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[格拉司琼口服III期临床试验——格拉司琼对造血器官肿瘤化疗所致恶心/呕吐抑制作用的研究]

[Granisetron oral phase III clinical trial--study on the inhibitory effect of granisetron for nausea/vomiting induced by chemotherapy for tumors in the hematopoietic organs].

作者信息

Hiraoka A, Masaoka T, Nagai K, Kakishita E, Oshiba S, Kageyama T, Okuda K, Tatsumi N, Uchino H, Matsuzawa Y

机构信息

Center for Adult Diseases, Osaka.

出版信息

Gan To Kagaku Ryoho. 1993 Sep;20(12):1835-41.

PMID:8397489
Abstract

The efficacy and safety of oral granisetron against nausea and vomiting induced by chemotherapy for tumors in the hematopoietic organs were investigated. Depending on the day of anticancer drug administration, single administration or 2 to 6-day repeated administration of granisetron at 2 mg once daily was conducted. The clinical efficacy rate against nausea and vomiting was 91.6% on the first day of administration of anti-cancer drugs and 90% or over on and after the second day of administration. Compared with the status at the previous chemotherapy, a significant decrease in vomiting frequency was observed during the present trial. Adverse events which were suspected to be related to granisetron included 1 case of mild feeling of residual urine and another demonstrating very mild eosinophilia. From the above results, it was confirmed that granisetron was a safe and effective antiemetic against nausea and vomiting induced by anticancer drug administration.

摘要

研究了口服格拉司琼对造血器官肿瘤化疗所致恶心和呕吐的疗效及安全性。根据抗癌药物给药日,每日一次给予2mg格拉司琼进行单次给药或2至6日重复给药。抗癌药物给药第一天对恶心和呕吐的临床有效率为91.6%,给药第二天及以后为90%及以上。与上次化疗时的情况相比,本次试验期间呕吐频率显著降低。疑似与格拉司琼相关的不良事件包括1例轻度残余尿感和另一例表现为非常轻度的嗜酸性粒细胞增多。从上述结果证实,格拉司琼是一种安全有效的抗恶心和呕吐药物,可用于对抗抗癌药物给药所致的恶心和呕吐。

相似文献

1
[Granisetron oral phase III clinical trial--study on the inhibitory effect of granisetron for nausea/vomiting induced by chemotherapy for tumors in the hematopoietic organs].[格拉司琼口服III期临床试验——格拉司琼对造血器官肿瘤化疗所致恶心/呕吐抑制作用的研究]
Gan To Kagaku Ryoho. 1993 Sep;20(12):1835-41.
2
[Study on the inhibitory effect of oral granisetron against nausea/vomiting induced by cytosine arabinoside containing chemotherapy for tumors in the hematopoietic organs].
Gan To Kagaku Ryoho. 1993 Aug;20(10):1339-48.
3
Clinical evaluation of granisetron as an inhibitor of nausea and vomiting induced by oral anticancer drugs.格拉司琼作为口服抗癌药物所致恶心和呕吐抑制剂的临床评价
Oncol Rep. 2002 Mar-Apr;9(2):277-82.
4
[Clinical evaluation of granisetron for nausea and vomiting induced by anticancer drugs--optimal dose-finding study].[格拉司琼用于抗癌药物所致恶心和呕吐的临床评价——最佳剂量探索研究]
Gan To Kagaku Ryoho. 1993 Jul;20(9):1203-10.
5
Comparative study of low-dose oral granisetron plus dexamethasone and high-dose metoclopramide plus dexamethasone in prevention of nausea and vomiting induced by CHOP-therapy in young patients with non-Hodgkin's lymphoma.低剂量口服格拉司琼加地塞米松与高剂量甲氧氯普胺加地塞米松预防年轻非霍奇金淋巴瘤患者CHOP化疗所致恶心呕吐的比较研究
J Med Assoc Thai. 2002 Nov;85(11):1156-63.
6
[Clinical evaluation of granisetron for nausea and vomiting induced by anticancer drugs--multi-centered placebo-controlled double-blind comparative study].
Gan To Kagaku Ryoho. 1993 Jul;20(9):1211-9.
7
[A randomized cross-over comparative study of granisetron alone and combination of granisetron, methylprednisolone and droperidol as antiemetic prophilaxis in CDDP-based chemotherapy for gynecologic cancer].
Gan To Kagaku Ryoho. 1997 Apr;24(6):691-7.
8
[Clinical study on the inhibitory effect of a 5-HT3 antagonist, granisetron, for nausea and vomiting induced by chemotherapy (CHOP, VEPA, high-dose ETP) for non-Hodgkin's lymphoma].
Gan To Kagaku Ryoho. 1998 Apr;25(5):723-9.
9
[Efficacy and safety of two methods of administration of granisetron injection for nausea and vomiting induced by chemotherapy for tumors in hematopoietic organs--a randomized crossover comparison between intravenous drip infusion and intravenous bolus injection].格拉司琼注射液两种给药方法对造血器官肿瘤化疗所致恶心呕吐的疗效与安全性——静脉滴注与静脉推注的随机交叉比较
Gan To Kagaku Ryoho. 1998 Sep;25(11):1747-53.
10
A double-blind comparison of the efficacy of two dose regimens of oral granisetron in preventing acute emesis in patients receiving moderately emetogenic chemotherapy.口服格拉司琼两种剂量方案预防中度致吐性化疗患者急性呕吐疗效的双盲比较。
Cancer. 1996 Jul 1;78(1):144-51. doi: 10.1002/(SICI)1097-0142(19960701)78:1<144::AID-CNCR20>3.0.CO;2-Z.

引用本文的文献

1
Granisetron. An update of its therapeutic use in nausea and vomiting induced by antineoplastic therapy.格拉司琼。其在抗肿瘤治疗引起的恶心和呕吐治疗应用方面的最新进展。
Drugs. 1994 Nov;48(5):761-93. doi: 10.2165/00003495-199448050-00008.