Efficacy and Safety of Xiezhuoxiaozheng Therapy in Diabetic Kidney Disease: a Clinical Study

doi:10.12114/j.issn.1007-9572.2022.0193

Chinese General Practice ›› 2022, Vol. 25 ›› Issue (26): 3252-3257.DOI: 10.12114/j.issn.1007-9572.2022.0193

Special Issue: 泌尿系统疾病最新文章合集

• Original Research • Previous Articles Next Articles

Efficacy and Safety of Xiezhuoxiaozheng Therapy in Diabetic Kidney Disease: a Clinical Study

1. Department of Nephrology and Endocrinology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China
2. Beijing University of Chinese Medicine, Beijing 100029, China
3. Department of Nephrology, Beijing Dongcheng First People's Hospital, Beijing 100077, China
4. No. 1 Department of Nephrology, the Affiliated Hospital of Shandong University of TCM, Shandong 250011, China

Received:2021-12-05 Revised:2022-05-10 Published:2022-09-15 Online:2022-05-20
Contact: Weiwei SUN
About author:
YANG H W, WANG Y X, WU Q R, et al. Efficacy and safety of Xiezhuoxiaozheng therapy in diabetic kidney disease: a clinical study[J]. Chinese General Practice, 2022, 25 (26) : 3252-3257, 3262.

泄浊消癥法治疗晚期糖尿病肾脏病的临床研究

1．100700　北京市，北京中医药大学东直门医院肾病内分泌科
2．100029　北京市，北京中医药大学
3．100077　北京市东城区第一人民医院肾病科
4．250011　山东省济南市，山东中医药大学附属医院肾病一科

通讯作者: 孙卫卫
作者简介:
本文作者贡献：杨涵雯负责病例收集，数据统计，文章撰写，研究管理与实施；王耀献指导研究设计，指导文章撰写；吴巧茹负责病例收集，数据整理，文章协作；张佳乐、闫润泽、王晓娜负责病例收集，数据整理；王珍负责病例收集，指导研究设计及文章撰写；孙卫卫负责指导研究设计，指导文章撰写，研究管理与实施，病例收集，指导数据统计分析，对文章负责。杨涵雯，王耀献，吴巧茹，等.泄浊消癥法治疗晚期糖尿病肾脏病的临床研究[J].中国全科医学，2022，25（26）：3252-3257，3262.[www.chinagp.net]
基金资助:
首都卫生发展科研专项项目重点攻关(首发2016-1-4192)

Abstract

Abstract:

Background

The incidence of diabetic kidney disease (DKD) is increasing, which has become a major cause of end-stage renal disease. DKD has an insidious onset, and progresses rapidly since the presence of proteinuria, it is difficult to slow down its progression with conventional therapy especially when renal function is significantly impaired. 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 (χ²=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

摘要：

背景

糖尿病肾脏病（DKD）的发病率逐年升高，已成为全世界终末期肾病的主要病因。然而DKD起病隐匿，进入临床蛋白尿期后进展迅速，当肾功能明显受损后，常规治疗难以延缓疾病进展。因此，探究能够延缓晚期DKD疾病进展的切实有效的治疗方法是亟待解决的临床问题。王耀献教授针对DKD晚期浊毒与癥瘕为主的病机特点，提出泄浊消癥法治疗晚期DKD，在临床实践中取得了良好疗效。

目的

以"伏热"理论和"肾络癥瘕"理论为基础，探讨泄浊消癥法治疗晚期DKD的临床疗效。

方法

采用基于真实世界的前瞻性队列研究设计，2016—2020年，于北京中医药大学东直门医院、中国中医科学院广安门医院、首都医科大学附属北京中医医院、中国中医科学院望京医院、中国中医科学院西苑医院、北京市中西医结合医院、北京市房山区中医医院就诊并符合本课题纳入标准的DKD患者为研究对象，以泄浊消癥法作为暴露因素，分为对照组和试验组。对照组予西医基础治疗，试验组在西医基础治疗的基础上联合泄浊消癥法治疗。观察周期为24周，分别于0、4、12、24周时检测两组血肌酐（Scr）、尿素氮（BUN）、24小时尿蛋白定量（24 hUTP）、总胆固醇（TC），计算估算肾小球滤过率（eGFR），记录中医症状积分；于0、12、24周时检测两组糖化血红蛋白（HbA_1c）。记录试验期间记录不良事件，评价安全性。

结果

本研究共59例患者完成试验，其中试验组36例、对照组23例。时间对两组受试者eGFR、Scr、BUN水平主效应显著（P<0.05）。组间与时间对两组受试者中医症状积分变化存在交互作用（P<0.05）。组内比较发现，相较于0周，对照组在24周时Scr水平、中医症状积分升高，在12周和24周时BUN水平升高（P<0.05）；相较于0周，试验组在4周时eGFR水平升高（P<0.05）。组间比较发现，24周时试验组eGFR水平高于对照组，Scr、BUN水平和中医症状积分低于对照组（P<0.05）。对照组不良事件发生率为21.74%（5/23），试验组不良事件发生率为8.33%（3/36），两组间不良事件发生率比较，差异无统计学意义（χ²=2.15，P=0.14）。

结论

在晚期DKD治疗中，泄浊消癥法联合西医常规治疗相较于单纯西医常规治疗在延缓eGFR降低，减缓Scr、BUN水平升高，保护肾脏功能，降低热证积分，改善中医症状方面具有优势，能够提高临床疗效。

关键词: 糖尿病肾病, 泄浊消癥, 肾络癥瘕, 真实世界研究, 疗效比较研究

Hanwen YANG,Yaoxian WANG,Qiaoru WU, et al. Efficacy and Safety of Xiezhuoxiaozheng Therapy in Diabetic Kidney Disease: a Clinical Study[J]. Chinese General Practice, 2022, 25(26): 3252-3257. DOI: 10.12114/j.issn.1007-9572.2022.0193.
杨涵雯,王耀献,吴巧茹等. 泄浊消癥法治疗晚期糖尿病肾脏病的临床研究[J]. 中国全科医学, 2022, 25(26): 3252-3257. DOI: 10.12114/j.issn.1007-9572.2022.0193.

Figures/Tables 3

References 27

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组别	例数	Scr（μmol/L）				BUN（mmol/L）
组别	例数	0周	4周	12周	24周	0周	4周	12周	24周
对照组	23	155.23±42.46	151.25±40.03	168.46±60.72	179.34±65.04^a	11.29±4.45	12.11±4.34	13.03±5.87^a	13.39±5.96^a
试验组	36	143.33±34.49	139.21±41.74	144.35±43.80	147.02±47.04^b	10.33±3.23	10.66±3.51	11.09±3.70	11.08±3.19^b
F值		F_组间=3.22，F_时间=4.45，F_交互=1.34				F_组间=3.07，F_时间=5.23，F_交互=1.04
P值		P_组间=0.08，P_时间=0.01，P_交互=0.27				P_组间=0.08，P_时间<0.01，P_交互=0.37
组别	24 hUTP（mg/24 h）				TC（mmol/L）
组别	0周	4周	12周	24周	0周	4周	12周	24周
对照组	3 789±3 090	3 887±2 747	4 175±2 767	4 366±3 808	5.28±2.65	5.08±1.55	5.48±2.29	5.14±1.51
试验组	3 701±3 002	4 155±3 151	3 940±3 571	3 346±3 346	5.13±1.70	5.14±1.36	5.02±1.72	5.12±1.42
F值	F_组间=0.13，F_时间=0.42，F_交互=1.48				F_组间=0.15，F_时间=0.15，F_交互=0.55
P值	P_组间=0.72，P_时间=0.72，P_交互=0.23				P_组间=0.70，P_时间=0.93，P_交互=0.65
组别	eGFR〔ml·min^-1·（1.73 m²）^-1〕				HbA_1c（%）
组别	0周	4周	12周	24周	0周	4周	12周	24周
对照组	42.82±11.30	44.30±12.59	41.74±17.16	38.13±13.92	6.83±1.06	—	7.01±1.38	6.85±1.09
试验组	45.74±9.92	48.91±12.82^a	47.40±14.63	47.31±17.41^b	7.04±1.02	—	6.93±1.11	6.90±1.20
F值	F_组间=3.09，F_时间=2.90，F_交互=1.06				F_组间=0.07，F_时间=0.17，F_交互=0.56
P值	P_组间=0.08，P_时间=0.04，P_交互=0.37				P_组间=0.79，P_时间=0.84，P_交互=0.57

组别	例数	Scr（μmol/L）				BUN（mmol/L）
组别	例数	0周	4周	12周	24周	0周	4周	12周	24周
对照组	23	155.23±42.46	151.25±40.03	168.46±60.72	179.34±65.04^a	11.29±4.45	12.11±4.34	13.03±5.87^a	13.39±5.96^a
试验组	36	143.33±34.49	139.21±41.74	144.35±43.80	147.02±47.04^b	10.33±3.23	10.66±3.51	11.09±3.70	11.08±3.19^b
F值		F_组间=3.22，F_时间=4.45，F_交互=1.34				F_组间=3.07，F_时间=5.23，F_交互=1.04
P值		P_组间=0.08，P_时间=0.01，P_交互=0.27				P_组间=0.08，P_时间<0.01，P_交互=0.37
组别	24 hUTP（mg/24 h）				TC（mmol/L）
组别	0周	4周	12周	24周	0周	4周	12周	24周
对照组	3 789±3 090	3 887±2 747	4 175±2 767	4 366±3 808	5.28±2.65	5.08±1.55	5.48±2.29	5.14±1.51
试验组	3 701±3 002	4 155±3 151	3 940±3 571	3 346±3 346	5.13±1.70	5.14±1.36	5.02±1.72	5.12±1.42
F值	F_组间=0.13，F_时间=0.42，F_交互=1.48				F_组间=0.15，F_时间=0.15，F_交互=0.55
P值	P_组间=0.72，P_时间=0.72，P_交互=0.23				P_组间=0.70，P_时间=0.93，P_交互=0.65
组别	eGFR〔ml·min^-1·（1.73 m²）^-1〕				HbA_1c（%）
组别	0周	4周	12周	24周	0周	4周	12周	24周
对照组	42.82±11.30	44.30±12.59	41.74±17.16	38.13±13.92	6.83±1.06	—	7.01±1.38	6.85±1.09
试验组	45.74±9.92	48.91±12.82^a	47.40±14.63	47.31±17.41^b	7.04±1.02	—	6.93±1.11	6.90±1.20
F值	F_组间=3.09，F_时间=2.90，F_交互=1.06				F_组间=0.07，F_时间=0.17，F_交互=0.56
P值	P_组间=0.08，P_时间=0.04，P_交互=0.37				P_组间=0.79，P_时间=0.84，P_交互=0.57

组别	例数	0周	4周	12周	24周
对照组	23	9.4±6.4	8.9±5.4	9.4±6.7	15.1±14.2^a
试验组	36	10.5±6.5	9.3±4.9	8.6±5.7	7.6±5.2^b
F值		F_组间=1.57，F_时间=1.77，F_交互=3.48
P值		P_组间=0.22，P_时间=0.16，P_交互=0.02

组别	例数	0周	4周	12周	24周
对照组	23	9.4±6.4	8.9±5.4	9.4±6.7	15.1±14.2^a
试验组	36	10.5±6.5	9.3±4.9	8.6±5.7	7.6±5.2^b
F值		F_组间=1.57，F_时间=1.77，F_交互=3.48
P值		P_组间=0.22，P_时间=0.16，P_交互=0.02

组别	例数	病情加重住院	急性左心力衰竭	肺部感染	进入ESRD
对照组	23	3	1	0	1
试验组	36	2	0	1	0

Efficacy and Safety of Xiezhuoxiaozheng Therapy in Diabetic Kidney Disease: a Clinical Study

泄浊消癥法治疗晚期糖尿病肾脏病的临床研究

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