复方苦参注射液联合吉西他滨治疗老年晚期非小细胞肺癌的临床观察

目的：探讨复方苦参注射液在老年晚期非小细胞肺癌化疗中的作用。方法：经病理学或细胞学检查确诊的Ⅲ、Ⅳ期老年晚期NSCLC,随机分为试验组和对照组。试验组53例,采用复方苦参注射液联合吉西他滨方案化疗;对照组56例,单纯采用吉西他滨方案化疗。两组均设定每28d为1个周期,化疗4个周期。每2个周期评价疗效,监测治疗前后患者血常规、T细胞亚群及血清免疫球蛋白（Ig）含量变化。结果：试验组和对照组的有效率分别为37.7%和33.9%（P〉0.05）,疾病进展（PD）率分别为11.3%和21.4%（P〈0.05）。试验组胃肠道反应和骨髓抑制较对照组减轻,差异有统计学意义（P〈0.05）。试验组治疗前后CD8＋分别为（25.21±4.28）%和（16.51±3.92）%,CD4＋/CD8＋分别为1.56±0.21和2.01±0.11;而对照组治疗前后分别为（32.11±4.16）%和（34.98±4.92）%,CD4＋/CD8＋分别为1.08±0.12和1.09±0.98,两组比较,差异有统计学意义（P〈0.05,P〈0.01）。且试验组化疗后KPS评分明显高于对照组（P〈0.01）。化疗后试验组血清IgM含量为（1.42±0.28）g·L^-1,IgG含量为（17.98±4.56）g·L^-1,与对照组差异有统计学意义（P〈0.05）。结论：复方苦参注射液联合吉西他滨方案治疗老年晚期非小细胞肺癌疗效较好,患者不良反应轻,具有提高机体免疫功能和改善患者生活质量的作用。

Composite Kusheng Injection plus Gemcitabine for Advanced Elderly Nonsmall Cell Lung Cancer

OBJECTIVE：To investigate the clinical efficacy of Composite Kusheng Injection for advanced nonsmall cell lung cancer（NSCLC） in elderly patients.METHODS：The elderly patients with advanced NSCLC（stage Ⅲ or Ⅳ） confirmed pathologicallly or cytologically were randomly assigned to receive either gemcitabine alone（control group,n = 56） or gemcitabine in combination with Composite Kusheng Injection（treatment group,n = 53） for 4 cycles（one cycle = 28 days）.The curative efficacy was evaluated after treatment for every 2 cycles to monitor blood routine,T cell subsets and serum immunoglobulin（Ig） content.RESULTS：The effective rate in the experimental group was 37.7% as compared with 33.9% in the control group（P 〉 0.05） with the disease progression（PD） rates of 11.3% and 21.4%,respectively（P 〈 0.05）.The gastrointestinal reaction and bone marrow suppression in the experimental group were milder than in the control group,showing statistical differences between the two groups（P 〈 0.05）.In the treatment group before and after treatment,CD 8^＋ were（25.21 ± 4.28）% and（16.51 ± 3.92）%,respectively and the ratios of CD 4^＋ /CD 8^＋ were 1.56 ± 0.21 and 2.01 ± 0.11,respectively;and in the control group,the CD 8＋ stood at（32.11 ± 4.16）% and（34.98 ± 4.92）%,respectively and the ratios of CD 4^＋ /CD 8^＋ stood at 1.08 ± 0.12 and 1.09 ± 0.98,respectively,and the differences between the two groups were significant（P 〈 0.05,P 〈 0.01）.And after chemotherapy,KPS scores were significantly higher in the treatment group than in the control group（P 〈 0.01）.In the treatment group after undergoing chemotherapy,serum IgM content was（1.42 ± 0.28） g· L^-1 and serum IgG content was（17.98 ± 4.56） g·L^-1,showing significant differences as compared with the control group（P 〈 0.05）.CONCLUSION：Composite Kusheng Injection combined with Gemcitabine is effective and safe in the treatment patients with advanced NSCLC,and it improves patients＇immune function as well as their quality of life.