昆葵保肾膏治疗糖尿病肾脏病的临床疗效：一项回顾性队列研究

Clinical Efficacy of Kunkui Kidney Protection Ointment in the Treatment of Diabetic Kidney Disease： A Retrospective Cohort Study

    摘要
  • 摘要:
    目的 通过真实世界研究评估昆葵保肾膏降低糖尿病肾脏疾病（Diabetic kidney disease，DKD）患者蛋白尿的临床疗效。
    方法 回顾性收集2021年2月15日至2024年9月30日在江苏省中医院就诊的DKD患者资料，通过用药史将患者分为昆葵组、黄葵组和西药组3组。对3组进行描述性分析，并通过Cox比例风险回归模型和Kaplan-Meier曲线评估昆葵保肾膏对尿微量白蛋白/尿肌酐（Urinary albumin-to-creatinine ratio，UACR）下降达标的影响，并进行分层分析。
    结果 共纳入601例2型糖尿病肾脏病伴蛋白尿患者。昆葵组（n=133）在UACR下降30%和50%的达标率（68.4%、63.9%）及达标时间（4.0个月、4.0个月）均显著优于黄葵组（n=290，达标率56.9%、52.1%，达标时间5.5个月、6.5个月）和西药组（n=178，达标率46.6%、25.8%，达标时间8.0个月、10.5个月）（P<0.001）。多因素Cox分析显示，校正混杂因素后昆葵组UACR下降30%和50%的风险比（Hazard ratio，HR）分别为2.17395%置信区间（Confidence interval，CI）：1.560~3.026和4.984（95%CI：3.370~7.369），关联仍有统计学意义（P<0.001）。Kaplan-Meier曲线显示3组间差异有统计学意义（P<0.000 1）。亚组分析表明，昆葵保肾膏在不同特征的患者中均具有积极作用。
    结论 DKD人群服用昆葵保肾膏可以降低UACR，其疗效具有广泛性和稳健性。

     

    Abstract:
    OBJECTIVE To evaluate the clinical efficacy of Kunkui Kidney Protection Ointment in reducing proteinuria among patients with Diabetic Kidney Disease (DKD) through a real-world study.
    METHODS Data from Jiangsu Provincial Hospital of Chinese Medicine between February 15, 2021, and September 30, 2024 were retrospectively collected. Patients were divided into three groups based on their medication history: the Kunkui group, the Huangkui group, and the Western medicine group. Descriptive analyses were conducted across the three groups. Cox proportional hazards regression models and Kaplan-Meier curves were employed to evaluate the impact of Kunkui Kidney Protection Ointment on achieving urinary albumin-to-creatinine ratio (UACR) reduction targets (30% or 50% from baseline), with stratified analyses conducted.
    RESULTS A total of 601 patients with type 2 diabetic kidney disease and proteinuria were included. The Kunkui group (n=133) demonstrated significantly higher achievement rates for both 30% (68.4%) and 50% (63.9%) reductions in UACR, along with shorter time to achievement (4.0 and 4.0 months), compared to the Huangkui group (n=290, achievement rates of 56.9% and 52.1%, achievement time of 5.5 and 6.5 months) and conventional Western medicine group (n=178, achievement rates of 46.6% and 25.8%, achievement time of 8.0 and 10.5 months) (all P<0.001). Multivariable Cox proportional hazards analysis demonstrated that after adjusting for confounding factors, the Kunkui group exhibited significantly higher likelihoods of achieving both 30% and 50% reductions in UACR, with HRs of 2.173 (95% CI: 1.560-3.026; P<0.001) and 4.984 (95% CI: 3.370-7.369; P<0.001) respectively. Kaplan-Meier curves confirmed significant between-group differences (P<0.000 1). Subgroup analyses demonstrated positive effects of Kunkui Kidney Protection Ointment in patients with diverse characteristics.
    CONCLUSION Kunkui Kidney Protection Ointment effectively reduces UACR in individuals with DKD, with consistent and reliable therapeutic effects.

     

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