口服格拉司琼加地塞米松与静脉注射昂丹司琼加地塞米松控制中/重度致吐性化疗引起的恶心和呕吐的疗效及安全性比较。

Comparison of the efficacy and safety of oral granisetron plus dexamethasone with intravenous ondansetron plus dexamethasone to control nausea and vomiting induced by moderate/severe emetogenic chemotherapy.

作者信息

Chiou T J, Tzeng W F, Wang W S, Yen C C, Fan F S, Liu J H, Chen P M

机构信息

Department of Medicine, Taipei Veterans General Hospital, and National Yang-Ming University School of Medicine, Taiwan, ROC.

出版信息

Zhonghua Yi Xue Za Zhi (Taipei). 2000 Oct;63(10):729-36.

PMID:11076429

Abstract

BACKGROUND

Chemotherapy-induced nausea and vomiting can affect cancer patients' compliance with cytotoxic chemotherapy. Currently, there are some new antiemetic therapies for the treatment of chemotherapy-induced emesis. A single institution, randomized, open, parallel trial was done to compare oral granisetron plus intravenous (i.v.) dexamethasone with intravenous ondansetron for the prevention of moderate or severe emetogenic chemotherapy-induced acute and delayed emesis.

METHODS

Fifty-one cancer patients were treated with moderate/severe emetogenic chemotherapy and randomized to receive either oral granisetron 1 mg twice daily or i.v. ondansetron 8 mg every 8 hours combined with i.v. dexamethasone 10 mg on the day of chemotherapy. The efficacy and safety of the two antiemetic regimens were compared.

RESULTS

Oral granisetron plus i.v. dexamethasone had comparable antiemetic efficacy for the prevention of nausea in the first 24-hour period after initiation of chemotherapy compared with intravenous ondansetron plus i.v. dexamethasone. The complete response of antiemesis in the first 24-hour period after initiation of antiemetic therapy between granisetron and ondansetron were 84.0% (95% CI, 62.9%-95.6%) and 84.6 (95% CI, 64.0%-97.5%). The complete response for delayed emesis after initiation of antiemetic therapy between granisetron and ondansetron were 16.0% (95% CI, 4.5%-36.1%) and 19.2% (95% CI, 6.8%-40.7%0. There was diarrhea in 12% of patients receiving granisetron therapy and constipation in 23.1% of the ondansetron group.

CONCLUSIONS

Oral granisetron plus i.v. dexamethasone and i.v. ondansetron plus i.v. dexamethasone are potentially equally effective antiemetic agents in the prevention of moderate or severe emetogenic chemotherapy-induced acute or delayed emesis. Oral granisetron with dexamethasone appears to be a suitable alternative antiemetic agent in cancer patients who receive moderately or severely emetogenic chemotherapy.

摘要

背景

化疗引起的恶心和呕吐会影响癌症患者对细胞毒性化疗的依从性。目前，有一些新的止吐疗法用于治疗化疗引起的呕吐。进行了一项单机构、随机、开放、平行试验，比较口服格拉司琼加静脉注射地塞米松与静脉注射昂丹司琼预防中度或重度致吐性化疗引起的急性和延迟性呕吐的效果。

方法

51例接受中度/重度致吐性化疗的癌症患者被随机分为两组，一组每天两次口服1毫克格拉司琼，另一组每8小时静脉注射8毫克昂丹司琼，并在化疗当天静脉注射10毫克地塞米松。比较两种止吐方案的疗效和安全性。

结果

与静脉注射昂丹司琼加静脉注射地塞米松相比，口服格拉司琼加静脉注射地塞米松在化疗开始后的前24小时预防恶心方面具有相当的止吐效果。格拉司琼组和昂丹司琼组在开始止吐治疗后的前24小时内呕吐完全缓解率分别为84.0%（95%可信区间，62.9%-95.6%）和84.6%（95%可信区间，64.0%-97.5%）。格拉司琼组和昂丹司琼组在开始止吐治疗后延迟性呕吐的完全缓解率分别为16.0%（95%可信区间，4.5%-36.1%）和19.2%（95%可信区间，6.8%-40.7%）。接受格拉司琼治疗的患者中有12%出现腹泻，昂丹司琼组有23.1%出现便秘。