补肾生血方治疗慢性再生障碍性贫血的临床疗效及对T细胞亚群、T-bet与GATA3表达的影响  

Clinical Effect of Bushen Shengxue Prescription on Chronic Aplastic Anemia and Its Effect on T Cell Subsets and Expression of T-bet and GATA3

作　　者：李芮 丁宇斌 王文儒 蒋佩珍 王金环[3] 徐瑞荣[4] 杨淑莲 王涛[6] 刘奇峰[7] 王海霞[8] 孙岸弢[9] 沈建平[10] 许亚梅[11] 李建英 姚宇红 丁晓庆[14] 史哲新[15] 周永明[16] 胡琦[17] 申小惠[18] 许勇钢[1] 刘风[1] 麻柔[1] 唐旭东[1] LI Rui;DING Yubin;WANG Wenru;JIANG Peizhen;WANG Jinhuan;XU Ruirong;YANG Shulian;WANG Tao;LIU Qifeng;WANG Haixia;SUN Antao;SHEN Jianping;XU Yamei;LI Jianying;YAO Yuhong;DING Xiaoqing;SHI Zhexin;ZHOU Yongming;HU Qi;SHEN Xiaohui;XU Yonggang;LIU Feng;MA Rou;TANG Xudong(Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing 100091,China;Shenzhen Traditional Chinese Medicine(TCM)Hospital,Shenzhen 518005,China;First Affiliated Hospital,Heilongjiang University of Chinese Medicine,Haerbin 150040,China;Affiliated Hospital of Shandong University of TCM,Jinan 250011,China;LangFang TCM Hospital,Langfang 065099,China;The First Affiliated Hospital of Henan University of Chinese Medicine,Zhengzhou 450099,China;Jilin Province People's Hospital,Changchun 130021,China;Affiliated Hospital of Weifang Medical University,Weifang 261035,China;Guang'anmen Hospital,China Academy of Chinese Medical Sciences,Beijing 100053,China;Zhejiang Provincial Hospital of Chinese Medicine,Hangzhou 310003,China;Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing 100007,China;Shijiazhuang Pingan Hospital Co.Ltd.,Shijiazhuang 050025,China;Second Affiliated Hospital of Guizhou University of TCM,Guiyang 550003,China;Dongfang Hospital,Beijing University of Chinese Medicine,Beijing 100078,China;First Teaching Hospital of Tianjin University of TCM,Tianjin 300073,China;Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of TCM,Shanghai 200083,China;Shanghai Municipal Hospital of TCM,Shanghai 200071,China;Gansu Provincial Hospital of TCM,Lanzhou 730050,China)

机构地区：[1]中国中医科学院西苑医院,北京100091 [2]深圳市中医院,广东深圳518005 [3]黑龙江中医药大学附属第一医院,哈尔滨150040 [4]山东中医药大学附属医院,济南250011 [5]廊坊市中医医院,河北廊坊065099 [6]河南中医药大学第一附属医院,郑州450099 [7]吉林省人民医院,长春130021 [8]潍坊医学院附属医院,山东潍坊261035 [9]中国中医科学院广安门医院,北京100053 [10]浙江省中医院,杭州310003 [11]北京中医药大学东直门医院,北京100007 [12]石家庄平安医院,石家庄050025 [13]贵州中医药大学第二附属医院,贵阳550003 [14]北京中医药大学东方医院,北京100078 [15]天津中医药大学第一附属医院,天津300073 [16]上海中医药大学附属岳阳医院,上海200083 [17]上海市中医医院,上海200071 [18]甘肃省中医院,兰州730050

出　　处：《中国实验方剂学杂志》2022年第15期94-101,共8页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家中医药管理局中医药行业科研专项(201507001-13);国家自然科学基金面上项目(81673819,82074258)。

摘　　要：目的:探讨补肾生血方与益气养血方治疗慢性再生障碍性贫血疗效及T细胞亚群与T-box家族的新型转录因子(T-bet)、Gata转录因子家族的转录因子3(GATA3)表达的影响。方法:收集2018年5月至2021年6月,在全国19家医院就诊的慢性再生障碍性贫血患者共585例,利用前瞻性、双盲、随机对照方法,采用分层区组随机法将患者分为3组,肾虚组、气血两虚组、对照组,中药治疗分别予补肾生血方颗粒、益气养血方颗粒、安慰剂(半量补肾生血方颗粒),均联合口服西药环孢素及雄激素。每组治疗以3个月为一疗程,连续观察2个疗程,分析治疗前后检测患者血常规,T细胞亚群及融合基因T-bet、GATA3,并监测安全性指标。结果:观察期间共脱落75例,剔除18例,最终肾虚组161例,气血两虚组164例,对照组167例,共492例完成治疗。治疗6个月后,肾虚组的总有效率98.8%(159/161)高于气血两虚组的79.9%(131/164)(χ^(2)=30.135,P<0.01);肾虚组明显高于对照组的总有效率61.7%(103/167)(χ^(2)=70.126,P<0.01);气血两虚组总有效率高于对照组(χ^(2)=13.232,P<0.01)。与本组治疗前比较,治疗后3组患者的血红蛋白(HGB)明显提升(P<0.05,P<0.01),且肾虚组HGB含量提高更为显著(P<0.01);治疗后与气血两虚组比较,肾虚组与对照组的白细胞(WBC)及血小板(PLT)均显著升高(P<0.01);3组患者治疗后的中性粒细胞(ANC)差异无统计学意义。3组患者在相同时间点进行比较,肾虚组T辅助细胞1(Th1)、Th1/Th2水平均明显降低(P<0.05),且肾虚组CD4^(+)水平明显下降,CD4^(+)/CD8^(+)明显降低(P<0.05)。肾虚组与其余两组CD19^_(-)、HLA/DR^(+)、CD25^(+)比较差异无统计学意义,肾虚组与对照组T-bet均低于气血两虚组(P<0.05)。结论:补肾生血方治疗再生障碍性贫血可能通过改善免疫调节机制,抑制免疫系统活性,调节T细胞亚群,抑制Th1及CD4^(+)水平,促进骨髓造血,且安全、不良反应小,方案值得进一�Objective:To investigate the efficacy of Bushen Shengxue prescription and Yiqi Yangxue prescription in the treatment of chronic aplastic anemia and the effect on T cell subsets and the expression of T-box expressed in T cells(T-bet)and GATA binding protein 3(GATA3).Method:A total of 585 patients with chronic aplastic anemia who were treated in 19 hospitals in China from May 2018 to June 2021 were enrolled.With the prospective,double-blind and randomized control methods,the patients were randomized into three groups:kidney deficiency group,Qi and blood deficiency group,and control group.The three groups were respectively treated with Bushen Shengxue prescription granule,Yiqi Yangxue prescription granule,and Placebo(half the dose of Bushen Shengxue formula granules).In addition,all of them were given oral cyclosporin and androgen.The treatment lasted 6 months,with 3 months as a course.The blood routine indexes,T cell subsets,and fusion genes T-bet and GATA3 before and after treatment were analyzed,and the safety indexes were monitored.Result:During the observation,a total of 75 cases dropped out and 18 were rejected.Finally,161cases in the kidney deficiency group,164 in the Qi and blood deficiency group,and 167 in the control group were included.After 6 months of treatment,the total effective rate was 98.8%(159/161) in the kidney deficiency group,which was higher than the 79.9%(131/164)in the Qi and blood deficiency group(χ^(2)=30.135,P<0.01)and the 61.7%(103/167)in the control group(χ^(2)=70.126,P<0.01).The total effective rate was higher in the Qi and blood deficiency group than in the control group(χ^(2)=13.232,P<0.01).After treatment,the hemoglobin(HGB)content increased significantly in three groups(P<0.05)as compared with that before treatment,particularly the kidney deficiency group(P<0.01).After treatment,the white blood cell(WBC)count and platelet(PLT)count in the kidney deficiency group and the control group increased compared with those in the Qi and blood deficiency group(P<0.01).There was no specific

关 键 词：补肾生血方 慢性再生障碍性贫血 免疫调节 T辅助细胞1 T辅助细胞2 T-box家族的新型转录因子(T-bet) gata转录因子家族的转录因子3(GATA3) 

分 类 号：R22[医药卫生—中医基础理论] R242[医药卫生—中医学] R2-031R287