Beck T M, Ciociola A A, Jones S E, Harvey W H, Tchekmedyian N S, Chang A, Galvin D, Hart N E
Mountain States Tumor Institute, Boise, Idaho 83712-6297.
Ann Intern Med. 1993 Mar 15;118(6):407-13. doi: 10.7326/0003-4819-118-6-199303150-00002.
To evaluate the efficacy and safety of oral ondansetron (Zofran) as an antiemetic in patients receiving cyclophosphamide-based chemotherapy.
A multicenter, randomized, double-blind, stratified, placebo-controlled trial conducted between March 1989 and January 1990.
Twenty-seven oncology centers including university hospitals, community cancer centers, and private medical oncology practices.
A total of 349 chemotherapy-naive patients having their first cycle of cyclophosphamide (> or = 450 mg/m2)-based chemotherapy. Patients also received methotrexate (> or = 30 mg/m2) or doxorubicin (> or = 35 mg/m2). All patients were evaluated for safety and 318 (91%) were evaluated for efficacy.
Patients were randomly assigned to one of four treatment groups: placebo, 1 mg, 4 mg, or 8 mg of ondansetron. Assigned study medication was taken three times per day for 3 consecutive days.
Time and number of emetic episodes as well as degree of nausea were recorded by patients for each of the 3 study days.
Compared with placebo, all three doses of ondansetron were superior (P < 0.001) in preventing vomiting and controlling nausea. A complete response (no emetic episodes) was observed in 19%, 57%, 65%, and 66% of patients in the placebo, 1-mg, 4-mg, and 8-mg ondansetron groups, respectively. For patients who received higher-dose cyclophosphamide and doxorubicin, a dose-related trend in antiemetic efficacy of ondansetron was observed. Mild headache and constipation were the most frequently reported adverse events. No extrapyramidal reactions were observed.
Oral ondansetron is a safe and effective antiemetic that is more efficacious than placebo for patients receiving cyclophosphamide-based chemotherapy.
评估口服昂丹司琼（枢复宁）作为接受环磷酰胺化疗患者的止吐药的疗效和安全性。
1989年3月至1990年1月进行的一项多中心、随机、双盲、分层、安慰剂对照试验。
27个肿瘤中心，包括大学医院、社区癌症中心和私立医学肿瘤诊所。
总共349例未接受过化疗的患者进行其首个基于环磷酰胺（≥450mg/m²）的化疗周期。患者还接受了甲氨蝶呤（≥30mg/m²）或多柔比星（≥35mg/m²）。所有患者均进行了安全性评估，318例（91%）进行了疗效评估。
患者被随机分配到四个治疗组之一：安慰剂、1mg、4mg或8mg昂丹司琼。指定的研究药物每天服用三次，连续服用3天。
患者在3个研究日中的每一天记录呕吐发作的时间和次数以及恶心程度。
与安慰剂相比，所有三个剂量的昂丹司琼在预防呕吐和控制恶心方面均更具优势（P<0.001）。安慰剂组、1mg、4mg和8mg昂丹司琼组分别有19%、57%、65%和66%的患者出现完全缓解（无呕吐发作）。对于接受高剂量环磷酰胺和多柔比星的患者，观察到昂丹司琼的止吐疗效呈剂量相关趋势。轻度头痛和便秘是最常报告的不良事件。未观察到锥体外系反应。
口服昂丹司琼是一种安全有效的止吐药，对于接受基于环磷酰胺化疗的患者比安慰剂更有效。
