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外周作用的μ-阿片受体拮抗剂阿维莫潘与根治性膀胱切除术后成本降低相关:一项4期随机对照试验的经济分析

Alvimopan, a peripherally acting μ-opioid receptor antagonist, is associated with reduced costs after radical cystectomy: economic analysis of a phase 4 randomized, controlled trial.

作者信息

Kauf Teresa L, Svatek Robert S, Amiel Gilad, Beard Timothy L, Chang Sam S, Fergany Amr, Karnes R Jeffrey, Koch Michael, O'Hara Jerome, Lee Cheryl T, Sexton Wade J, Slaton Joel W, Steinberg Gary D, Wilson Shandra S, Techner Lee, Martin Carolyn, Moreno Jessica, Kamat Ashish M

机构信息

Cubist Pharmaceuticals, Lexington, Massachusetts.

University of Texas Health Science Center at San Antonio, San Antonio, Texas.

出版信息

J Urol. 2014 Jun;191(6):1721-7. doi: 10.1016/j.juro.2013.12.015. Epub 2013 Dec 14.

DOI:10.1016/j.juro.2013.12.015
PMID:24342144
Abstract

PURPOSE

We evaluated the effect of alvimopan treatment vs placebo on health care utilization and costs related to gastrointestinal recovery in patients treated with radical cystectomy in a randomized, phase 4 clinical trial.

MATERIALS AND METHODS

Resource utilization data were prospectively collected and evaluated by cost consequence analysis. Hospital costs were estimated from 2012 Medicare reimbursement rates and medication wholesale acquisition costs. Differences in base case mean costs between the study cohorts for total postoperative ileus related costs (hospital days, study drug, nasogastric tubes, postoperative ileus related concomitant medication and postoperative ileus related readmissions) and total combined costs (postoperative ileus related, laboratory, electrocardiograms, nonpostoperative ileus related concomitant medication and nonpostoperative ileus related readmission) were evaluated by probabilistic sensitivity analysis using a bootstrap approach.

RESULTS

Mean hospital stay was 2.63 days shorter for alvimopan than placebo (mean±SD 8.44±3.05 vs 11.07±8.23 days, p=0.005). Use of medications or interventions likely intended to diagnose or manage postoperative ileus was lower for alvimopan than for placebo, eg total parenteral nutrition 10% vs 25% (p=0.001). Postoperative ileus related health care costs were $2,340 lower for alvimopan and mean total combined costs were decreased by $2,640 per patient for alvimopan vs placebo. Analysis using a 10,000-iteration bootstrap approach showed that the mean difference in postoperative ileus related costs (p=0.04) but not total combined costs (p=0.068) was significantly lower for alvimopan than for placebo.

CONCLUSIONS

In patients treated with radical cystectomy alvimopan decreased hospitalization cost by reducing the health care services associated with postoperative ileus and decreasing the hospital stay.

摘要

目的

在一项随机4期临床试验中,我们评估了阿维莫潘治疗与安慰剂治疗对根治性膀胱切除术后患者胃肠道恢复相关的医疗资源利用和成本的影响。

材料与方法

通过成本后果分析前瞻性收集并评估资源利用数据。根据2012年医疗保险报销率和药品批发采购成本估算医院成本。使用自抽样法通过概率敏感性分析评估研究队列之间术后肠梗阻相关总成本(住院天数、研究药物、鼻胃管、术后肠梗阻相关伴随用药和术后肠梗阻相关再入院)和总合并成本(术后肠梗阻相关、实验室检查、心电图、非术后肠梗阻相关伴随用药和非术后肠梗阻相关再入院)的基础病例平均成本差异。

结果

阿维莫潘组的平均住院时间比安慰剂组短2.63天(均值±标准差 8.44±3.05天对11.07±8.23天,p = 0.005)。阿维莫潘组用于可能旨在诊断或处理术后肠梗阻的药物或干预措施的使用低于安慰剂组,例如全胃肠外营养分别为10%对25%(p = 0.001)。阿维莫潘组术后肠梗阻相关的医疗成本降低了2340美元,与安慰剂相比,阿维莫潘组每位患者平均总合并成本降低了2640美元。使用10000次迭代自抽样法的分析表明,阿维莫潘组术后肠梗阻相关成本的平均差异(p = 0.04)显著低于安慰剂组,但总合并成本的平均差异(p = 0.068)并非如此。

结论

在接受根治性膀胱切除术的患者中,阿维莫潘通过减少与术后肠梗阻相关的医疗服务并缩短住院时间,降低了住院成本。

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