Moore R A, McQuay H J, Tomaszewski J, Raba G, Tutunaru D, Lietuviete N, Galad J, Hagymasy L, Melka D, Kotarski J, Rechberger T, Fülesdi B, Nizzardo A, Guerrero-Bayón C, Cuadripani S, Pizà-Vallespir B, Bertolotti M
Pain Research & Nuffield Division of Anaesthetics, University of Oxford, The Churchill, Oxford, UK.
Balliol College, University of Oxford, Oxford, UK.
BMC Anesthesiol. 2016 Jan 22;16:9. doi: 10.1186/s12871-016-0174-5.
Dexketoprofen trometamol plus tramadol hydrochloride is a new oral combination of two analgesics, which have different mechanisms of action for the treatment of moderate to severe acute pain.
Randomised, double-blind, parallel, placebo and active-controlled, single and multiple-dose study to evaluate the analgesic efficacy and safety of dexketoprofen/tramadol 25 mg/75 mg in comparison with the single agents (dexketoprofen 25 mg and tramadol 100 mg) in moderate to severe acute pain after abdominal hysterectomy. Patients received seven consecutive doses of study drug within a 3-day period, each dose separated by an 8-hour interval. A placebo arm was included during the single-dose phase to validate the pain model. Efficacy assessments included pain intensity, pain relief, patient global evaluation and use of rescue medication. The primary endpoint was the mean sum of pain intensity differences over the first 8 h (SPID8).
The efficacy analysis included 606 patients, with a mean age of 48 years (range 25-73). The study results confirmed the superiority of the combination over the single agents in terms of the primary endpoint (p <0.001). Secondary endpoints were generally supportive of the superiority of the combination for both single and multiple doses. Most common adverse drug reactions (ADRs) were nausea (4.6%) and vomiting (2.3%). All other ADRs were experienced by less than 2% of patients.
The study results provided robust evidence of the superiority of dexketoprofen/tramadol 25 mg/75 mg over the single components in the management of moderate to severe acute pain, as confirmed by the single-dose efficacy, repeated-dose sustained effect and good safety profile observed.
EU Clinical Trials Register (EudraCT number 2012-004545-32, registered 04 October 2012); Clinicaltrials.gov ( NCT01904149, registered 17 July 2013).
右酮洛芬氨丁三醇加盐酸曲马多是两种镇痛药的新型口服复方制剂，它们治疗中重度急性疼痛的作用机制不同。
一项随机、双盲、平行、安慰剂和阳性对照、单剂量及多剂量研究，旨在评估右酮洛芬/曲马多25毫克/75毫克与单药（右酮洛芬25毫克和曲马多100毫克）相比，在腹部子宫切除术后中重度急性疼痛治疗中的镇痛疗效和安全性。患者在3天内连续接受7剂研究药物，每剂间隔8小时。单剂量阶段纳入了安慰剂组以验证疼痛模型。疗效评估包括疼痛强度、疼痛缓解情况、患者整体评估和急救药物的使用。主要终点是前8小时疼痛强度差异的平均总和（SPID8）。
疗效分析纳入了606例患者，平均年龄48岁（范围25 - 73岁）。研究结果证实，就主要终点而言，复方制剂优于单药（p <0.001）。次要终点总体上支持复方制剂在单剂量和多剂量时的优越性。最常见的药物不良反应（ADR）是恶心（4.6%）和呕吐（2.3%）。所有其他ADR的发生率均低于2%的患者。
研究结果有力地证明了右酮洛芬/曲马多25毫克/75毫克在治疗中重度急性疼痛方面优于单一组分，单剂量疗效、重复剂量持续效应及良好的安全性概况均证实了这一点。
欧盟临床试验注册库（EudraCT编号2012 - 004545 - 32，于2012年10月4日注册）；Clinicaltrials.gov（NCT01904149，于2013年7月17日注册）。
