复方丹参滴丸联合化疗治疗中晚期非小细胞肺癌的临床研究

Clinical Study on Efficacy of Compound Danshen Droplet Pill with Chemotherapy in Treating Advanced Non-small Cell Lung Cancer

目的观察复方丹参滴丸联合化疗治疗中晚期非小细胞肺癌的临床疗效、不良反应及对免疫功能的影响。方法将88例中晚期非小细胞肺癌患者随机分为两组,治疗组(45例)采用复方丹参滴丸加GP方案治疗,对照组(43例)采用单纯GP方案化疗;观察两组临床疗效和治疗后T淋巴细胞亚群的变化情况。结果治疗组和对照组的有效率(CR+PR)分别为46.3%和34.9%(P>0.05),临床获益率(CR+PR+SD)分别为84.4%和62.8%(P<0.05);治疗后治疗组T淋巴细胞亚群中的CD4/CD8比值明显提高(P<0.05),对照组明显降低(P<0.05);治疗组生存质量高于对照组(P<0.05);对照组白细胞减少、血红蛋白下降和恶心呕吐的改善情况高于治疗组(P<0.05)。结论复方丹参滴丸与化疗同时应用治疗非小细胞肺癌,能降低化疗对患者免疫功能的影响及减轻化疗的某些不良反应,提高临床获益率,改善患者生存质量。

Objective To compare the therapeutic effect,side effects and immune functions of life with advanced non-small cell lung cancer（NSCLC） with Compound Danshen Droplet Pill in combination with chemotherapy or only chemotherapy. Methods 88 subjects were randomly divided to receive GP regimen combined with the Pill （group A,45 cases） or only GP regimen（group B,43 cases）. Results The response rate（CR＋PR） was 46.30% in group A, compared to 34.9% in group B（P〉0.05）;the clinical benefit response rate（CR＋PR＋SD） was 84.4% in group A, compared to 62.8% in group B（P〈0.05）; the median survival time was 37 weeks in group A,which was higher than that in group B （30 weeks）,the level of CD4/CD8 was significantly increased in group A（P〈 0.05）,the level of CD4/CD8 was significantly decreased in group B（P〈 0.05）, quality of life in group A was higher than that in group B （P〈0.05）; leucopenia and hemoglobin descended,nausea and vomiting,in group B were more improved than those in group A （P〈 0.05）. Conclusion Chemotherapy with the Pill could enhance the influence on immune functions,decrease side effects of chemotherapy,give a satisfactory clinical benefit response rate,elongate median survival time, and improve life quality of the patients with advanced NSCLC.