Dupeyron J P, Conseiller C, Levarlet M, Hemmingsen C, Schoeffler P, Pedersen F M, Gribomont B, Kaplan L A
Département d'Anesthésie, CHU, Strasbourg, France.
Anaesthesia. 1993 Mar;48(3):214-8. doi: 10.1111/j.1365-2044.1993.tb06904.x.
The efficacy and safety of ondansetron in preventing postoperative nausea and vomiting following major gynaecological surgery was evaluated in this multicentre, double-blind study. A total of 243 patients were randomised to receive three doses of oral ondansetron 8 mg or matching placebo at 8-hourly intervals, with the first dose being given an hour before surgery. A standard general anaesthetic technique was employed throughout. Nausea, vomiting and safety assessments were performed continuously during the 24 h postrecovery period. Of the 237 patients evaluated for efficacy, significantly fewer ondansetron 8 mg treated patients (65/117; 56%) experienced postoperative nausea and/or vomiting compared with placebo-treated patients (94/120; 78%) during the study period (p < 0.001). In addition, ondansetron 8 mg reduced the severity of nausea (p < 0.001) and the total number of vomiting episodes experienced (p < 0.001). Overall, ondansetron 8 mg was well tolerated and effective in preventing postoperative nausea and vomiting in this surgical setting.
在这项多中心、双盲研究中,评估了昂丹司琼预防妇科大手术后恶心和呕吐的疗效及安全性。总共243例患者被随机分组,每8小时接受三剂8毫克口服昂丹司琼或匹配的安慰剂,首剂在手术前1小时服用。整个过程采用标准的全身麻醉技术。在恢复后的24小时内持续进行恶心、呕吐及安全性评估。在237例评估疗效的患者中,在研究期间,与接受安慰剂治疗的患者(94/120;78%)相比,接受8毫克昂丹司琼治疗的患者出现术后恶心和/或呕吐的明显较少(65/117;56%)(p<0.001)。此外,8毫克昂丹司琼降低了恶心的严重程度(p<0.001)以及呕吐发作的总数(p<0.001)。总体而言,在这种手术环境中,8毫克昂丹司琼耐受性良好且能有效预防术后恶心和呕吐。