Diemunsch P, Korttila K, Leeser J, Helmers J H, Wilkey B, Navé S, Radke A J, Hahne W F, Brown R A
Department of Anesthesiology, Les Hôpitaux Universitaires de Strasbourg, France.
J Clin Anesth. 1998 Mar;10(2):145-52. doi: 10.1016/s0952-8180(97)00259-6.
To examine the safety and effectiveness of a range of single oral doses of dolasetron mesylate for the prevention of postoperative nausea and vomiting.
Randomized, double-blind, placebo-controlled trial.
32 hospitals.
789 female ASA physical status I, II, and III patients, ages 18 to 60 years, weighing between 45 and 100 kg, scheduled for major gynecologic surgery (including abdominal hysterectomy, gynecologic laparotomy, or vaginal hysterectomy) with general anesthesia.
25, 50, 100, or 200 mg oral doses of dolasetron mesylate or placebo were administered 1 to 2 hours before induction of anesthesia. Efficacy was assessed for 24 hours postrecovery by measuring complete response (no emetic episodes, no rescue medication), total response (complete response with no nausea), time to first emetic episode or rescue, and patient visual analog scale evaluations of nausea severity and satisfaction with antiemetic therapy.
Complete response rates for the 50, 100, and 200 mg dose groups were statistically greater than placebo (p < or = 0.018). Likewise, total response rates were statistically greater in the 50, 100, and 200 mg dose groups than in the placebo group (p = 0.012). Percentage of patients with no nausea and patient satisfaction scores were significantly higher for each dolasetron dose group than placebo (p < or = 0.047 and p < or = 0.004, respectively). Efficacy peaked at the 50 mg dose. The incidence of adverse events was similar in the placebo (30.1%) and dolasetron groups (29.4%). Headache was the most frequent treatment-related adverse event, with 2% to 5% incidence across groups. Incidence of adverse events did not increase with increasing dolasetron doses. Dose-related decreases in blood pressure at acute time points were not clinically significant.
Single oral doses of dolasetron, administered 1 to 2 hours before induction of anesthesia, are safe and effective for preventing postoperative nausea and vomiting in this patient sample. Maximal antiemetic response was seen with the 50 mg oral dolasetron dose.
探讨一系列单剂量口服甲磺酸多沙普仑预防术后恶心和呕吐的安全性及有效性。
随机、双盲、安慰剂对照试验。
32家医院。
789例年龄在18至60岁之间、ASA身体状况为I、II和III级、体重45至100千克、计划接受全身麻醉的大型妇科手术（包括腹部子宫切除术、妇科剖腹术或阴道子宫切除术）的女性患者。
在麻醉诱导前1至2小时给予25、50、100或200毫克口服甲磺酸多沙普仑或安慰剂。通过测量完全缓解（无呕吐发作、无需急救药物）、总缓解（完全缓解且无恶心）、首次呕吐发作或急救时间以及患者视觉模拟量表对恶心严重程度和对抗呕吐治疗满意度的评估，在恢复后24小时评估疗效。
50、100和200毫克剂量组的完全缓解率在统计学上高于安慰剂组（p≤0.018）。同样，50、100和200毫克剂量组的总缓解率在统计学上高于安慰剂组（p = 0.012）。各甲磺酸多沙普仑剂量组无恶心患者的百分比和患者满意度得分均显著高于安慰剂组（分别为p≤0.047和p≤0.004）。疗效在50毫克剂量时达到峰值。安慰剂组（30.1%）和多沙普仑组（29.4%）的不良事件发生率相似。头痛是最常见的与治疗相关的不良事件，各组发生率为2%至5%。不良事件发生率并未随多沙普仑剂量增加而升高。急性时间点上与剂量相关的血压下降在临床上无显著意义。
在麻醉诱导前1至2小时给予单剂量口服多沙普仑，对该患者样本预防术后恶心和呕吐安全有效。50毫克口服多沙普仑剂量的抗呕吐反应最大。
