Diemunsch P, Gan T J, Philip B K, Girao M J, Eberhart L, Irwin M G, Pueyo J, Chelly J E, Carides A D, Reiss T, Evans J K, Lawson F C
Services d'Anesthesiologie-Reanimation Chirurgicale, CHU, Hôpital de Hautepierre, 1 Avenue de Moliere, Strasbourg 67000, France.
Br J Anaesth. 2007 Aug;99(2):202-11. doi: 10.1093/bja/aem133. Epub 2007 May 30.
The neurokinin(1) antagonist aprepitant is effective for prevention of chemotherapy-induced nausea and vomiting. We compared aprepitant with ondansetron for prevention of postoperative nausea and vomiting.
Nine hundred and twenty-two patients receiving general anaesthesia for major abdominal surgery were assigned to receive a single preoperative dose of oral aprepitant 40 mg, oral aprepitant 125 mg, or i.v. ondansetron 4 mg in a randomized, double-blind trial. Vomiting episodes, use of rescue therapy, and nausea severity (verbal rating scale) were documented for 48 h after surgery. Primary efficacy endpoints were complete response (no vomiting and no use of rescue therapy) 0-24 h after surgery and no vomiting 0-24 h after surgery. The secondary endpoint was no vomiting 0-48 h after surgery.
Aprepitant at both doses was non-inferior to ondansetron for complete response 0-24 h after surgery (64% for aprepitant 40 mg, 63% for aprepitant 125 mg, and 55% for ondansetron, lower bound of 1-sided 95% CI > 0.65), superior to ondansetron for no vomiting 0-24 h after surgery (84% for aprepitant 40 mg, 86% for aprepitant 125 mg, and 71% for ondansetron; P < 0.001), and superior for no vomiting 0-48 h after surgery (82% for aprepitant, 40 mg, 85% for aprepitant, 125 mg, and 66% for ondansetron; P < 0.001). The distribution of peak nausea scores was lower in both aprepitant groups vs ondansetron (P < 0.05).
Aprepitant was non-inferior to ondansetron in achieving complete response for 24 h after surgery. Aprepitant was significantly more effective than ondansetron for preventing vomiting at 24 and 48 h after surgery, and in reducing nausea severity in the first 48 h after surgery. Aprepitant was generally well tolerated.
神经激肽-1拮抗剂阿瑞匹坦对预防化疗引起的恶心和呕吐有效。我们比较了阿瑞匹坦与昂丹司琼预防术后恶心和呕吐的效果。
在一项随机、双盲试验中，922例接受腹部大手术全身麻醉的患者被分配接受术前单剂量口服40mg阿瑞匹坦、125mg阿瑞匹坦或静脉注射4mg昂丹司琼。记录术后48小时内的呕吐发作次数、急救治疗的使用情况以及恶心严重程度（语言评定量表）。主要疗效终点为术后0至24小时完全缓解（无呕吐且未使用急救治疗）以及术后0至24小时无呕吐。次要终点为术后0至48小时无呕吐。
术后0至24小时完全缓解方面，两种剂量的阿瑞匹坦均不劣于昂丹司琼（40mg阿瑞匹坦组为64%，125mg阿瑞匹坦组为63%，昂丹司琼组为55%，单侧95%CI下限>0.65）；术后0至24小时无呕吐方面，阿瑞匹坦优于昂丹司琼（40mg阿瑞匹坦组为84%，125mg阿瑞匹坦组为86%，昂丹司琼组为71%；P<0.001）；术后0至48小时无呕吐方面，阿瑞匹坦也更优（40mg阿瑞匹坦组为82%，125mg阿瑞匹坦组为85%，昂丹司琼组为66%；P<0.001）。与昂丹司琼组相比，两个阿瑞匹坦组的恶心峰值评分分布更低（P<0.05）。
术后24小时内实现完全缓解方面，阿瑞匹坦不劣于昂丹司琼。在预防术后24小时和48小时呕吐以及减轻术后48小时内恶心严重程度方面，阿瑞匹坦显著优于昂丹司琼。阿瑞匹坦总体耐受性良好。
