肺岩宁颗粒治疗男性精气两亏型中晚期肺鳞癌的临床研究

Clinical study on Feiyanning Granule in treating intermediate and advanced stage lung squamous cell carcinoma of male patients with essence and qi deficiency syndrome

目的 观察肺岩宁颗粒治疗男性精气两亏型中晚期肺鳞癌的临床疗效。方法 将60例男性精气两亏型中晚期肺鳞癌患者随机分为治疗组(30例)和对照组(30例),治疗组服用肺岩宁颗粒,对照组服用肺岩宁颗粒模拟剂,两组疗程均为2个月。观察临床疗效,比较中医证候积分、卡氏(KPS)评分及肿瘤标志物、免疫指标水平的变化情况。结果 (1)治疗组疾病控制率为80.0%,对照组疾病控制率为56.7%,治疗组临床疗效优于对照组(P<0.05)。(2)治疗前后组内比较,治疗组疲乏、咳嗽、咯血、疼痛、失眠评分减少(P<0.05),对照组上述中医证候评分差异无统计学意义(P>0.05);组间治疗后比较,治疗组疲乏、咳嗽、咯血、疼痛、失眠评分少于对照组(P<0.05)。(3)治疗组KPS评分控制情况优于对照组(P<0.05)。(4)治疗前后组内比较,治疗组癌抗原12-5(CA12-5)、细胞角质蛋白19片段抗原21-1(CYFRA21-1)、鳞癌相关抗原(SCC)水平降低(P<0.05),对照组肿瘤标志物水平差异无统计学意义(P>0.05);组间治疗后比较,治疗组CA12-5、CYFRA21-1、SCC水平低于对照组(P<0.05)。(5)治疗前后组内比较,两组各免疫指标差异均无统计学意义(P>0.05);组间治疗后比较,治疗组NK细胞、CD4+水平高于对照组(P<0.05)。结论 肺岩宁颗粒治疗男性精气两亏型中晚期肺鳞癌疗效满意,可有效改善患者临床症状及免疫功能,提高生存质量,降低血清肿瘤标志物水平,抑制肿瘤生长。

Objective To observe the clinical efficacy of Feiyanning Granule in treating the intermediate and advanced stage lung squamous cell carcinoma(LSCC)of male patients with essence and qi deficiency syndrome.Methods Sixty male patients with intermediate and advanced stage LSCC of essence and qi deficiency syndrome were randomly divided into a treatment group(n=30)and a control group(n=30). The treatment group was treated with Feiyanning Granule,while the control group was treated with Feiyanning Granule simulant. The course of treatment of both groups lasted 2 months. We observed the clinical efficacy,and compared the changes of Traditional Chinese Medicine(TCM)syndrome score,Karnofsky Performance Status(KPS)score,serum tumor markers and related immune indexes.Results (1) After treatment,the disease control rate of the treatment group was 80.0% and that of the control group was 56.7%. The clinical efficacy of the treatment group was better than that of the control group(P<0.05).(2)According to the intra-group comparison before and after treatment,the scores of fatigue,cough,hemoptysis,pain and insomnia in the treatment group decreased(P<0.05),while there was no significant difference in the above-mentioned TCM syndrome scores in the control group(P>0.05). After treatment,the scores of fatigue,cough,hemoptysis,pain and insomnia in the treatment group were lower than those in the control group(P<0.05).(3)The KPS score of the treatment group was better than that of the control group(P<0.05).(4)The intra-group comparison before and after treatment showed that the levels of cancer antigen12-5(CA12-5),cytokeratin 19 fragment antigen 21-1(CYFRA21-1)and squamous cell cancinoma associated antigen(SCC) in the treatment group decreased(P<0.05);there was no significant difference in the level of tumor markers in the control group(P>0.05);after treatment,the levels of CA125,CYFRA21-1 and SCC in the treatment group were lower than those in the control group(P<0.05).(5)There was no significant difference in the immune indexes between the two groups before and after treatment(P>0.05);After treatment,the levels of CD4and NK cells in the treatment group were higher than those in the control group(P<0.05).Conclusion Feiyanning Granule is effective in the treatment of intermediate and advanced stage lung squamous cell carcinoma of male patients with essence and qi deficiency syndrome,as it can effectively improve the clinical symptoms and immune function,enhance the quality of life,reduce serum levels of tumor markers and inhibit tumor growth.