Roan Jun-Neng, Lin Wei-Hung, Tsai Meng-Ta, Kuo Te-Hui, Lin Ting-Wei, Chen Di-Yung, Fang Shih-Yuan, Hsieh Ya-Ping, Li Chung-Yi, Lam Chen-Fuh
Department of Surgery, Division of Cardiovascular Surgery.
Medical Device Innovation Center.
Acta Cardiol Sin. 2021 Jan;37(1):18-29. doi: 10.6515/ACS.202101_37(1).20200703B.
Very limited therapeutic strategies exist to prevent the primary failure of arteriovenous (AV) fistulas in patients with diabetes.
To investigate whether rosuvastatin could improve the primary patency of AV fistulas in diabetic patients with stage 5 chronic kidney disease (CKD).
This was a double-blind randomized clinical trial. From July 2012 to September 2018, patients aged between 18 and 65 years with type 2 diabetes and stage 5 CKD were randomized to receive placebo or rosuvastatin (5 mg/day) for 7 days prior to the creation of an AV fistula on the forearm until the 21 day after surgery. Patients were followed up for 180 days after the operation. The primary composite endpoint was the development of fistula immaturity or stenosis. The secondary endpoints were changes in inflammatory markers, oxidative stress, and occurrence of postoperative complications.
A total of 60 patients were enrolled in the study. Rosuvastatin resulted in a 20% reduction in total cholesterol from postoperative day 0 to 28 (p = .0006). The overall rate of AV fistula failure (immaturity or stenosis) was 30%, with no significant difference between patients receiving rosuvastatin and those receiving the placebo (33.3% vs. 26.7%, p = .5731). Although not statistically significant, the administration of rosuvastatin might have increased the incidence of postoperative complications (2.99 vs. 2.39 event rate per 1000 patient-days; odds ratio, 1.33; p = .5986).
Rosuvastatin showed no significant beneficial effects on the primary patency of AV fistulas in diabetic patients with stage 5 CKD, but might have been associated with the risk of drug-related complications.
对于预防糖尿病患者动静脉（AV）内瘘的原发性失败，可用的治疗策略非常有限。
探讨瑞舒伐他汀是否能改善5期慢性肾脏病（CKD）糖尿病患者AV内瘘的原发性通畅情况。
这是一项双盲随机临床试验。2012年7月至2018年9月，年龄在18至65岁之间的2型糖尿病和5期CKD患者被随机分为两组，在在前臂建立AV内瘘前7天接受安慰剂或瑞舒伐他汀（5毫克/天）治疗，持续至术后21天。术后对患者进行180天的随访。主要复合终点是内瘘未成熟或狭窄的发生。次要终点是炎症标志物、氧化应激的变化以及术后并发症的发生情况。
共有60名患者纳入研究。瑞舒伐他汀使术后第0天至28天的总胆固醇降低了20%（p = 0.0006）。AV内瘘失败（未成熟或狭窄）的总体发生率为30%，接受瑞舒伐他汀治疗的患者与接受安慰剂治疗的患者之间无显著差异（33.3%对26.7%，p = 0.5731）。尽管无统计学意义，但使用瑞舒伐他汀可能增加了术后并发症的发生率（每1000患者日的事件发生率分别为2.99和2.39；优势比为1.33；p = 0.5986）。
瑞舒伐他汀对5期CKD糖尿病患者AV内瘘的原发性通畅情况无显著有益影响，但可能与药物相关并发症的风险有关。
