Fox-Geiman M P, Fisher S G, Kiley K, Fletcher-Gonzalez D, Porter N, Stiff P
Department of Pharmacy, Nursing and Medicine, and the Bone Marrow Transplant Program, Loyola University Medical Center, Maywood, Illinois 60154, USA.
Biol Blood Marrow Transplant. 2001;7(11):596-603. doi: 10.1053/bbmt.2001.v7.pm11760147.
The optimal management of transplantation preparative regimen-induced nausea and vomiting remains unknown. We conducted a Phase III double-blind study to determine the efficacy and costs of oral ondansetron versus oral granisetron versus IV ondansetron and PRN rescue antiemetics for the prevention/control of nausea and vomiting associated with high-dose chemotherapy or chemoradiotherapy prior to stem cell transplantation. One hundred two patients were randomized to receive either 8 mg PO ondansetron every 8 hours, 1 mg PO granisetron every 12 hours, or 32 mg IV ondansetron every 24 hours plus 10 mg IV dexamethasone daily during and 1 day after the various preparative regimens. Study arms were compared in terms of emetic episodes, subjective nausea, amount and cost of rescue antiemetics used, and total costs. Response was defined as complete response (CR), no emesis with no or mild nausea and no rescue antiemetics; major response (MR), 1 episode of emesis or moderate nausea with or without rescue antiemetics; and major efficacy (ME), CR + MR. Subjective nausea was assessed using a 100-mm visual analog scale (VAS) with 0 = no nausea. Ninety-six patients completed the study; the trial was analyzed according to intention-to-treat. Overall CR rates were: 48% for oral ondansetron, 47% for oral granisetron, and 49% for IV ondansetron. Overall ME rates were 82% for oral ondansetron, 84% for oral granisetron, and 81% for IV ondansetron. Mean VAS scores were 32 for oral ondansetron, 32 for oral granisetron, and 27 for IV ondansetron. None of the differences were statistically significant. A cost analysis revealed significant differences among all arms (P = .0001, all comparisons). All 3 regimens had similar efficacy in this BMT population; oral ondansetron was the most cost-effective.
移植预处理方案引起的恶心和呕吐的最佳管理方法尚不清楚。我们进行了一项III期双盲研究，以确定口服昂丹司琼、口服格拉司琼、静脉注射昂丹司琼与按需使用的解救性止吐药相比，在预防/控制干细胞移植前大剂量化疗或放化疗相关的恶心和呕吐方面的疗效和成本。102名患者被随机分为三组，分别每8小时口服8毫克昂丹司琼、每12小时口服1毫克格拉司琼、或每24小时静脉注射32毫克昂丹司琼，并在各种预处理方案期间及之后1天每天静脉注射10毫克地塞米松。比较各研究组的呕吐发作次数、主观恶心程度、所用解救性止吐药的数量和成本以及总成本。反应定义为完全缓解（CR），即无呕吐、无或轻度恶心且无需使用解救性止吐药；主要反应（MR），即1次呕吐发作或中度恶心，无论是否使用解救性止吐药；以及主要疗效（ME），即CR + MR。使用100毫米视觉模拟量表（VAS）评估主观恶心程度，0表示无恶心。96名患者完成了研究；根据意向性分析对试验进行分析。总体CR率分别为：口服昂丹司琼组48%，口服格拉司琼组47%，静脉注射昂丹司琼组49%。总体ME率分别为：口服昂丹司琼组82%，口服格拉司琼组84%，静脉注射昂丹司琼组81%。口服昂丹司琼组的平均VAS评分为32，口服格拉司琼组为32，静脉注射昂丹司琼组为27。这些差异均无统计学意义。成本分析显示所有组之间存在显著差异（P = .0001，所有比较）。在这个骨髓移植人群中，所有三种方案的疗效相似；口服昂丹司琼是最具成本效益 的。
