补肾生血法和益气养血法治疗再生障碍性贫血的血常规变化规律比较及分阶段治疗模式  

Comparison of Blood Routine Changes in Treatment of Aplastic Anemia by Kidney-tonifying and Blood-generating Method and Qi-promoting and Blood-nourishing Method and Mode of Treatment by Stages

作　　者：吕妍[1] 李芮 唐旭东[1] LYU Yan;LI Rui;TANG Xudong(Xiyuan Hospital of China Academy of Chinese Medical Sciences,Beijing 100091,China;Graduate School of China Academy of Chinese Medical Sciences,Beijing 100029,China)

机构地区：[1]中国中医科学院西苑医院,北京100091 [2]中国中医科学院研究生院,北京100029

出　　处：《中国实验方剂学杂志》2023年第14期73-79,共7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)。

摘　　要：目的:探讨补肾生血和益气养血法联合西药治疗再生障碍性贫血临床疗效及血常规恢复特征,探索分阶段治疗再生障碍性贫血新模式。方法:此项研究来源于一项前瞻性、多中心、双盲、随机对照临床试验,分析了19个中心的再生障碍性贫血患者,分为补肾生血组、益气养血组予以中药联合西药治疗,评价临床疗效及各组治疗过程中血常规变化规律。结果:观察期间共入组375例再生障碍性贫血患者,中医辨证均同时符合肾虚和气血两虚型,随机分为2组,其中补肾生血组184例,益气养血组191例,中药治疗分别予以补肾生血方颗粒剂及益气养血方颗粒剂,均联合口服雄激素及环孢素软胶囊。治疗共6个月,分为3个阶段:从治疗开始到第1个月末、第4个月末和第6个月末进行访视。6个月后评价疗效,补肾生血组总有效率86.4%(159/184),明显优于益气养血组的68.6%(131/191,P<0.01)。分析2组患者各阶段血细胞增长幅度百分比四分位数结果,补肾生血组患者血红蛋白浓度和血小板计数在治疗后持续增长,与第一阶段比较,第二阶段和第三阶段显著增长(P<0.05);网织红细胞计数增长幅度在治疗第一阶段最为显著(P<0.05)。益气养血组患者的网织红细胞计数在治疗第一、第二阶段均有显著增长(P<0.05)。其余观察指标各阶段均有增长但增长幅度无统计学差异。分阶段对比2组疗效,在治疗第二阶段,补肾生血组的血红蛋白浓度增长幅度优于益气养血组(P<0.05);益气养血组血小板计数和红细胞计数增长幅度更大(P<0.05);治疗第三阶段,补肾生血组血红蛋白浓度增长幅度更明显(P<0.05)。结论:补肾生血法治疗再生障碍性贫血总体有效率优于益气养血法,临床疗效确切,安全有效;该研究提出三阶段论治再障的早期治疗模式,治疗第一、第三阶段(0~1、5~6个月)采取补肾生血法为主;治疗第二阶段(2~4个月)采用补肾生�Objective:To explore the clinical effect of kidney-tonifying and blood-generating method and qi-promoting and blood-nourishing method combined with western medicine on the treatment of aplastic anemia and the characteristics of blood routine recovery,and to explore a new phased treatment model for aplastic anemia.Method:This study was based on a prospective,multicenter,double-blind,and randomized controlled clinical trial.Patients with aplastic anemia from 19 centers were analyzed and divided into a kidneytonifying and blood-generating group and a Qi-promoting and blood-nourishing group,which were treated with traditional Chinese medicine(TCM)combined with western medicine.The clinical effect and the changes in blood routine in each group during treatment were evaluated.Result:During the observation period,375 cases of aplastic anemia were included in two groups,and TCM syndrome differentiation conformed these cases as Qideficiency type and both Qi and blood-deficiency type.These cases were randomly divided into two groups,including 184 in the kidney-tonifying and blood-generating group and 191 in the Qi-promoting and bloodnourishing group,being treated by kidney-tonifying and blood-generating granules and Qi-promoting and bloodnourishing granules,respectively,and combined oral androgen and ciclosporin soft capsules.The treatment lasted for six months and was divided into three stages.Visits were conducted from the beginning of the treatment to the end of the first,fourth,and sixth months.The curative effect was evaluated six months later.The total effective rate of the kidney-tonifying and blood-generating group was 86.4%(159/184),which was significantly better than that of the Qi-promoting and blood-nourishing group[68.6%(131/191),P<0.01)].The results of the percentage quartile of blood cell growth in each stage of the 2 groups were analyzed.The hemoglobin concentration and platelet count of the patients in the kidney-invigorating blood group continued to increase after treatment,and significantly increased in

关 键 词：再生障碍性贫血 补肾生血法 益气养血法 临床疗效 阶段性 血常规 

分 类 号：R2-0[医药卫生—中医学] R22R242R2-031R287