Alvimopan, a novel, peripherally acting g opioid antagonist - Results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial of major abdominal surgery and postoperative ileus
Alvimopan, a novel, peripherally acting g opioid antagonist - Results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial of major abdominal surgery and postoperative ileus
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DOI：
10.1097/01.sla.0000141158.27977.66
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发表时间：
2004-10-01
影响因子：
9
通讯作者：
Wallin, BA
中科院分区：
文献类型：
--
作者：
Wolff, BG;Michelassi, F;Wallin, BA
目的：为了证明alvimopan（6或12 mg）加速接受剖腹手术进行肠切除术或根治性子宫切除术的患者的胃肠道（GI）功能的恢复，摘要背景数据：剖腹手术后肠梗阻（POI）可能会增加发病率并延长住院时间。阿片类药物可以促进POI的持续时间。方法：将510例拟行肠切除术或根治性子宫切除术的患者随机（1：1：1）分为3组，分别于术前≥ 2 h口服阿维莫泮6 mg、阿维莫泮12 mg或安慰剂，然后每日2次（b.i.d.）直至出院或最多7天。主要疗效终点是上、下消化道功能恢复时间的复合终点，相关的次要终点是出院书面医嘱的时间。结果：修改后的意向治疗人群包括469例患者（451例肠切除术和18例根治性子宫切除术患者）。与安慰剂相比，6 mg（风险比[HR] = 1.28; P < 0.05）和12 mg（HR = 1.54; P < 0.001）组的GI功能恢复时间加快，平均差异分别为15和22小时。alvimopan 12 mg组中至开具出院令的时间也加快（HR = 1.42; P = 0.003），与安慰剂组相比，平均差异为20小时。治疗组之间不良事件的发生率相似。
Objective: To demonstrate that alvimopan (6 or 12 mg) accelerates recovery of gastrointestinal (GI) function in patients undergoing laparotomy for bowel resection or radical hysterectomy.Summary Background Data: Postoperative ileus (POI) following laparotomy may increase morbidity and extend hospitalization. Opioids can contribute to the duration of POI. Alvimopan is a novel opioid receptor antagonist in development for the management of POI.Methods: A total of 510 patients scheduled for bowel resection or radical hysterectomy were randomized (1:1:1) to receive alvimopan 6 mg, alvimopan 12 mg, or placebo orally greater than or equal to2 hours before surgery, then twice a day (b.i.d.) until hospital discharge or for up to 7 days. The primary efficacy end point was a composite of time to recovery of upper and lower GI function, An associated secondary end point was time to hospital discharge order written.Results: The modified intent-to-treat population included 469 patients (451 bowel resection and 18 radical hysterectomy patients). Time to recovery of GI function was accelerated for the alvimopan 6 mg (hazard ratio [HR] = 1.28; P < 0.05) and 12 mg (HR = 1.54; P < 0.001) groups with a mean difference of 15 and 22 hours, respectively, compared with placebo. The time to hospital discharge order written was also accelerated in the alvimopan 12 mg group (HR = 1.42; P = 0.003) with a mean difference of 20 hours compared with placebo. The incidence of adverse events was similar among treatment groups.