国产奥沙利铂治疗晚期大肠癌临床验证研究

Trial of Domestic-made Oxaliplatin in Patients with Advanced Colorectal Carcinoma

目的 评价国产奥沙利铂治疗晚期大肠癌的疗效和安全性。方法 将 78例大肠癌患者随机分为 A、B两组。 A组为奥沙利铂试验组 ,B组为顺铂对照组 ,治疗 2周后评价疗效 ,有效病例在 4周后确认疗效。结果 共入组 78例 ,可评价病例 74例中 ,A组有效率为 2 8.9% ,B组有效率为 5 .5 6 % (P<0 .0 1 )。不良反应主要为恶心、呕吐和感觉神经毒性。结论 国产奥沙利铂联合氟脲嘧啶 -甲酰四氢叶酸钙治疗晚期大肠癌疗效与同方案进口奥沙利铂疗效基本相近 ,比以顺铂为主的对照组方案疗效要高 (P<0 .0 1 )

Objective The aim of this project was to evaluate the efficacy and adverse effects of Oxaliplatin(L\|OHP) in advanced colorectal cancer(ACRC). Methods A randomized study of this drug versus combination with 5\|FU/FA in ACRC patients was conducted in 12 hospitals. Arm A with L\|0HP Arm B is a group contrasted with cisplatin, Tumor assessment dosdone every 2 cycles and responders were confirmed four weeks later.Results 78 ACRC patients entered the study, 74 cases evaluable for efficacy, the response rate for arm A and B of ACRC was 28.95%(11/38) and5.56%(2/36)( P <0.01). The main adverse effects were nauseu and vomiting ,alopecia and neuro\|sensory toxicity.Conclusion The response rate in ACRC of domestic\|made L\|OHP was encouraging and comparable with eloxatin, The response rate was better than arm B of cisplatin.