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[静脉注射昂丹司琼与甲氧氯普胺预防术后恶心和呕吐的比较]

[Intravenous administration of ondansetron vs. metoclopramide for the prophylaxis of postoperative nausea and vomiting].

作者信息

Rust M

机构信息

Institut für Anaesthesiologie der Technischen Universität München.

出版信息

Anaesthesist. 1995 Apr;44(4):288-90. doi: 10.1007/s001010050156.

DOI:10.1007/s001010050156
PMID:7785758
Abstract

This randomized, double-blind, multicentre, parallel-group study compared the efficacy and safety of an intravenous dose of ondansetron 4 mg for the prevention of postoperative nausea and vomiting (PONV) with metoclopramide 10 mg and placebo in patients undergoing major gynaecological surgery. A total of 1044 patients (465 ondansetron, 462 metoclopramide, 117 placebo) received study medication immediately prior to induction of anaesthesia and were included in the analysis of data. The proportion of patients experiencing no emesis and no nausea or provided with rescue antiemetic medication, the number of emetic episodes, and the duration and severity of nausea were recorded during the 24-h period after recovery. Significantly more patients who received ondansetron had no emetic episodes (44%) than those who received metoclopramide (36%, P = 0.049) or placebo (25%, P < 0.001). A higher proportion of patients receiving ondansetron (32%) did not experience nausea (metoclopramide 24%, P = 0.009; placebo 16%, P < 0.001). Significantly fewer patients in the ondansetron group required rescue medication or were withdrawn due to treatment failure (P < 0.05). In the ondansetron group the total number of emetic episodes, the median time to the first emetic episode or treatment failure, and the duration and severity of nausea were reduced significantly compared with metoclopramide or placebo (P < 0.05). The safety profile was similar for each treatment group.

摘要

这项随机、双盲、多中心、平行组研究比较了静脉注射4毫克昂丹司琼预防大妇科手术后恶心和呕吐(PONV)的疗效及安全性,与10毫克甲氧氯普胺和安慰剂在接受大妇科手术患者中的效果。共有1044名患者(465名接受昂丹司琼、462名接受甲氧氯普胺、117名接受安慰剂)在麻醉诱导前立即接受研究药物治疗,并纳入数据分析。记录了恢复后24小时内未出现呕吐、未出现恶心或未使用急救止吐药物的患者比例、呕吐发作次数以及恶心的持续时间和严重程度。接受昂丹司琼治疗的患者中无呕吐发作的比例(44%)显著高于接受甲氧氯普胺治疗的患者(36%,P = 0.049)或接受安慰剂治疗的患者(25%,P < 0.001)。接受昂丹司琼治疗的患者中未出现恶心的比例更高(32%)(甲氧氯普胺为24%,P = 0.009;安慰剂为16%,P < 0.001)。昂丹司琼组中需要急救药物或因治疗失败而退出的患者明显较少(P < 0.05)。与甲氧氯普胺或安慰剂相比,昂丹司琼组的呕吐发作总数、首次呕吐发作或治疗失败的中位时间以及恶心的持续时间和严重程度均显著降低(P < 0.05)。各治疗组的安全性概况相似。

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When placebo controlled trials are essential and equivalence trials are inadequate.
当安慰剂对照试验必不可少且等效性试验不充分时。
BMJ. 1998 Sep 26;317(7162):875-80. doi: 10.1136/bmj.317.7162.875.