健脾益气摄血颗粒影响免疫性血小板减少症患者出血与免疫功能研究  

Clinical Research on Specific Immune Function of Immune Thrombocytopenia Treated by Jianpi Yiqi Shexue Granule

作　　者：郎海燕[1] 张玲 王佳[3] 张雅月[3] 王冲[3] 范秋月[3] 张佳诺 陈信义[3] Lang Haiyan;Zhang Ling;Wang Jia(Dongfang Hospital,Beijing University of Chinese Medicine,Beijing 100078,China)

机构地区：[1]北京中医药大学东方医院,100078 [2]云南中医药大学,昆明650500 [3]北京中医药大学东直门医院,100700

出　　处：《医学研究杂志》2019年第9期45-49,共5页Journal of Medical Research

基　　金：国家重点基础研究发展计划(“973”计划)项目(2013CB531705);国家自然科学基金青年基金资助项目(81803904)

摘　　要：目的观察健脾益气摄血颗粒对“脾不统血证(脾气虚)”型免疫性血小板减少症(ITP)患者特异性免疫功能的影响。方法应用中央随机对照、多中心竞争入组临床试验方法,共入组273例,经反复核对临床试验资料,进入全分析集受试者共272例,其中,试验组(健脾益气摄血组)104例,联合组(健脾益气摄血联合泼尼松组)103例,西药组(泼尼松组)65例。21天为1个疗程,临床试验结束后进行统计分析。结果从治疗第7天开始,试验组、联合组的出血程度评分值较入组时明显下降,与治疗前比较,差异有统计学意义(P<0.05),而西药组从14天开始,说明西药组止血效果晚于试验组、联合组;3组病例治疗后各访视点血小板减少程度评分值较治疗前有所下降,差异有统计学意义(P<0.05)。末次访视点,联合组血小板评分值下降幅度最优,与试验组比较,差异有统计学意义(P<0.05)。试验组CD4^+CD25^+细胞疗后测定值与疗前比较,差异有统计学意义(P<0.05),其余各组比较差异无统计学意义(P>0.05)。与试验组比较,第4次访视点联合组检测的CD3^+CD4^+细胞、CD19^+细胞正常和异常差异有统计学意义(P<0.05)。各组治疗前后血小板抗体测定值组内或组间比较,差异无统计学意义(P>0.05)。结论健脾益气摄血颗粒能有效止血和提升患者外周血小板效果,调节免疫可能是治疗机制之一。Objective To observe Jianpi Yiqi Shexue granule improve immune(spleen qi deficiency),explore the effect mechanism from the perspective of specific immunity.Methods A central randomized,multicenter clinical trial was applied with the ITP patients on TCM syndrome of"spleen failing to control blood(spleen qi deficiency)".272 patients were divided 104 cases into Jianpi Yiqi Shexue prescription group(trial group),103 cases into Jianpi Yiqi Shexue prescription combined with prednisone group(combination group),and 65 cases into prednisone group.The subjects took medicine for 21 days,collected data of their bleeding,lymphocytes and their sub-groups,and platelet related antibody.And then analyzed curative effect and mechanism.Results After 7 days of treatment,the level of bleeding in the trial group and the combination group began to decrease(P=0.000),the effect in the prednisone group appeared 14 days later.The results showed that the hemostasis effect of prednisone group was later than that of the trial group and the combined group.In the three groups,the scores of platelets reduction of each site after treatment were lower than that before treatment,which were statistically significant(P<0.05).The measured value of CD4^+CD25^+in the trial group was significant different before-and-after treatment(P<0.05),while the other two groups were not(P<0.05).Compared with the experimental group,the normal and abnormal CD3^+CD4^+and CD19^+detected in the combined group of the 4th visit were statistically significant(P<0.05).No statistical significance was found in either group of PAIgG,PAIgA,PAIgM before and after treatment(P>0.05).Conclusion The regulation of immunity,especially the regulation of T cell function,probably is one of the mechanisms for the treatment of ITP by Jianpi Yiqi Shexue granule.

关 键 词：健脾益气摄血颗粒 免疫性血小板减少症 免疫调控 

分 类 号：R255.7[医药卫生—中医内科学]