Fixed-ratio combination oxycodone/naloxone compared with oxycodone alone for the relief of opioid-induced constipation in moderate-to-severe noncancer pain
Fixed-ratio combination oxycodone/naloxone compared with oxycodone alone for the relief of opioid-induced constipation in moderate-to-severe noncancer pain
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DOI：
10.1185/03007990802584454
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发表时间：
2008-12-01
影响因子：
2.3
通讯作者：
Reimer, K.
中科院分区：
文献类型：
--
作者：
Simpson, K.;Leyendecker, P.;Reimer, K.
目的：阿片类药物治疗经常与治疗限制性便秘相关。纳洛酮是一种口服全身生物利用度低的阿片类拮抗剂。这项III期临床试验评估了羟考酮缓释剂（PR）和纳洛酮PR的口服固定比例组合与羟考酮PR相比在缓解阿片类药物引起的便秘方面的安全性和有效性。研究设计：这项双盲、多中心试验在门诊环境下在四个欧洲国家的专科和初级保健中心进行。该研究包括322名患有中度至重度非癌症疼痛的成年患者，需要阿片类药物治疗，剂量范围>= 20 mg/天，
Objective: Opioid therapy is frequently associated with treatment-limiting constipation. Naloxone is an opioid antagonist with low oral systemic bioavailability. This Phase III clinical trial assessed the safety and efficacy of an oral fixed-ratio combination of oxycodone prolonged-release (PR) and naloxone PR compared with oxycodone PR in relieving opioid-induced constipation.Study design: This double-blind, multicenter trial was conducted in specialist and primary care centers in four European countries in an out-patients setting. The study included 322 adult patients with moderate-to-severe, noncancer pain requiring opioid therapy in a range of >= 20 mg/day and