Page 56 - 2022-26-中国全科医学

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Therefore，it is urgently necessary to explore an effective treatment for delaying the progression of advanced DKD. The
Xiezhuoxiaozheng therapy，proposed by Professor WANG Yaoxian in accordance with the pathogenesis of advanced DKD
manifested by turbid poison and mass signs and symptoms（zhengjia），has proven to be effective in clinical treatment of
advanced DKD. Objective To assess the clinical efficacy and safety of Xiezhuoxiaozheng therapy in advanced DKD based on
the theory of "latent internal heat causing renal collateral mass". Methods A real-world，prospective cohort study design was
used to investigate the clinical efficacy and safety of Xiezhuoxiaozheng therapy for advanced DKD in seven hospitals（Dongzhimen
Hospital，Beijing University of Chinese Medicine，Guang'anmen Hospital，China Academy of Chinese Medical Sciences，
Beijing Hospital of Traditional Chinese Medicine，Wangjing Hospital of CACMS，Xiyuan Hospital of CACMS，Beijing
Hospital of Integrated Traditional Chinese and Western Medicine，and Beijing Fangshan District Hospital of Traditional Chinese
Medicine） from 2016 to 2020. Patients with DKD who met the inclusion criteria were recruited and divided into a control group
（basic western medical treatment） and a test group（basic western medical treatment plus Xiezhuoxiaozheng therapy）taking
the method of Xiezhuoxiaozheng and eliminating symptoms as the exposure factor，and received 24-week interventions. At
baseline，and the end of 4，12，and 24 weeks of interventions，serum creatinine（Scr），blood urea nitrogen（BUN），24-
hour urine protein，and total cholesterol（TC），estimated glomerular filtration rate（eGFR）were measured，TCM symptom
score was assessed. HbA 1c was measured at baseline，and the end of 12，and 24 weeks of interventions. Adverse events were
recorded during treatment，and safety was evaluated. Results A total of 59 cases completed the study，including 36 in the test
group and 23 in the control group. The intervention duration had significant main effect on eGFR，Scr，and BUN levels in both
groups（P<0.05）. The intervention therapy and duration had significant interaction effect on the change in the TCM symptom
score in both groups（P<0.05）. The control group had increased BUN level at the end of 12 weeks of intervention，and increased
BUN，Scr and heat syndrome score at the end of 24 weeks of intervention（P<0.05）. In contrast，the test group had increased
eGFR at the end of 4 weeks of intervention（P<0.05）. The test group had higher eGFR and lower Scr，BUN and TCM symptom
score at the end of intervention than did the control group（P<0.05）. The incidence of adverse reactions was 21.74%（5/23）
in the control group and 8.33%（3/36） in the experimental group. There was no significant difference between the two groups
2
（χ =2.15，P=0.14）. Conclusion For advanced DKD，Xiezhuoxiaozheng therapy combined with usual western medicine
treatment may be superior to usual western medicine treatment alone in delaying the decrease of eGFR，slowing down the increase
of Scr and BUN levels，protecting kidney function，reducing the heat syndrome score and improving the TCM symptoms，which
could improve the clinical efficacy.
【Key words】 Diabetic nephropathies；Xiezhuoxiaozheng；Shenluozhengjia；Real world study；Comparative
effectiveness research

据国际糖尿病联合会（IDF）统计，2017 年全球约 明显受损，治疗手段局限，效果欠佳，所以寻找 DKD
有 4.51 亿糖尿病患者，预计到 2045 年将增加至 6.93 亿， 晚期有效治疗方法是亟待解决的科学问题。
［1］
其中有30%~40%的患者进展为糖尿病肾脏病（DKD） 。 中医药在糖尿病及其并发症的治疗中历史悠久、
DKD 一旦发生，就会出现持续性蛋白尿，肾脏病变常 理论丰富，经过古今医家的不断探索，中医药治疗在
不可逆转，最终在较短时间内进入终末期肾病（ESRD）。 DKD 的治疗中疗效确切且具有优势。王耀献教授在“伏
我国的 DKD 患病形势同样严峻，2 型糖尿病患者中 热”理论和“肾络癥瘕”理论的指导下，针对 DKD 晚
DKD 患病率为 21.8%，在西部地区高达 41.3% ［2］ 。北 期热邪的病机特点和肾络癥瘕的状态，以泄浊消癥为基
京大学第一医院 2016 年的统计结果显示，住院患者中 本治疗原则进行辨证施治，取得良好疗效。因此，本研
糖尿病引起的慢性肾脏病已经超过肾小球肾炎相关慢性 究开展队列研究，观察消癥散结法治疗晚期 DKD 的疗
肾脏病，成为慢性肾脏病的首要病因，并且估计目前的 效及安全性。
患病人数已达 2 400 万以上 ［3］ 。 1 资料与方法
DKD 是现代医学治疗的重点和难点，虽然近年来不 1.1 临床资料 采用基于真实世界的前瞻性队列研究
断有新型药物包括钠 - 葡萄糖协同转运蛋白 2（SGLT2） 设计，选取 2016—2020 年于北京中医药大学东直门医
抑制剂、胰高血糖素样肽 -1（GLP-1）受体激动剂应用 院、中国中医科学院广安门医院、首都医科大学附属北
于临床，但在中、重度肾病人群中的应用仍十分受限， 京中医医院、中国中医科学院望京医院、中国中医科学
DKD 仍然是导致 ESRD 的主要原因，亦已成为心脑血 院西苑医院、北京市中西医结合医院、北京市房山区中
管疾病的重要危险因素，是严重威胁人类生命健康的重 医医院就诊并符合本研究纳入标准的 DKD 患者，以泄
大慢性非传染性疾病之一 ［4］ 。DKD 晚期患者的肾功能 浊消癥法作为暴露因素，分为治疗组和对照组。