基于前瞻性队列研究的滋肾益血丸治疗肾性贫血临床疗效评价  

Clinical effi cacy evaluation of Zishen Yixue Pills in the treatment of renal anemia based on a prospective cohort study

作　　者：李星锐[1] 华琼[1] 王娇[1] 唐桂军[1] LI Xingrui;HUA Qiong;WANG Jiao;TANG Guijun(Affi liated Hospital of Henan Academy of Traditional Chinese Medicine,Zhengzhou 450004,China)

机构地区：[1]河南省中医药研究院附属医院,郑州450004

出　　处：《吉林中医药》2021年第8期1062-1065,共4页Jilin Journal of Chinese Medicine

基　　金：河南省中医药科学研究专项(2017ZY1008)。

摘　　要：目的采用前瞻性队列研究评价滋肾益血丸对肾性贫血(renal anemia,RA)患者的临床疗效,构建中西医结合治疗肾性贫血的循证证据,为肾性贫血的中西医结合治疗提供决策依据。方法研究队列人群为符合肾性贫血诊断标准的300例肾性贫血患者,以滋肾益血丸的使用与否将队列人群分为暴露组和非暴露组,患者的年龄、性别、患病情况、服药情况等将以现场随访的方式调查采集;疗效评价指标为患者接受治疗前后的中医症状积分及血红细胞(RBC)、血红蛋白(Hb)、红细胞压积(HCT)、血清铁蛋白(SF)、转铁蛋白饱和度(TSAT)、血肌酐(Scr)、尿素氮(Bun)等;利用倾向评分法处理混杂因素,分析滋肾益血丸对肾性贫血的治疗效果。结果2组患者治疗后中医症状积分较前改善,治疗组改善情况优于对照组(P<0.01);治疗后2组患者的RBC、HCT、Hb、SF、TSAT有所上升,暴露组上升更明显(P<0.01);治疗后2组患者的Bun、Scr有所下降,2组比较差异有统计学意义(P<0.01),未出现不良事件。结论滋肾益血丸对肾性贫血患者的治疗效果确切,安全性好,可为中西医结合治疗肾性贫血方案的优化形成提供依据。Objective To evaluate the clinical effi cacy of Zishen Yixue Pills in the treatment of renal anemia(RA)by a prospective cohort study,construct an evidence-based evidence and provide a decision-making basis for the treatment of RA with the integration of traditional and western medicine.Methods A total of 300 patients who met the diagnostic criteria for RA constituted the subjects of the cohort study and they were divided into exposure group and non-exposure group based on whether Zishen Yixue Pills was used or not.The age,gender,prevalence and medication of the patients were investigated and collected in the form of an on-site follow-up.The effi cacy evaluation indexes consisted of the TCM symptom score,red blood cell(RBC),hemoglobin(Hb),hematocrit(HCT),serum ferritin(SF),transferrin saturation(TSAT),serum creatinine(Scr),blood urea nitrogen(Bun),etc.The propensity score method was used to deal with those confounding factors and analyze the therapeutic eff ect of Zishen Yixue Pills on RA.Results The TCM symptom scores of the two groups were improved after treatment,and the improvement of the treatment group was better than that of the control group(P<0.01).After treatment,the contents of RBC,HCT,Hb,SF and TSAT were increased in the two groups,while the increase was more obvious in the exposure group(P<0.01).The Bun and Scr contents of the two groups were decreased after treatment,and the diff erence between the two groups was statistically signifi cant(P<0.01),and no adverse events occurred in both of the two groups.Conclusion Zishen Yixue Pills is eff ective and safe in the treatment of RA patients,which provides a basis for the optimization of the integrated traditional Chinese and western medicine in the treatment of RA.

关 键 词：滋肾益血丸 前瞻性队列研究 肾性贫血 

分 类 号：R256.5[医药卫生—中医内科学]