疗。患者使用语言量表,每隔一段时间对疼痛强度、疼痛缓解情况和副作用进行6小时的评分。与安慰剂相比,100毫克阿尼洛尔(P≤0.001)和萘普生(P≤0.001)诱导的镇痛评分总和最高,其次是50毫克阿尼洛尔(P≤0.005)。在第一小时后的每次评估中,50毫克和100毫克阿尼洛尔以及萘普生诱导的镇痛效果均明显强于安慰剂。与安慰剂相比,所有三种活性药物导致的嗜睡报告在统计学上均显著更多。我们的结果表明,对于产后子宫疼痛,50毫克或100毫克阿尼洛尔的镇痛效果与550毫克萘普生相当。