Department of Surgery, McGill University, Montreal, QC, Canada; Steinberg-Bernstein Centre for Minimally Invasive Surgery and Innovation, McGill University, Montreal, QC, Canada.
Department of Surgery, McGill University, Montreal, QC, Canada; Steinberg-Bernstein Centre for Minimally Invasive Surgery and Innovation, McGill University, Montreal, QC, Canada; Centre for Outcomes Research and Evaluation (CORE), Research Institute of the McGill University Health Centre, Montreal, QC, Canada.
Surgery. 2021 Apr;169(4):934-944. doi: 10.1016/j.surg.2020.11.025. Epub 2020 Dec 27.
Alvimopan is a Food and Drug Administration-approved treatment to accelerate gastrointestinal recovery after abdominal surgery; however, benefits may vary across different procedures and contexts of care. The purpose of this study is to summarize the evidence regarding the effect of alvimopan on postoperative outcomes after abdominal surgery.
Major databases (Medline, Embase, Biosis, Cochrane, Web of Science, and Scopus) were searched for randomized controlled trials and nonrandomized studies comparing alvimopan versus control. Risk of bias was assessed using Cochrane's risk of bias tool 2.0 (for randomized controlled trials) and Risk of Bias in Nonrandomized Studies-of Intervention tool (for nonrandomized studies). Results were appraised descriptively as heterogeneity in reporting and risk of bias hindered meta-analysis. Quality of evidence across different surgical procedures and contexts of care (ie, open versus minimally invasive surgery, traditional care versus enhanced recovery pathway) was evaluated using Grading of Recommendations Assessment, Development, and Evaluation.
Nine randomized controlled trials and 35 nonrandomized studies were identified. Evidence of low to moderate certainty supports that alvimopan reduces length of stay and improves gastrointestinal recovery after open bowel resection and open radical cystectomy. Limited evidence supports alvimopan for surgeries not listed in Food and Drug Administration labels (ie, total abdominal hysterectomy and retroperitoneal lymph node dissection). Similar effects were observed in traditional and enhanced recovery pathway settings, but enhanced recovery pathway elements varied across studies. There is very low certainty of evidence supporting alvimopan for patients undergoing minimally invasive surgery.
Evidence supports that alvimopan improves outcomes after open bowel resection and open radical cystectomy. Benefits for patients undergoing minimally invasive surgery and treated in contemporary enhanced recovery pathway settings remain uncertain. These findings contribute important new knowledge to inform evidence-based alvimopan prescribing.
阿维莫潘是一种获得美国食品药品监督管理局批准的治疗药物，可加速腹部手术后胃肠道的恢复；然而，其益处可能因手术类型和护理环境的不同而有所差异。本研究旨在总结阿维莫潘对腹部手术后手术结局影响的证据。
主要数据库（Medline、Embase、Biosis、Cochrane、Web of Science 和 Scopus）中检索了比较阿维莫潘与对照组的随机对照试验和非随机研究。使用 Cochrane 偏倚风险工具 2.0（针对随机对照试验）和非随机干预研究偏倚风险工具（针对非随机研究）评估偏倚风险。由于报告中的异质性和偏倚风险，无法进行 meta 分析，因此对结果进行了描述性评估。不同手术类型和护理环境（即开腹手术与微创、传统护理与加速康复路径）的证据质量使用推荐评估、制定与评价进行评估。
共确定了 9 项随机对照试验和 35 项非随机研究。有低到中等确定性证据支持阿维莫潘可缩短开腹肠切除和开腹根治性膀胱切除术患者的住院时间并改善胃肠道恢复。有限的证据支持阿维莫潘用于食品和药物管理局标签未列出的手术（即全子宫切除术和腹膜后淋巴结清扫术）。在传统和加速康复路径环境中观察到类似的效果，但研究中的加速康复路径要素不同。有非常低确定性证据支持阿维莫潘用于接受微创手术的患者。
证据支持阿维莫潘可改善开腹肠切除和开腹根治性膀胱切除术患者的结局。对于接受微创手术且处于当代加速康复路径环境的患者，其获益仍不确定。这些发现为基于证据的阿维莫潘处方提供了重要的新知识。
