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目的观察固本消瘤胶囊联合FOLFOX4化疗方案治疗晚期大肠癌的疗效。方法将120例晚期大肠癌患者随机分成治疗组和对照组各60例,治疗组采用固本消瘤胶囊联合FOLFOX4方案,对照组仅采用FOLFOX4方案化疗。固本消瘤胶囊口服每次1.6g,每日2次,连续服用8周。FOLFOX4化疗方案采用草酸铂85mg·m-2,第1天;CF200mg·m-2,第1、2天静脉滴注;5-FU400mg·m-2,第1、2天静脉冲入;5-FU600mg·m-2,第1天连续48h泵入。4周期后评定两组近期疗效;并定期随访,比较两组患者的1年生存率。结果两组的临床受益率(CR+PR+SD)分别为78.3%、58.3%,两组比较差异有统计学意义(P<0.05);1年生存率分别为65.0%、41.7%,两组比较差异有统计学意义(P<0.05)。治疗组治疗后Karnofskv评分改善情况与对照组比较差异有统计学意义(P<0.05)。治疗组中性粒细胞减少、腹泻程度、神经毒性等不良反应与对照组比较差异有统计学意义(P<0.05)。治疗组治疗后纤维蛋白原、D-二聚体明显降低(P<0.05),APTT明显延长(P<0.05),而对照组纤维蛋白原显著升高(P<0.05);治疗后治疗组的NK细胞活性及T4/T8升高(P<0.05),而对照组未见明显变化。两组患者治疗后血清VEGF均有下降,其中治疗组差异显著(P<0.05)。结论固本消瘤胶囊联合FOLFOX4方案治疗晚期大肠癌有较好的疗效。
Objective To observe the curative effect of Gubenxiaoli capsule combined with FOLFOX4 chemotherapy in the treatment of advanced colorectal cancer. Methods A total of 120 patients with advanced colorectal cancer were randomly divided into treatment group (60 cases) and control group (60 cases). The treatment group was treated with Gubenxiao tumor capsule combined with FOLFOX4 and the control group with only FOLFOX4 chemotherapy. Guben capsule tumor oral 1.6g each time, 2 times a day for 8 weeks. FOLFOX4 chemotherapy using oxaliplatin 85mg · m-2 on the first day; CF200mg · m-2, intravenous infusion on the first and second days; 5-FU400mg · m-2, FU600mg · m-2, the first day of 48h pump. Four cycles after the assessment of the two groups of short-term efficacy; and regular follow-up, comparison of two groups of patients 1 year survival rate. Results The clinical benefit rates (CR + PR + SD) of the two groups were 78.3% and 58.3% respectively, with significant difference between the two groups (P <0.05). The 1-year survival rates were 65.0% and 41.7% The difference was statistically significant (P <0.05). The treatment group improved Karnofskv score after treatment compared with the control group was statistically significant (P <0.05). The treatment group neutropenia, diarrhea, neurotoxicity and other adverse reactions compared with the control group, the difference was statistically significant (P <0.05). After treatment, fibrinogen and D-dimer in the treatment group were significantly decreased (P <0.05), APTT was significantly prolonged (P <0.05), while fibrinogen in the control group was significantly increased (P <0.05) NK cell activity and T4 / T8 increased (P <0.05), while no significant changes in the control group. Serum VEGF decreased after treatment in both groups, of which the treatment group had significant difference (P <0.05). Conclusion Gubenxiao tumor capsule combined with FOLFOX4 regimen for the treatment of advanced colorectal cancer have a good effect.