中国临床药理学杂志2025，Vol.41Issue(20)：2881-2886,6.DOI:10.13699/j.cnki.1001-6821.2025.20.006
罗沙司他联合左卡尼汀治疗组合式血液灌流联合血液透析肾衰竭患者的临床研究
Clinical trial of roxadustat combined with levocarnitine in hemoperfusion combined with hemodialysis renal failure patients
摘要
Abstract
Objective To observe the clinical efficacy of roxadustat capsules combined with levocarnitine injection in patients with renal failure undergoing combined hemoperfusion(HP)and hemodialysis(HD).Methods Patients with chronic renal failure were randomly divided into control group and treatment group using a random number table method.The control group was treated with HP+HD combined with intravenous levocarnitine(1.0 g per session,3 times per week).On the basis of control group,treatment group received additional oral roxadustat capsules.The starting dose was selected according to the patient's body weight:100 mg per dose(45-60 kg)or 120 mg per dose(≥60 kg),3 times per week,with dose adjustments made every 4 weeks.The total course of treatment was 12 weeks.The renal function parameters,nutritional status indicators,iron metabolism-related indices,medical research council(MRC)scores and clinical efficacy were compared between the two groups,and the safety was assessed.Results A total of 165 patients who met the preliminary screening criteria were screened for this study.According to the inclusion and exclusion criteria,17 ineligible patients were excluded,resulting in 148 patients being ultimately enrolled.These participants were randomly assigned to either the treatment group or the control group,with 74 patients in each.No dropouts occurred in either group during the trial.After treatment,the levels of serum creatinine(Scr)in the control group and the treatment group were(338.46±35.69)and(321.94±49.87)mL·min-1,respectively;the albumin(ALB)levels were(35.74±5.32)and(38.12±6.07)g·L-1,respectively;the hemoglobin(HB)levels were(112.26±11.79)and(118.17±8.16)g·L-1,respectively;the HB compliance rates were 60.81％and 82.43％,respectively;the serum iron(SI)levels were(13.85±2.87)and(15.34±2.93)μmol·L-1,respectively;the serum ferritin(SF)levels were(328.87±54.36)and(351.87±42.74)ng·mL-1,respectively;the transferrin saturation(TSAT)levels were(28.97±6.29)％and(32.17±6.75)％,respectively;and the MRC total scores were(49.20±8.77)and(53.26±6.91)points,respectively.The treatment group demonstrated statistically significantly greater improvement in the aforementioned indices compared to control group(P＜0.05,P＜0.01).The main adverse drug reactions of treatment group were nausea and vomiting,elevated blood pressure,muscle spasm and diarrhea;the control group had nausea and vomiting,elevated blood pressure,headache,muscle spasm and diarrhea.The total incidence of adverse drug reactions in treatment group and control group were 9.46％and 12.16％,respectively,with no statistically significant difference(P＞0.05).Conclusion The combination of roxadustat capsules and levocarnitine injection effectively reduces renal impairment,improves nutritional and iron status,alleviates muscle weakness,and is well-tolerated in chronic renal failure patients undergoing combined HP+HD therapy.关键词
罗沙司他胶囊/左卡尼汀注射液/慢性肾衰竭/营养状态/肌无力Key words
roxadustat capsule/levocarnitine injection/chronic renal failure/nutritional status/myasthenia分类
医药卫生引用本文复制引用
FENG Ji,YANG Wen,WEI Zhi-feng,LIU Shu-ting,WEN Hong-mei,SUN Yi-bing..罗沙司他联合左卡尼汀治疗组合式血液灌流联合血液透析肾衰竭患者的临床研究[J].中国临床药理学杂志,2025,41(20):2881-2886,6.基金项目
河北省卫生健康委员会科研基金资助项目(20231438) （20231438）
