DH与DF方案治疗晚期食管癌的前瞻性随机对照研究

Randomized Clinical Trial of HCPT Plus Cisplatin Versus DDP Plus 5-Fu in the Treatment of Advanced Esophageal Cancer

目的：本研究拟比较羟基喜树碱（喜素，HCPT）联合顺铂（DDP）与顺铂联合5-氟尿嘧啶（5-Fu）治疗晚期食管癌的近期疗效及不良反应。方法：对60例经病理证实的晚期食管癌初治患者给予联合化疗，随机分为DH组或DF。每组各30例，DH组病例应用HCPT（6mg／m^2d1～3）加DDP（25mg／m^2dl～3），DF组病例应用5-Fu（750mg／m^2dl～5）加DDP（25mg／m^2dl～3），21d为一个周期。每例患者治疗少于2个周期。结果：DH组患者总有效率为46．7％，中位缓解期4．2个月；DF组患者总有效率为50．0％，中位生存期3．8个月，两组有效率比较差异无显著性。最常见的毒副反应为骨髓抑制和恶心、呕吐，DH组20．0％（6／30）出现Ⅲ～Ⅵ度白细胞下降，DF组13．3％（4／30）出现Ⅲ～Ⅳ度白细胞下降，二者比较差异无统计学意义，DH组和DF的Ⅲ＋Ⅵ度恶心、呕吐反应发生率分别为33．3％和30．0％。差别无统计学意义。DH组腹泻发生率26．7％，但可耐受。结论：DH与DF方案相比，疗效相似，不良反应虽有所不同，但毒性可以耐受，是对晚期食管癌有效的化疗方案之一。

Objective： To compare the response rate and the side effects of the regimen DH （DDP , HCPT） with DF （ DDP, 5 - Fu ） in the treament of advanced esophageal cancer. Methods： A total of 60 cases with advanced esophageal entered this trial. The patients were randomly divided into trial group and control group , and received chemotherapy of DH regimen or DF regimen respectively . Each patient received at least 2cycles of chemotherapy. Results： The overall response rate was 46.7% in the DH group and 50.0% in the DF group , the difference between the two groups did not reach statistical significance （ P 〉 0. 05 ） . The major effects were leucopenia,nause in the two groups , the incidence of diarrhea was significantly higer in DH group than in DF group（ 26.7% VS 3.3%, P 〈 0. 05 ）, but the toxicity was tolerable. Conclusion： Both DH and DF regimens are effective for advanced esophageal cancer and have no significant difference , the side effect of the two regimens are different but all adverse reactions are tolerable.