消积饮治疗晚期非小细胞肺癌对循环血管内皮细胞影响的临床观察

Xiaojiyin for Advanced Non-Small-Cell Lung Cancer(NSCLC) and Its Influence on CECs Expression

目的:观察中药消积饮治疗晚期非小细胞肺癌的循环血管内皮细胞(CECs)数量变化与CEA、CYFRA 21-1、NSE、客观应答率(ORR)、无进展生存期(PFS)的关系,旨在探讨CECs作为评价消积饮治疗晚期NSCLC的抗血管生成作用的临床应用价值。方法:50例晚期NSCLC患者,随机分为试验组和治疗组,试验组25例,对照组25例。试验组给予消积饮联合TP方案化疗治疗,对照组给予单纯TP方案化疗治疗,首要观察指标两组CECs的表型(CD_(146)^+)的数量变化,次要观察指标包括CD_(146)^+与CEA、CYFRA 21-1、NSE数值变化关系、CD_(146)^+与客观应答率(RECIST标准)关系、CD_(146)^+与无进展生存期关系及毒副反应。结果:全部50例随机患者参与评价。首要观察指标CD_(146)^+值治疗后试验组(0.76±0.35)明显低于对照组(1.93±2.39),具统计学差异(P<0.05)。次要观察指标,CD_(146)^+与CEA、NSE呈线性正相关,相关系数为0.99、0.34(P<0.05);CD_(146)^+与CYFRA21-1未见明显相关性;CD_(146)^+与ORR无明确相关性;CD_(146)^+与PFS是负性相关,PFS的偏相关系数分别为-1.16(P<0.05)。两组均无严重不良反应及毒副反应。结论:CD_(146)^+可作为新的一种评价中药抗肺癌肿瘤血管生成作用、指导临床用药的手段。

Objective： This clinical study observed Xiaojiyin in treatment for advanced NSCLC and its influence on the CECs expression and its numerical change with the CEA,CYFRA21- 1,NSE,objective response rate（ ORR） and progression- free survival（ PFS） to investigate the clinical practice value of anti- angiogenic effect in CECs with Xiaojiyin treatment for advanced NSCLC. Methods： Fifty patients of advanced NSCLC were randomized,25 patients in the test group and 25 patients in the control group. The test group received Xiaojiyin combined with TP chemotherapy. The control group received single TP chemotherapy. The primary endpoints were the changes of phenotypic CECs（ CD146＋）. Secondary endpoints included the numerical changes of CD146＋with the CEA,CYFRA21- 1,NSE,objective response rate（ ORR） and progression- free survival（ PFS）. Results： All 50 patients were evaluated. After treatment,the number of CD146＋in the test group was significantly lower than that in the control group（ P 〈 0. 05）. The numerical change of CD146＋with the CEA and NSE was linear positive correlation and their coefficients were 0. 99 and 0. 34（ P 〈 0. 05）. The numerical change of CD146＋with CYFRA21- 1 and ORR had no correlation. The numerical change of CD146＋with PFS had negative correlation and its coefficient was- 1. 16（ P 〈 0. 05）. NO serious adverse reactions and toxicities were observed. Conclusion： CECs may be used for assessment of anti- angiogenic effect of Chinese medicine treatment for advanced NSCLC.