复方苦参注射液联合索拉非尼和白细胞介素-2治疗晚期肾癌的临床研究

Clinical study on Compound Kushen Injection combined with sorafenib and interleukin-2 in treatment of advanced kidney cancer

目的探讨复方苦参注射液联合索拉菲尼和白细胞介素-2治疗晚期肾癌的临床疗效。方法选择2013年7月—2015年3月在中国医科大学附属盛京医院接受治疗的晚期肾癌患者86例,按照治疗方法不同分为对照组和治疗组,每组各43例。对照组于饭后2 h口服甲苯磺酸索拉非尼片,400 mg/次,2次/d。注射用重组人白细胞介素-2以3×105 U/m2加入0.9%生理盐水500 m L中经PICC管滴注,静滴2~3 h,1次/d,每周连用4 d,连用4周为1个疗程。治疗组在对照组治疗基础上经PICC管滴注复方苦参注射液,20 m L加入到0.9%生理盐水250 m L中,1次/d,1个疗程连用14 d。4周为一个疗程,两组均连续治疗3个疗程。观察两组的临床疗效和生活质量改善情况,同时比较两组患者治疗前后免疫功能的变化情况。结果治疗后,对照组有效率为20.93%,临床获益率为65.12%;治疗组有效率为41.86%,临床获益率为83.72%,两组有效率、临床获益率比较差异有统计学意义(P<0.05)。对照组和治疗组生活质量改善率分别为67.44%、86.05%,两组比较差异有统计学意义(P<0.05)。治疗后,两组CD^(3+)、CD^(4+)、CD(4+)/CD^(8+)较治疗前均有不同程度增高,CD^(8+)水平降低,同组治疗前后差异有统计学意义(P<0.05);治疗后,治疗组这些观察指标的改善程度优于对照组,两组比较差异有统计学意义(P<0.05)。结论复方苦参注射液联合索拉非尼和白细胞介素-2治疗晚期肾癌疗效较好,可改善患者的生活质量和免疫功能,具有一定的临床推广应用价值。

Objective To explore the clinical effect of Compound Kushen Injection combined with sorafenib and interleukin-2 in treatment of advanced kidney cancer. Methods Patients（86 cases） with advanced kidney cancer in Shengjing Hospital of China Medical University from July 2013 to March 2015 were enrolled in this study. According to the different treatment plan, patients were divided into treatment（43 cases） and control（43 cases） groups. The patients in the control group were po administered with Sorafenib Tosylate Tablets 2 h after meals, 400 mg/time, twice daily. They were also iv administered with Recombinant Human Interleukin-2 for injection by PICC tube during 2-3 h, 3 × 105 U/m2 added into normal saline 500 m L. The patients were treated with Recombinant Human Interleukin-2 for 4 d in one week, and 4 weeks were as one course. The patients in the treatment group were iv administered with Compound Kushen Injection by PICC tube on the basis of control group, 20 m L added into 0.9% normal saline 250 m L, once daily, 14 d in one course. One course of treatment included 4 weeks, and two groups were treated for three courses. The clinical efficacy and improvement of life quality in two groups were evaluated, and the changes of immune function in two groups before and after treatment were compared. Results After treatment, the total effective rate of control group was 20.93%, and the clinical benefit rate was 65.12%, while the total effective rate of treatment group was 41.86%, and the clinical benefit rate was 83.72%, and there were differences between two groups（P〈0.05）. The improvement rate of life quality in the control and treatment groups were 67.44% and 86.05%, respectively, and there were differences between two groups（P〈0.05）. After treatment, CD^（3＋）, CD^（4＋）, and CD^（4＋）/CD^（8＋） cell in two groups were increased, and the level of CD^（8＋ cell was lower, and the difference was statistically significant in the same group（P〈0.05）. After treatment, the observational indexes in the treatment group were significantly better than those in the control group, with significant difference between two groups（P〈0.05）. Conclusion Compound Kushen Injection combined with sorafenib and interleukin-2 has the good clinical effect in treatment of advanced kidney cancer, and can improve the life quality and immune function, which has a certain clinical application value.