中国临床药理学杂志

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

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冯季 ^a , 杨文 ^a , 卫志锋 ^b , 刘淑婷 ^a , 温红梅 ^a , 孙亦兵 ^a

中国临床药理学杂志 | 临床与基础桥接研究 2025,41(20): 2881-2886

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中国临床药理学杂志 |临床与基础桥接研究 2025 , 41 (20) : 2881 -2886

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

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冯季^a, 杨文^a, 卫志锋^b, 刘淑婷^a, 温红梅^a, 孙亦兵^a

作者信息

^a.河北北方学院附属第一医院血液净化科，河北张家口 075000

^b.河北北方学院附属第一医院肾内科，河北张家口 075000

通讯作者:

孙亦兵，副主任医师，硕士导师 MP: 15530396535 E-mail: fengji121212@163.com

作者简介:

冯季（1990-），女，主治医师，主要从事肾病血液净化方面的临床工作和研究

Clinical trial of roxadustat combined with levocarnitine in hemoperfusion combined with hemodialysis renal failure patients

Ji FENG^a, Wen YANG^a, Zhi-feng WEI^b, Shu-ting LIU^a, Hong-mei WEN^a, Yi-bing SUN^a

Affiliations

^a.Department of Blood Purification, The First Affiliated Hospital of Hebei North University, Zhangjiakou 075000, Hebei Province, China

^b.Department of Nephrology, The First Affiliated Hospital of Hebei North University, Zhangjiakou 075000, Hebei Province, China

出版时间: 2025-10-28 doi: 10.13699/j.cnki.1001-6821.2025.20.006

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摘要

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目的

观察罗沙司他胶囊联合左卡尼汀注射液对组合式血液灌流（HP）联合血液透析（HD）肾衰竭患者的临床疗效及安全性。

方法

将本院收治的慢性肾衰竭患者按随机数表法分为对照组和试验组。对照组治疗方案为HP+HD联合静脉注射左卡尼汀（每次1.0 g，每周3次），试验组在对照组基础上加用口服罗沙司他，根据患者体质量选择起始剂量，每次100 mg（45~60 kg）或每次120 mg（≥60 kg），每周3次，每4周调整1次用药剂量，总疗程为12周。比较2组患者的肾功能指标、营养状况相关指标、铁代谢相关指标、英国医学研究理事会评分法（MRC）评分和临床疗效，并进行安全性评价。

结果

本研究共筛选符合初筛条件的患者165例，依据纳入与排除标准排除不符合条件的患者17例，最终纳入148例，其中试验组和对照组各74例。实验过程中，2组均未发生脱落。治疗后，对照组与试验组患者的血清肌酐（Scr）水平分别为（338.46±35.69）和（321.94±49.87）μmol·L^-1，白蛋白（ALB）水平分别为（35.74±5.32）和（38.12±6.07）g·L^-1，血红蛋白（HB）水平分别为（112.26±11.79）和（118.17±8.16）g·L^-1，HB达标率分别为60.81%和82.43%，血清铁（SI）分别为（13.85±2.87）和（15.34±2.93）μmol·L^-1，血清铁蛋白（SF）分别为（328.87±54.36）和（351.87±42.74）ng·mL^-1，转铁蛋白饱和度（TSAT）分别为（28.97±6.29）%和（32.17±6.75）%，MRC总分分别为（49.20±8.77）和（53.26±6.91）分，试验组的上述指标均显著优于对照组（P<0.05，P<0.01）。试验组主要的药物不良反应有恶心呕吐、血压升高、肌肉痉挛和腹泻；对照组有恶心呕吐、血压升高、头痛、肌肉痉挛和腹泻。试验组和对照组的药物不良反应总发生率分别9.46%和12.16%，在统计学上差异无统计学意义（P>0.05）。

结论

罗沙司他胶囊联合左卡尼汀注射液能减轻接受组合式HP+HD慢性肾衰竭患者肾功能损伤，调节营养状态及铁代谢，改善肌无力症状，且安全性良好。

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

Abstract

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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.

Key words

roxadustat capsule / levocarnitine injection / chronic renal failure / nutritional status / myasthenia

引用本文

冯季, 杨文, 卫志锋, 刘淑婷, 温红梅, 孙亦兵. 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. 中国临床药理学杂志, 2025 , 41 (20) : 2881 -2886 . DOI: 10.13699/j.cnki.1001-6821.2025.20.006

Ji FENG, Wen YANG, Zhi-feng WEI, Shu-ting LIU, Hong-mei WEN, Yi-bing SUN. Clinical trial of roxadustat combined with levocarnitine in hemoperfusion combined with hemodialysis renal failure patients[J]. Chinese Journal of Clinical Pharmacology, 2025 , 41 (20) : 2881 -2886 . DOI: 10.13699/j.cnki.1001-6821.2025.20.006

基金

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河北省卫生健康委员会科研基金资助项目(20231438)

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2025年第41卷第20期

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doi: 10.13699/j.cnki.1001-6821.2025.20.006

接收时间：2025-05-14
首发时间：2026-08-07
出版时间：2025-10-28

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收稿日期：2025-05-14

基金

河北省卫生健康委员会科研基金资助项目(20231438)

作者信息

^a.河北北方学院附属第一医院血液净化科，河北张家口 075000

^b.河北北方学院附属第一医院肾内科，河北张家口 075000

通讯作者:

孙亦兵，副主任医师，硕士导师 MP: 15530396535 E-mail: fengji121212@163.com

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https://castjournals.cast.org.cn/joweb/zglcylxzz/CN/10.13699/j.cnki.1001-6821.2025.20.006

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2种不同金属材料的力学参数

科 Family	属数 Number of genus	种数 Number of species	占总种数比例 Percentage of total species (%)	属 Genus	种数 Number of species	占总种数比例 Percentage of total species (%)
鹅膏菌科Amanitaceae	2	11	5.26	鹅膏菌属 Amanita	10	4.78
小菇科 Mycenaceae	2	12	5.74	丝盖伞属 Inocybe	5	2.39
多孔菌科 Polyporaceae	8	14	6.70	蜡蘑属 Laccaria	5	2.39
红菇科 Russulaceae	3	23	11.00	小皮伞属 Marasmius	6	2.87
				小菇属 Mycena	11	5.26
				光柄菇属 Pluteus	5	2.39
				红菇属 Russula	17	8.13
				栓菌属 Trametes	5	2.39

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