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酮洛芬、布洛芬与安慰剂治疗原发性痛经:双盲交叉对照研究

Ketoprofen, ibuprofen, and placebo in the treatment of primary dysmenorrhea: a double-blind crossover comparison.

作者信息

Mehlisch D R

机构信息

Biomedical Research Group, Austin, Texas.

出版信息

J Clin Pharmacol. 1988 Dec;28(s1):S29-33. doi: 10.1002/j.1552-4604.1988.tb05974.x.

Abstract

Under double-blind, crossover conditions, 43 women with primary dysmenorrhea received ketoprofen, ibuprofen, and placebo during three consecutive menstrual cycles. Pain intensity and pain relief were determined before and for 6 hours after the loading dose (ketoprofen 150 mg, ibuprofen 800 mg) and before and 2 hours after the maintenance dose (ketoprofen 75 mg, ibuprofen 400 mg). Mean pain intensity difference and pain relief scores consistently indicated greater pain relief after the loading doses of ketoprofen and ibuprofen than after placebo. Significant (P less than 0.05) mean changes that were measured by 13 indices of analgesia after the loading doses of both ketoprofen and ibuprofen indicated greater efficacy for the active treatments than for placebo. The patients' global evaluations after the loading doses were significantly (P less than 0.05) better for the active treatments than for placebo. The efficacy results were similar after the maintenance doses. The rates of a "good" to "excellent" response were 77% for ketoprofen, 73% for ibuprofen, and 35% for placebo. Ketoprofen and ibuprofen were equally well tolerated, the most frequent adverse experiences being gastrointestinal symptoms for ketoprofen and central nervous system side effects for ibuprofen.

摘要

在双盲、交叉试验条件下,43名原发性痛经女性在连续三个月经周期中分别接受了酮洛芬、布洛芬和安慰剂治疗。在负荷剂量(酮洛芬150毫克、布洛芬800毫克)给药前及给药后6小时,以及维持剂量(酮洛芬75毫克、布洛芬400毫克)给药前及给药后2小时,测定疼痛强度和疼痛缓解情况。平均疼痛强度差异和疼痛缓解评分始终表明,与安慰剂相比,酮洛芬和布洛芬负荷剂量给药后的疼痛缓解效果更佳。酮洛芬和布洛芬负荷剂量给药后,通过13项镇痛指标测得的显著(P<0.05)平均变化表明,与安慰剂相比,活性治疗药物的疗效更佳。负荷剂量给药后,患者对活性治疗药物的总体评价显著(P<0.05)优于安慰剂。维持剂量给药后的疗效结果相似。酮洛芬的“良好”至“优秀”反应率为77%,布洛芬为73%,安慰剂为35%。酮洛芬和布洛芬的耐受性相当,最常见的不良反应分别是酮洛芬引起的胃肠道症状和布洛芬引起的中枢神经系统副作用。

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