仙蟾片联合GP化疗方案治疗老年中晚期非小细胞肺癌的临床研究

Clinical study on Xianchan Tablets combined with GP chemotherapy in treatment of elderly advanced non-small cell lung cancer

目的观察仙蟾片联合GP化疗方案治疗老年中晚期非小细胞肺癌的临床疗效。方法选取延安大学附属医院2014年5月—2016年5月收治的老年中晚期NSCLC患者114例,随机分为对照组和治疗组,每组各57例。对照组患者在第1、8天静脉注射注射用盐酸吉西他滨,1 g/(m^2·d);同时于第1~5天静脉注射顺铂氯化钠注射液,20 mg/(m^2·d)。治疗组在对照组的基础上口服仙蟾片,4片/次,3次/d。两组患者连续治疗4个疗程,每个疗程21 d。评价两组患者临床疗效,同时比较治疗前后两组患者免疫功能指标、血清神经特异性烯醇化酶(NSE)、癌胚抗原(CEA)、细胞角蛋白19片段(CYFRA21-1)和鳞状上皮细胞癌抗原(SCC)水平以及不良反应情况。结果治疗后,对照组的客观缓解率(ORR)和临床获益率(CBR)分别为61.40%、82.46%,治疗组的ORR和CBR分别为77.19%、85.96%,两组ORR比较差异具有统计学意义(P<0.05)。治疗后,对照组Ig G、Ig A、CD^(3+)、CD^(4+)和CD^(8+)等免疫功能指标显著降低,而治疗组上述免疫功能指标水平则明显增高,且均明显高于对照组,两组比较差异具有统计学意义(P<0.05)。治疗后,两组患者血清NSE、CEA、CYFRA21-1和SCC水平均明显降低(P<0.05);且治疗组的水平明显低于对照组(P<0.05)。治疗组不良反应发生率均明显低于对照组,两组比较差异具有统计学意义(P<0.05)。结论仙蟾片联合GP化疗方案可有效提高老年中晚期非小细胞肺癌患者免疫功能,具有一定的临床推广应用价值。

Objective To study the clinical efficacy of Xianchan Tablets combined with GP chemotherapy in treatment of elderly advanced non-small cell lung cancer. Methods Patients （114 cases） with advanced non-small cell lung cancer in Yan＆#39;an University Affiliated Hospital from May 2014 to May 2016 were randomly divided into control and treatment groups, and each group had 57 cases. Patients in the control group were iv administered with Gemcitabine Hydrochloride Injection at first and eighth day, 1 g/（m2＆#183;d）. And at the same time, they were iv administered with Cisplation and Sodium Chloride Injection from the first to the fifth day, 20 mg/（m2＆#183;d）.Patients in the treatment group were po administered with Xianchan Tablets on the basis of the control group,4 tablets/time, three times daily. Patients in two groups were treated for 4 courses of treatment, and each course was 21 d. After treatment, the clinical efficacy was evaluated, and the immune function indexes, serum NSE, CEA, CYFRA21-1, and SCC levels, and adverse actions in two groups before and after treatment were compared. Results After treatment, the ORR and CBR in the control group were 61.40% and 82.46%, the ORR and CBR in the treatment group were 77.19% and 85.96%, and there were differences in ORR between two groups （P 〈 0.05）. After treatment, the IgG, IgA, CD3＋, CD4＋, and CD8＋level in the control group was significantly decreased, and the levels of immune function indexes in the treatment group were obviously increased and higher than those in the control group, with significant difference between two groups （P 〈 0.05）. After treatment, the serum NSE, CEA, CYFRA21-1, and SCC level in two groups was significantly decreased （P 〈 0.05）. And the serum level in the treatment group was obviously lower than that the control group （P 〈 0.05）. The incidence of adverse reactions in the treatment group was significantly lower than that in the control group, with significant difference between two groups （P 〈 0.05）. Conclusion Xianchan Tablets combined with GP chemotherapy can promote the immune function in treatment of advanced non-small cell lung cancer in elderly, which has a certain clinical application value.