国产长春瑞滨软胶囊的Ⅱ期临床研究  

A randomized phase Ⅱ study of oral vinorelbine in advanced non-small-cell lung cancer patients

作　　者：潘跃银[1] 郝吉庆[1] 顾康生[1] 洪素珍[1] 孙国平[1] 彭万仁[1] 熊福星[1] 陈振东[1] 

机构地区：[1]安徽医科大学第一附属医院,合肥230022

出　　处：《临床肿瘤学杂志》2004年第4期376-378,共3页Chinese Clinical Oncology

摘　　要：目的 :观察和评价国产长春瑞滨软胶囊联合顺铂治疗Ⅲ～Ⅳ期非小细胞肺癌的安全性和有效性。方法 :本试验采用随机对照试验设计 ,随机将入组的 4 8例非小细胞肺癌分为二组。联合试验组 (A) :长春瑞滨软胶囊 ,6 0mg/m2 ,1次服用 ,d1、d8;顺铂 (PDD) ,80mg/m2 ,d1,每 3周重复。联合对照组 (B) :注射试用长春瑞滨 ,2 5mg/m2 d1、d8;PDD ,80mg/m2 d1,每 3周重复。两组止吐方案相同。结果 :两组均无CR病例 ;试验组 (A组 )有效率为 2 2 73% (5 / 2 2 ) ,对照组的有效率为 2 9 17% (7/2 4 )。两组有效率比较差异无显著性 (P =0 74 2 )。毒副反应 :联合试验组主要不良反应为恶心、呕吐及骨髓抑制。其它毒副反应少见。结论 :重酒石酸长春瑞滨软胶囊联合PDD治疗中晚期非小细胞肺癌与重酒石酸长春瑞滨注射剂 (盖诺 )联合DDP对比 ,疗效相当 ,毒副反应相仿 ,建议扩大验证且延长观察期进一步观察。Objective:A phase Ⅱ trial of oral vi no relbine was designed to determine the efficacy and safety of oral vinorelbine in the patients with advanced non-small-cell lung cancer (NSCLC). Methods:48 patients with stage Ⅲ B or Ⅳ NSCLC were randomized to two groups. Group A: receive oral vinorelbine at a dose of 60 mg/m 2/week for two weeks (day 1,8) and cisplatin 80 mg/m 2/week (day 1);Group B: receive vinorelbine at a dose of 25 mg/m 2/week for two weeks (day 1,8) and cisplatin at a dose of 80 mg/m 2/week (day 1);three weeks per cycle. Results:46 cases were eligible and assessable. No patient required CR. The response rates in evaluable patients were 22.73% in the Group A and 29.17% in the Group B,respectively. The most common non-hematological toxicities were nausea,vomiting,anorexia. Vomiting was more common in Group A (75%),which was generally mild to moderate. The most common hematological toxicity was neutropenia,which was severe (grade 3～4) in 4.17% of patients in Group A and in 12.5% of patients in the Group B. Conclusion:The activity of oral and vinorelbine in i.v. advanced NSCLC appears to be comparable. The safety profiles of both formulations look qualitatively similar. Oral vinorelbine can therefore be considered as a p ossible alternative to i.v. administration.

关 键 词：长春瑞滨软胶囊 安全性 有效性 Ⅲ~Ⅳ期非小细胞肺癌 顺铂 联合化疗 

分 类 号：R734.2[医药卫生—肿瘤] R979.1[医药卫生—临床医学]