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[盐酸昂丹司琼与类固醇联合用于肺癌顺铂化疗患者的疗效与安全性研究]

[Examination on efficacy and safety of concurrent use of ondansetron hydrochloride and steroid in lung cancer patients on cisplatin].

作者信息

Horichi N, Taguchi T, Furue H, Ikeda M, Tsukakoshi S

机构信息

1st Dept. of Internal Medicine, Showa University.

出版信息

Gan To Kagaku Ryoho. 2001 Jul;28(7):953-60.

Abstract

The anti-emetic effect and safety in patients receiving ondansetron hydrochloride (OND group) and concurrent use of ondansetron and dexamethasone (DEX group) in cases of acute and delayed onset emesis induced by a single high dose of cisplatin, given as a chemotherapy to lung cancer patients, were comparatively studied. The study subjects were 78 lung cancer patients. The OND group received 4 mg of ondansetron via slow intravenous injection on Day 1, 30 minutes prior to cisplatin, and for Days 2 to 5, the subjects orally received 4 mg ondansetron tablet each day. The DEX group received the same dose regimen of ondansetron as the OND group for Days 1-5, but in addition the subjects received dexamethasone injection in doses of 8 mg twice daily on Day 1 and 4 mg (1 mg QID) daily for Days 2-5. An anti-emetic effect against acute nausea and vomiting was achieved in 83.8% of the OND group and in a higher rate of 94.6% of the DEX group. Significantly better efficacy was seen in the DEX group as to the complete suppression rate of nausea and vomiting and the improvement of food intake. The group also achieved better efficacy in delayed onset of emesis. Two cases of adverse reactions (hiccups and elevation of ALT and BUN) were observed in the DEX group; however, since the symptoms were all mild, we did not consider there was any problem in safety. We conclude from the above findings that concurrent administration of ondansetron hydrochloride and dexamethasone is a clinically useful treatment for acute and delayed onset emesis induced by a single high dose of cisplatin given to lung cancer patients.

摘要

对肺癌患者进行化疗时,单次大剂量顺铂诱导的急性和迟发性呕吐,比较研究了盐酸昂丹司琼(OND组)及昂丹司琼与地塞米松联合使用(DEX组)的止吐效果和安全性。研究对象为78例肺癌患者。OND组在第1天顺铂给药前30分钟通过缓慢静脉注射给予4 mg昂丹司琼,第2至5天,受试者每天口服4 mg昂丹司琼片。DEX组在第1至5天接受与OND组相同剂量方案的昂丹司琼,但除此之外,受试者在第1天每天接受2次8 mg地塞米松注射,第2至5天每天接受4 mg(1 mg,每日4次)地塞米松注射。OND组83.8%的患者对急性恶心和呕吐有止吐效果,DEX组的止吐率更高,为94.6%。DEX组在恶心和呕吐的完全抑制率及食物摄入量改善方面疗效显著更好。该组在迟发性呕吐方面也取得了更好的疗效。DEX组观察到2例不良反应(打嗝、谷丙转氨酶和尿素氮升高);然而,由于症状均较轻,我们认为安全性方面没有任何问题。根据上述研究结果,我们得出结论,盐酸昂丹司琼与地塞米松联合给药是治疗肺癌患者单次大剂量顺铂诱导的急性和迟发性呕吐的一种临床有效治疗方法。

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