METHODS: From February 2022 to March 2023, 90 patients with type 2 DM and DKD (micro-albuminuria) were enrolled in this randomized-controlled study. The patients were randomized into three equal groups: control group, TAD group, and PTX group. The three groups received traditional blood glucose lowering therapy + ramipril 10 mg PO. The TAD group also received tadalafil 20 mg PO every other day. The PTX group also received pentoxifylline 400 mg PO twice daily.
RESULTS: Both TAD and PTX groups produced statistically significant improvement in the primary outcomes by a significant reduction in Urinary albumin/creatinine ratio (UACR) which was pronounced by a reduction percentage of-47.47%, -53.73% respectively. In addition to a significant decrease in Hemoglobin A1C (HbA1c) (mmol/mol), Fasting blood glucose (FBG), 2-h postprandial blood glucose (2-h PPG) (p < 0.001). Only the PTX group showed a significant increase in Cr Cl and a significant decrease in S. Cr (p < 0.001). Only the TAD group showed a significant increase in high-density lipoprotein-cholesterol (HDL-C) (p < 0.001), while the PTX group showed a significant decrease in low-density lipoprotein-cholesterol (LDL-C) (p-value 0.011), and triglyceride (p-value 0.002). Both TAD and PTX groups showed a decrease in tumor necrosis factor-α (TNF-α) which was significant only in the PTX group (p < 0.001). There was a significant increase in malondialdehyde (MDA) (p < 0.001), and an increase in urinary neutrophil gelatinase-associated Lipocalin (uNGAL) (p-value 0.850, 0.014 respectively) which was significant only in the PTX group.
CONCLUSIONS: The use of tadalafil or pentoxifylline may serve as an effective adjuvant therapy for patients with diabetic kidney disease.
BACKGROUND: ClinicalTrials.gov identifier NCT05487755, July 25, 2022.
方法:从2022年2月至2023年3月,90例2型DM和DKD(微量白蛋白尿)患者纳入本随机对照研究。将患者随机分为3组:对照组,TAD组,和PTX组。三组均接受传统降糖治疗+雷米普利10mgPO。TAD组还每隔一天接受他达拉非20mgPO。PTX组还每天两次接受己酮可可碱400mgPO。
结果:TAD组和PTX组均通过尿白蛋白/肌酐比值(UACR)显着降低,显著降低了-47.47%,在主要结局方面有统计学意义的改善。-分别为53.73%。除了血红蛋白A1C(HbA1c)显着降低(mmol/mol),空腹血糖(FBG),餐后2小时血糖(2小时PPG)(p<0.001)。只有PTX组表现出CrCl的显著增加和S.Cr的显著降低(p<0.001)。只有TAD组显示高密度脂蛋白胆固醇(HDL-C)显着增加(p<0.001),而PTX组显示低密度脂蛋白胆固醇(LDL-C)显着降低(p值0.011),和甘油三酯(p值0.002)。TAD和PTX组均显示肿瘤坏死因子-α(TNF-α)降低,仅在PTX组中显着(p<0.001)。丙二醛(MDA)显著增加(p<0.001),尿中性粒细胞明胶酶相关脂质运载蛋白(uNGAL)增加(p值分别为0.850,0.014),仅在PTX组中显着。
结论:他达拉非或己酮可可碱可作为糖尿病肾病患者的有效辅助治疗。
背景:ClinicalTrials.gov标识符NCT05487755,2022年7月25日。