自拟固金消积合剂联合温针灸对晚期非小细胞肺癌气阴两虚证患者临床疗效及免疫功能的影响  

Effects of Gujin Xiaoji Mixture combined with warming needle therapy on the clinical efficacy and immune function of patients with qi and yin deficiency syndrome of advanced non-small cell lung cancer

作　　者：何爽 臧建华 龙麟 赵丽丽 田金 管程程 肖军 He Shuang;Zang Jianhua;Long Lin;Zhao Lili;Tian Jin;Guan Chengcheng;Xiao Jun(Master Degree Student of Grade 2021,the First Clinical Medical College of Shandong University of Traditional Chinese Medicine,Jinan 250014,China;Oncology Centre,Qingdao Hiser Hospital Affiliated of Qingdao University(Qingdao Traditional Chinese Medicine Hospital),Qingdao 266033,China)

机构地区：[1]山东中医药大学第一临床医学院,济南250014 [2]青岛大学附属青岛市海慈医院(青岛市中医医院)肿瘤中心,青岛266033

出　　处：《国际中医中药杂志》2024年第11期1426-1432,共7页International Journal of Traditional Chinese Medicine

基　　金：山东省中医药科技重点项目(2020Z31);山东省中医药科技青年项目(2020Q75);青岛市医药卫生科研计划项目(2021-WJZD034)。

摘　　要：目的探讨自拟固金消积合剂联合温针灸对晚期非小细胞肺癌(NSCLC)气阴两虚证患者临床疗效及免疫功能的影响。方法随机对照试验研究。选择2021年3月-2022年8月青岛市中医医院肿瘤中心180例晚期NSCLC气阴两虚证患者作为观察对象,采用随机数字表法分为2组,每组90例。对照组给予常规化疗联合信迪利单抗注射液治疗,21 d为1个周期,共治疗4个周期。观察组在对照组基础上加用固金消积合剂联合温针灸治疗,7 d为1个疗程,共治疗12个疗程。2组均随访12个月。分别于治疗前后进行中医证候评分,采用肺癌患者生活质量测定量表(FACT-L)评估生活质量;采用流式细胞仪检测CD3^(+)、CD4^(+)、CD8^(+)、NK细胞水平,计算CD4^(+)/CD8^(+)比值;观察记录治疗期间的药物不良反应及患者无进展生存期,评价中医证候疗效与实体瘤客观疗效。结果观察组治疗后中医证候积分[(5.67±1.99)分比(7.12±2.31)分,t=-4.53]低于对照组(P<0.001);活动能力[(23.03±2.80)分比(20.69±2.46)分,t=5.96]、日常生活[(23.06±2.56)分比(20.71±2.33)分,t=6.42]、情感状况[(18.44±2.32)分比(16.12±2.71)分,t=6.18]、其他因素[(33.14±4.11)分比(27.39±4.64)分,t=8.81]评分及总分[(97.68±7.23)分比(84.91±7.49)分,t=11.64]高于对照组(P<0.01)。观察组治疗后CD3^(+)[(65.14±6.06)%比(59.84±5.74)%,t=6.02]、CD4^(+)[(40.09±4.09)%比(35.69±3.86)%,t=7.43]、NK细胞[(29.11±4.81)%比(22.38±4.51)%,t=9.68]水平及CD4^(+)/CD8^(+)[(1.52±0.27)比(1.14±0.12),t=12.63]比值高于对照组(P<0.01),CD8^(+)[(26.82±3.79)%比(31.76±4.65)%,t=-7.81]水平低于对照组(P<0.01)。观察组治疗后客观缓解率为7.8%(7/90)、疾病控制率为87.8%(79/90),对照组治疗后客观缓解率为5.5%(5/90)、疾病控制率为82.2%(74/90),2组客观缓解率与疾病控制率比较,差异无统计学意义(χ^(2)值分别为0.09、0.70,P值分别为0.765、0.407)。观察组治疗后总有效率为62.2%(56/90)、对照组34.4%(3Objective To investigate the effects of self-made Gujin Xiaoji Mixture combined with warming needle therapy on the clinical efficacy and immune function of patients with advanced non-small cell lung cancer(NSCLC)with qi and yin deficiency syndrome.Methods This experiment was a randomized controlled trial study.180 patients with advanced NSCLC qi and yin deficiency syndrome in the oncology centre of Qingdao Hospital of Traditional Chinese Medicine were selected as the observation subjects from March 2021 to August 2022,and were divided into 2 groups using the random number table method,with 90 cases in each group.The control group received conventional chemotherapy combined with Sintilimab injection,21 days as a cycle,with a total of 4 cycles of treatment;and the observation group received Gujin Xiaoji Mixture combined with warming needle therapy based on the control group,7 days as one course of treatment,with a total of 12 courses.Both groups were followed up for 12 months.The TCM syndrome scores were performed before and after treatment.The functional assessment of cancer therapy-lung(FACT-L)was used to evaluate the quality of life of patients;flow cytometry was used to detect the levels of CD3^(+),CD4^(+),CD8^(+)and NK cell,and the CD4^(+)/CD8^(+)ratio was calculated;adverse drug reactions and progression free survival of patients during treatment were observed and recorded,the efficacy of TCM syndrome and objective efficacy of solid tumors were evaluated.Results After treatment,the observation group's post-treatment TCM syndrome score(5.67±1.99 vs.7.12±2.31,t=-4.53)was lower than that of the control group(P<0.001);mobility(23.03±2.80 vs.20.69±2.46,t=5.96),daily living(23.06±2.56 vs.20.71±2.33,t=6.42),emotional status(18.44±2.32 vs.16.12±2.71,t=6.18),and other factors(33.14±4.11 vs.27.39±4.64,t=8.81)and total score(97.68±7.23 vs.84.91±7.49,t=11.64)were higher than those in the control group(P<0.01).In the observation group,after treatment,the levels of CD3^(+)[(65.14±6.06)%vs.(59.84±5.74)%,t=6.02

关 键 词：癌 非小细胞肺 气阴两虚 固金消积合剂 温针疗法 抗肿瘤联合化疗方案 信迪利单抗注射液 中西医结合疗法 免疫力 无进展生存期 

分 类 号：R273[医药卫生—中西医结合]