Open Access低剂量秋水仙碱对2型糖尿病合并微量白蛋白尿的作用:一项随机双盲临床试验
Author(s) -
Wang Yue,
Peng Xiaoqiong,
Hu Jinbo,
Luo Ting,
Wang Zhihong,
Cheng Qingfeng,
Mei Mei,
He Wenwen,
Peng Chuan,
Ma Linqiang,
Gong Lilin,
Yang Shumin,
Li Qifu
Publication year - 2021
Publication title -
journal of diabetes
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.949
H-Index - 43
eISSN - 1753-0407
pISSN - 1753-0393
DOI - 10.1111/1753-0407.13174
Subject(s) - medicine , microalbuminuria , gastroenterology , placebo , type 2 diabetes , diabetes mellitus , creatinine , renal function , albuminuria , clinical endpoint , diabetic nephropathy , hazard ratio , nephropathy , urology , randomized controlled trial , confidence interval , endocrinology , pathology , alternative medicine
Background Neutrophil‐related chronic inflammation (NRCI) may contribute to the pathogenesis of diabetic kidney disease (DKD). We evaluated whether blocking NRCI with low‐dose colchicine prevents DKD. Methods A double‐blind, randomized, placebo‐controlled study was conducted. A total of 160 patients with type 2 diabetes (T2D) and microalbuminuria (urinary albumin creatinine ratio [UACR] 30 to 300 mg/g Cr) who received angiotensin‐converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARBs) for at least 3 months were included. Subjects were 1:1 randomized to a placebo or colchicine group (0.5 mg/day). Results The primary end point was the incidence of overt nephropathy (UACR > 300 mg/g Cr). During the 36 months, 38 patients (51.4%) in colchicine group and 39 (54.1%) in the control group developed overt nephropathy (hazard ratio, 1.066; 95% confidence interval, 0.679‐1.673; P = .78). Compared with placebo, colchicine modestly lowered levels of NRCI parameters ( P values <.05 for high‐sensitivity C‐reactive protein, white blood cell counts, neutrophil counts, and neutrophil‐to‐lymphocyte ratio), whereas the changes of UACR and estimated glomerular filtration rate (eGFR) were similar between the two groups. There were no significant differences between the two groups in drug‐related adverse events, including infection, gastrointestinal symptoms, and limb numbness. Conclusions In patients with T2D with microalbuminuria, low‐dose colchicine effectively and safely lowered NRCI but did not prevent the incidence of overt nephropathy.