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帕洛诺司琼与昂丹司琼预防腹腔镜胆囊切除术术后恶心呕吐：一项非劣效性随机对照试验
贵州医科大学 麻醉与心脏电生理课题组
翻译：文春雷 编辑：杨荣峰 审校：曹莹
作者检验了以下假设：在风险差异的15%的范围内，帕洛诺司琼在减少腹腔镜胆囊切除术后恶心和呕吐（PONV）的发生率方面不低于昂丹司琼。
在两家二级医院开展了一项双盲、非劣效性随机对照试验，共有212名18至65岁的患者接受了全身麻醉下的腹腔镜胆囊切除术。患者随机分配接受静脉注射帕洛诺司琼（0.075毫克）或昂丹司琼（8毫克）作为麻醉诱导药物。术后8小时和16小时也给予昂丹司琼（8 mg）。所有麻醉和外科手术程序均标准化。术后24小时内对患者进行评估，以观察PONV的发生情况。
术后2-6小时PONV发生率较高，帕洛诺司琼组的发生率为36.8%（95%置信区间[CI] 28.2–46.3），而昂丹司琼组的发生率为43.4%（95% CI 34.4–52.9）。帕洛诺司琼与昂丹司琼在PONV的风险差异（95% CI）为：在0–2小时时为0（-10.9至10.9），在2–6小时时为-6.6（-19.4至6.5），在6–12小时时为-0.9（-11.0至9.2），在12–24小时时为-2.8（-9.6至3.6）。帕洛诺司琼组和昂丹司琼在使用抢救药物（苯海拉明）方面的差异无统计学差异。没有发生与所研究的药物相关的不良事件。
帕洛诺司琼对于接受腹腔镜胆囊切除术的有 PONV 风险的患者来说并不逊色于昂丹司琼，为 PONV 预防提供了一个很好的选择，因为它可以单剂量给药。
原始文献来源： Francisco José Chiaradia Davolos, Norma S. Modolo, Leandro G. Braz,et al. Palonosetron versus ondansetron for prophylaxis of postoperative nausea and vomiting in laparoscopic cholecystectomy: a non-inferiority randomized controlled trial.[J]. Critical Care Medicine, 2024, 74 (1): 744216.
Palonosetron versus ondansetron for prophylaxis of postoperative nausea and vomiting in laparoscopic cholecystectomy: a non-inferiority randomized controlled trial
Background: We tested the hypothesis that, within the margin of 15% of risk difference, palonosetron is not inferior to ondansetron in reducing the incidence of postoperative nausea and vomiting (PONV) in laparoscopic cholecystectomy.
Methods: We conducted a double-blind, non-inferiority, randomized, controlled trial of 212 patients aged 18 to 65 years undergoing laparoscopic cholecystectomy under general anesthesia in two secondary care hospitals. Patients were randomly assigned to receive either palonosetron(0.075 mg) or ondansetron (8 mg) intravenously at induction of anesthesia. Ondansetron (8 mg) was also administered 8 and 16 hours postoperatively. All anesthetic and surgical procedures were standardized. Patients were evaluated for 24 hours postoperatively for the occurrence of PONV.
Results: A high incidence of PONV was observed at 2-6 hours postoperatively, with a rate of 36.8% (95% confidence interval [CI] 28.2-46.3) in the palonosetron group, as compared to 43.4% (95% CI 34.4-52.9) in the ondansetron group. The risk difference (95% CI) between palonosetron and ondansetron for PONV was 0 (-10.9 to 10.9) at 0-2 hours, -6.6 (-19.4 to 6.5) at 2-6 hours,-0.9 (-11.0 to 9.2) at 6-12 hours, and -2.8 (-9.6 to 3.6) at 12-24 hours. There was no statistically significant difference between the palonosetron and ondansetron groups in the use of rescue medication (dimenhydrinate). There were no adverse events associated with the medications under study.
Conclusion:Palonosetron is not inferior to ondansetron in patients at risk of PONV undergoing laparoscopic cholecystectomy, providing a good option for PONV prophylaxis, as it can be administered in a single dose.
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