alvimopan对接受简单腹式全子宫切除术患者安全性的一项双盲、随机、安慰剂对照Ⅲ期临床研究

作     者：Herzog T.J. Coleman R.L. Guerrieri Jr. J.P. 翁梨驹 

作者机构：Columbia UniversityNew YorkNYUnited States Dr. 

出 版 物：《世界核心医学期刊文摘（妇产科学分册）》 (Core Journal in Obstetrics/Gynecology)

年 卷 期：2006年第2卷第12期

页      面：7-7页

学科分类：1002[医学-临床医学] 100211[医学-妇产科学] 10[医学] 

主　　题：alvimopan 安慰剂对照 阿片受体拮抗剂 排粪 于术 不良反应 消化道功能 研究设计 随机分配 

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.