Slabý J, Trnený M, Procházka B, Klener P
1st Department of Medicine, General University Hospital, Charles University, Prague 2, Czech Republic.
Neoplasma. 2000;47(5):319-22.
The aim of this study was to compare antiemetic efficacy of three serotonin antagonists, granisetron, tropisetron and ondansetron, during conditioning for autologous stem cell transplantation (ASCT). Forty-five malignant lymphoma patients (mean age 38 years, M:F 30:15), undergoing the highly emetogenic regimen BEAM prior to ASCT, were randomized to receive IV granisetron (G) 3 mg once a day, IV tropisetron (T) 5 mg once a day, or IV ondansetron (0) 8 mg twice daily, for six days. The treatment groups were comparable with respect to age, sex and previous experience of nausea and/or vomiting. Nausea and/or emesis control failure was defined as a nausea lasting > or = 4 hours and/or > or = 3 episodes of vomiting/24 h, emesis control failure as > or = 3 episodes of vomiting/24 h. Both the period of chemotherapy (6 days) and the whole period of observation (10 days) were evaluated. Nausea and/or emesis control failure occurred in 24% of patients during the period of chemotherapy and in 51% of patients throughout the whole period of observation, while emesis control failed in 2% and 27% of patients, respectively. The efficacy of three serotonin antagonists was comparable during the chemotherapy period (5 patients with nausea and/or emesis control failure in the granisetron group, 2 in the tropisetron group and 4 in the ondansetron group,p = 0.40). When evaluating the whole period of observation, the antiemetic response to G and T was significantly better than to O, nausea and/or emesis control failure having occurred in 7 (47%) patients treated with G, 5 (33%) patients treated with T, and 12 (80%) patients treated with O, p = 0.03. The results concerning emesis control failures were similar, G 4 (27%), T 1 (7%), O 7 (47%), p = 0.04. Headache was the only frequent side effect of serotonin antagonists (30% incidence). All three serotonin antagonists sufficiently controlled nausea and vomiting during high-dose chemotherapy (BEAM) administration in 67-87% of patients. In comparison with ondansetron, both tropisetron and granisetron proved to be more effective after ASCT, when emetogenic factors other than chemotherapy alone participated.
本研究的目的是比较三种5-羟色胺拮抗剂(格拉司琼、托烷司琼和昂丹司琼)在自体干细胞移植(ASCT)预处理期间的止吐效果。45例恶性淋巴瘤患者(平均年龄38岁,男:女为30:15)在ASCT前接受高致吐性BEAM方案化疗,被随机分为三组,分别静脉注射格拉司琼(G)3mg/天、托烷司琼(T)5mg/天或昂丹司琼(O)8mg,每日2次,共6天。治疗组在年龄、性别以及既往恶心和/或呕吐经历方面具有可比性。恶心和/或呕吐控制失败定义为恶心持续≥4小时和/或呕吐发作≥3次/24小时,呕吐控制失败定义为呕吐发作≥3次/24小时。对化疗期(6天)和整个观察期(10天)进行评估。化疗期间,24%的患者出现恶心和/或呕吐控制失败,整个观察期内这一比例为51%;而呕吐控制失败的患者分别为2%和27%。三种5-羟色胺拮抗剂在化疗期的效果相当(格拉司琼组5例恶心和/或呕吐控制失败,托烷司琼组2例,昂丹司琼组4例,p = 0.40)。在评估整个观察期时,格拉司琼和托烷司琼的止吐反应明显优于昂丹司琼,接受格拉司琼治疗的7例(47%)患者、托烷司琼治疗的5例(33%)患者以及昂丹司琼治疗的12例(80%)患者出现恶心和/或呕吐控制失败,p = 0.03。呕吐控制失败的结果相似,格拉司琼组4例(27%)、托烷司琼组1例(7%)、昂丹司琼组7例(47%),p = 0.04。头痛是5-羟色胺拮抗剂唯一常见的副作用(发生率为30%)。在高剂量化疗(BEAM)期间,所有三种5-羟色胺拮抗剂在67% - 87%的患者中充分控制了恶心和呕吐。与昂丹司琼相比,在ASCT后,当除单纯化疗外还有其他致吐因素时,托烷司琼和格拉司琼均被证明更有效。