Sun Weiwei, Zhang Jiale, Yang Hanwen, Yan Runze, Wei Shuwu, W U Qiaoru, Cui Zhaoli, Zheng Huijuan, Wang Yaoxian
{"title":"中药清热消正方改善糖尿病肾病患者肾脏预后的回顾性研究","authors":"Sun Weiwei, Zhang Jiale, Yang Hanwen, Yan Runze, Wei Shuwu, W U Qiaoru, Cui Zhaoli, Zheng Huijuan, Wang Yaoxian","doi":"10.19852/j.cnki.jtcm.2025.04.017","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>To assess the benefits of Qingre Xiaozheng formula (, QRXZF) as an adjunct to standard Western medical management on renal outcomes in patients with diabetic kidney disease (DKD).</p><p><strong>Methods: </strong>This retrospective study included patients with DKD who received the QRXZF between May 2017 and May 2021. A total of 144 patients with DKD, 24 h urinary total protein (24 h-UTP) ≥ 0.5 g, and estimated glomerular filtration rate (eGFR) ≥ 30 mL/min per 1.73 m<sup>2</sup> were divided into the treatment group or the control group based on whether they received QRXZF treatment. The long-term renal outcomes of patients with DKD were analyzed to evaluate the effectiveness of the QRXZF. Differences in overall survival (OS) were assessed using Kaplan-Meier curve analysis. Cox proportional hazards regression analysis was used to determine the independent risk factors for renal endpoints.</p><p><strong>Results: </strong>The mean follow-up period was (28±15) months. Nine (12.5%) patients in the treatment group and 27 (37.5%) patients in the control group met the renal endpoints. Multivariate Cox regression analysis showed that 24 h-UTP ≥ 3.5 g [hazard ratio (<i>HR</i>) = 4.70, 95% confidence interval (<i>CI</i>) (1.83, 12.05), <i>P =</i> 0.001], combined coronary artery disease [<i>HR</i> = 3.39, 95% <i>CI</i> (1.65, 6.98), <i>P =</i> 0.001], total cholesterol [<i>HR</i> = 1.34, 95% <i>CI</i> (1.05, 1.70), <i>P =</i> 0.019] and low-density lipoprotein [<i>HR</i> = 1.65, 95% <i>CI</i> (1.111, 2.45), <i>P =</i> 0.013] were independent prognostic factors for renal endpoints in patients with DKD. Compared with the treatment group, the risk of renal endpoint events increased 2.68-fold in the control group [<i>HR</i> = 2.68, 95% <i>CI</i> (1.19, 6.02); <i>P =</i> 0.017]. We included 48 patients with 24 h-UTP ≥ 3.5 g in a further stratification analysis of patients with DKD. The independent risk factor for the renal endpoints in patients with 24h-UTP ≥ 3.5 g was smoking history [<i>HR</i> = 5.52, 95% <i>CI</i> (1.131, 26.92), <i>P =</i> 0.035]. Compared with the treatment group, the risk of renal endpoint events increased 3.01-fold in the control group [<i>HR</i> = 3.01, 95% <i>CI</i> (1.05, 8.67); <i>P =</i> 0.041].</p><p><strong>Conclusions: </strong>The results show that QRXZF treatment improved renal outcomes and reduced proteinuria in patients with DKD. These results indicate that Traditional Chinese Medicine is likely to have a positive therapeutic effect on established and advanced DKD. Further well-designed clinical trials with longer follow-up periods are required.</p>","PeriodicalId":94119,"journal":{"name":"Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan","volume":"45 4","pages":"873-880"},"PeriodicalIF":0.0000,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12340587/pdf/","citationCount":"0","resultStr":"{\"title\":\"Traditional Chinese herbal medicine Qingre Xiaozheng formula improves renal outcomes in patients with diabetic kidney disease: a retrospective study.\",\"authors\":\"Sun Weiwei, Zhang Jiale, Yang Hanwen, Yan Runze, Wei Shuwu, W U Qiaoru, Cui Zhaoli, Zheng Huijuan, Wang Yaoxian\",\"doi\":\"10.19852/j.cnki.jtcm.2025.04.017\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>To assess the benefits of Qingre Xiaozheng formula (, QRXZF) as an adjunct to standard Western medical management on renal outcomes in patients with diabetic kidney disease (DKD).</p><p><strong>Methods: </strong>This retrospective study included patients with DKD who received the QRXZF between May 2017 and May 2021. A total of 144 patients with DKD, 24 h urinary total protein (24 h-UTP) ≥ 0.5 g, and estimated glomerular filtration rate (eGFR) ≥ 30 mL/min per 1.73 m<sup>2</sup> were divided into the treatment group or the control group based on whether they received QRXZF treatment. The long-term renal outcomes of patients with DKD were analyzed to evaluate the effectiveness of the QRXZF. Differences in overall survival (OS) were assessed using Kaplan-Meier curve analysis. Cox proportional hazards regression analysis was used to determine the independent risk factors for renal endpoints.</p><p><strong>Results: </strong>The mean follow-up period was (28±15) months. Nine (12.5%) patients in the treatment group and 27 (37.5%) patients in the control group met the renal endpoints. Multivariate Cox regression analysis showed that 24 h-UTP ≥ 3.5 g [hazard ratio (<i>HR</i>) = 4.70, 95% confidence interval (<i>CI</i>) (1.83, 12.05), <i>P =</i> 0.001], combined coronary artery disease [<i>HR</i> = 3.39, 95% <i>CI</i> (1.65, 6.98), <i>P =</i> 0.001], total cholesterol [<i>HR</i> = 1.34, 95% <i>CI</i> (1.05, 1.70), <i>P =</i> 0.019] and low-density lipoprotein [<i>HR</i> = 1.65, 95% <i>CI</i> (1.111, 2.45), <i>P =</i> 0.013] were independent prognostic factors for renal endpoints in patients with DKD. Compared with the treatment group, the risk of renal endpoint events increased 2.68-fold in the control group [<i>HR</i> = 2.68, 95% <i>CI</i> (1.19, 6.02); <i>P =</i> 0.017]. We included 48 patients with 24 h-UTP ≥ 3.5 g in a further stratification analysis of patients with DKD. The independent risk factor for the renal endpoints in patients with 24h-UTP ≥ 3.5 g was smoking history [<i>HR</i> = 5.52, 95% <i>CI</i> (1.131, 26.92), <i>P =</i> 0.035]. Compared with the treatment group, the risk of renal endpoint events increased 3.01-fold in the control group [<i>HR</i> = 3.01, 95% <i>CI</i> (1.05, 8.67); <i>P =</i> 0.041].</p><p><strong>Conclusions: </strong>The results show that QRXZF treatment improved renal outcomes and reduced proteinuria in patients with DKD. These results indicate that Traditional Chinese Medicine is likely to have a positive therapeutic effect on established and advanced DKD. Further well-designed clinical trials with longer follow-up periods are required.</p>\",\"PeriodicalId\":94119,\"journal\":{\"name\":\"Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan\",\"volume\":\"45 4\",\"pages\":\"873-880\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2025-08-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12340587/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.19852/j.cnki.jtcm.2025.04.017\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.19852/j.cnki.jtcm.2025.04.017","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
摘要
目的：评价清热消正方辅助西医标准治疗对糖尿病肾病（DKD）患者肾脏预后的影响。方法：本回顾性研究纳入了2017年5月至2021年5月期间接受QRXZF治疗的DKD患者。将144例DKD患者，24 h尿总蛋白(24 h- utp)≥0.5 g，估计肾小球滤过率(eGFR)≥30 mL/min / 1.73 m2，根据是否接受QRXZF治疗分为治疗组和对照组。分析DKD患者的长期肾脏预后，以评估QRXZF的有效性。采用Kaplan-Meier曲线分析评估总生存期（OS）的差异。采用Cox比例风险回归分析确定肾脏终点的独立危险因素。结果：平均随访时间（28±15）个月。治疗组9例（12.5%）和对照组27例（37.5%）患者达到肾脏终点。多因素Cox回归分析显示，24 h-UTP≥3.5 g[危险比(HR) = 4.70, 95%可信区间（CI） （1.83, 12.05）， P = 0.001]、合并冠状动脉疾病[HR = 3.39, 95% CI (1.65, 6.98), P = 0.001]、总胆固醇[HR = 1.34, 95% CI (1.05, 1.70), P = 0.019]和低密度脂蛋白[HR = 1.65, 95% CI (1.111, 2.45), P = 0.013]是DKD患者肾脏终点的独立预后因素。与治疗组相比，对照组发生肾终点事件的风险增加了2.68倍[HR = 2.68, 95% CI (1.19, 6.02)；P = 0.017]。我们纳入48例24 h-UTP≥3.5 g的患者，对DKD患者进行进一步的分层分析。24h-UTP≥3.5 g患者肾脏终点的独立危险因素为吸烟史[HR = 5.52, 95% CI (1.131, 26.92), P = 0.035]。与治疗组相比，对照组发生肾终点事件的风险增加了3.01倍[HR = 3.01, 95% CI (1.05, 8.67)；P = 0.041]。结论：QRXZF治疗改善了DKD患者的肾脏预后，减少了蛋白尿。这些结果表明，中药可能对已建立和晚期DKD有积极的治疗作用。需要进一步设计良好、随访时间较长的临床试验。
Traditional Chinese herbal medicine Qingre Xiaozheng formula improves renal outcomes in patients with diabetic kidney disease: a retrospective study.
Objective: To assess the benefits of Qingre Xiaozheng formula (, QRXZF) as an adjunct to standard Western medical management on renal outcomes in patients with diabetic kidney disease (DKD).
Methods: This retrospective study included patients with DKD who received the QRXZF between May 2017 and May 2021. A total of 144 patients with DKD, 24 h urinary total protein (24 h-UTP) ≥ 0.5 g, and estimated glomerular filtration rate (eGFR) ≥ 30 mL/min per 1.73 m2 were divided into the treatment group or the control group based on whether they received QRXZF treatment. The long-term renal outcomes of patients with DKD were analyzed to evaluate the effectiveness of the QRXZF. Differences in overall survival (OS) were assessed using Kaplan-Meier curve analysis. Cox proportional hazards regression analysis was used to determine the independent risk factors for renal endpoints.
Results: The mean follow-up period was (28±15) months. Nine (12.5%) patients in the treatment group and 27 (37.5%) patients in the control group met the renal endpoints. Multivariate Cox regression analysis showed that 24 h-UTP ≥ 3.5 g [hazard ratio (HR) = 4.70, 95% confidence interval (CI) (1.83, 12.05), P = 0.001], combined coronary artery disease [HR = 3.39, 95% CI (1.65, 6.98), P = 0.001], total cholesterol [HR = 1.34, 95% CI (1.05, 1.70), P = 0.019] and low-density lipoprotein [HR = 1.65, 95% CI (1.111, 2.45), P = 0.013] were independent prognostic factors for renal endpoints in patients with DKD. Compared with the treatment group, the risk of renal endpoint events increased 2.68-fold in the control group [HR = 2.68, 95% CI (1.19, 6.02); P = 0.017]. We included 48 patients with 24 h-UTP ≥ 3.5 g in a further stratification analysis of patients with DKD. The independent risk factor for the renal endpoints in patients with 24h-UTP ≥ 3.5 g was smoking history [HR = 5.52, 95% CI (1.131, 26.92), P = 0.035]. Compared with the treatment group, the risk of renal endpoint events increased 3.01-fold in the control group [HR = 3.01, 95% CI (1.05, 8.67); P = 0.041].
Conclusions: The results show that QRXZF treatment improved renal outcomes and reduced proteinuria in patients with DKD. These results indicate that Traditional Chinese Medicine is likely to have a positive therapeutic effect on established and advanced DKD. Further well-designed clinical trials with longer follow-up periods are required.
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