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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。
OBJECTIVE: To evaluate the safety and efficacy of levofloxacin injection in the treatment of advanced gastric cancer and colorectal cancer with calcium folate injection as a control. Methods: A multicenter, randomized, parallel controlled trial design was used. The patients were randomly divided into experimental group and control group according to gastric cancer and colorectal cancer. L-LV combined with 5-fluorouracil, L-OHP or DDP ) And leucovorin (LV) combined with 5-FU and L-OHP (DDP) in the treatment of advanced gastric cancer and colorectal cancer. The clinical efficacy and toxicity were compared. Results: The effective rates of gastric cancer group and control group were 25.00% and 23.08% respectively, and the clinical benefit rates were 65.63% and 66.15% respectively. The effective rates of colorectal cancer group and control group were 21.95% and 19.51% The rates of interest are 78.05% and 70.73% respectively. There was no significant difference in efficacy between the two groups (P> 0.05). CONCLUSIONS: The combination of levoflavone and 5-FU for the treatment of advanced gastric cancer and colorectal cancer at a dose equivalent to half of leucovorin for injection is comparable to the combination of chemotherapy with leucovorin for injection, with toxic side effects More associated with the combination of chemotherapy drugs, the incidence of injection and leucovorin chemotherapy with similar programs.