Effect of Tongluo Digui Decoction on Non-dipper Blood Pressure，Urinary Sodium Excretion，and Renin-angiotensin-aldosterone System in Patients with Stage Ⅳ Diabetic Kidney Disease

doi:10.12114/j.issn.1007-9572.2021.00.079

Abstract

Abstract: Background　Diabetic kidney disease（DKD）has become the leading cause of end-stage renal disease worldwide，whose development is independently associated with non-dipper blood pressure，but there is a lack of curative treatments.Traditional Chinese medicine treatment is considered to have potentials to treat DKD and non-dipper blood pressure.Objective　To explore the effect of Tongluo Digui decoction on non-dipper blood pressure，urinary sodium excretion，and renin-angiotensin-aldosterone system（RAAS）in patients with stage Ⅳ DKD.Methods　From January 2019 to March 2020，a total of 80 outpatients and inpatients with stage Ⅳ DKD were selected from the Departments of Nephrology and Endocrinology，Henan Province Hospital of TCM /The Second Affiliated Hospital of Henan University of Chinese Medicine，and were equally randomized into control group and observation group by random number table，receiving conventional Western treatment，and conventional Western treatment with Tongluo Digui decoction for 8 weeks，respectively.Pre- and post-treatment indicators of renal function（including Scr，BUN，24-hour urine protein quantification and eGRF），HbA1c，24-hour ambulatory blood pressure，blood pressure variability，percentage of non-dipper blood pressure，24-hour urinary sodium，and plasma levels of renin，angiotensin Ⅱ receptor and aldosterone as well as calculated reverse rate of non-dipper blood pressure were compared between the two groups.The incidence of adverse reactions during treatment was recorded.Results　There were no dropouts，all cases completed the follow-up.Compared to baseline，mean levels of post-treatment Scr，BUN，24-hour urine protein quantification，HbA1c，24 hSBP，dSBP，dSBPCV and nSBPCV significantly lowered but eGFR increased in the two groups，moreover mean levels of post-treatment nSBP，nDBP，24 hSBPCV and nDBPCV significantly lowered in observation group（P<0.05）.The mean levels of post-treatment Scr，24-hour urine protein quantification，24 hDBP，nSBP，nDBP，nSBPCV and nDBPCV lowered more significantly and mean post-treatment eGFR level increased more notably in observation group than those in control group（P<0.05）.The observation group showed a lowered percentage of non-dipper blood pressure after treatment（P<0.05）.The post-treatment percentage of non-dipper blood pressure in observation group was lower than that in control group，so did the reverse rate of non-dipper blood pressure（P<0.05）.Plasma aldosterone level decreased significantly in both groups after treatment（P<0.05）.The post-treatment 24-hour urinary sodium showed a significant increase in observation group（P<0.05）.No one in the two groups occurred any obvious adverse reactions during treatment.Conclusion　In patients with stage Ⅳ DKD，Tongluo Digui decoction based on conventional Western treatment is more helpful to improve the renal function，reduce the nocturnal blood pressure and blood pressure variability，as well as percentage of non-dipper blood pressure，improve the reverse rate of dipper blood pressure and 24 urinary sodium excretion，with relatively high safety and without significant effect on RAAS.

Key words: Diabetic nephropathies, Renin-angiotensin system, Aldosterone, Tongluo Digui decoction, Blood pressure, Urinary sodium excretion

摘要： 背景　糖尿病肾病（DKD）已成为世界范围内终末期肾脏病的首要病因，非杓型血压是DKD进展的独立危险因素，但目前尚缺乏有效干预手段，而中医药治疗DKD及非杓型血压具有一定优势。目的　探讨通络地龟汤对DKD Ⅳ期患者非杓型血压、尿钠排泄及肾素-血管紧张素-醛固酮系统（RAAS）的影响。方法　选择2019年1月—2020年3月在河南省中医院（河南中医药大学第二附属医院）肾病科、内分泌科门诊就诊或住院的DKD Ⅳ期患者80例，采用随机数字表法分为对照组和观察组，每组40例。对照组患者采用西医常规治疗，观察组患者在对照组基础上加用通络地龟汤治疗；两组患者疗程均为8周。比较两组患者治疗前后肾功能指标〔血肌酐、尿素氮、24 h尿蛋白定量、估算肾小球滤过率（eGFR）〕、糖化血红蛋白、24 h动态血压、血压变异性、非杓型血压比例、24 h尿钠及血浆肾素、血管紧张素Ⅱ受体、醛固酮水平，计算杓型血压逆转率并记录两组患者治疗期间不良反应发生情况。结果　所有患者完成8周随访，无中途退出或脱落病例。与对照组相比，观察组患者治疗后血肌酐、24 h尿蛋白定量、24 h平均舒张压（24 hDBP）、夜间平均收缩压（nSBP）、夜间平均舒张压（nDBP）、夜间收缩压变异性（nSBPCV）、夜间舒张压变异性（nDBPCV）降低，eGFR升高（P<0.05）。与治疗前相比，两组患者治疗后血肌酐、尿素氮、24 h尿蛋白定量、糖化血红蛋白、24 h平均收缩压（24 hSBP）、日间平均收缩压（dSBP）、日间收缩压变异性（dSBPCV）、nSBPCV降低，eGFR升高，且观察组患者治疗后nSBP、nDBP、24 h平均收缩压变异性（24 hSBPCV）、nDBPCV降低（P<0.05）。观察组患者治疗后非杓型血压比例低于对照组及治疗前，杓型血压逆转率高于对照组（P<0.05）。与治疗前相比，两组患者治疗后血浆醛固酮水平降低，观察组患者治疗后24 h尿钠升高（P<0.05）。两组患者治疗期间均未出现明显不良反应。结论　在西医常规治疗基础上加用通络地龟汤有利于更好地改善DKD Ⅳ期患者肾功能，降低患者夜间血压、血压变异性、非杓型血压比例，提高患者杓型血压逆转率及24 h尿钠排泄，且安全性较高，但对RAAS并无明显影响。

关键词: 糖尿病肾病, 肾素-血管紧张素系统, 醛固酮, 通络地龟汤, 血压, 尿钠排泄

PANG Xinxin,SHI Xiujie,ZHANG Yage, et al. Effect of Tongluo Digui Decoction on Non-dipper Blood Pressure，Urinary Sodium Excretion，and Renin-angiotensin-aldosterone System in Patients with Stage Ⅳ Diabetic Kidney Disease　[J]. Chinese General Practice, 2021, 24(15): 1943-1950. DOI: 10.12114/j.issn.1007-9572.2021.00.079.
庞欣欣,石秀杰,张雅歌等. 通络地龟汤对糖尿病肾病Ⅳ期患者非杓型血压和尿钠排泄及肾素-血管紧张素-醛固酮系统的影响研究[J]. 中国全科医学, 2021, 24(15): 1943-1950. DOI: 10.12114/j.issn.1007-9572.2021.00.079.

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