摘要：Objective:The purpose of this study was to investigate the safety and efficacy of alvimopan,a novel peripherally acting mu-opioid receptor antagonist,in patients who undergo simple total abdominal hysterectomy. Study design:Women (n = 519)-were randomized (4:1) to receive alvimopan 12 mg (n = 413) or placebo (n = 106)≥2 hours before the operation then twice daily for 7 days (hospital and home). Adverse events were monitored up to 30 days after the last dose of study drug was administered. Efficacy was assessed for 7 postoperative days. Results:Overall,the most common adverse events were nausea,vomiting,and constipation; < 5%of patients discontinued use because of adverse events. Alvimopan significantly accelerated the time to first bowel movement (hazard ratio,2.33; p < .001). Average time to first bowel movement was reduced by 22 hours,with more frequent bowel movement and better bowel movement quality found in the treatment cohort. Conclusion:Alvimopan has a safety profile that is similar to that of placebo and provides significantly improved lower gastrointestinal recovery in women who undergo simple total abdominal hysterectomy.