Diemunsch P, D'Hollander A, Paxton L, Schoeffler P, Wessel P, Navé S, Brown R A, Hahne W F
Department of Anesthesiology, Les Hôpitaux Universitaires de Strasbourg, France.
J Clin Anesth. 1997 Aug;9(5):365-73. doi: 10.1016/s0952-8180(97)00063-9.
To evaluate a range of doses of intravenous (i.v.) dolasetron mesilate, in preventing postoperative nausea and vomiting (PONV).
Double-blind, placebo-controlled, randomized, multicenter trial.
Ten hospitals and/or surgical centers.
281 women undergoing gynecologic surgery with general anesthesia.
Patients received one of four single, i.v. doses of dolasetron mesilate (12.5 mg, 25 mg, 50 mg, and 100 mg) or placebo administered following cessation of anesthesia.
Patients were monitored for 24 hours following study drug administration. The antiemetic efficacy of each dolasetron mesilate dose was evaluated by recording the number and timing of emetic episodes, and the effects on nausea were assessed by use of visual analog scales (VAS). Safety was assessed by adverse event reports, clinical laboratory tests, electrocardiographic (ECG) measurements, and monitoring vital signs. Complete responses (patients with no emetic episodes and no escape antiemetic medication requirements in 24 hours) were achieved by 54% in the 12.5-mg, 67% in the 25-mg, and 59% in both the 50-mg and 100-mg dolasetron mesilate dose groups, and by 43% in the placebo group. Nausea VAS assessments demonstrated that dolasetron-treated patients were significantly (p = 0.048) more likely to report no nausea (VAS score < 5 mm) than those in the placebo group. Adverse events reported generally were mild in intensity, and there were no clinically significant changes in laboratory tests, vital signs, or ECG parameters.
Dolasetron was effective and well tolerated for the prevention of PONV in female patients undergoing gynecologic surgery with general anesthesia.
评估一系列剂量的静脉注射甲磺酸多拉司琼预防术后恶心和呕吐（PONV）的效果。
双盲、安慰剂对照、随机、多中心试验。
十家医院和/或外科中心。
281例接受全身麻醉的妇科手术女性患者。
患者在麻醉结束后接受四种单剂量静脉注射甲磺酸多拉司琼（12.5毫克、25毫克、50毫克和100毫克）之一或安慰剂。
在给予研究药物后对患者进行24小时监测。通过记录呕吐发作的次数和时间来评估每种甲磺酸多拉司琼剂量的止吐效果，并使用视觉模拟量表（VAS）评估对恶心的影响。通过不良事件报告、临床实验室检查、心电图（ECG）测量和生命体征监测来评估安全性。12.5毫克甲磺酸多拉司琼剂量组中54%的患者、25毫克剂量组中67%的患者、50毫克和100毫克甲磺酸多拉司琼剂量组中59%的患者以及安慰剂组中43%的患者实现了完全缓解（24小时内无呕吐发作且无需额外的止吐药物）。恶心VAS评估表明，与安慰剂组相比，接受多拉司琼治疗的患者更有可能报告无恶心（VAS评分<5毫米）（p = 0.048）。报告的不良事件一般强度较轻，实验室检查、生命体征或心电图参数无临床显著变化。
多拉司琼对接受全身麻醉的妇科手术女性患者预防PONV有效且耐受性良好。
