Evaluation of efficacy of compound Kushen injection as an adjuvant for chemotherapy in treatment of advanced digestive tract cancer / 中国中西医结合急救杂志

ABSTRACT

Objective To evaluate the efficacy and safety of compound Kushen injection as an adjuvant for chemotherapy in treatment of advanced digestive tract cancer. Methods A prospective, randomized, parallel controlled, single center clinical trial was conducted. One hundred and forty-four patients with advanced gastrointestinal cancer admitted to the Department of Oncology of Fangta Traditional Chinese Medicine (TCM) Hospital of Songjiang District in Shanghai from July 2014 to December 2016 were enrolled, and they were divided into a control group and an observation group, 72 cases in each group. The patients in control group received routine chemotherapy, and on the basis of routine chemotherapy, the patients in the observation group was given compound Kushen injection 20 mL having diluted with 250 mL sodium chloride for intravenous drip, once a day for 14 days constituting 1 therapeutic course. After consecutive 2 therapeutic courses, the clinical efficacy was observed, the differences in disease control rate (DCR), Karnofsky score (KPS), TCM syndrome curative effect and adverse reactions were compared between the two groups, follow-up was carried out for 7-24 months, survival rate and progression free survival (PFS) time was observed in the two groups. Results After treatment, the DCR, KPS score, total effective rate of TCM syndrome in the observation group were significantly higher than those of control group [DCR 59.7% (43/72) vs. 43.1% (31/72), KPS score 70.9±6.2 vs. 64.8±4.8, total curative effect of TCM syndrome 63.89% (46/72) vs. 41.67% (30/72), all P < 0.05], and the adverse effect rate was significantly lower than that of control group [25.0% (18/72) vs. 41.7% (30/72), P < 0.05]. In the end of follow-up, there were 12 survival cases in the control group, and 22 survival cases in observation group, and survival rate and the PFS time in observation group were significantly longer than those in the control group [survival rate 30.6% vs. 16.7%; PFS time (months) 15.3±4.0 vs. 13.2±4.2, P < 0.05]. Conclusions The therapeutic effect of using Kushen injection as an adjuvant for chemotherapy in treatment of patients with advanced digestive tract cancer is relatively good, can improve the life quality of patients, and lower the incidence of adverse reactions.