长期低剂量阿司匹林治疗与2型糖尿病患者肾功能不全有关吗？JPAD2队列研究。
Is Long-Term Low-Dose Aspirin Therapy Associated with Renal Dysfunction in Patients with Type 2 Diabetes? JPAD2 Cohort Study.
作者信息
Okada Sadanori, Morimoto Takeshi, Ogawa Hisao, Sakuma Mio, Soejima Hirofumi, Nakayama Masafumi, Jinnouchi Hideaki, Waki Masako, Akai Yasuhiro, Ishii Hitoshi, Saito Yoshihiko
机构信息
Department of Diabetology, Nara Medical University, Kashihara, Nara, Japan.
First Department of Internal Medicine, Nara Medical University, Kashihara, Nara, Japan.
出版信息
PLoS One. 2016 Jan 25;11(1):e0147635. doi: 10.1371/journal.pone.0147635. eCollection 2016.
BACKGROUND
Low-dose aspirin is widely recommended for patients at high risk for cardiovascular disease (CVD); however, it remains uncertain whether long-term treatment adversely affects renal function in patients with diabetes. We investigated whether long-term low-dose aspirin affects renal dysfunction in patients with diabetes.
METHODS
We conducted a randomized controlled trial (RCT), the Japanese Primary Prevention of Atherosclerosis with Aspirin for Diabetes (JPAD) trial, to evaluate low-dose aspirin as primary prevention for CVD in patients with type 2 diabetes. We followed the patients with negative urine dipstick albumin of the JPAD trial in a cohort study after the RCT period was completed. Patients were randomly allocated to receive aspirin (81 mg or 100 mg daily, aspirin group) or no aspirin (no aspirin group). After the RCT, the treating physician decided whether to administer aspirin. We evaluated the incidence of positive urine dipstick albumin and annual changes in estimated glomerular filtration rate (eGFR).
RESULTS
Positive urine dipstick albumin developed in 297 patients in the aspirin group (n = 1,075) and 270 patients in the no aspirin group (n = 1,098) during follow-up (median, 8.5 years). Intention-to-treat analysis showed low-dose aspirin did not increase the incidence of positive urine dipstick albumin (hazard ratio [HR], 1.17; 95% confidence interval [CI], 0.995-1.38). On-treatment analysis yielded similar results (HR, 1.08; 95% CI, 0.92-1.28). Multivariable analysis showed the incidence of positive urine dipstick albumin was higher among the elderly and those with elevated serum creatinine, high hemoglobin A1c, or high blood pressure; however, low-dose aspirin did not increase the risk of positive urine dipstick albumin. There were no significant differences in annual changes in eGFR between the groups (aspirin, -0.8 ± 2.9; no aspirin, -0.9 ± 2.5 ml/min/1.73 m(2)/year).
CONCLUSION
Long-term low-dose aspirin does not affect eGFR and positive urine dipstick albumin in patients with type 2 diabetes.
背景
低剂量阿司匹林被广泛推荐用于心血管疾病（CVD）高危患者；然而，长期治疗是否会对糖尿病患者的肾功能产生不利影响仍不确定。我们调查了长期低剂量阿司匹林是否会影响糖尿病患者的肾功能不全。
方法
我们进行了一项随机对照试验（RCT），即日本阿司匹林用于糖尿病的动脉粥样硬化一级预防（JPAD）试验，以评估低剂量阿司匹林作为2型糖尿病患者CVD一级预防的效果。在RCT期结束后，我们在一项队列研究中对JPAD试验中尿试纸白蛋白阴性的患者进行了随访。患者被随机分配接受阿司匹林（每日81毫克或100毫克，阿司匹林组）或不接受阿司匹林（无阿司匹林组）。RCT后，治疗医生决定是否给予阿司匹林。我们评估了尿试纸白蛋白阳性的发生率以及估计肾小球滤过率（eGFR）的年度变化。
结果
在随访期间（中位数为8.5年），阿司匹林组（n = 1075）有297例患者出现尿试纸白蛋白阳性，无阿司匹林组（n = 1098）有270例患者出现尿试纸白蛋白阳性。意向性分析显示，低剂量阿司匹林并未增加尿试纸白蛋白阳性的发生率（风险比[HR]，1.17；95%置信区间[CI]，0.995 - 1.38）。治疗中分析得出了类似结果（HR，1.08；95% CI，0.92 - 1.28）。多变量分析显示，老年人以及血清肌酐升高、糖化血红蛋白高或血压高的患者尿试纸白蛋白阳性的发生率较高；然而，低剂量阿司匹林并未增加尿试纸白蛋白阳性的风险。两组之间eGFR的年度变化无显著差异（阿司匹林组，-0.8 ± 2.9；无阿司匹林组，-0.9 ± 2.5 ml/min/1.73 m²/年）。
结论
长期低剂量阿司匹林对2型糖尿病患者的eGFR和尿试纸白蛋白阳性无影响。
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