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首页> 外文期刊>Pain. >Alvimopan, a peripherally acting mu-opioid receptor (PAM-OR) antagonist for the treatment of opioid-induced bowel dysfunction: results from a randomized, double-blind, placebo-controlled, dose-finding study in subjects taking opioids for chronic non-cancer pain.
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Alvimopan, a peripherally acting mu-opioid receptor (PAM-OR) antagonist for the treatment of opioid-induced bowel dysfunction: results from a randomized, double-blind, placebo-controlled, dose-finding study in subjects taking opioids for chronic non-cancer pain.

机译：Alvimopan，一种外周作用的阿片类药物受体（PAM-OR）拮抗剂，用于治疗阿片类药物引起的肠功能障碍：一项针对服用阿片类药物治疗慢性非糖尿病患者的随机，双盲，安慰剂对照剂量寻找研究的结果癌痛。

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Our objective was to investigate the efficacy and safety of alvimopan, a peripherally acting mu-opioid receptor (PAM-OR) antagonist, in subjects with non-cancer pain and opioid-induced bowel dysfunction (OBD), and to identify at least one treatment regimen that improves OBD. Following a 2-week baseline period, 522 subjects reporting 3 spontaneous bowel movements (SBMs)/week (with or=25% accompanied by a sensation of incomplete evacuation, straining, or lumpy hard stools), requiring analgesia equivalent to or=30 mg oral morphine/day were randomized to alvimopan 0.5mg twice daily (BID), 1mg once daily (QD), 1mg BID, or placebo for 6 weeks. Compared with placebo, there was a statistically and clinically significant increase in mean weekly SBM frequency over the initial 3 weeks of treatment (primary endpoint) with alvimopan 0.5mg BID (+1.71 mean SBMs/week), alvimopan 1mg QD (+1.64) and alvimopan 1mg BID (+2.52); P0.001 for all comparisons. Increased SBM frequency and additional treatment effects, including improvements in symptoms such as straining, stool consistency, incomplete evacuation, abdominal bloating/discomfort, and decreased appetite, were sustained over 6 weeks. The most frequently reported adverse events were abdominal pain, nausea, and diarrhea, occurring more frequently in the higher dosage groups. The alvimopan 0.5mg BID regimen demonstrated the best benefit-to-risk profile for managing OBD with alvimopan in this study population, with a side effect profile similar to that of placebo. There was no evidence of opioid analgesia antagonism. Competitive peripheral antagonism of opioids with alvimopan can restore GI function and relieve OBD without compromising analgesia.
机译：我们的目的是研究外周作用性阿片类药物受体（PAM-OR）拮抗剂alvimopan在患有非癌性疼痛和阿片类药物引起的肠功能障碍（OBD）的受试者中的疗效和安全性，并确定至少一种治疗方法改善OBD的方案。在为期2周的基线期后，有522名受试者报告每周<3次自发排便（SBM）（>或= 25％，伴有不完全排空，劳损或硬块状大便的感觉），需要镇痛效果等于或大于将= 30 mg口服吗啡/天随机分配至alvimopan 0.5mg，每天两次（BID），1mg，每天一次（QD），1mg BID，或安慰剂治疗6周。与安慰剂相比，阿尔维潘0.5mg BID（+1.71平均SBM /周），阿尔维潘1mg QD（+1.64）和治疗前3周（主要终点）的平均每周SBM频率在统计学和临床​​上均有显着增加。 alvimopan 1mg BID（+2.52）;对于所有比较，P ＜0.001。在6周内，SBM频率增加和其他治疗效果得到改善，包括改善症状，如劳损，粪便稠度，排空不完全，腹胀/不适和食欲下降。最常报告的不良事件是腹痛，恶心和腹泻，在较高剂量组中更频繁发生。在该研究人群中，阿尔维莫潘0.5mg BID方案显示了用阿尔维莫潘管理OBD的最佳获益风险比，其副作用与安慰剂相似。没有证据表明阿片类药物具有镇痛作用。阿维莫潘与阿片类药物的竞争性外周拮抗作用可恢复胃肠道功能并缓解OBD，而不会影响镇痛作用。

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