Perez E A, Hesketh P, Sandbach J, Reeves J, Chawla S, Markman M, Hainsworth J, Bushnell W, Friedman C
Mayo Clinic, Jacksonville, FL 32224, USA.
J Clin Oncol. 1998 Feb;16(2):754-60. doi: 10.1200/JCO.1998.16.2.754.
The antiemetic effectiveness and safety of single-dose oral granisetron were compared with intravenous (I.V.) ondansetron in chemotherapy-naive patients who received moderately emetogenic chemotherapy.
In this double-blind, parallel-group study, patients naive to emetogenic chemotherapy (N = 1,085) who were scheduled to receive cyclophosphamide- (500 to 1,200 mg/m2) or carboplatin (> or = 300 mg/m2) based chemotherapy, were randomized to receive either oral granisetron (n = 542) or I.V. ondansetron (n = 543). Efficacy assessments included the proportion of patients in each treatment group with total control over the 24 and 48 hours following chemotherapy initiation, as well as incidence and severity of nausea and emesis and use of antiemetic rescue medication. Prophylactic corticosteroids were allowed. Safety assessment was based on patients' reports of adverse experiences.
Approximately 80% of patients received prophylactic corticosteroids. Single-dose oral granisetron (2 mg) and I.V. ondansetron (32 mg) resulted in equivalent levels of total emetic control during the first 48 hours after chemotherapy. The proportion of nausea- and emesis-free patients at 24 and 48 hours were also approximately equivalent. The most commonly reported adverse experiences were headache, asthenia, and constipation. More patients who received ondonsetron than granisetron reported dizziness (9.6% v 5.4%, respectively; P = .011) and abnormal vision (4.2% v 0.6%, respectively; P < .001).
A single oral dose of granisetron (2 mg) resulted in equivalent levels of antiemetic protection as I.V. ondansetron (32 mg). Both agents were well tolerated, although more dizziness and abnormal vision were reported with ondansetron. Because the two antiemetic regimens exhibited equivalent efficacies, additional factors such as convenience and cost of therapy should be considered.
在接受中度致吐性化疗的初治患者中，比较单剂量口服格拉司琼与静脉注射昂丹司琼的止吐效果和安全性。
在这项双盲、平行组研究中，计划接受基于环磷酰胺（500至1200mg/m²）或卡铂（≥300mg/m²）化疗的初治致吐性化疗患者（N = 1085），被随机分为接受口服格拉司琼（n = 542）或静脉注射昂丹司琼（n = 543）。疗效评估包括每个治疗组中在化疗开始后24小时和48小时完全控制症状的患者比例，以及恶心、呕吐的发生率和严重程度，还有止吐解救药物的使用情况。允许使用预防性皮质类固醇。安全性评估基于患者对不良事件的报告。
约80%的患者接受了预防性皮质类固醇。单剂量口服格拉司琼（2mg）和静脉注射昂丹司琼（32mg）在化疗后的前48小时内产生了相当的完全止吐控制水平。在24小时和48小时时无恶心和呕吐的患者比例也大致相当。最常报告的不良事件是头痛、乏力和便秘。接受昂丹司琼的患者比接受格拉司琼的患者更多报告头晕（分别为9.6%对5.4%；P = 0.011）和视力异常（分别为4.2%对0.6%；P < 0.001）。
单剂量口服格拉司琼（2mg）产生的止吐保护水平与静脉注射昂丹司琼（32mg）相当。两种药物耐受性均良好，尽管昂丹司琼报告的头晕和视力异常更多。由于两种止吐方案疗效相当，应考虑治疗便利性和成本等其他因素。
