岩舒注射液治疗晚期非小细胞肺癌的临床研究

目的观察和探讨岩舒注射液(复方苦参注射液)联合以顺铂为主的化疗方案治疗晚期非小细胞肺癌(NSCLC)的疗效。方法将182例晚期(Ⅲa、Ⅲb、Ⅳ期)非小细胞肺癌患者随机分为两组,均按TP、NP、GP方案进行化疗,治疗组(n=92)在对照组治疗基础上加用岩舒注射液20 ml/d,静脉滴注。观察两组治疗前后中位生存期、肿瘤客观疗效、中医症状、生存质量、免疫功能、血清肿瘤标志物及化疗相关不良反应的情况。结果治疗组中位生存期明显延长(P<0.05)。治疗组和对照组的临床受益率(CBR)分别是85.9%和66.7%,两组比较,差异有显著性(P<0.05)。治疗组血浆T淋巴细胞亚群NK、CD3、CD4、CD4/CD8比值较对照组明显升高(P<0.05)。治疗后治疗组CEA、VEGF较对照组明显下降(P<0.05)。治疗组中医症状及生活质量明显优于对照组(P<0.05或P<0.01),且治疗组化疗药物常见不良反应发生率较对照组明显降低(P<0.05)。结论岩舒注射液(复方苦参注射液)治疗晚期非小细胞肺癌(NSCLC)可以延长中位生存期,提高总体临床受益率,增强免疫功能,降低血清肿瘤标志物水平,减少化疗不良反应并提高生活质量。

Clinical study of Yanshu injection on treating advanced non-small cell lung cancer

Objective To observe the efficacy of Yanshu injection（compound matrine injection） combined with cisplatin chemotherapy in the treatment of advanced non-small cell lung cancer（NSCLC）.Methods 182 patients with advanced（Ⅲa,Ⅲb,IV phase） NSCLC were randomly divided into two groups,both groups received TP,NP,GP programs of chemotherapy,the treatment group（n=92） was treated with Yanshu injection 20 ml/days,intravenous drip in addition.The median survival time,tumor objective response,clinical symptoms,quality of life,immune function,serum tumor markers and chemotherapy-related adverse reactions were observed before and after the treatment.Results The median survival time of the treatment group was significantly prolonged（P0.05）.The clinical benefit rates（CBR） of treatment group and control group were 85.9% and 66.7% respectively,with significant difference between the two groups（P0.05）.The subsets of plasma T lymphocyte NK,CD3,CD4,CD4/CD8 ratio of treatment group were significantly higher than those of the control group（P0.05）.After treatment,CEA,VEGF of treatment group significantly decreased compared with the control group（P0.05）.The clinical symptoms and quality of life of the treatment group were better than those of the control group（P0.05 or P0.01）,and the rates of common chemotherapy-related adverse reaction in the treatment group were markedly lower than those in the control group（P0.05）.Conclusion Yanshu injection（compound matrine injection） for the treatment of advanced NSCLC can prolong median survival time,improve the overall CBR,enhance immune function,reduce the level of serum tumor markers,reduce chemotherapy-related adverse reaction and improve quality of life.