复方苦参注射液辅助化疗对晚期消化道恶性肿瘤的疗效评价

摘要

目的 评价复方苦参注射液辅助化疗对晚期消化道恶性肿瘤的有效性和安全性.方法 采用前瞻性、随机、平行对照、单中心临床试验.选择2014年7月至2016年12月在上海市松江区方塔中医医院肿瘤科行化疗的晚期消化道恶性肿瘤患者144例.将患者按随机数字表法分为对照组和观察组,每组72例.对照组进行常规化疗;观察组在常规化疗基础上用250 mL氯化钠注射液稀释复方苦参注射液20 mL后静脉滴注(静滴),每日1次,14 d为1个周期.连续治疗2个周期后观察临床疗效,比较两组疾病控制率(DCR)、卡洛夫斯基行为表现量表(KPS)评分、中医证候疗效和不良反应发生情况的差异,并随访7~24个月,观察两组存活率和无进展生存期(PFS)的变化.结果 观察组治疗后DCR、KPS评分、中医证候总有效率均明显高于对照组〔DCR:59.7%(43/72)比43.1%(31/72),KPS评分(分):70.9±6.2比64.8±4.8,中医证候总有效率:63.89%(46/72)比41.67%(30/72),均P<0.05〕,不良反应发生率明显低于对照组〔25.0%(18/72)比41.7%(30/72),P<0.05〕.至随访结束,对照组存活12例,观察组存活22例,观察组存活率和PFS较对照组明显延长〔存活率:30.6%比16.7%;PFS(月):15.3±4.0比13.2±4.2,P<0.05〕.结论 复方苦参注射液辅助化疗治疗晚期恶性消化道肿瘤疗效较好,能改善患者生活质量,降低不良反应发生率.%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.