Phase II trials of the serotonin antagonist GR38032F for the control of vomiting caused by cisplatin.
Phase II trials of the serotonin antagonist GR38032F for the control of vomiting caused by cisplatin.
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血清素拮抗剂 GR38032F 用于控制顺铂引起的呕吐的 II 期试验。
DOI：
10.1093/jnci/81.1.42
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发表时间：
1989
期刊：
影响因子：
--
通讯作者：
Tyson,LB
中科院分区：
文献类型：
--
作者：
Kris,MG;Gralla,RJ;Clark,RA;Tyson,LB
进行了三项5-羟色胺拮抗剂GR 38032 F的II期研究。在试验1中，20名给予顺铂初始化疗（剂量>=100 mg/m2）的患者随机接受三个剂量的GR 38032 F（0.18 mg/kg），每2小时或每4小时给药一次。在试验2中，8名相似的患者每2小时给予3次0.04 mg/kg剂量。在试验3中，连续4或5天接受20-25 mg/m2顺铂的12名先前接受治疗的患者，每2小时接受3次每日GR 38032 F剂量（0.15 mg/kg）。在试验1中，35%的患者没有呕吐（95%置信区间（CI），16%-58%），55%的患者有一次或两次呕吐发作（95% CI，32%-76%）。每2小时和每4小时方案的结果相似。在试验2中，8名患者中只有1名（13%）没有呕吐（95% CI，1%-50%）。在研究既往接受过治疗的患者的试验3中，完全控制的范围从第1天的75%到第3天的33%。观察到轻度镇静、头痛和血清SGOT（AST）一过性升高。无锥体外系症状发生。推荐剂量为0.15-0.18 mg/ kg，每2小时一次，共3次静脉给药。需要对GR 38032 F进行进一步的比较和联合研究。[J Natl Cancer Inst 1989;81：42-46]
Three phase II studies of the serotonin antagonist GR38032F were conducted. In trial 1, 20 patients given initial chemotherapy with cisplatin at doses >=100 mg/m were randomized to receive three GR38032F doses (0.18 mg/kg) on an every–2–hour or every–4–hour schedule. In trial 2, eight similar patients were given three 0.04–mg/kg doses every 2 hours. In trial 3, 12 previously treated patients receiving cisplatin at 20–25 mg/m on 4 or 5 consecutive days each received three daily GR38032F doses (0.15 mg/kg) every 2 hours. In trial 1, 35% of the patients had no emesis (95%) confidence interval (CI), 16%–58%) and 55% had one or two emetic episodes (95% CI, 32%–76%). Results were similar between the every–2–hour and every–4–hour schedules. In trial 2, only one of eight patients (13%) had no vomiting (95% CI, 1%–50% ). In trial 3, in which previously treated patients were studied, complete control ranged from 75% on day 1 to 33% on day 3. Mild sedation, headache, and transient elevations of serum SGOT (AST) were observed. No extrapyramidal symptoms occurred. A dose of 0.15–0.18 mg/ kg every 2 hours for three iv doses is recommended. Further comparison and combination studies of GR38032F are warranted. [J Natl Cancer Inst 1989;81:42–46]