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
• 机 构: Columbia University New York,NY,United States Dr. ,
• 出 处: 世界核心医学期刊文摘(妇产科学分册)
• 发表日期: 2006年12期
• 关键词: 安慰剂对照 安全性 双盲 用药 阿片受体拮抗剂 有效性 排粪 于术 不良反应 研究设计

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.

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 for twice daily for 7 days (hospital and home). Adverse events were monitored up to 30 days after the last dose 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 lower lower gastrointestinal recovery in women who undergo simple total abdominal hysterectomy.