中国临床药理学杂志

目的 观察罗沙司他胶囊联合多维度运动康复训练对老年血透患者微炎症及血管内皮功能的临床疗效和安全性。方法 将规律透析且服用罗沙司他胶囊的老年患者依据随机数表法分为试验组和对照组。对照组患者口服罗沙司他胶囊。试验组患者在此基础上联合多维运动康复训练。罗沙司他胶囊:体重低于60 kg者，每次100 mg;体重高于60 kg者，每次120 mg;每周3次。多维运动康复训练在透析过程中进行，每周3次，每次70 min;包括抗阻运动、有氧运动及正念冥想训练。2组治疗时长为6个月。对2组的临床疗效、微炎症因子、内皮功能指标和生化指标进行对比，并进行安全性评价。结果 本研究共入组235例，试验组115例，对照组120例。治疗后，试验组和对照组的总有效率分别为90.43%(104例/115例)和79.17%(95例/120例);非糖尿病患者总有效率分别为94.38%(84例/89例)和80.65%(75例/93例)，在统计学上差异均有统计学意义(均P<0.05)。治疗后，试验组和对照组的血清核转录因子(NF-κB)分别为(24.78±4.67)和(36.09±4.25) ng·L^-1，白介素-6(IL-6)分别为(25.38±4.24)和(28.47±4.62 ) ng·L^-1，干扰素-γ(IFN-γ)分别为(40.66±4.89)和(50.01±5.95) ng·L^-1，血清内皮素-1(ET-1)分别为(87.41±26.59)和(120.70±28.52) ng·L^-1，可溶性血管细胞粘附分子-1(s VCAM-1)分别为(2 848.50±84.75)和(5 639.82±125.63)μg·L^-1，血浆内皮细胞微颗粒(EMP)分别为每微升(95.43±20.19)和(110.55±26.78)个，上述指标在2组间比较，在统计学上差异均有统计学意义(均P<0.05)。试验组和对照组的药物不良反应主要为恶心呕吐、消化不良、乏力。试验组和对照组的药物不良反应总发生率分别为11.30%(13例/115例)和11.67%(14例/120例)，在统计学上差异无统计学意义(P >0.05)。结论 罗沙司他胶囊及多维运动康复训练治疗老年血透患者微炎症及血管内皮功能障碍的疗效显著，能够降低微炎症反应，改善血管内皮功能，优于单药罗沙司他胶囊的效果，且安全性良好。

Objective To investigate the effects of roxadustat capsules combined with multi-dimensional exercise rehabilitation training on microinflammation and vascular endothelial function in elderly hemodialysis patients.Methods Elderly patients who underwent regular dialysis and took roxadustat capsules were randomly divided into the treatment group and the control group according to the random number table.Patients in the control group took roxadustat capsules.Patients in the treatment group were given roxadustat capsules combined with multidimensional exercise rehabilitation training.For those weighing less than 60 kg,treated with roxadustat capsules 100 mg per time; for those weighing more than 60 kg,took roxadustat capsules 120 mg each time; three times a week.The multidimensional exercise included resistance exercise,aerobic exercise,and mindfulness meditation during dialysis,3 times per week,70 minutes each session,lasting 6 months.Clinical efficacy,microinflammatory factor indicators,endothelial function indicators,biochemical indicators,and adverse drug reactions were collected before and after the study.Results A total of 235 cases were enrolled in this study.The treatment group included 115 cases.The control group included 120 cases.After the treatment,the total effective rates of the treatment group and the control group were90.43%( 104 cases/115 cases) and 79.17%( 95 cases/120 cases),respectively,and the difference was statistically significant( P < 0.05).The total effective rate in the non-diabetic patients of the treatment group was94.38%( 84 cases/89 cases),significantly higher than the 80.65%( 75 cases/93 cases) in the diabetic patients of the treatment group( P < 0.05).After treatment,the levels of serum nuclear transcription factor( NF-κB) in the treatment and the control groups were( 24.78 ± 4.67) and( 36.09 ± 4.25) ng ·L^-1,respectively; interleukin-6( IL-6) levels were( 25.38 ±4.24) and( 28.47 ±4.62) ng·L^-1; interferon-γ( IFN-γ) levels were( 40.66 ±4.89)and( 50.01 ± 5.95) ng·L^-1; serum endothelin-1( ET-1) levels were( 87.41 ± 26.59) and( 120.70 ± 28.52)ng · L^-1; soluble vascular cell adhesion molecule-1( s VCAM-1) levels were( 2 848.50 ± 84.75) and( 5 639.82 ± 125.63) μg·L^-1; and plasma endothelial microparticles( EMP) counts were( 95.43 ± 20.19) and( 110.55 ± 26.78) per μL,respectively.The above indicators in the treatment group were statistically significantly different from those in the control group( all P < 0.05).The main adverse drug reactions in the treatment group and the control group were nausea,vomiting,indigestion and fatigue.The total incidence of adverse drug reaction rates in the treatment group and the control group were 11.30%( 13 cases/115 cases) and 11.67%( 14 cases/120 cases),respectively.There was no statistically significant difference( P > 0.05).Conclusion Roxadustat capsules combined with multidimensional exercise rehabilitation training has shown significant efficacy in microinflammation and vascular endothelial dysfunction in elderly hemodialysis patients,which can reduce microinflammatory responses and improve vascular endothelial function,outperforming the effects of roxadustat capsules alone,with good safety.