上海交通大学学报(医学版) ›› 2026, Vol. 46 ›› Issue (6): 759-769.doi: 10.3969/j.issn.1674-8115.2026.06.008

• 论著 · 临床研究 • 上一篇    

腹膜透析患者应用艾考糊精腹透液的临床获益及心血管风险分析

冯琳鸿1, 吴迪1, 朱迎春1, 许佳瑞2, 张翀3, 王亚琨1,3()   

  1. 1.复旦大学附属中山医院青浦分院肾内科,上海 201700
    2.复旦大学附属中山医院肾内科,上海 200032
    3.上海交通大学医学院附属新华医院肾内科,上海 200092
  • 收稿日期:2025-09-10 接受日期:2026-01-12 出版日期:2026-06-28 发布日期:2026-06-29
  • 通讯作者: 王亚琨,副主任医师,硕士;电子信箱:kyky1818@163.com
  • 基金资助:
    上海市青浦区科学技术委员会长三角数字干线青浦区科技发展基金(QKY2023-13);上海市青浦区卫健系统第五轮学科建设和人才培养(XD2023-7);上海市健康科普青年英才能力提升专项(JKKPYC-2023-A19)

Clinical benefits of icodextrin-based peritoneal dialysis solution and its impact on cardiovascular risk in patients undergoing peritoneal dialysis

Feng Linhong1, Wu Di1, Zhu Yingchun1, Xu Jiarui2, Zhang Chong3, Wang Yakun1,3()   

  1. 1.Department of Nephrology, Qingpu Branch of Zhongshan Hospital, Fudan University, Shanghai 201700, China
    2.Department of Nephrology, Zhongshan Hospital, Fudan University, Shanghai 200032, China
    3.Department of Nephrology, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200092, China
  • Received:2025-09-10 Accepted:2026-01-12 Online:2026-06-28 Published:2026-06-29
  • Contact: Wang Yakun, E-mail: kyky1818@163.com.
  • Supported by:
    Science and Technology Development Fund of Qingpu District, Yangtze River Delta Digital Corridor, Science and Technology Commission of Qingpu District in Shanghai(QKY2023-13);The Fifth Round of Discipline Construction and Talent Training Project of Qingpu District Health System in Shanghai(XD2023-7);Youth Talent Capacity Improvement Project for Shanghai Health Science Popularization(JKKPYC-2023-A19)

摘要:

目的·探讨腹膜透析(腹透)患者使用艾考糊精腹透液(icodextrin-based peritoneal dialysis solution,ICO)的临床获益,分析ICO对腹透患者主要不良心血管事件(major adverse cardiovascular event,MACE)发生率等的影响。方法·该研究为多中心、前瞻性、随机对照临床研究。纳入2023年1月至2024年1月3家临床中心的120例腹透患者作为研究对象,按照1∶2随机对照分组,分为ICO组40例和对照组80例:ICO组患者每日白天使用1.5%或2.5%葡萄糖腹透液,夜间使用7.5% ICO留腹8~12 h;对照组患者每日白天使用1.5%或2.5%葡萄糖腹透液,夜间使用2.5%葡萄糖腹透液留腹8~12 h。干预期为12个月。收集患者的基本信息,以及干预前后实验室指标、人体多余水分(overhydration,OH)值、腹膜平衡试验结果、超声心动图指标等,记录2组患者的MACE、住院和死亡情况。采用Kaplan-Meier生存曲线比较2组MACE发生率、住院率、全因死亡率和心血管疾病死亡率的差异。使用多因素Cox回归分析腹透患者发生MACE的相关因素。结果·经过12个月的干预,ICO组的空腹血糖、糖化血红蛋白、体质量指数、OH值和N末端B型钠尿肽前体(N-terminal pro-B-type natriuretic peptide,NT-proBNP)均显著低于对照组(均P<0.05),ICO组的24 h超滤量、残肾Kt/V(residual urea clearance index,r-Kt/V)、总Kt/V(total urea clearance index,t-Kt/V)均显著高于对照组(均P<0.05);心脏超声结果显示ICO组的左心室舒张末期内径(left ventricular end-diastolic diameter,LVEDd)和左心室心肌质量指数(left ventricular mass index,LVMI)均显著低于对照组(均P<0.05),左室射血分数(left ventricular ejection fraction,LVEF)显著高于对照组(P<0.05)。Kaplan-Meier生存曲线分析结果显示:ICO组的心血管疾病死亡率(Log-rank P=0.048)及MACE发生率(Log-rank P=0.043)均显著低于对照组;2组全因死亡率及住院率差异无统计学意义。多因素Cox回归分析显示,既往存在心血管疾病(HR=1.57,95%CI 1.07~2.33,P=0.035)、腹膜高转运(HR=1.65,95%CI 1.08~2.89,P=0.045)以及高NT-proBNP(HR=1.38,95%CI 1.13~2.89,P=0.013)是腹透患者发生MACE的危险因素,使用ICO(HR=0.35,95%CI 0.17~0.89,P=0.012)是其保护性因素。结论·ICO可改善腹透患者的糖代谢、减轻容量负荷、提高透析充分性,并减少腹透患者MACE发生率及心血管疾病死亡率。

关键词: 艾考糊精腹透液, 腹膜透析, 主要不良心血管事件, 危险因素

Abstract:

Objective ·To evaluate the clinical benefits of icodextrin-based peritoneal dialysis solution (ICO) in patients undergoing peritoneal dialysis (PD), and analyze its impact on the incidence of major adverse cardiovascular events (MACE). Methods ·This multicenter, prospective, and randomized controlled trial enrolled 120 patients undergoing PD from three clinical centers between January 2023 and January 2024. The participants were randomly assigned in a 1:2 ratio to the ICO group (n=40) or the control group (n=80). Patients in the ICO group received 1.5% or 2.5% glucose-based PD solution during the day and a nightly 8‒12 h dwell of 7.5% ICO. Patients in the control group received 1.5% or 2.5% glucose-based PD solution during the day and a once-daily 8‒12 h dwell of 2.5% glucose-based PD solution. The intervention period was 12 months. Demographic data of the patients were collected, as well as laboratory parameters, overhydration (OH) values, peritoneal equilibration test results, and echocardiographic parameters before and after the intervention. The incidences of MACE, hospitalization, and death were recorded in both groups. Kaplan-Meier survival curves were used to compare the differences in MACE incidence, hospitalization rate, all-cause mortality, and cardiovascular mortality between the two groups. Multivariable Cox regression analysis was performed to identify factors associated with MACE in patients undergoing PD. Results ·After 12 months of intervention, the ICO group showed significantly lower levels of fasting blood glucose, glycated hemoglobin, body mass index, OH values, and N-terminal pro-B-type natriuretic peptide (NT-proBNP) compared with the control group (all P<0.05). The ICO group also had significantly higher 24-h ultrafiltration volume, residual renal Kt/V (r-Kt/V), and total Kt/V (t-Kt/V) than the control group (all P<0.05). Echocardiographic data revealed that the ICO group had significantly lower left ventricular end-diastolic diameter (LVEDd) and left ventricular mass index (LVMI) (both P<0.05), and significantly higher left ventricular ejection fraction (LVEF) (P<0.05) compared with the control group. Kaplan-Meier survival analysis showed that the ICO group had significantly lower cardiovascular mortality (Log-rank P=0.048) and MACE incidence (Log-rank P=0.043) than the control group. No significant differences were observed in all-cause mortality or hospitalization rate between the two groups. Multivariable Cox regression analysis identified pre-existing cardiovascular disease (HR=1.57, 95%CI 1.07‒2.33, P=0.035), high peritoneal transport status (HR=1.65, 95%CI 1.08‒2.89, P=0.045), and elevated NT-proBNP levels (HR=1.38, 95%CI 1.13‒2.89, P=0.013) as independent risk factors for MACE in patients undergoing PD, while the use of ICO (HR=0.35, 95%CI 0.17‒0.89, P=0.012) was identified as a protective factor. Conclusion ·ICO improves glucose metabolism, alleviates volume overload, enhances dialysis adequacy, and reduces the incidence of MACE and cardiovascular mortality in patients undergoing PD.

Key words: icodextrin-based peritoneal dialysis solution, peritoneal dialysis, major adverse cardiovascular event (MACE), risk factor

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