| 引用本文:涂元宝，李传平，高磊.益肾化湿颗粒辅助治疗早期糖尿病肾病的疗效及安全性分析[J].世界中医药,2020,(07):. |
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| 益肾化湿颗粒辅助治疗早期糖尿病肾病的疗效及安全性分析 |
| Efficacy and Safety Analysis of Yishen Huashi Granule in the Adjuvant Treatment of Early Diabetic Nephropathy |
| 投稿时间：2019-03-01 |
| DOI：10.3969/j.issn.1673-7202.2020.07.016 |
| 中文关键词: 早期糖尿病肾病 益肾化湿颗粒 肾小球滤过率 中医证候积分 一氧化氮 内皮素-1 氧化应激 不良反应 |
| English Keywords:Early diabetic nephropathy Yishen Huashi Granule Glomerular filtration rate TCM score Nitric oxide Endothelin-1 Oxidative stress Side effects |
| 基金项目:安徽全科医学临床科研项目（2016QK012） |
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| 中文摘要: |
| 目的：探讨益肾化湿颗粒辅助治疗早期糖尿病肾病的疗效，评估用药安全性。方法：选取2015年1月至2018年11月安徽省六安市中医院收治的首诊早期糖尿病肾病患者80例作为研究对象，按照随机数字表法随机分为对照组和观察组，每组40例。对照组患者接受临床早期糖尿病肾病常规西医治疗，观察组患者在对照组基础上加入益肾化湿颗粒治疗，持续治疗4周后评估疗效。比较2组患者的治疗效果、中医证候积分值、血清内皮功能指标［一氧化氮（NO）、内皮素-1（ET-1）］及氧化应激指标［8-羟基脱氧鸟苷（8-OHDG）、丙二醛（MDA）、谷胱甘肽过氧化物酶（GSH-Px）、超氧化物歧化酶（SOD）］水平的差异，以及服药期间药物不良反应发生情况。结果：观察组患者的治疗有效率高于对照组患者（P<0.05），神疲乏力、口干咽燥、腰膝酸软、自汗盗汗、口唇紫黯、舌胖齿痕等中医证候积分值低于对照组患者（P<0.05），血清NO水平高于对照组患者，ET-1水平低于对照组患者，血清8-OHDG、MDA水平低于对照组患者，GSH-Px、SOD水平高于对照组患者（P<0.05）。用药期间，2组患者的瘙痒皮疹、头晕头痛、恶心呕吐发生率比较差异无统计学意义（P>0.05）。结论：益肾化湿颗粒辅助治疗可提升早期糖尿病肾病患者的疗效，且具有良好的用药安全性。 |
| English Summary: |
| To explore the efficacy of Yishen Huashi Granule in the adjuvant treatment of early diabetic nephropathy，and to evaluate the safety of medication.Methods:From January 2015 to November 2018，a total of 80 patients with early diabetic nephropathy who were first diagnosed and treated in Traditional Chinese Hospital of Luan Nephropathy，were divided into a control group and an observation group by random number table.Patients in the control group underwent routine Western medicine treatment，while those in the observation group were treated with Yishen Huashi Granule on the basis of the control group.The curative effects were evaluated after 4 weeks of continuous treatment.The therapeutic effects，TCM syndrome scores，serum endothelial function indexes［(NO，ET-1)］ and oxidative stress indexes［(8-OHDG，MDA，GSH-Px，SOD)］ were compared between the 2 groups，and the occurrence of adverse drug reactions during medication were also compared.Results:The total effective rate of treatment in the observation group was higher than that in control group; The scores of TCM syndromes such as fatigue，dry mouth and throat，soreness and weakness of waist and knee，spontaneous and night sweating，purple lips，fat tongue and teeth marks were lower than those in the control group; Serum level of NO was higher than that in control group and ET-1 level was lower than that in control group; Serum levels of 8-OHDG and MDA were lower than those in control group，and GSH-Px and SOD levels were higher than those in control group(P<0.05).During medication，there were no significant difference in the incidence of pruritus，rash，dizziness，headache，nausea and vomiting between 2 groups(P>0.05).Conclusion:The adjuvant treatment of Yishen Huashi Granule can improve the curative effects of patients with early diabetic nephropathy，and has good medication safety. |
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