Polati E, Verlato G, Finco G, Mosaner W, Grosso S, Gottin L, Pinaroli A M, Ischia S
Institute of Anesthesiology and Intensive Care, University of Verona, Italy.
Anesth Analg. 1997 Aug;85(2):395-9. doi: 10.1097/00000539-199708000-00027.
In this prospective, randomized, double-blind study, we compared the efficacy and safety of ondansetron and metoclopramide in the treatment of postoperative nausea and vomiting (PONV). One hundred seventy-five patients with PONV during recovery from anesthesia for gynecological laparoscopy were treated intravenously with either ondansetron 4 mg (58 patients), metoclopramide 10 mg (57 patients), or placebo (60 patients). Early antiemetic efficacy (abolition of vomiting within 10 min and of nausea within 30 min from the administration of the study drugs with no further vomiting or nausea episodes during the first hour) was obtained in 54 of 58 patients (93.1%) in the ondansetron group, in 38 of 57 patients (66.7%) in the metoclopramide group, and in 21 of 60 patients (35%) in the placebo group (P < 0.001). This difference was still significant when controlling for age, body weight, history of motion sickness, previous PONV episodes, duration of anesthesia, and intraoperative fentanyl consumption using a logistic model. Early antiemetic efficacy was inversely related to the amount of fentanyl administered during anesthesia, regardless of treatment. According to the Kaplan-Meier method, the probability of remaining PONV-free for 48 h after a successful treatment was 0.59 (95% confidence interval 0.45-0.71) in the ondansetron group, 0.45 (0.29-0.60) in the metoclopramide group, and 0.33 (0.15-0.53) in the placebo group (P = 0.003). In conclusion, ondansetron 4 mg is more effective than metoclopramide 10 mg and placebo in the treatment of established PONV.
在这项前瞻性、随机、双盲研究中,我们比较了昂丹司琼和甲氧氯普胺治疗术后恶心呕吐(PONV)的疗效和安全性。175例在妇科腹腔镜手术麻醉恢复期间发生PONV的患者,分别静脉注射4mg昂丹司琼(58例患者)、10mg甲氧氯普胺(57例患者)或安慰剂(60例患者)。昂丹司琼组58例患者中有54例(93.1%)获得早期止吐疗效(从给予研究药物后10分钟内呕吐停止且30分钟内恶心停止,且在第一小时内无进一步呕吐或恶心发作),甲氧氯普胺组57例患者中有38例(66.7%),安慰剂组60例患者中有21例(35%)(P<0.001)。使用逻辑模型控制年龄、体重、晕动病史、既往PONV发作史、麻醉持续时间和术中芬太尼用量时,这种差异仍然显著。无论采用何种治疗,早期止吐疗效与麻醉期间给予的芬太尼量呈负相关。根据Kaplan-Meier方法,成功治疗后48小时内无PONV的概率在昂丹司琼组为0.59(95%置信区间0.45-0.71),在甲氧氯普胺组为0.45(0.29-0.60),在安慰剂组为0.33(0.15-0.53)(P=0.003)。总之,4mg昂丹司琼在治疗已发生的PONV方面比10mg甲氧氯普胺和安慰剂更有效。