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柠檬酸钠与碳酸氢钠治疗慢性肾脏病患者代谢性酸中毒的随机对照试验。

Sodium citrate versus sodium bicarbonate for metabolic acidosis in patients with chronic kidney disease: A randomized controlled trial.

机构信息

"Carol Davila" University of Medicine and Pharmacy, Department of Nephrology, Bucharest, Romania.

Fundeni Clinical Institute, Department of Kidney Transplantation, Bucharest, Romania.

出版信息

Medicine (Baltimore). 2024 Mar 8;103(10):e37475. doi: 10.1097/MD.0000000000037475.

Abstract

BACKGROUND

Metabolic acidosis (MA) is frequently associated with chronic kidney disease (CKD) progression. Our aim was to compare the effect of oral sodium citrate (SC) with that of oral sodium bicarbonate (SB) on renal function and serum bicarbonate correction, as well as to evaluate their safety profile in patients with MA of CKD.

METHODS

We conducted a prospective, single-center, randomized 1:1, parallel, controlled, unblinded clinical trial of 124 patients with MA and CKD stages 3b and 4. The primary outcome was the mean change in estimated glomerular filtration rate (eGFR). The secondary outcomes were mean change in serum bicarbonate level, eGFR decrease by 30%, eGFR decrease by 50%, dialysis, death or prolonged hospitalization, and a combined endpoint.

RESULTS

No significant difference was found between the groups in terms of mean eGFR change [adjusted mean difference = -0.99 mL/min/1.73 m2 (95% CI: -2.51 to 0.93, P = .20)]. We observed a mean serum bicarbonate change of 6.15 mmol/L [(95% CI: 5.55-6.74), P < .001] in the SC group and of 6.19 mmol/L [(95% CI: 5.54-6.83), P < .001] in the SB group, but no significant difference between the 2 groups [adjusted mean difference = 0.31 mmol/L (-0.22 to 0.85), P = .25]. Cox proportional hazard analysis showed similar risks regarding eGFR decrease by 30% (P = .77), eGFR decrease by 50% (P = .50), dialysis (P = .85), death or prolonged hospitalization (P = .29), and combined endpoint (P = .57). Study drug discontinuation due to adverse events was significantly more common in the SB group (17.7% vs 4.8%, P = .02).

CONCLUSIONS

SC and SB have a similar effect on kidney function decline, both improve serum bicarbonate level, but SB is associated with higher rates of medication discontinuation due to adverse events.

摘要

背景

代谢性酸中毒(MA)常与慢性肾脏病(CKD)进展有关。我们的目的是比较口服柠檬酸钠(SC)和碳酸氢钠(SB)对肾功能和血清碳酸氢盐纠正的影响,并评估它们在 MA 合并 CKD 患者中的安全性。

方法

我们进行了一项前瞻性、单中心、随机、1:1、平行、对照、非盲临床试验,纳入了 124 名 MA 合并 CKD 3b 和 4 期患者。主要结局是估算肾小球滤过率(eGFR)的平均变化。次要结局是血清碳酸氢盐水平的平均变化、eGFR 下降 30%、eGFR 下降 50%、透析、死亡或延长住院时间以及联合终点。

结果

两组在 eGFR 平均变化方面无显著差异[调整平均差异=-0.99 mL/min/1.73 m2(95%CI:-2.51 至 0.93,P=0.20)]。我们观察到 SC 组的血清碳酸氢盐平均变化为 6.15 mmol/L(95%CI:5.55-6.74,P<0.001),SB 组为 6.19 mmol/L(95%CI:5.54-6.83,P<0.001),但两组间无显著差异[调整平均差异=0.31 mmol/L(-0.22 至 0.85),P=0.25]。Cox 比例风险分析显示,eGFR 下降 30%(P=0.77)、eGFR 下降 50%(P=0.50)、透析(P=0.85)、死亡或延长住院时间(P=0.29)和联合终点(P=0.57)的风险相似。由于不良事件,SB 组研究药物停药的发生率明显高于 SC 组(17.7%比 4.8%,P=0.02)。

结论

SC 和 SB 对肾功能下降的影响相似,均可改善血清碳酸氢盐水平,但 SB 因不良事件导致药物停药的发生率更高。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9d70/10919529/4a0153aebefb/medi-103-e37475-g001.jpg

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