恩丹西酮（齐鲁）预防非顺铂化疗所致呕吐的Ⅲ期临床研究

目的改进用药方法,进一步确定恩丹西酮的临床应用价值。方法首次用非顺铂药出现呕吐者为入组对象。再次化疗时,给予恩丹西酮（齐鲁）８ｍｇ静脉注射,每日１次。化疗结束后口服８ｍｇ,每日２次,用１天的简化方法。结果经多中心１９３例患者应用,第１天止吐有效率达９３．３％,对迟发性呕吐也有很好疗效。第１～５天平均呕吐次数为０．４～０．０１。结论本法疗效高,副作用小,且经济方便,更适于临床推广应用。

Phase III clinical studies with ondansetron (Qilu) in the prophylaxis of nausea and vomiting induced by non-cisplatin chemotherapy

OBJECTIVE: This study was undertaken to further determine the clinical value of ondansetron (OND, supplied by Qilu Pharmaceutical Company) in the prophylaxis of nausea and vomiting induced by non-cisplatin chemotherapy. METHODS: A total of 193 patients were enrolled in the multicenter prospective study and were given treatment of non-cisplatin based chemotherapy. All patients were treated with OND 8 mg i.v. once a day during chemotherapy, followed by OND 4 mg orally twice a day for one day after chemotherapy. RESULTS: The effective control rate (0-2 emetic episodes) on the first day was 93.3%. Total control of delayed vomiting (day 2-5) was as high as 94.8 to 99.5%. The mean frequency of vomiting was 0.4, 0.4, 0.2, 0.1 and 0.1, respectively from day 1 to day 5. Adverse effects were minor and tolerable. CONCLUSION: This modified regimen of treatment with OND is effective in the control of vomiting induced by non-DDP chemotherapy.