注射用左亚叶酸钙联合治疗晚期胃癌和结直肠癌的Ⅱ期临床研究

目的：以注射用亚叶酸钙为对照，评价注射用左亚叶酸钙联合治疗晚期胃癌和结直肠癌的安全性和有效性。方法：采用多中心、随机、平行对照试验设计。入组患者按胃癌与结直肠癌分别随机分为试验组和对照组，左亚叶酸钙（Ｌ-ＬＶ）联合氟尿嘧啶（５-ＦＵ）、奥沙利铂（Ｌ-ＯＨＰ）或顺铂（ＤＤＰ）以及亚叶酸钙（ＬＶ）联合５-ＦＵ、Ｌ-ＯＨＰ（ＤＤＰ）治疗晚期胃、结直肠癌，比较其临床有效性和毒性。结果：胃癌试验组和对照组有效率分别为２５.００％和２３.０８％，临床获益率分别为６５.６３％、６６.１５％；结直肠癌试验组和对照组有效率分别为２１.９５％和１９.５１％，临床获益率分别为７８.０５％和70.７3％。两组之间疗效比较差异皆无统计学意义（Ｐ＞０.０５）。结论：注射用左亚叶酸钙联合５-ＦＵ治疗晚期胃癌和结直肠癌，其使用剂量为注射用亚叶酸钙一半时达到的疗效与注射用亚叶酸钙联合化疗方案相当，发生的毒副反应多与联合化疗药物有关，其发生率与注射用亚叶酸钙联合化疗方案相似。

The clinical research for calcium levofolinate with 5-fluorouracH for the treatment of advanced gastric cancer and colorectal cancer

Take the calcium levofolinate piece as the comparison medicine, appraises the safety and the validity of the calcium levofolinate with 5-fluorouracil to treat the advanced gastric cancer and eolorectal cancer. Methods：The patients who entered the group divided into the experimental group and the comparison group stochasticly, calcium levofolinate or calcium folinate with 5-fluorouracil, oxaliplatin （cisplatin）. Contrast the clinical validity and toxicity of treating the advanced gastric cancer and colorectal cancer. Results：The gastric cancer the experiments group and the comparison group effectiveness was 25.00% , 23.08% respectively,clinical obtaining benefits rate was 65.63%, 66. 15% respectively. The colorectal cancer the experiments group and the comparison group effectiveness was 21.95% , 19.51% respectively, clinical obtaining benefits rate was 78.05% , 70. 73% respectively. There were no statistics significance between the two groups compares non-statistics significance（P 〉 0. 05 ）. Conclusion：The injection calcium levofolinate unites the 5-fluorouracil treat the advanced gastric cancer and colorectal cancer, the curative effect was similar to the injection calcium folinate unites the chemotherapy plan when its use dosage was half o＇clock of calcium folinate. Occurs not good responded many with union chemotherapy medicine related, its formation rate was similar to the injection calcium folinate unites the chemotherapy plan.