癌康宁合剂对晚期非小细胞肺癌化疗后患者维持治疗的临床评价

目的:评价晚期非小细胞肺癌(NSCLC)化疗后,患者以癌康宁合剂维持治疗对无进展生存期(PFS),生活质量和免疫功能的影响。方法:将115例化疗后获得稳定的NSCLC患者,随机分为对照组58例和观察组57例。对照组口服参一胶囊,2粒/次,2次/d。观察组口服癌康宁合剂,30 m L/次,3次/d。两组疗程均为每1~2周随访1次,持续给药,直至肿瘤进展。记录两组患者维持治疗周期;每4周行CT检查,评价肿瘤大小变化,并记录PFS从入组至患者死亡或病变进展(PD)的时间];每4周进行Karnofsky功能状态评分(KPS);进行中医证候评价;检测治疗前后T淋巴细胞亚群(CD3~+,CD4~+,CD8~+,CD4~+/CD8~+)和自然杀伤细胞(NK)水平;检测血管内皮生长因子(VEGF),癌胚抗原(CEA),糖抗原125(CA125),细胞角蛋白19片段21-1(CYFRA21-1)等水平。结果:对照组平均维持治疗(15.75±4.81)周,短于观察组的(20.23±5.94)周(P0.01);对照组PFS为(25.37±7.43)周,短于观察组的(37.41±9.15)周,观察组的中位PFS较对照组延长了约12周;在12和16周时,观察组实体瘤疗效,KPS疗效均优于对照组(P0.05,P0.01);观察组除神疲乏力、气短外,其他各症状评分均低于对照组(P0.01);治疗后观察组CD4~+,CD4~+/CD8~+均高于对照组,CD8~+低于对照组(P0.05);治疗后两组患者的血清VEGF,CEA,CA125,CYFRA21-1水平均升高(P0.01),但观察组患者血清VEGF,CEA,CA125,CYFRA21-1水平均低于对照组(P0.01)。结论:采用癌康宁合剂用于化疗后NSCLC患者的维持治疗,可延长无进展生存期,稳定病情,减轻临床症状,提高患者的生活质量和机体免疫功能,并可抑制血清VEGF,CEA,CA125,CYFRA21-1等肿瘤标志物的表达。

Clinical Effect of Aikangning Mixture to Patients with Maintenance Therapy After Chemotherapy for Advanced Non-small Cell Lung Cancer

Objective: To observe the effect of maintenance therapy of Aikangning mixture on progression free survival (FFS), quality of life and immunity of patients after chemotherapy for non-small cell lung cancer (NSCLC). Method: One hundred and fifteen NSCLC patients at a stable period after chemotherapy were randomly divided into control group (58 cases) and observation group (57 cases) by random number table. Patients in control group got Shenyi capsules, 2 grains/time, 2 times/days. Patients in observation group got Aikangning mixture, 30 mL/time, 3 times/days. The course of follow-up was once every 1-2 weeks, and the treatment was continued to the tumor progression. Cycle of maintaining the treatment was recorded. CT detection every 4 weeks to evaluate the size of tumor, and PFS (time from patients joining to the team to death or progression of disease) was recorded in both groups; karnofsky performance scale (KPS) was scored every 4 weeks. Traditional Chinese medicine (TCM) syndromes were graded for every 4 weeks. Levels of T lymphocyte subgroup (CD3⁺, CD4⁺, CD8⁺ and CD4⁺/CD8⁺), natural killer cells (NK), vascular endothelial growth factor (VEGF), carcinoembryonic antigen (CEA), sugar antigen 125 (CA125), and cytokeratin19 fragment21-1 (CYFRA21-1) were detected before and after treatment. Result: The average maintenance therapy in observation group was (20.23±5.94) weeks, longer than (15.75±4.81) weeks in control group (P<0.01). PFS was (25.37±7.43) weeks in control group, shorter than (37.41±9.15) weeks in observation group. The median PFS in observation group was 12 weeks later than control group. At 12^th and 16^th weeks, the effects for solid tumor and KPS in observation group were superior to those in control group (P<0.05,P<0.01). Except for scores of nerve fatigue, weakness and shortness of breath, the other scores of observation group were all lower than those in control group (P<0.01). After treatment, the levels of CD4⁺ and CD4⁺/CD8⁺ in observation group were higher than those in control group, and CD8⁺ was lower than that in control group (P<0.05). Levels of VEGF, CEA, CA125 and CYFRA21-1 in serum were increased in both groups (P<0.01), but levels of VEGF, CEA, CA125 and CYFRA21-1 in observation group were lower than those in control group after treatment (P<0.01). Conclusion: Aikangning mixture for patients with non-small cell lung cancer after chemotherapy can extend progression free survival, stabilize the illness, relieve clinical symptoms and improve patients'' quality of life and immune function of body, and can also inhibit expression of VEGF, CEA, CA125 and CYFRA21-1 in serum.