不同剂量环硅酸锆钠快速纠正肾移植等待人群围手术期高钾血症的疗效和安全性

Short-term efficacy and safety of different doses of sodium zirconium cyclosilicate on potassium reduction in patients with hyperkalemia in the perioperative period of kidney transplantation

目的探讨不同剂量环硅酸锆钠(SZC)快速纠正不同血钾水平的肾移植等待人群围手术期高钾血症的疗效和安全性。方法采用前瞻性研究,选取2023年6月至2024年1月于南方医科大学南方医院服用SZC治疗高钾血症(随机静脉血钾>5.0mmol/L)的患者。纳入标准:①诊断为慢性肾脏病(CKD)5期的首次肾移植术等待患者;②年龄18~65岁;③血清钾5.0~7.0mmol/L排除标准:①联合其他降钾治疗者;②妊娠或哺乳期妇女;③经研究者判断认为不适合参与本试验的患者。采用随机数字表法,随机予3种剂量(5g、10g、15g)SZC,分别于服药后0.5、1、2、3、4h检测静脉血钾,记录服药后4h内血钾降低幅度和恢复正常例数,观察不良反应发生情况。根据基线血钾水平将患者分为轻度高钾组(血钾5.0~5.5mmol/L)和中重度高钾组(血钾≥5.5mmol/L),记录两组服药后4h内血钾降低幅度和恢复正常例数。分析服药剂量、基线血钾水平与服药后4h血钾恢复情况的相关性。记录患者是否出现水肿、胃肠道症状等,评估药物安全性。结果本研究纳入34例患者,5g组10例,10g组13例,15g组11例,3组的年龄[(41.90±11.51)岁与(44.15±10.51)岁与(42.91±10.78)岁]、性别比(男/女:9/1例与9/4例与8/3例)、体质量指数[(23.08±3.54)kg/m^(2)与(23.03±2.92)kg/m^(2)与(23.47±2.99)kg/m^(2)]、估算肾小球滤过率[(4.80±2.13)ml/(min·1.73m^(2))与(5.26±1.14)ml/(min·1.73m^(2))与(4.85±1.48)ml/(min·1.73m^(2))、基线血钾[(5.65±0.43)mmol/L与(5.59±0.25)mmol/L与(5.94±0.64)mmol/L]差异均无统计学意义(P>0.05)。服药后4h,5、10、15g组的血钾水平分别为(5.20±0.65)、(5.03±0.35)、(5.10±0.46)mmol/L,与基线相比差异均有统计学意义(P<0.05);3组分别有3例(30.0%)、5例(38.5%)5例(45.5%)血钾恢复正常,差异无统计学意义(χ^(2)=0.530,P=0.904)。轻度高钾组12例,中重度高钾组22例,两组的年龄[(43.83±9.38)岁与(42.73±11.30)岁]、性别比(男/女:11/1例与15/7例)、体质量指数(24.27±2.69)kg/m^(2)与(22.35±2.89)kg/m^(2)]、估算肾小球滤过率[(4.89±1.39)ml/(min1.73m^(2))与(5.21±1.68)ml/(min·1.73m^(2))]和服药剂量(5g/10g/15g:4/4/4例与6/9/7例)差异无统计学意义(P>0.05)。服药后4h,轻度高钾组和中重度高钾组分别有9例(75.0%)和4例(18.2%)血钾恢复正常,差异有统计学意义(χ^(2)=10.614,P=0.002)。服药后4h血钾是否恢复正常与基线血钾显著相关(r=0.483,P=0.001),与服药剂量无显著相关性(r=0.118,P=0.474)。所有患者服药后4h内均未发生低钾血症、水肿、恶心、呕吐等不良反应。结论SZC用于并发轻度高钾血症的肾移植围手术期患者安全、有效,可达到4h内快速降低血钾水平的目的。

Objective To investigate the efficacy and safety of different doses of sodium zirconium cyclosilicate(SZC)in the rapid correction of hyperkalemia in patients with different blood potassium levels in the perioperative period of kidney transplantation.Methods A prospective study waw performed to select patients admitted to Nanfang Hospital from June 2023 to January 2024.Inclusion criteria:Patients with chronic kidney disease stage 5;@Patients aged 18 to 65 years old;@Serum potassium is between 5.0 mmol/L and 7.0 mmol/L.Exclusion criteria:OCombined with other potassium reduction measures;②Pregnant woman or suckling period woman;Patients judged by the investigator as unsuitable for participation in this trial.Qualified patients were randomly given different doses(5g,10g,15g)of SZC by means of random number table.Venous potassium was measured at 0.5h,1h,2h,3h and 4h after medication and adverse effects were observed.In addition,patients were retrospectively divided into mild hyperkalemia group(serum potassium 5.0-5.5 mmol/L)and moderate/severe hyperkalemia group(serum potassium≥5.5 mmol/L)according to the baseline serum potassium.The extent of decrease of blood potassium and the number of people who recovered to normal within 4 hours afer medication in different dose groups,and the correlation between dosage,baseline potassium and recovery of blood potassium 4h after dosing were evaluated.Additionally,safety was evaluated by observing whether the patient had edema,gastrointestinal symptoms,etc.Results A total of 34 patients were enrolled,including 10 in 5g group,13 in 10g group,and 11 in 15g group.Among the three groups,age were[(41.90±11.51)years old vs.(44.15±10.51)years old vs.(42.91±10.78)years old],gender(male/female:9/1 cases vs.9/4 cases vs.8/3 cases),body mass index[(23.08±3.54)kg/m^(2)vs.(23.03±2.92)kg/m^(2)vs.(23.47±2.99)kg/m^(2)],estimated glomerular filtration rate[(4.80±2.13)ml/(min·1.73m^(2))vs.(5.26±1.14)ml/(min·1.73m^(2))vs.(4.85±1.48)ml/(min·1.73m)],baseline blood potassium[(5.65±0.43)mmol/L vs.(5.59±0.25)mmol/L vs.(5.94±0.64)mmol/L].There was no statistically significant difference among the three groups(P>0.05).The blood potassium levels decreased to(5.20±0.65)mmol/L vs.(5.03±0.35)mmol/L vs.(5.10±0.46)mmol/L in the three groups 4h after dosing,respectively,with statistically significant difference compared with baseline(P<0.05).In three(30.0%),five(38.5%)and five(45.5%)cases in the three groups respectively,serum potassium returned to normal(3.5-5.0 mmol/L)4 hours after medication,with no statistically significant diference(χ^(2)=0.530,P=0.904).Mild hyperkalemia group includes 12 cases while moderate/severe hyperkalemia group includes 22 cases.For the two groups,age were[(43.83±9.38)years old vs.(42.73±11.30)years old],gender(male/female:11/1 cases vs.15/7 cases),body mass index[(24.27±2.69)kg/m^(2)vs.(22.35±2.89)kg/m^(2)],estimated glomerular filtration rate[(4.89±1.39)ml/(min·1.73m^(2))vs.(5.21±1.68)ml/(min.1.73m^(2))],and dosage(5g/10g/15g:4/4/4 cases vs.6/9/7cases).There was no statistically significant difference between the two groups(P>0.05).In nine(75.0%)and four(18.2%)cases in the two groups respectively,serum potassium returmned to normal 4 hours after medication,with statistically significant diference(χ^(2)=10.614,P-0.002).Whether blood potassium level returned to normal 4 hours after medication was significantly related to the baseline potassium level(r=0.483,P=0.001),but not to the dosage(r=0.118,P=0.474).No adverse effects such as hypokalemia,edema,nausea or vomiting occurred in all patients.Conclusions SZC can be safely and effectively applied to patients with mild hyperkalemia in the perioperative period of kidney transplantation to achieve rapid potassium reduction within 4 hours.