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首页> 外文期刊>Endocrinology, Diabetes & Metabolism >Propagermanium administration for patients with type 2 diabetes and nephropathy: A randomized pilot trial
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Propagermanium administration for patients with type 2 diabetes and nephropathy: A randomized pilot trial

机译：2型糖尿病和肾病患者的宣传均施用：随机试验试验

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Aims We assessed the potential efficacy and safety of propagermanium (PG), an organic compound that inhibits the C–C chemokine receptor type 2, administration in patients with type 2 diabetes and nephropathy. Furthermore, we assessed the feasibility of future studies. Materials and methods We recruited patients from nine medical institutions in Japan for this randomized, open‐label, parallel two‐arm pilot trial. Inclusion criteria were diagnosis of type 2 diabetes, age 30‐75?years, dipstick proteinuria of ≥1+ or urinary albumin‐to‐creatinine ratio (UACR) of ≥30?mg/g and estimated glomerular filtration rate of ≥30?mL/min/1.73?msup2/sup. Patients were randomly assigned (1:2) using a minimization algorithm to either continuing usual care or concomitant administration of 30?mg PG per day for 12?months. The primary outcome was the change in UACR from baseline to 12?months. We also collected safety information for all patients who received at least one dose of PG. Results We enrolled 29 patients, 10 were assigned to continue usual care and 19 to receive PG. Changes in UACR by PG in addition to the usual care were 25.0% (95% CI ?20.4%, 96.5%, P =?.33). No severe adverse events or renal events were observed during the study. Conclusion Although the treatment with PG was generally well tolerated, the dosage of 30?mg/d for 12?months did not reduce albuminuria when used in addition to usual care in patients with type 2 diabetes and nephropathy. Efficacy of PG should be verified in future definitive trials.
机译：目的我们评估了培养型（PG）的潜在功效和安全性，其抑制C-C趋化因子受体2型，患有2型糖尿病和肾病的患者的给药。此外，我们评估了未来研究的可行性。我们征聘日本九个医疗机构患者的材料和方法为这款随机开放标签，平行双臂试验试验。纳入标准是2型糖尿病患者的诊断，年龄30-75岁？岁月，二镁蛋白尿蛋白≥1+或尿白霉素 - 肌酐比（UACR）≥30Ω·mg / g，估计肾小球过滤速率≥30？ml / min/1.73?M 2 。使用最小化算法随机分配患者（1：2），以持续通常护理或伴随每天30μgPg的持续含量或伴随施用12个月。主要结果是UACR的变化从基线到12个月。我们还为所有接受一剂PG的患者收集了安全信息。结果我们注册了29名患者，10名患者被分配到继续普通护理和19岁以获得PG。除了通常护理外，PG还通过PG的变化为25.​​0％（95％CI？20.4％，96.5％，P = 33）。在研究期间没有观察到严重的不良事件或肾脏事件。结论虽然PG的处理通常耐受，但30μmmg/ d的剂量为12？月份，除了常规护理患者2型糖尿病和肾病患者外，还没有减少白蛋白尿。 PG的功效应在未来的明确试验中核实。

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