恩丹西酮（齐鲁）预防顺铂所致呕吐的：Ⅲ期临床研究

目的进一步确定恩丹西酮（齐鲁）的临床应用价值及改进的用药方案。方法多中心协作研究,观察单用恩丹西酮和恩丹西酮合并地塞米松对顺铂（每次３０ｍｇ～２００ｍｇ）所致呕吐的预防效果。结果３３０例接受恩丹西酮、４４３例接受恩丹西酮加地塞米松治疗。结果对急性恶心有效率分别为７３．３％和８０．８％,对急性呕吐有效率分别为８６．７％和９４．８％,第１天平均呕吐次数分别为０．９和０．５次,表明加用地塞米松可显著提高对急性恶心呕吐有效率。但对迟发性呕吐的疗效相似。此外,单用恩丹西酮８ｍｇ静脉注射也能取得疗效。结论该药对预防顺铂所致呕吐疗效突出,改进的方案用法简便,可减少用药次数,疗效好。

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

OBJECTIVE: To further evaluate the clinical usefulness of ondensetron(OND, supplied by Qilu Pharmaceutical Company) with modified regime in the prevention of cisplatin (DDP)-induced nausea and vomiting. METHODS: A total of 773 patients were enrolled in a multicenter cooperative study. Of them, 330 patients were given i.v. OND 8 mg once or twice a day and 443 patients were given i.v. OND 8 mg plus dexamethasone(DXM) 10 mg once a day during the therapeutic period of DDP, followed by OND 4 mg orally twice a day for two days after DDP treatment. RESULTS: Effective control of acute nausea was achieved in 86.7% and 94.8% of the patients receiving OND alone and OND plus DXM, respectively(P < 0.001). The mean frequency of vomiting was 0.9 times in OND and 0.4 times in OND plus DXM(P < 0.01). Total control of delayed vomiting (day 2-5) was comparable in both groups. Complete inhibition of vomiting (CR rate) was more frequently observed in males than in females. Adverse effects were identical and well tolerated. CONCLUSION: OND with modified regimen is effective in the control of DDP-induced vomiting. It is more effective when OND and DXM are given than OND given alone.