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[昂丹司琼(齐鲁)在预防非顺铂所致呕吐中的作用——一项随机临床试验]

[The role of ondansetron (Qilu) in the prevention of non-cisplatin-induced vomiting--a randomized clinical trial].

作者信息

Zeng W, Zhou J, Zhang P

出版信息

Zhonghua Zhong Liu Za Zhi. 1995 Jul;17(4):294-7.

PMID:7587900
Abstract

The antiemetic effect of ondansetron (supplied by Qilu Pharmaceutical Company) in patients receiving non-cisplatin chemotherapy (containing CTX and/or ADM) was studied in a multiple centre, randomized cross-over trial. The patients who had vomiting in the first turn of chemotherapy entered the trial. The patients received randomly ondansetron or control drugs-metoclopramide or Zofran (Glaxo) in the second turn of chemotherapy. In the third, the patients were cross-over to use the other antiemetic drug. A total of 155 patients were enrolled into the study. The results showed, the effective control rate (0-2 emetic episodes) on the first day were 87.7% of patients treated with ondansetron and 61.6% treated with metoclopramide. The mean frequency of vomiting was 0.8 times in ondansetron and 2.7 times in metoclopramide (P < 0.01). Ondansetron was superior to metoclopramide for the control of emesis. The antiemetic effects of ondansetron (Qilu) and Zofran (Glaxo) were very similar. The side-effects of ondansetron were mild.

摘要

在一项多中心、随机交叉试验中,研究了齐鲁制药公司提供的昂丹司琼对接受非顺铂化疗(含环磷酰胺和/或阿霉素)患者的止吐效果。首轮化疗时出现呕吐的患者进入试验。患者在第二轮化疗时随机接受昂丹司琼或对照药物——甲氧氯普胺或格拉司琼(葛兰素史克公司生产)。在第三轮时,患者交叉使用另一种止吐药物。共有155例患者纳入研究。结果显示,第一天的有效控制率(呕吐发作0 - 2次),接受昂丹司琼治疗的患者为87.7%,接受甲氧氯普胺治疗的患者为61.6%。呕吐的平均次数,昂丹司琼组为0.8次,甲氧氯普胺组为2.7次(P < 0.01)。昂丹司琼在控制呕吐方面优于甲氧氯普胺。齐鲁版昂丹司琼与葛兰素史克版格拉司琼的止吐效果非常相似。昂丹司琼的副作用较轻。

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