Efficacy and safety of granisetron, a selective 5-hydroxytryptamine-3 receptor antagonist, in the prevention of nausea and vomiting induced by high-dose cisplatin.
Efficacy and safety of granisetron, a selective 5-hydroxytryptamine-3 receptor antagonist, in the prevention of nausea and vomiting induced by high-dose cisplatin.
复制标题
格拉司琼（一种选择性 5-羟色胺-3 受体拮抗剂）预防大剂量顺铂引起的恶心和呕吐的功效和安全性。
DOI：
10.1200/jco.1994.12.10.2204
复制
发表时间：
1994
期刊：
影响因子：
--
通讯作者：
D. Fitts
中科院分区：
文献类型：
--
作者：
R. Navari;H. G. Kaplan;R. Gralla;S. Grunberg;R. Palmer;D. Fitts
目的
评估四种不同剂量格拉司琼（Kytril; SmithKline Beecham Pharmaceuticals，Philadelphia，PA）单次静脉（IV）给药预防顺铂诱导的恶心和呕吐时的止吐作用和安全性特征。
患者和方法
184例接受高剂量顺铂（81 - 120 mg/m2）的化疗初治患者在化疗前随机接受4种格拉司琼剂量（5、10、20或40 μ g/kg）。住院观察患者18至24小时，评估生命体征、恶心、呕吐、干呕和食欲。安全性分析包括不良事件发生率和实验室参数变化。
结果
格拉司琼剂量为5、10、20和40微克/kg后，分别有23%、57%、58%和60%的患者出现了呕吐或干呕发作（≤ 2次，无止吐药抢救），（无呕吐或干呕，无止吐急救）分别为18%、41%、40%和47%。恶心（P = 0.0015）和呕吐（P = 0.0001）首次发作的时间在统计学上更长，10微克/kg给药组中给予额外止吐药物的患者少于5微克/kg给药组。随着格拉司琼剂量的增加，食欲恢复增加（P = 0.040）。头痛是最常报告的不良事件（20%）。
结论
单次10、20或40 μ g/kg剂量的格拉司琼可有效控制57%至60%接受顺铂剂量大于81 mg/m2的患者的呕吐，并可完全预防40%至47%的患者的呕吐。10 μ g/kg剂量与20和40 μ g/kg剂量之间的疗效无统计学显著差异。格拉司琼在所有剂量下均耐受良好。
PURPOSE
To assess the antiemetic effects and safety profile of four different doses of granisetron (Kytril; SmithKline Beecham Pharmaceuticals, Philadelphia, PA) when administered as a single intravenous (IV) dose for prophylaxis of cisplatin-induced nausea and vomiting.
PATIENTS AND METHODS
One hundred eighty-four chemotherapy-naive patients receiving high-dose cisplatin (81 to 120 mg/m2) were randomized to receive one of four granisetron doses (5, 10, 20, or 40 micrograms/kg) administered before chemotherapy. Patients were observed on an inpatient basis for 18 to 24 hours, and vital signs, nausea, vomiting, retching, and appetite were assessed. Safety analyses included incidence of adverse experiences and laboratory parameter changes.
RESULTS
After granisetron doses of 5, 10, 20, and 40 micrograms/kg, a major response (< or = two vomiting or retching episodes, and no antiemetic rescue) was recorded in 23%, 57%, 58%, and 60% of patients, respectively, and a complete response (no vomiting or retching, and no antiemetic rescue) in 18%, 41%, 40%, and 47% of patients, respectively. There was a statistically longer time to first episode of nausea (P = .0015) and vomiting (P = .0001), and fewer patients were administered additional antiemetic medication in the 10-micrograms/kg dosing groups than in the 5-micrograms/kg dosing group. As granisetron dose increased, appetite return increased (P = .040). Headache was the most frequently reported adverse event (20%).
CONCLUSION
A single 10-, 20-, or 40-micrograms/kg dose of granisetron was effective in controlling vomiting in 57% to 60% of patients who received cisplatin at doses greater than 81 mg/m2 and totally prevented vomiting in 40% to 47% of patients. There were no statistically significant differences in efficacy between the 10-micrograms/kg dose and the 20- and 40-micrograms/kg doses. Granisetron was well tolerated at all doses.
血清素拮抗剂 GR-C507/75 (GR38032F) 在接受抗癌化疗的患者中用作止吐剂时的剂量范围评估。
DOI：
10.1200/jco.1988.6.4.659
发表时间：
1988
期刊：
Journal of clinical oncology : official journal of the American Society of Clinical Oncology
影响因子：
--
作者：
Kris,MG;Gralla,RJ;Clark,RA;Tyson,LB
通讯作者：
Tyson,LB
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
发表时间：
1989
期刊：
Journal of the National Cancer Institute
影响因子：
--
作者：
Kris,MG;Gralla,RJ;Clark,RA;Tyson,LB
通讯作者：
Tyson,LB