Ludwig Kirk, Enker Warren E, Delaney Conor P, Wolff Bruce G, Du Wei, Fort John G, Cherubini Maryann, Cucinotta James, Techner Lee
Department of Surgery, Medical College of Wisconsin, 9200 W Wisconsin Ave, Milwaukee, WI 53226, USA.
Arch Surg. 2008 Nov;143(11):1098-105. doi: 10.1001/archsurg.143.11.1098.
OBJECTIVE: To investigate the efficacy and safety of alvimopan, 12 mg, administered orally 30 to 90 minutes preoperatively and twice daily postoperatively in conjunction with a standardized accelerated postoperative care pathway for managing postoperative ileus after bowel resection. DESIGN, SETTING, AND PATIENTS: This multicenter, randomized, placebo-controlled, double-blind, phase 3 trial enrolled adult patients undergoing partial bowel resection with primary anastomosis by laparotomy and scheduled to receive intravenous, opioid-based, patient-controlled analgesia. A standardized accelerated postoperative care pathway including early ambulation, oral feeding, and postoperative nasogastric tube removal was used to facilitate gastrointestinal (GI) tract recovery in all of the patients. MAIN OUTCOME MEASURES: The primary end point was time to GI-2 recovery (toleration of solid food and first bowel movement). Secondary end points included time to GI-3 recovery (toleration of solid food and first flatus or bowel movement), hospital discharge order written, and actual hospital discharge. Postoperative length of hospital stay based on calendar day of hospital discharge order written, opioid consumption, and overall postoperative ileus-related morbidity were recorded. RESULTS: Alvimopan, 12 mg, was well tolerated and significantly accelerated GI-2 recovery, GI-3 recovery, and actual hospital discharge compared with a standardized accelerated postoperative care pathway alone (hazard ratio = 1.5, 1.5, and 1.4, respectively; P < .001 for all). Time to hospital discharge order written as measured by hazard ratio (1.4) and by postoperative calendar days (mean for alvimopan, 5.2 days; mean for placebo, 6.2 days) was also accelerated. Opioid consumption was comparable between groups, and alvimopan was associated with reduced postoperative ileus-related morbidity compared with placebo. CONCLUSIONS: Alvimopan, 12 mg, administered 30 to 90 minutes before and twice daily after bowel resection is well tolerated, accelerates GI tract recovery, and reduces postoperative ileus-related morbidity without compromising opioid analgesia.
目的：研究术前30至90分钟口服12毫克爱维莫潘，并在术后每日两次联合标准化加速术后护理方案用于处理肠切除术后肠梗阻的有效性和安全性。 设计、地点和患者：本多中心、随机、安慰剂对照、双盲3期试验纳入了接受剖腹术行部分肠切除并一期吻合且计划接受静脉注射、基于阿片类药物的患者自控镇痛的成年患者。所有患者均采用包括早期活动、经口进食和术后拔除鼻胃管在内的标准化加速术后护理方案以促进胃肠道恢复。 主要观察指标：主要终点为胃肠道功能恢复至2级的时间（能耐受固体食物和首次排便）。次要终点包括胃肠道功能恢复至3级的时间（能耐受固体食物和首次排气或排便）、下达出院医嘱以及实际出院情况。记录基于下达出院医嘱的日历日计算的术后住院时间、阿片类药物消耗量以及总体术后肠梗阻相关发病率。 结果：与单纯的标准化加速术后护理方案相比，12毫克爱维莫潘耐受性良好，能显著加速胃肠道功能恢复至2级、胃肠道功能恢复至3级以及实际出院时间（风险比分别为1.5、1.5和1.4；均P <.001）。通过风险比（1.4）以及术后日历日测量的下达出院医嘱时间也有所加快（爱维莫潘组均值为5.2天；安慰剂组均值为6.2天）。两组间阿片类药物消耗量相当，与安慰剂相比，爱维莫潘与降低术后肠梗阻相关发病率相关。 结论：肠切除术前30至90分钟及术后每日两次给予12毫克爱维莫潘耐受性良好，可加速胃肠道恢复，并降低术后肠梗阻相关发病率，且不影响阿片类药物镇痛效果。
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