复方苦参注射液联合FOLFOX方案治疗结直肠癌的临床研究

Clinical study on Compound Kushen Injection combined with FOLFOX regimen in treatment of colorectal cancer

目的探讨复方苦参注射液联合FOLFOX方案治疗结直肠癌的临床疗效。方法选取2010年3月—2014年2月新乡市中心医院治疗的结直肠癌患者82例,随机分为对照组和治疗组,每组各41例。对照组给予FOLFOX方案:第1天静脉滴注注射用奥沙利铂,100 mg/m2加入到5%葡萄糖溶液250 m L中,滴注2 h;第1天静脉滴注亚叶酸钙注射液,400mg/m2加入到生理盐水250 m L中,滴注2 h;第1天静脉推注氟尿嘧啶注射液400 mg/m2,然后2 400 mg/m^2静脉持续滴注46 h。治疗组在对照组基础上静脉滴注复方苦参注射液,20 m L加入生理盐水中250 m L中,1次/d,连续治疗7 d。两组均以2周为一个疗程,治疗4个疗程。观察两组的临床疗效,比较两组外周血淋巴细胞亚群、不良反应和生存率情况。结果治疗后,对照组和治疗组的缓解率分别为39.02%、51.22%,疾病控制率分别为73.17%、87.80%,两组比较差异有统计学意义(P<0.05)。治疗后,对照组外周血CD^(3+)、CD^(4+)、CD^(16+)/CD^(56+)和CD^(4+)/CD^(8+)均显著下降,CD^(8+)显著升高;治疗组外周血CD^(3+)、CD^(4+)、CD^(16+)/CD^(56+)和CD^(4+)/CD^(8+)均显著升高,CD^(8+)显著下降,两组比较差异具有统计学意义(P<0.05)。对照组和治疗组的骨髓抑制率分别为56.10%、39.02%,胃肠道反应发生率为58.54%、34.15%,两组比较差异有统计学意义(P<0.05)。随访1、2、3年,对照组生存率分别为85.37%、68.29%、56.10%,治疗组生存率分别为92.68%、80.49%、70.73%,两组生存率比较差异具有统计学意义(P<0.05)。结论复方苦参注射液联合FOLFOX方案治疗结直肠癌具有较好的临床疗效,可提高患者免疫功能,减少不良反应,延长生存期,具有一定的临床推广应用价值。

Objective To investigate the clinical effect of Compound Kushen Injection combined with FOLFOX regimen in treatment of colorectal cancer. Methods Patients （82 cases） with colorectal cancer in Xinxiang Central Hospital from March 2010 to February 2014 were randomly divided into control and treatment groups, and each group had 41 cases. Patients in the control group were given FOLFOX regimen. Patients in the control group were iv administered with Oxaliplatin for injection on day 1, 100 mg/m2 added into 5% glucose solution （250 mL）, infusion of 2 h. The patients in control group were iv administered with Calcium Folinate Injection at the first day, 400 mg/m^2 added into normal saline 250 mL, infusion of 2 h. And patients in the control group were iv injected with Fluorouracil Injection 400 mg/m2 at the first day, then 2 400 mg/m^2 continuous iv infusion of 46 h. Patients in the treatment group were iv administered with Compound Kushen Injection on the basis of the control group, 20 mL added into normal saline 250 mL, once daily, treatment of 7 d. A course of treatment was 2 weeks, and patients in two groups were treated for 4 courses. After treatment, the clinical efficacies were evaluated, and lymphocyte subsets in peripheral blood, adverse reactions, and survival rate in two groups were compared. Results After treatment, the remission rate in the control and treatment groups were 39.02% and 51.22%, respectively, and the disease control rate in the control and treatment groups were 73.17% and 87.80%, respectively, and there was difference between two groups （P 〈 0.05）. After treatment, CD^3＋, CD^4＋, CD^16＋/CD^56＋, and CD^4＋/CD^8＋ in the control group were significantly decreased, but the CD^8＋ in the control group was significantly increased, and CD^3＋, CD^4＋, CD^16＋/CD^56＋, and CD^4＋/CD^8＋ in the treatment group were significantly increased, but the CD^8＋ in the treatment group was significantly decreased, and there was difference between two groups （P 〈 0.05）. The bone marrow inhibitory rates in the control and treatment groups were 56.10% and 39.02%, respectively, the gastrointestinal reaction rates in the control and treatment groups were 58.54% and 34.15%, respectively, and there was difference between two groups （P 〈 0.05）. Followed up for 1, 2, and 3 years, the survival rates in the control group were 85.37%, 68.29%, and 56.10%, respectively, the survival rates in the treatment group were 92.68%, 80.49% and 70.73%, respectively, and there was difference between two groups （P 〈 0.05）. Conclusion Compound Kushen Injection combined with FOLFOX regimen has clinical curative effect in treatment of colorectal cancer, and can improve immune function, reduce adverse reactions, and prolong survival times, which has a certain clinical application value.