FOLFOX4方案联合益气健脾汤治疗结直肠癌的临床研究

Clinical trial of FOLFOX4 regimen combined with Yiqi Jianpi soup in the treatment of patients with colorectal carcinoma

目的观察FOLFOX4方案结合益气健脾汤治疗结直肠癌(AC)的临床疗效。方法 68例接受腹腔镜手术治疗的结直肠癌患者分为对照组33例和试验组35例。对照组按常规的FOLFOX4化疗方案治疗,化疗第1天静脉滴注奥沙利铂100 mg·m^(-2),静脉滴注2 h,化疗第1,2天静脉滴注5-氟尿嘧啶(5-Fu)400 mg·m^(-2),静脉滴注2 h,口服卡培他滨片1000 mg,静脉注射鸦胆子油乳30m L,康艾注射液60 m L,亚叶酸钙300 mg,每天1次。试验组在常规的FOLFOX4化疗方案基础上加服益气健脾汤治疗,在化疗前1周持续至化疗后1周,每日1剂以水煎服,每次150 m L,每日2次,14 d为1个疗程,连续治疗3个疗程。比较2组治疗的中医证候疗效、药物不良反应、SF-36生活质量评分以及术后不同时间段的生存率情况。结果治疗后,对照组中医证候总有效率为66.67%(22/33例),试验组为80.00%(28/35例,P<0.05)。试验组治疗后6个月的SF-36评分为(67.21±7.21)分,对照组为(45.46±5.22)分,2组差异有统计学意义(P<0.05)。试验组术后1年的生存率为88.57%(31/35例),3年的生存率为51.43%(18/35例);对照组术后1年的生存率为75.76%(25/33例),3年的生存率为39.39%(13/33例),差异有统计学意义(P<0.05)。试验组骨髓抑制反应、胃肠道反应、白细胞下降、血小板下降及肝功能异常等药物不良反应的发生率与对照组比较,差异有统计学意义(P<0.05)。结论 FOLFOX4方案结合益气健脾汤治疗腹腔镜术后结直肠癌的临床疗效确切,能显著提升患者的生活质量,且安全性高。

Objective To observe the clinical effect of FOLFOX4 regimen combined with Yiqi Jianpi soup in patients with colorectal carcinoma（ AC）. Methods Sixty- eight patients with AC after treatment of laparoscopic surgery were selected and randomly divided into treatment group（ n = 35） and control group（ n = 33）. Control group was treated with conventional FOLFOX4 regimen after surgery,intravenous drip oxaliplatin 100 mg·m-2at the first day of the chemotherapy for 2 h,intravenous drip 5- fluoro-2,4- pyrimidinedione（ 5- Fu） 400 mg·m-2on first and second day of the chemotherapy for 2 h,with capecitabine 1000 mg by oral administration,Java brucea fruit oil emulsion 30 m L,Kang’ai injection 60 m L and leucovorin calcium 300 mg by intravenous injection.Treatment group was added Yiqi Jianpi soup on the basis of control groupfrom 1 week before chemotherapy to 1 week after chemotherapy,150 m L each time,2 times a day,14 d a course,and the treatment continued for 3 courses. Traditional Chinese medicine（ TCM） syndrome effect,adverse drug reactions,SF- 36 score and survival rates in different period of the two groups were compared. Results Total rates of TCM syndrome effect in control group and treatment group were respectively 66. 67%（ 22 /33） and 80. 00%（ 28 /35,P 〈 0. 05）. The SF- 36 score at 6 months after treatment in treatment group was 67. 21 ± 7. 21,had significant difference with 45. 46 ± 5. 22 in control group（ P 〈 0. 05）. The survival rates of 1 year and 3 years after treatment in treatment group were respectively 88. 57%（ 31 /35） and 51. 43%（ 18 /35）,had significant difference with 75. 76%（ 25 /33） and 39. 39%（ 13 /33） in control group（ P 〈 0. 05）. The incidence of bone marrow suppression,gastrointestinal reactions,leukocyte decrease,platelet decrease and liver function abnormalities in treatment group were significantly lower than those in control group（ P 〈 0. 05）. Conclusion FOLFOX4 regimen combined with Yiqi Jianpi soup on patients with AC after the treatment of laparoscopic surgery had a significant effect and significantly improved the quality of life of patients with less adverse reactions.