复方苦参注射液对晚期肺癌患者近期疗效、 带瘤生存及T 细胞亚群的影响

Effect of compound Kushen injection on short-term efficacy, survival with tumor and T cell subsets of patients with advanced lung cancer

摘要:

目的 观察复方苦参注射液联合化疗对晚期肺癌患者近期疗效、不良反应、带瘤生存及免疫功 能的影响。方法 选取2015 年1 月—2016 年10 月在北京航天总医院肿瘤内科就诊的120 例Ⅲ b ～Ⅳ期肺 癌患者，随机分为对照组和中药治疗组，每组60 例。对照组采用GP 化疗方案，中药治疗组在GP 化疗基础 上同步注射复方苦参注射液。治疗4 个疗程后，评估两组近期疗效、中医症状积分、Karnofsky 评分及不良 反应发生率，并采用流式细胞术检测T 细胞亚群的变化。采用Kaplan-Meier 法绘制生存曲线，并进行Logrank χ2 检验。结果 参照RECIST V 1.0 实体肿瘤疗效评价标准，对照组与中药治疗组患者治疗总有效率比 较，差异无统计学意义（58.33% VS 73.33%）（P >0.05）。中药治疗组患者中医临床症状总缓解率高于对照组 （33.33% VS 61.67%）（P <0.05）。中医治疗组患者Karnofsky 评分较治疗前和对照组逐渐升高，（P <0.05）。中 药治疗组患者3 年总生存率高于对照组（50.0% VS 23.64%）（P <0.05）。中药治疗组患者胃肠道反应（28.33% VS 10.00%）、水肿（30.0% VS 10.00%）和肝肾毒性（13.33% VS 1.67%）发生率低于对照组（P <0.05）。中药 治疗组和对照组患者中位生存时间分别为38.0 个月和26.0 个月（P <0.05）。结论 复方苦参注射液可有效提 高晚期肺癌患者近期疗效和生活质量，改善T 淋巴细胞免疫功能，降低化疗毒副作用，最终延长患者的带瘤 生存期。

Abstract:

Objective To confirm the short-term efficacy, survival with tumor and T cell subsets of advanced lung cancer patients treated with compound Kushen injection. Methods A total of 120 advanced lung cancer patients from January 2015 to October 2016 were collected and divided into control group with GP chemotherapy treatment (n = 60) and TCM group (n = 60) with compound Kushen injection on basis of GP chemotherapy. After 4 chemotherapy cycles, the short-time efficacy on basis of RECIST v1.0, TCM syndrome scores, Karnofsky scores, safety and the T cell subsets were evaluated. Kaplan-Meier curve and Log-rank χ2 test were used to analyzed the overall survival (OS) with tumor. Results According to RECIST V 1.0, there was no significant difference of total efficacy rate between control group and TCM group [58.33% (35/60) VS 73.33% (44/60)] (P > 0.05). According to TCM scores, the overall response rates of patients in TCM group were higher than that of control group [33.33% (20/60) VS 61.67% (37/60)] (P < 0.05). And Karnofsky scores of patients in TCM group were climbed trend (all P < 0.05). The 3-year OS in TCM was higher than that in control group [50.0% (26/52) VS 23.64% (13/55)] (P < 0.05). The incidence rates of adverse gastrointestinal reaction [28.33% (17/60) VS 10.0% (6/60)], oedema [30.0% (18/60) VS 10.0% (6/60)] and liver or renal toxicity [13.33% (8/60) VS 1.67% (1/60)] in TCM group were all lower than those in control group (all P < 0.05). Compared with control group, the differences after and before treatment of CD4+T cell levels [(0.95±1.23) VS (5.52±1.48)], CD4+/CD8+ ratio [(0.10±0.08) VS (0.40±0.17)], CD4+T cell levels [(0.34±1.02) VS (-4.89±1.73)] in TCM group were higher (all P < 0.05). The median OS of control group and TCM group were 26.0 months and 38.0 months (P < 0.05). Conclusion Compound Kushen injection can effectively improve the short-term efficacy and quality of life, ameliorate the immune function of T lymphocytes and reduce the side effects of chemotherapy, in order to prolong the survival with tumor of patients with advanced lung cancer.