肿瘤安胶囊辅助治疗气虚痰结夹瘀证非小细胞肺癌的临床研究

Clinical effect of non-small cell lung cancer treated by combined chemotherapy with Zhongliuan Capsule

目的:评价肿瘤安胶囊辅助治疗非小细胞肺癌(气虚痰结夹瘀证)的临床疗效及安全性。方法:随机、平行、双盲单模拟、安慰剂对照的多中心临床研究。432例非小细胞肺癌随机分为试验组(A组)和对照组(B组),所有受试者在化疗基础上服用试验用药如下:A组324例服用肿瘤安胶囊,B组108例服用安慰剂,每次6粒,每日3次,化疗的当天开始服用,连续服药21 d为1周期,共2个周期。观察两组化疗通过率、化疗减毒作用、中医证候、体重变化、实体瘤疗效、安全性指标及不良事件的观察。结果:与B组比较,A组治疗第1周期、第2周期后化疗毒副反应分度积分均明显低于B组(P<0.05或P<0.001),且A组治疗第2周期积分低于自身治疗第1周期(P<0.01);A组在改善中医症候、改善患者行为状况、保持体重稳定性方面疗效显著优于B组(P<0.05或P<0.001)。A组在化疗通过率、实体瘤疗效方面与B组比较差异无统计学意义(P>0.05)。试验期间未发现明显的毒副反应。结论:肿瘤安胶囊辅助治疗非小细胞肺癌-气虚痰结夹瘀证,可减轻化疗毒副反应,改善临床症状,提高患者生存质量,无毒副作用,是理想的癌症辅助治疗药物。

AIM： To observe the clinical efficiency and side effects of non-small cell lung cancer treated by combined Zhongliuan Capsule and chemotherapy. METHODS： Randomism, double-blindness and comparison has been adopted during the test. Four hundred and thirty two lung cancer patients were randomly divided into two groups, the treatment group （Group A, 324 patients） and the control group （Group B, 108 patients）. Patients in group A were treated with combined chemotherapy with Zhongliuan Capsule. Patients in group B were treated with combined chemotherapy with placebo. Zhongliuan Capsules or placebos were given 6 pills, three times a day, 21 days as one cycle. After 2 cycles of treatment, chemotherapy passed rate, toxicity, living quality, body weight, symptoms of TCM, the size of tumor, side effects, were analysed. RESULTS ： The incidence rate of adverse reactions of group A was lower than that of the group B after 1 or 2 cycles of treatment （P 〈0.05 or P 〈 0.001 ） . The incidence rate of adverse reactions of group A after 2 cycles of treatment was lower than that of 1 cycles treatment, but group B was higher（ P 〈 0.01 ）. The effective rate of the living quality , clinical symptoms, symptoms of TCM and body weight of group A were higher than those of group B （ P 〈 0.05 或 P 〈 0. 001 ）. However, there was no significant difference between two groups of the chemotherapy passed rate, the size of tumor, vital signs, electrocardiogram, blood routine test, urine routine test, stool routine test, liver function test, renal routine test, bleeding and coagulation function （P 〉 0.05 ）. All adverse events of two groups were not related to the drugs. CONCLUSION ： It is safe and effective to treat non-small cell lung cancer with QI-deficiency mingled with sputum and blood coagulation symptom combined chemotherapy with Zhongliuan Capsule.