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一项国际多中心、安慰剂对照研究,旨在评估昂丹司琼与甲氧氯普胺预防术后恶心和呕吐的有效性。

International, multicentre, placebo-controlled study to evaluate the effectiveness of ondansetron vs. metoclopramide in the prevention of post-operative nausea and vomiting.

作者信息

Morris R W, Aune H, Feiss P, Hanson A, Hasselstrøm L, Maltby J R, Rocke D A, Rozenberg B, Rust M, Cohen L A

机构信息

Department of Anaesthetics, Princess of Wales Hospital, Bridgend, Mid Glamorgan, UK.

出版信息

Eur J Anaesthesiol. 1998 Jan;15(1):69-79. doi: 10.1017/s0265021598000131.

DOI:10.1017/s0265021598000131
PMID:9522145
Abstract

Ondansetron 4 mg was compared with metoclopramide 10 mg for prevention of post-operative nausea and emesis in in-patients undergoing major gynaecological surgery in this double-blind, randomized, placebo-controlled, multicentre study. A total of 1044 patients received a single intravenous (i.v.) injection of study medication immediately before induction of anaesthesia. Nausea and emesis were assessed over the 24 h post-operative period. Significantly more patients who received ondansetron experienced no emetic episodes (44%) compared with those who received metoclopramide (37%, P = 0.049) or placebo (25%, P < 0.001). No nausea was experienced by significantly more patients who received ondansetron (32%) than with patients who received metoclopramide (24%, P = 0.009) or placebo (16%, P < 0.001). In addition, fewer emetic episodes, less severe nausea and a reduced need for rescue antiemetics were also observed with ondansetron (P < 0.05 vs. metoclopramide and placebo). Metoclopramide and placebo-treated patients were also 1.5 times (95% Cl 1.5-4.2) and 2.5 times (95% Cl 1.1-2.0) more likely, respectively, to experience nausea post-operatively. Overall, ondansetron was the most effective antiemetic in this patient population.

摘要

在这项双盲、随机、安慰剂对照、多中心研究中,对4毫克昂丹司琼与10毫克甲氧氯普胺预防接受大型妇科手术的住院患者术后恶心和呕吐的效果进行了比较。共有1044例患者在麻醉诱导前立即接受了单次静脉注射研究药物。在术后24小时内对恶心和呕吐情况进行评估。与接受甲氧氯普胺(37%,P = 0.049)或安慰剂(25%,P < 0.001)的患者相比,接受昂丹司琼的患者中无呕吐发作的比例显著更高(44%)。接受昂丹司琼的患者中无恶心的比例显著高于接受甲氧氯普胺(24%,P = 0.009)或安慰剂(16%,P < 0.001)的患者。此外,使用昂丹司琼还观察到呕吐发作次数减少、恶心程度减轻以及急救止吐药需求减少(与甲氧氯普胺和安慰剂相比,P < 0.05)。接受甲氧氯普胺和安慰剂治疗的患者术后出现恶心的可能性分别是接受昂丹司琼患者的1.5倍(95%可信区间1.5 - 4.2)和2.5倍(95%可信区间1.1 - 2.0)。总体而言,昂丹司琼是该患者群体中最有效的止吐药。

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