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首页> 外文期刊>Journal of Clinical Pharmacy and Therapeutics >Efficacy of oxycodone/paracetamol for patients with bone-cancer pain: A multicenter, randomized, double-blinded, placebo-controlled trial
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Efficacy of oxycodone/paracetamol for patients with bone-cancer pain: A multicenter, randomized, double-blinded, placebo-controlled trial

机译：羟考酮/扑热息痛对骨癌疼痛患者的疗效：一项多中心，随机，双盲，安慰剂对照试验

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What is known and Objective: Bone-cancer pain is a common and refractory cancer pain. Opioids, on their own, do not control this type of pain well enough, and co-analgesics are necessary. Methods: Patients with bone metastasis-related pain at Numeric Rating Scale ≥4 were enrolled to this randomized placebo-controlled trial. They had also received morphine or transdermal fentanyl patches for at least 1 week. During the 3-day efficacy phase, patients received placebo or 1-3 tablets of oxycodone/paracetamol (5/325 mg), four times daily for 3 days. All patients kept a daily pain diary. The primary endpoint was the Pain Intensity Difference (PID). Secondary endpoints were cases of breakthrough pain and rescue morphine consumption. Additional analyses included the Short Form-6 Dimensions (SF-6D) quality-of-life scale and a general impression (GI) of patient satisfaction with treatment at the end of the phase. Results and Discussion: Of the 246 patients in the intent-to-treat set, 89·4% completed the 3-day efficacy phase. PIDs were 0·9 and 0·3 in the oxycodone/paracetamol and placebo groups respectively, on day 1 (P < 0·001), and 1·5 and 0·3 respectively on day 3 (P < 0·001). Thirty-eight patients in the treatment group, and 58 in the placebo group, suffered breakthrough pain on day 3 (P < 0·001). The SF-6D score decreased to 21·2 ± 2·5 in the oxycodone/paracetamol group at the end of the phase (P = 0·001). In the oxycodone/paracetamol group, 67% rated GI as good, very good, or excellent. What is new and Conclusion: Patients with bone-cancer pain, already on opioids, obtain clinically important, additional pain-control, with regular oxycodone/paracetamol dosing.
机译：已知和目的：骨癌疼痛是常见的难治性癌症疼痛。阿片类药物本身不能很好地控制这种类型的疼痛，因此需要联合镇痛药。方法：将数字等级评分≥4的骨转移相关疼痛患者纳入该随机安慰剂对照试验。他们还接受了吗啡或芬太尼透皮贴剂至少1周。在3天的疗效阶段，患者接受安慰剂或1-3片羟考酮/对乙酰氨基酚（5/325毫克），每天3次，每天4次。所有患者均保留每日疼痛日记。主要终点是疼痛强度差异（PID）。次要终点是突破性疼痛和吗啡的抢救。其他分析包括6期短尺寸（SF-6D）生活质量量表和阶段结束时患者对治疗的满意度的总体印象（GI）。结果与讨论：在意向治疗组的246例患者中，有89·4％的患者完成了3天的疗效期。羟考酮/扑热息痛组和安慰剂组的PID在第1天分别为0·9和0·3（P <0·001），在第3天分别为1·5和0·3（P <0·001）。治疗组38例患者，安慰剂组58例，在第3天出现突破性疼痛（P <0·001）。在该阶段结束时，羟考酮/扑热息痛组的SF-6D评分下降至21·2±2·5。在羟考酮/扑热息痛组中，有67％的人将GI评为好，非常好或极好。新内容和结论：已经接受过阿片类药物治疗的骨癌疼痛患者，通过常规羟考酮/对乙酰氨基酚给药，可获得具有重要临床意义的疼痛控制。

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