Friedman C J, Burris H A, Yocom K, Blackburn L M, Gruben D
Clinical Research and Development, North America, SmithKline Beecham Pharmaceuticals, Collegeville, Pennsylvania, USA.
Oncologist. 2000;5(2):136-43. doi: 10.1634/theoncologist.5-2-136.
To demonstrate the efficacy of oral granisetron 1 mg twice daily for the prevention of late onset nausea and vomiting after moderately emetogenic chemotherapy that includes cyclophosphamide, carboplatin, or doxorubicin.
Prior to chemotherapy, patients were stratified by gender and randomized to receive oral granisetron (1 mg tablet twice daily) or prochlorperazine (10 mg sustained release capsule twice daily). Study agents were administered 1 h prior to and 12 h after chemotherapy. Antiemetics were administered for seven consecutive days. Efficacy variables were assessed 48 and 72 h after administration of chemotherapy, and included no emesis, no nausea, no moderate or severe nausea, and no antiemetic rescue. Safety analysis included all patients who received medication.
A total of 230 patients were included in the intent-to-treat analysis; 119 patients received granisetron and 111 patients received prochlorperazine. Females, and all patients combined, who received granisetron had significantly higher no-emesis rates at 48 h (p =.010 and p =.016, respectively) than patients who received prochlorperazine. No-nausea rates at 48 h were numerically higher for all patients combined and females who received granisetron rather than prochlorperazine. Response rates for no nausea or mild nausea were also numerically higher in females treated with granisetron, compared to prochlorperazine, at 48 h. Significantly more patients (p <.001) and females (p <.001) in the granisetron group than in the prochlorperazine group did not require rescue antiemetics at 48 h. At 72 h, efficacy results were comparable for granisetron and prochlorperazine.
Oral granisetron is well tolerated and more effective than prochlorperazine in preventing nausea and vomiting for up to 48 h following treatment with moderately emetogenic chemotherapy.
证明口服1毫克格拉司琼每日两次对预防含环磷酰胺、卡铂或阿霉素的中度致吐性化疗后迟发性恶心和呕吐的疗效。
化疗前，根据性别对患者进行分层，并随机分为接受口服格拉司琼（1毫克片剂，每日两次）或丙氯拉嗪（10毫克缓释胶囊，每日两次）。研究药物在化疗前1小时和化疗后12小时给药。止吐药连续给药7天。在化疗给药后48小时和72小时评估疗效变量，包括无呕吐、无恶心、无中度或重度恶心以及无需止吐药解救。安全性分析包括所有接受药物治疗的患者。
共有230例患者纳入意向性分析；119例患者接受格拉司琼治疗，111例患者接受丙氯拉嗪治疗。接受格拉司琼治疗的女性患者以及所有患者在48小时时的无呕吐率显著高于接受丙氯拉嗪治疗的患者（分别为p = 0.010和p = 0.016）。接受格拉司琼治疗的所有患者以及女性患者在48小时时的无恶心率在数值上高于接受丙氯拉嗪治疗的患者。在48小时时，接受格拉司琼治疗的女性患者无恶心或轻度恶心的反应率在数值上也高于接受丙氯拉嗪治疗的患者。在48小时时，格拉司琼组比丙氯拉嗪组有更多患者（p < 0.001）和女性患者（p < 0.001）无需解救性止吐药。在72小时时，格拉司琼和丙氯拉嗪的疗效结果相当。
口服格拉司琼耐受性良好，在预防中度致吐性化疗后长达48小时的恶心和呕吐方面比丙氯拉嗪更有效。
