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昂丹司琼预防乳腺癌手术患者术后恶心呕吐的安慰剂对照双盲研究。

Ondansetron in prophylaxis of postoperative nausea and vomiting in patients undergoing breast surgery: a placebo-controlled double blind study.

作者信息

Sinha Prabhat Kumar, Ambesh Sushil P

机构信息

Department of Anaesthesiology and Critical Care Medicine, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow 226014.

出版信息

J Indian Med Assoc. 2004 Feb;102(2):73-4, 76, 78-9.

Abstract

The present study was to evaluate the efficacy of ondansetron, 5-HT3 receptor antagonist, versus placebo in the prevention of postoperative nausea and vomiting (PONV) in a homogenous group of female patients undergoing breast reduction surgery under general anaesthesia. Approximately one hour before skin closure, 70 patients were randomly divided into two groups of 35 each. In a double blind manner each group of patients received either intravenous ondansetron (4mg) or a matching placebo. The overall incidences of PONV during first 24-hour were 60% and 20% in placebo and ondansetron group respectively (p<0.05). However, there was no significant difference after 24-hour postoperatively. In placebo group 42.9% of patients received rescue anti-emetic (metoclopramide) for the treatment of severe PONV (ie, 2 or more episodes of PONV), whereas, only 8.6% patients were administered such intervention in the ondansetron group (p<0.05). It is, therefore, concluded that prophylactic administration of intravenous ondansetron (4mg) one hour before skin closure is safe and effective in preventing PONV in female patients undergoing breast surgery and routine use of ondansetron in the patient population is recommended.

摘要

本研究旨在评估5-羟色胺3(5-HT3)受体拮抗剂昂丹司琼与安慰剂相比,在全身麻醉下接受乳房缩小手术的同质女性患者群体中预防术后恶心和呕吐(PONV)的疗效。在皮肤缝合前约一小时,70名患者被随机分为两组,每组35人。两组患者均以双盲方式分别接受静脉注射昂丹司琼(4mg)或匹配的安慰剂。安慰剂组和昂丹司琼组在前24小时内PONV的总体发生率分别为60%和20%(p<0.05)。然而,术后24小时后两组之间没有显著差异。在安慰剂组中,42.9%的患者因严重PONV(即PONV发作2次或更多次)接受了补救性止吐药(甲氧氯普胺)治疗,而在昂丹司琼组中,只有8.6%的患者接受了此类干预(p<0.05)。因此,得出结论,在皮肤缝合前一小时预防性静脉注射昂丹司琼(4mg)在预防接受乳房手术的女性患者PONV方面是安全有效的,建议在该患者群体中常规使用昂丹司琼。

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