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首页> 外文期刊>Clinical therapeutics >Comparison of the Efficacy and Safety of Dual-Opioid Treatment With Morphine Plus Oxycodone Versus Oxycodone/Acetaminophen for Moderate to Severe Acute Pain After Total Knee Arthroplasty
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Comparison of the Efficacy and Safety of Dual-Opioid Treatment With Morphine Plus Oxycodone Versus Oxycodone/Acetaminophen for Moderate to Severe Acute Pain After Total Knee Arthroplasty

机译：用吗啡加羟考酮与羟考酮与羟考酮/乙酰氨基酚的疗效和安全性比较中度至重度急性疼痛的总膝关节置换术

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Background: In acute pain models, coadministration of low doses of morphine and oxycodone markedly enhanced analgesia relative to either opioid given alone. Enhanced analgesia with coadministration of morphine and oxycodone has also been reported in acute and chronic moderate to severe pain conditions during double-blind studies. Objective: The goal of this study was to compare the efficacy and tolerability of a flexible dose regimen of the morphine/oxycodone combination versus oxycodone/acetaminophen and fixed low-dose morphine/oxycodone. Methods: This was a 5-center, randomized, open-label study of hospitalized patients (n = 44) with acute moderate to severe postoperative pain after total knee arthroplasty. Inpatients were randomized to a flexible dose regimen of morphine/oxycodone (3 mg/2 mg to 24 mg/16 mg), fixed low-dose morphine/oxycodone regimen (3 mg/2 mg), or oxycodone/acetaminophen (5 mg/325 mg). Treatment was initiated following surgery after intravenous (IV) morphine patient-controlled analgesia. An algorithm was evaluated for converting the patient-controlled analgesia morphine dose to an initial oral dose of morphine/oxycodone. The primary efficacy variable was the time-weighted sum of pain intensity difference from 0 to 48 hours. Results: The median values for the sum of the pain intensity difference from 0 to 48 hours for the morphine/oxycodone flexible dose and oxycodone/acetaminophen were similar and approximately twice that of fixed morphine/oxycodone 3 mg/2 mg (148.0, 139.5, and 71.3, respectively). Moderate to severe gastrointestinal adverse events occurred in 50% of patients in the oxycodone/acetaminophen group compared with 15% of the equianalgesic morphine/oxycodone group. On several items of the Brief Pain Inventory (general activity, walking ability, and sleep), the morphine/oxycodone flexible dose produced greater benefit than oxycodone/acetaminophen. Conclusions: Flexible dose morphine/oxycodone was superior to low-dose morphine/oxycodone and comparable to oxycodone/acetaminophen. Flexible dose morphine/oxycodone-treated patients had a lower rate of moderate to severe nausea or vomiting than equianalgesic oxycodone/acetaminophen-treated patients. Thus, morphine/oxycodone offers an attractive alternative to oxycodone/acetaminophen for the management of moderate to severe postoperative pain. ClinicalTrials.gov: identifier: NCT00818493.
机译：背景：在急性疼痛模型中，低剂量的吗啡和羟考酮的共同分析，相对于单独给予的阿片类药物显着增强镇痛。急性和慢性中度至重度疼痛条件下，急性和羟考酮的共同统计增强镇痛增强镇痛。目的：本研究的目的是比较吗啡/羟考酮组合与羟考酮/乙酰氨基酚和固定低剂量吗啡/羟考酮的柔性剂量方案的疗效和耐受性。方法：这是一个5中心，随机开放的住院，开放标签研究，住院患者（n = 44），颈部间关节置换术后急剧中度至严重术后疼痛。将存放剂随机化为吗啡/羟考酮（3mg / 2mg至24mg / 16mg）的柔性剂量方案，固定低剂量吗啡/羟氢化酮方案（3mg / 2mg）或羟考酮/乙酰氨基酚（5mg / 325毫克）。在静脉内（IV）吗啡患者控制镇痛后手术后开始治疗。评价一种算法，将患者控制的镇痛吗啡剂量转化为初始口服剂量的吗啡/羟考酮。主要疗效变量是从0到48小时的疼痛强度差的时间加权和。结果：对吗啡/羟考酮柔性剂量和羟代酮/乙酰氨基酚的0至48小时的疼痛强度差异的中值值相似，大约是固定吗啡/羟考酮3mg / 2mg（148.0,139.5，和71.3分别）。中度至严重的胃肠道不良事件发生在羟考酮/乙酰氨基酚组中的50％患者中，而含15％的偶数吗啡/羟氢化酮组。在短暂的疼痛库存（一般活动，行走能力和睡眠）的几个项目中，吗啡/羟考酮柔性剂量比羟考酮/乙酰氨基酚产生更大的好处。结论：柔性剂量吗啡/羟考酮优于低剂量吗啡/羟考酮，可与羟考酮/乙酰氨基酚相媲美。柔性剂量吗啡/羟考酮治疗患者的中度至重度恶心或呕吐的较低速度低于偶数羟考酮/乙酰氨基酚治疗的患者。因此，吗啡/羟考酮提供羟考酮/乙酰氨基酚的有吸引力的替代品，用于管理中度至严重的术后疼痛。 ClinicalTrials.gov：标识符：NCT00818493。

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