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昂丹司琼预防术后恶心呕吐:90例患者的前瞻性、随机、双盲研究

[Prevention of postoperative nausea and vomiting with ondansetron: a prospective, randomized, double-blind study in 90 patients].

作者信息

Polati E, Finco G, Bartoloni A, Gottin L, Pinaroli A M, Zanoni L, Mazzetti C, Fontanive P

机构信息

Istituto di Anestesiologia e Rianimazione, Università degli Studi, Verona.

出版信息

Minerva Anestesiol. 1995 Sep;61(9):373-9.

PMID:8919833
Abstract

Postoperative nausea and vomiting (PONV) are among the most common complications in surgical patients. In this prospective, double blind, parallel group study we compare the prophylactic antiemetic efficacy of ondansetron versus placebo in 90 patients undergoing general balanced anaesthesia. The patients were stratified according to the kind of surgery and randomly allocated to three treatment groups: 30 patients (Group A) received ondansetron 4 mg i.v. 1 hour before the induction of anaesthesia and placebo 1 hour before the end of surgery; 30 patients (Group B) received placebo 1 hour before the end of anaesthesia and ondansetron 4 mg i.v. 1 hour before the end of surgery; 30 patients (Group C-control group) received placebo in both the administrations. Data were analyzed by Student t test and chi 2 test; significance was taken at p < 0.05. The three groups proved comparable with respect to demographic characteristics, duration of anaesthesia and fentanyl consumption. Analysis of the results showed that PONV had a significantly lower incidence in treated patients (Groups A and B) than in the control group patients (Group C): postoperative nausea occurred in 13%, 30% and 67% of patients in Group A, B and C respectively and it was associated with vomiting in 3%, 7% and 57% of patients in Group A, B and C respectively. Although the patients in Group A showed a lower incidence of PONV in comparison to the patients in Group B, such differences proved to be not statistically significant. No adverse effects in relation to drug administration were observed. We conclude that ondansetron 4 mg i.v. is safe and effective in preventing PONV in the surgical patients, particularly when administered before the induction of anaesthesia.

摘要

术后恶心呕吐(PONV)是外科患者中最常见的并发症之一。在这项前瞻性、双盲、平行组研究中,我们比较了90例接受全身平衡麻醉患者中昂丹司琼与安慰剂的预防性止吐效果。患者根据手术类型进行分层,并随机分配到三个治疗组:30例患者(A组)在麻醉诱导前1小时静脉注射4 mg昂丹司琼,在手术结束前1小时静脉注射安慰剂;30例患者(B组)在麻醉结束前1小时静脉注射安慰剂,在手术结束前1小时静脉注射4 mg昂丹司琼;30例患者(C组-对照组)在两次给药时均接受安慰剂。数据采用学生t检验和卡方检验进行分析;p<0.05时具有统计学意义。三组在人口统计学特征、麻醉持续时间和芬太尼消耗量方面具有可比性。结果分析表明,治疗组(A组和B组)患者PONV的发生率明显低于对照组患者(C组):A组、B组和C组患者术后恶心的发生率分别为13%、30%和67%,A组、B组和C组患者中分别有3%、7%和57%的患者伴有呕吐。尽管A组患者的PONV发生率低于B组患者,但这种差异无统计学意义。未观察到与药物给药相关的不良反应。我们得出结论,静脉注射4 mg昂丹司琼在预防外科患者PONV方面是安全有效的,尤其是在麻醉诱导前给药时。

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