益气摄血方治疗气不摄血证免疫性血小板减少症多中心、随机、双盲、对照研究  

Effect of Yiqi Shexue Formula Treating Immune Thrombocytopenia Patients with Syndrome of Qi Failing to Govern Blood:A Multicenter,Randomized,Double-Blind,Controlled Clinical Trial

作　　者：王明镜[1,2] 全日城 丁晓庆[3] 许勇钢[1] 朱世荣[1,4] 谌海燕 胡晓梅[1] WANG Ming-jing;QUAN Ri-cheng;DING Xiao-qing;XU Yong-gang;ZHU Shi-rong;CHEN Hai-yan;Hu Xiao-mei(Department of Hematology,Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing,100091;Graduate School of China Academy of Chinese Medical Sciences,Beijing,100700;Department of Hematology,Dongfang Hospital of Beijing University of Chinese Medicine,Beijing,100078;Graduate School of Beijing University of Chinese Medicine,Beijing,100029)

机构地区：[1]中国中医科学院西苑医院血液科,北京100091 [2]中国中医科学院研究生院,北京100700 [3]北京中医药大学东方医院血液科,北京100078 [4]北京中医药大学研究生院,北京100029

出　　处：《中国中西医结合杂志》2020年第8期929-934,共6页Chinese Journal of Integrated Traditional and Western Medicine

基　　金：国家重点基础研究发展计划(973计划)项目(No.2015CB554403)。

摘　　要：目的评价益气摄血方在治疗气不摄血证免疫性血小板减少症(ITP)中的作用。方法采取多中心、随机、双盲、对照研究方法,将在中国中医科学院西苑医院和北京中医药大学东方医院100例ITP患者,采用随机数字表法分为对照组和试验组,每组50例。对照组给予四物阿胶汤,试验组予益气摄血方,药物均为配方颗粒,每袋6 g,每次1袋,每日2次,温水冲服。治疗周期为2个月。观察患者血小板计数及激素撤减比例,并评估临床疗效;采用WHO出血评分量表评价出血程度;采用Karmofsky评分进行体力评分;采用FACIT量表进行疲劳量值评价;流式细胞术检测Th1、Th2、Th17、Treg细胞水平;采用RT-PCR检测T-bet、GATA-3、ROR-γt、Foxp3 mRNA表达。结果100例患者中,12例患者脱落,可评价患者88例,其中试验组41例,对照组47例。与对照组比较,试验组有效率显著提高[36.59%(15/41)vs.12.77%(6/47)],血小板计数显著上升,激素撤减比例显著增加,出血程度显著降低,疲劳程度、体力评分显著提升(P<0.05);同时试验组免疫细胞Th1、Th17表达水平显著降低(P<0.05),转录因子GATA-3、RORγt mRNA表达水平显著升高(P<0.05)。结论益气摄血方有助于提高血小板计数、减轻出血程度、减少激素使用、缓解疲劳状态,机制可与其抑制机体炎性反应有关。Objective To access the role of Yiqi Shexue Formula(YQSXF)in the treatment of immune thrombocytopenia(ITP)with syndrome of qi failing to govern blood(SQFGB).Methods Totally 100 patients with SQFGB from Xiyuan Hospital,China Academy of Chinese Medical Sciences and Dongfang Hospital,Beijing University of Chinese Medicine were selected and enrolled in this multicenter,randomized,double-blind,controlled trial.The patients were randomly assigned to control group and experimental group by table of random numbers,50 cases in each group.Patients in the control group were treated with Siwu Ejiao Formula(SWEJF),while those in the experimental group were treated with YQSXF.The drugs were all formulated granules,6 g in each package,1 package each time,twice a day,taken with warm water.The treatment period was 2 months.Platelet count,as well as hormone withdrawal rate,were used to evaluate the clinical effect.WHO Bleeding Scale was used to evaluate the degree of bleeding.Karmofsky Score was used to evaluate physical strength.Function Assessment of Chronic Illness Therapy-Fatigue(FACIT)Scale was used to evaluate fatigue.Flow cytometry was used to detect the expressions of Th1,Th2,Th17,Treg cell.RT-PCR was used to detect the expressions of T-bet,GATA-3,RORγt,Foxp3 mRNA.Results Among 100 patients,12 cases were dropped out,and 88 patients were evaluated,of which 47 cases in the control group and 41 cases in the experimental group.Compared with the control group,the effective rate of the experimental group was significantly increased[36.59%(15/41)vs.12.77%(6/47)],and the platelet count as well as the hormone withdrawal ratio were significantly increased,while the bleeding degree was significantly reduced,the fatigue degree and physical strength score were significantly improved(P<0.05).Meanwhile,the expressions of Th1 and Th17 in the immune cells of the experimental group were significantly reduced(P<0.05),and the mRNA expressions of transcription factors GATA-3 and RORγt were significantly increased(P<0.05).Conclusion YQSXF has

关 键 词：免疫性血小板减少症 益气摄血方 疲劳 气不摄血证 

分 类 号：R259[医药卫生—中西医结合]