作者檢驗了以下假設(shè)：在風(fēng)險差異的15%的范圍內(nèi),，帕洛諾司瓊在減少腹腔鏡膽囊切除術(shù)后惡心和嘔吐（PONV）的發(fā)生率方面不低于昂丹司瓊,。

在兩家二級醫(yī)院開展了一項雙盲、非劣效性隨機(jī)對照試驗,，共有212名18至65歲的患者接受了全身麻醉下的腹腔鏡膽囊切除術(shù),。患者隨機(jī)分配接受靜脈注射帕洛諾司瓊（0.075毫克）或昂丹司瓊（8毫克）作為麻醉誘導(dǎo)藥物,。術(shù)后8小時和16小時也給予昂丹司瓊（8 mg）,。所有麻醉和外科手術(shù)程序均標(biāo)準(zhǔn)化。術(shù)后24小時內(nèi)對患者進(jìn)行評估,，以觀察PONV的發(fā)生情況,。

術(shù)后2-6小時PONV發(fā)生率較高，帕洛諾司瓊組的發(fā)生率為36.8%（95%置信區(qū)間[CI] 28.2–46.3）,，而昂丹司瓊組的發(fā)生率為43.4%（95% CI 34.4–52.9）,。帕洛諾司瓊與昂丹司瓊在PONV的風(fēng)險差異（95% CI）為：在0–2小時時為0（-10.9至10.9），在2–6小時時為-6.6（-19.4至6.5）,，在6–12小時時為-0.9（-11.0至9.2）,，在12–24小時時為-2.8（-9.6至3.6）。帕洛諾司瓊組和昂丹司瓊在使用搶救藥物（苯海拉明）方面的差異無統(tǒng)計學(xué)差異,。沒有發(fā)生與所研究的藥物相關(guān)的不良事件,。

帕洛諾司瓊對于接受腹腔鏡膽囊切除術(shù)的有 PONV 風(fēng)險的患者來說并不遜色于昂丹司瓊，為 PONV 預(yù)防提供了一個很好的選擇,，因為它可以單劑量給藥,。

原始文獻(xiàn)來源： 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.