Article(id=1307269534675652880, tenantId=1146029695717560320, journalId=1302318977290174537, issueId=1307269516371719010, articleNumber=null, orderNo=null, doi=10.19664/j.cnki.1002-2392.260120, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1725379200000, receivedDateStr=2024-09-04, revisedDate=1765209600000, revisedDateStr=2025-12-09, acceptedDate=null, acceptedDateStr=null, onlineDate=1789606944960, onlineDateStr=2026-09-17, pubDate=1781884800000, pubDateStr=2026-06-20, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1789606944960, onlineIssueDateStr=2026-09-17, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1789606944960, creator=13701087609, updateTime=1789606944960, updator=13701087609, issue=Issue{id=1307269516371719010, tenantId=1146029695717560320, journalId=1302318977290174537, year='2026', volume='54', issue='6', pageStart='1', pageEnd='126', issueExtLink='null', onlineDate='null', pubDate='1781884800000', pubDateStr='2026-06-20', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1789606940596, creator='13701087609', updateTime=1789606940596, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext=null, issueFiles=null, downloadFileDto=null}, startPage=57, endPage=63, ext={EN=ArticleExt(id=1307269534839230737, articleId=1307269534675652880, tenantId=1146029695717560320, journalId=1302318977290174537, language=EN, title=Clinical Study on Tongxuan Qishen Formula in Treating Diabetic Nephropathy, columnId=null, journalTitle=Acta Chinese Medicine and Pharmacology, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: To explore the clinical efficacy of Tongxuan Qishen formula (clearing Xuan and activating kidney Therapy) in treating diabetic nephropathy (DN) patients with spleen and kidney deficiency, blood stasis and water stagnation syndrome.
Methods: A total of 85 patients with diabetic nephropathy who met the criteria of spleen and kidney deficiency, blood stasis and water stagnation syndrome, admitted to Wangjing Hospital of China Academy of Chinese Medical Sciences from January 2022 to April 2024, were randomly divided into a control group (receiving basic treatment) and an treatment group (receiving basic treatment + clearing Xuan and activating kidney Therapy). The treatment group consisted of 43 patients, and the control group had 42 patients. The clinical symptoms, FIB-4 index, glucose and lipid metabolism-related indicators [glycated hemoglobin (HbA1c), total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C)], renal function indicators [24-hour urine total protein (24h UTP), estimated glomerular filtration rate (eGFR), serum creatinine (Scr), blood urea nitrogen (BUN), and uric acid (UA)], and safety indicators were observed and compared between the two groups before and after treatment.
Results: After 12 weeks of intervention, the clinical treatment effective rate in the treatment group was 90.7% (39/43), significantly higher than the 64.3% (27/42) in the control group (P < 0.01). The Traditional Chinese Medicine (TCM) syndrome scores in the observation group decreased significantly (P <0.01), while in the control group, although there was a reduction in scores, the difference was not statistically significant (P > 0.05). Following treatment, the FIB-4 index decreased in both groups, but the improvement in the treatment group was significantly better than that in the control group (P < 0.05, P < 0.01). The lipid profile improvement in the treatment group was significantly better than that in the control group(P < 0.05). Specifically, total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) in the treatment group decreased significantly (P <0.01), triglycerides (TG) decreased markedly (P <0.05), and high-density lipoprotein cholesterol (HDL-C) showed slight improvement but the difference was not statistically significant (P >0.05). In the control group, TC decreased significantly (P < 0.05), but the reductions in TG, HDL-C, and LDL-C were not statistically significant (P >0.05). The HbA1c levels in the treatment group decreased significantly (P <0.05), while no significant improvement was observed in the HbA1c levels of the control group (P >0.05). The estimated glomerular filtration rate (eGFR) in the treatment group increased significantly (P < 0.05), while 24-hour urine total protein (24h UTP), serum creatinine (Scr) and uric acid (UA) decreased significantly (P < 0.05). No significant improvement was observed in blood urea nitrogen (BUN) (P > 0.05). In the control group, although there were improvements in 24h UTP, eGFR, Scr, BUN, and UA, the differences were not statistically significant (P > 0.05).
Conclusion: Tongxuan Qishen formula can significantly improve the FIB-4 index, renal function, and metabolism-related clinical indicators in DN patients with spleen-kidney deficiency, blood stasis and water stagnation syndrome. It reduces the accumulation of metabolic products in the human body and plays an important role in reducing the risk of liver fibrosis, improving renal function, and delaying disease progression.
, authors=Jiatong HAN, Beiliang MIAO, Mengqi GAO, Shiwei LIU
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目的： 探讨通玄启肾方治疗糖尿病肾病（DKD）脾肾亏虚、瘀阻水停证患者的临床疗效。
方法： 纳入中国中医科学院望京医院2022年1月—2024年4月收治的85例符合脾肾亏虚、瘀阻水停证的DKD患者，按照随机数字表法分为对照组42例（基础治疗）和治疗组43例（基础治疗+通玄启肾法治疗），比较两组患者治疗前后临床症状、FIB-4指数、糖脂代谢相关指标［糖化血红蛋白（HbA1c）、总胆固醇（TC）、甘油三酯（TG）、高密度脂蛋白（HDL-C）、低密度脂蛋白（LDL-C）］、肾功能指标［24 h尿蛋白（24h UTP）、肾小球滤过率（eGFR）、血肌酐（Scr）、尿素氮（BUN）、尿酸（UA）］及安全性指标。
结果： 干预12周后，治疗组临床治疗有效率为90.7%（39/43），显著高于对照组的64.3%（27/42），差异有统计学意义（P < 0.01）。治疗组中医证候评分显著降低（P < 0.01），而对照组评分虽有所降低，但差异无统计学意义（P > 0.05）。治疗后两组患者的FIB-4指数均下降（P < 0.05，P < 0.01），治疗组FIB-4指数改善效果明显优于对照组（P < 0.05）。治疗组TC、LDL-C显著下降（P < 0.01），TG明显下降（P <0.05），HDL-C虽略有改善，但差异无统计学意义（P > 0.05）；对照组TC明显下降（P < 0.05），TG、HDL-C、LDL-C虽有下降，但差异均无统计学意义（P > 0.05）。治疗组患者HbA1c指标明显下降（P < 0.05）；对照组患者HbA1c未见明显改善（P > 0.05）。治疗组患者eGFR指标明显上升（P <0.05），24h UTP、Scr、UA指标明显下降（P < 0.05），BUN未有明显改善（P > 0.05）；对照组患者的24h UTP、eGFR、Scr、BUN、UA虽有所改善，但差异无统计学意义（P > 0.05）。
结论： 通玄启肾方可显著改善脾肾亏虚、瘀阻水停证DKD患者的FIB-4指数、糖脂代谢指标及肾功能等相关临床指标，显著减少人体内代谢产物的异常蓄积，降低肝脏纤维化的风险，改善肾脏功能，延缓疾病的进展，且安全性良好。
, authors=韩佳童, 苗蓓亮, 高梦琦, 刘世巍
*, authorsList=韩佳童, 苗蓓亮, 高梦琦, 刘世巍, authorCompany=null, correspAuthors=刘世巍, authorNote=
韩佳童（1999-），女，硕士研究生，主要从事中医药防治慢性肾脏病临床研究。
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* 刘世巍（1977-），女，博士，主任医师，博士生导师，主要从事中医药防治慢性肾脏病临床研究。
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韩佳童（1999-），女，硕士研究生，主要从事中医药防治慢性肾脏病临床研究。
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韩佳童（1999-），女，硕士研究生，主要从事中医药防治慢性肾脏病临床研究。
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