达格列净治疗不同肾功能状态糖尿病肾脏疾病患者水肿的疗效与安全性分析

    Efficacy and safety of dapagliflozin on edema in patients with diabetic kidney disease at differential status of renal function

      摘要
    • 摘要:
      目的  评价达格列净治疗不同肾功能状态糖尿病肾脏疾病患者水肿的疗效性和安全性。
      方法  回顾性分析2020年1月1日至2021年6月31日武汉大学人民医院肾内科收治伴有水肿的糖尿病肾脏疾病患者相关资料，按照估算肾小球滤过率（estimated glomerular filtration rate，eGFR）水平分为三组：慢性肾脏病（chronic kidney disease，CKD）1～2期组eGFR≥60 mL·min−1·（1.73 m2）−1，n = 15，CKD 3期组60 mL·min−1·（1.73 m2）−1＞eGFR≥ 30 mL·min−1·（1.73 m2）−1，n = 18，CKD 4～5期组eGFR＜30 mL·min−1·（1.73 m2）−1，n = 23。所有患者均初次接受达格列净片口服治疗（10 mg，每日一次），根据水肿情况酌情联用利尿剂，记录住院期间及随访时期的水肿评分、24 h尿量、体重、尿糖、24 h尿钠、血肌酐、血尿素氮、eGFR、透析状态等指标。
      结果  入选患者年龄为（55.77 ± 1.67）岁，体重（70.45 ± 2.17）kg，水肿评分2.00（2.00，3.00）分，24 h尿量0.98（0.88，1.37）L，24 h尿钠（147.24 ± 7.48）mmol，尿糖阳性值1.00（0，2.00），eGFR（44.63 ± 4.06）mL·min−1·（1.73 m2）−1。与治疗前相比，治疗7 d后患者体重（70.45 ± 2.17）kg比（64.07 ± 1.55）kg，P＜0.001、水肿评分2.00（2.00，3.00）比1.00（1.00，1.00），P＜0.001均显著下降，24 h尿量0.98（0.88，1.37）L比2.50（2.28 ± 2.50）L，P＜0.001、24 h尿钠（147.24 ± 7.48）mmol比（271.79 ± 8.81）mmol，P＜0.001、尿糖指数1.00（0，2.00）比3.00（1.00，3.00），P＜0.001显著增加。随访3个月、6个月的水肿指数相较治疗7 d后无明显变化但均低于治疗前水平（均P＜0.001），3个月、6个月的体重相较治疗后7 d无明显变化但均明显低于治疗前水平（均P＜0.001），3个月、6个月的24 h尿量相较治疗后7 d无明显变化但均明显低于治疗前水平（均P＜0.05）。3个月、6个月的24 h尿量与治疗后7 d的差异无统计学意义。治疗后3个月、6个月的血肌酐相较治疗后7 d血肌酐无明显变化，但明显高于治疗前水平（均P＜0.01）。治疗6个月后的eGFR与治疗前eGFR差异有统计学意义（P＜0.01）。疗效分析显示不同肾功能状态组别治疗后7 d、3个月的疗效差异无统计学意义，治疗6个月后CKD 4～5期患者总体治疗有效率明显低于CKD 1～2期患者及CKD 3期患者（χ2 = 12.766，P = 0.002）。研究期间CKD 3期及CKD 4～5期患者心功能衰竭事件发生率均明显高于CKD 1～2期患者（均P＜0.01）。
      结论  对于伴有水肿的糖尿病肾脏疾病患者，达格列净联合利尿剂及白蛋白初始治疗7 d、3个月可显著改善水肿、降低体重、增加尿量，不同肾功能状态分组之间的疗效差异无统计学意义，随访6个月后CKD 4～5期患者的治疗有效率显著低于CKD 1～2期及CKD 3期。

       

      Abstract:
      Objective  To evaluate the efficacy and safety of dapagliflozin on edema in patients with diabetic kidney disease (DKD) at differential status of renal function.
      Methods  From January 1, 2020 to June 31, 2021, 56 patients with edema in presence of DKD on a daily oral dose of dapagliflozin 10 mg were reviewed retrospectively. According to the levels of estimated glomerular filtration rate (eGFR), they were assigned into three groups of chronic kidney disease (CKD) stage 1-2 (eGFR≥60 mL·min−1·(1.73m2)−1, n=15), CKD stage 3 (60 mL·min−1·(1.73m2)−1＞ eGFR≥ 30 mL·min−1·(1.73m2)−1, n=18) and CKD stage 4-5 (eGFR＜30 mL·min−1·(1.73m2)−1, n=23). Various doses of diuretics were added based upon the severity of edema. Edema score, 24 h urine volume, weight, urine glucose, 24 h urine sodium, blood creatinine, blood urea nitrogen, eGFR and dialysis status were accessed by a digital record system.
      Results  The baseline profiles were as follows: mean age (55.77±1.67)years, mean body weight (70.45±2.17)kg, mean edema score 2.00(2.00, 3.00), 24 h urine volume 0.98(0.88, 1.37)L, 24 h urine sodium (147.24±7.48)mmol, positive urine glucose value 1.00(0, 2.00) and mean eGFR (44.63±4.06)mL·min−1·(1.73m2)−1. In comparison to baseline levels, 7-day treatment lowered markedly weight (70.45±2.17)kg vs (64.07±1.55)kg, P<0.001 and edema score 2.00(2.00, 3.00) vs 1.00(1.00, 1.00), P<0.001. Whereas, 24 h urine volume 0.98(0.88, 1.37)L vs 2.50(2.28±2.50)L, P<0.001, 24 h urine sodium (147.24±7.48)mmol vs (271.79±8.81)mmol, P<0.001 and urinary glycemic index 1.00(0,2.00) vs 3.00(1.00, 3.00), P<0.001 spiked greatly. Follow-up data showed no significant change in edema index at Month 3/6 post-treatment as compared to that at Day 7 post-treatment (P<0.001). There was no significant change in weight at Month 3/6 post-treatment as compared to that at Day 7 post-treatment (P<0.001) and no significant change in 24 h urine volume at Month 3/6 post-treatment as compared to that at Day 7 post-treatment (P<0.05). And 24 h urine volume at Month 3/6 post-treatment was not statistically different from that at Day 7 post-treatment. Efficacy analysis revealed no statistically significant differences among groups with differential status of renal function at Day 7 and Month 3 post-treatment and overall treatment efficiency was significantly lower in patients with CKD stage 4-5 than that in those with CKD stage 1-2 and CKD stage 3 at Month 6 post-treatment (χ2=12.766, P=0.002). The incidence of heart failure events was significantly more frequent in CKD3/4-5 patients than in CKD1-2 counterparts during the study period (P<0.01).
      Conclusion  Initial treatment of dapagliflozin is effective and safe for improving edema and boosting urine volume in patients with DKD at CKD 1-5 stage within Month 3 post-treatment. At Month 6 post-treatment, dapagliflozin is less effective for correcting edema and heart failure status of DKD patients at CKD stage 4-5.

       

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