Sunshine A, Olson N Z, O'Neill E, Ramos I, Doyle R
NYU Medical Center, Analgesic Development Ltd., New York, New York 10021-3522, USA.
J Clin Pharmacol. 1997 Oct;37(10):908-15. doi: 10.1002/j.1552-4604.1997.tb04265.x.
Hydrocodone is a semisynthetic opioid with analgesic and antitussive properties qualitatively similar to other opioid agonists. Ibuprofen is a nonsteroidal antiinflammatory agent with analgesic and antipyretic activity and is an effective, primarily peripheral-acting antiinflammatory analgesic. The objective of this clinical trial was to determine the additive analgesic effect of the combination of 15 mg hydrocodone bitartrate with 400 mg ibuprofen, relative to 400 mg ibuprofen alone and placebo, in the treatment of postoperative pain. The single-dose analgesic efficacy of the combination of hydrocodone bitartrate with ibuprofen was compared with ibuprofen alone and placebo in 120 patients with moderate or severe postoperative pain after abdominal surgery. Analgesia was measured during the 6-hour period after dosing based on onset of relief, hourly and summary variables, and duration of effect. A significantly greater proportion of patients treated with the hydrocodone/ibuprofen combination reported onset of relief compared with ibuprofen or placebo; however, the distribution functions for time to onset of relief did not differ among treatments. Hydrocodone with ibuprofen and ibuprofen alone were significantly more effective than placebo for all measures of analgesia. The combination of hydrocodone with ibuprofen was significantly superior to ibuprofen for all hourly analgesic evaluations, weighted sum of pain intensity differences (SPID), total pain relief (TOTPAR), and global rating of study medication. No patients in the hydrocodone with ibuprofen group required analgesic remedication during the 6-hour study period, compared with 25% and 82% in the ibuprofen and placebo groups, respectively. The analgesic superiority of 15 mg hydrocodone bitartrate combined with 400 mg ibuprofen compared with 400 mg ibuprofen alone was demonstrated across many efficacy variables.
氢可酮是一种半合成阿片类药物，其镇痛和镇咳特性在质量上与其他阿片类激动剂相似。布洛芬是一种具有镇痛和解热活性的非甾体抗炎药，是一种有效的、主要作用于外周的抗炎镇痛药。本临床试验的目的是确定15毫克酒石酸氢可酮与400毫克布洛芬联合使用相对于单独使用400毫克布洛芬和安慰剂在治疗术后疼痛方面的附加镇痛效果。将酒石酸氢可酮与布洛芬联合使用的单剂量镇痛效果与单独使用布洛芬和安慰剂在120例腹部手术后中度或重度术后疼痛患者中进行了比较。在给药后的6小时内，根据缓解开始时间、每小时和汇总变量以及作用持续时间来测量镇痛效果。与布洛芬或安慰剂相比，接受氢可酮/布洛芬联合治疗的患者中报告缓解开始的比例显著更高；然而，缓解开始时间的分布函数在各治疗组之间没有差异。对于所有镇痛指标，氢可酮与布洛芬联合使用和单独使用布洛芬均显著优于安慰剂。对于所有每小时的镇痛评估、疼痛强度差异加权和（SPID）、总疼痛缓解（TOTPAR）以及对研究药物的总体评分，氢可酮与布洛芬联合使用显著优于布洛芬。在6小时的研究期间，氢可酮与布洛芬组没有患者需要追加镇痛药物，而布洛芬组和安慰剂组分别为25%和82%。在许多疗效变量方面，均证明了15毫克酒石酸氢可酮与400毫克布洛芬联合使用相对于单独使用400毫克布洛芬的镇痛优越性。
