Wideman G L, Keffer M, Morris E, Doyle R T, Jiang J G, Beaver W T
Brookwood Medical Center, Birmingham, AL, USA.
Clin Pharmacol Ther. 1999 Jan;65(1):66-76. doi: 10.1016/S0009-9236(99)70123-2.
Two randomized, double-blind, parallel-group single-dose 2 x 2 factorial analgesic studies compared a single-dose or a 2-tablet dose of a combination of 7.5 mg hydrocodone bitartrate with 200 mg ibuprofen with each constituent alone and with a placebo in women with moderate or severe postoperative pain from abdominal or gynecologic surgery. A nurse-observer recorded patient reports of pain intensity and pain relief periodically for 8 hours. In both studies, the combination was significantly superior to placebo for sum of the pain intensity differences (SPID), total pain relief (TOTPAR), peak pain intensity difference (PID) and pain relief, global evaluation, and time to remedication. The combination was likewise significantly superior to both hydrocodone and ibuprofen for most of these summary measures of analgesia. In a factorial analysis, both the hydrocodone and ibuprofen effects were significant for most summary measures of analgesia, whereas results of the interaction contrast were consistent with the concept that the analgesic effect of the combination represents the additive analgesia of its 2 constituents.
两项随机、双盲、平行组单剂量2×2析因镇痛研究，比较了7.5毫克酒石酸氢可酮与200毫克布洛芬联合使用的单剂量或两片剂量，与每种成分单独使用以及与安慰剂相比，对腹部或妇科手术后中度或重度疼痛女性的镇痛效果。一名护士观察员在8小时内定期记录患者的疼痛强度和疼痛缓解报告。在两项研究中，联合用药在疼痛强度差异总和（SPID）、总疼痛缓解（TOTPAR）、峰值疼痛强度差异（PID）、疼痛缓解、总体评估以及再次用药时间方面均显著优于安慰剂。在这些镇痛综合指标中，联合用药同样显著优于氢可酮和布洛芬。在析因分析中，氢可酮和布洛芬对大多数镇痛综合指标的作用均显著，而相互作用对比结果与联合用药的镇痛效果代表其两种成分相加性镇痛的概念一致。
