Effectiveness and Safety of Roxadustat for Renal Anemia in Dialysis-dependent Chronic Kidney Disease: a Meta-analysis

doi:10.12114/j.issn.1007-9572.2022.0581

Chinese General Practice ›› 2023, Vol. 26 ›› Issue (06): 704-710.DOI: 10.12114/j.issn.1007-9572.2022.0581

Special Issue: 泌尿系统疾病最新文章合辑；用药最新文章合辑

• Precision Medication·Renal Anemia • Previous Articles Next Articles

Effectiveness and Safety of Roxadustat for Renal Anemia in Dialysis-dependent Chronic Kidney Disease: a Meta-analysis

1. Department of Nephrology, First Affiliated Hospital of Kunming Medical University, Kunming 650032, China
2. Department of Medical Record, Kunming Third People's Hospital, Kunming 650032, China

Received:2022-07-21 Revised:2022-10-11 Published:2023-02-20 Online:2022-10-20
Contact: LI Qing
About author:
LI J Q, YANG Q, YUAN D L, et al. Effectiveness and safety of roxadustat for renal anemia in dialysis-dependent chronic kidney disease: a Meta-analysis[J]. Chinese General Practice, 2023, 26 (6) : 704-710.

罗沙司他治疗血液透析患者肾性贫血的有效性和安全性Meta分析

1．650032　云南省昆明市，昆明医科大学第一附属医院肾脏内科
2．650032　云南省昆明市第三人民医院病案科

通讯作者: 李青
作者简介:
李家青，杨晴，袁敦禄，等.罗沙司他治疗血液透析患者肾性贫血的有效性和安全性Meta分析[J].中国全科医学，2023，26（6）：704-710.[www.chinagp.net] 作者贡献：李家青负责研究的实施与可行性分析、文章的修订和审校；杨晴、袁敦禄、常青和聂静雯负责资料收集与整理分类；黄晶晶负责数据分析和统计学处理；周竹负责监督管理和结果的分析与解释；李青负责文章的构思与设计、论文撰写，对文章整体负责，监督管理。
基金资助:
云南省科技厅科技计划项目重大科技专项计划(202102AA100060); 云南省省院省校教育合作人文社科项目(SYSX202034); 昆明医科大学"百名中青年学术和技术骨干"培养计划(60118260103); 云南省卫生健康委员会医学后备人才培养计划(H-2018052)

Abstract

Abstract:

Background

As the most common clinical manifestation and a major complication in chronic kidney disease, anemia affects the patients' quality of life, increases the risk of renal disease progression and death. Hence, it is important to improve anemia, and monitor and evaluate drug efficacy and safety in the treatment of renal anemia.

Objective

To compare the efficacy and safety between roxadustat and erythropoiesis stimulating agents (ESAs) in treating renal anemia in patients with dialysis-dependent chronic kidney disease.

Methods

We searched PubMed, FMRS, Wanfang Data and ClinicalTrials.gov from inception to January 19, 2022 for randomized controlled trials (RCTs) about maintenance hemodialysis patients with dialysis duraion≥3 months treated with oral roxadustat (experimental group), versus injection of ESAs (control group). Two researchers independently conducted literature screening, data extraction and quality evaluation. Meta-analysis was performed using Review Manager 5.3.

Results

A total of 5 studies with 6 RCTs were included, involving 901 patients (549 in the experimental group and 352 in the control group). Meta-analysis showed that roxadustat was superior to ESAs in improving the levels of serum iron〔MD=2.49, 95%CI (0.82, 4.16), P=0.004〕, transferrin〔MD=0.31, 95%CI (0.17, 0.44), P<0.000 01〕, total iron-binding capacity〔MD=7.51, 95%CI (5.01, 10.01), P<0.000 01〕. The incidence of adverse events did not differ significantly between the two groups〔RR=1.10, 95%CI (0.99, 1.22), P=0.07〕.

Conclusion

Roxadustat demonstrates better effects than ESAs in increasing the levels of serum iron, transferrin and total iron-binding capacity, without increasing the risk of adverse events during a short-term duration of use.

Key words: Hemodialysis, Roxadustat, Hypoxia-inducible factor-prolyl hydroxylase inhibitor, Erythropoiesisstimulating agents, Renal anemia, Effectiveness and safety, Systematic review, Meta-analysis

摘要：

背景

贫血是慢性肾脏病患者最常见的临床表现，也是肾脏疾病的主要并发症，影响患者的生命质量、加速疾病进展并增加患者死亡风险，纠正贫血和监测改善肾性贫血药物的疗效及安全性意义重大。

目的

比较罗沙司他与红细胞生成刺激剂在治疗维持性血液透析患者肾性贫血中的疗效和安全性。

方法

计算机检索PubMed、FMRS、万方数据知识服务平台以及ClinicalTrials.gov，检索时间为建库至2022-01-19。筛选维持性血液透析患者透析龄≥3个月的随机对照试验，其中试验组口服罗沙司他，对照组注射红细胞生成刺激剂。由2名研究者独立完成文献筛选和资料提取，对文献进行质量评价后采用Review Manager 5.3软件进行Meta分析。

结果

共纳入5篇文献，包括6项随机对照研究、901例患者。其中试验组549例，对照组352例。Meta分析结果显示，罗沙司他在提高血液透析患者的血清铁〔MD=2.49，95%CI（0.82，4.16），P=0.004〕、转铁蛋白〔MD=0.31，95%CI（0.17，0.44），P<0.000 01〕、总铁结合力〔MD=7.51，95%CI（5.01，10.01），P<0.000 01〕水平方面均优于红细胞生成刺激剂。两组总的不良事件发生率比较，差异无统计学意义〔RR=1.10，95%CI（0.99，1.22），P=0.07〕。

结论

罗沙司他在升高血清铁、转铁蛋白、总铁结合力方面较红细胞生成刺激剂效果更好；短期内使用罗沙司他未增加血液透析患者不良事件风险。

关键词: 血液透析, 罗沙司他, 低氧诱导因子-脯氨酰羟化酶抑制剂, 红细胞生成刺激剂, 肾性贫血, 有效性和安全性, 系统评价, Meta分析

LI Jiaqing,YANG Qing,YUAN Dunlu, et al. Effectiveness and Safety of Roxadustat for Renal Anemia in Dialysis-dependent Chronic Kidney Disease: a Meta-analysis[J]. Chinese General Practice, 2023, 26(06): 704-710. DOI: 10.12114/j.issn.1007-9572.2022.0581.
李家青,杨晴,袁敦禄等. 罗沙司他治疗血液透析患者肾性贫血的有效性和安全性Meta分析[J]. 中国全科医学, 2023, 26(06): 704-710. DOI: 10.12114/j.issn.1007-9572.2022.0581.

Figures/Tables 14

References 28

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第一作者	发表年份（年）	国家	NCT	单中心/多中心	临床研究阶段	样本量（例）		男性〔n（%）〕		年龄（岁）
第一作者	发表年份（年）	国家	NCT	单中心/多中心	临床研究阶段	试验组	对照组	试验组	对照组	试验组	对照组
AKIZAWA^[9]	2020	日本	NCT02952092	多中心	Ⅲ期	150	151	101（67.3）	107（70.9）	64.6±11.7	64.9±10.1
AKIZAWA^[10]	2019	日本	NCT01964196	多中心	Ⅲ期	13	43	10（76.9）	26（60.5）	64.4±8.7	61.9±10.6
CHEN^[11]	2019	中国	NCT02652806	多中心	Ⅲ期	204	100	126（61.8）	58（58.0）	47.6±11.7	51.0±11.8
CHEN^[12]	2017	中国	NCT01596855	多中心	Ⅱ期	74	22	45（60.4）	13（59.1）	50.0±12.8	53.8±10.0
PROVENZANO^[13]	2016	美国	NCT01147666	多中心	Ⅱ期	41	13	27（66.0）	9（69.0）	55.8±13.4	59.5±10.1
PROVENZANO^[13]	2016	美国	NCT01147666	多中心	Ⅱ期	67	23	45（67.0）	14（61.0）	56.9±12.1	57.0±11.6
第一作者	基线血红蛋白（g/dl）		干预措施		罗沙司他剂量	干预时间（周）	结局指标
第一作者	试验组	对照组	试验组	对照组	罗沙司他剂量	干预时间（周）	结局指标
AKIZAWA^[9]	11.00±0.56	11.00±0.60	罗沙司他	ESAs	70 mg、100 mg，TIW	24	①②③④⑤⑥⑦⑧
AKIZAWA^[10]	9.35±0.75	10.85±0.54	罗沙司他	ESAs	50 mg、70 mg，TIW；70 mg、100 mg，TIW	24	①②③④⑤⑦⑧
CHEN^[11]	10.40±0.70	10.50±0.70	罗沙司他	ESAs	100 mg（体质量45~<60 kg）、120 mg（体质量≥60 kg）	26	①②③④⑤⑥⑦⑧
CHEN^[12]	10.80±0.70	10.60±1.00	罗沙司他	ESAs	1.1~1.8 mg/kg、1.5~3.0 mg/kg、1.7~2.3 mg/kg，TIW	6	①②③④⑤⑥⑦⑧
PROVENZANO^[13]	11.30±0.60	11.50±0.60	罗沙司他	ESAs	1.0 mg/kg、1.5 mg/kg、1.8 mg/kg、2.0 mg/kg，TIW	6	①②③⑤⑥⑦⑧
PROVENZANO^[13]	11.20±0.70	11.20±1.00	罗沙司他	ESAs	1.0 mg/kg、1.5 mg/kg、1.8 mg/kg、2.0 mg/kg，TIW	19	①②③⑤⑥⑦⑧

第一作者	发表年份（年）	国家	NCT	单中心/多中心	临床研究阶段	样本量（例）		男性〔n（%）〕		年龄（岁）
第一作者	发表年份（年）	国家	NCT	单中心/多中心	临床研究阶段	试验组	对照组	试验组	对照组	试验组	对照组
AKIZAWA^[9]	2020	日本	NCT02952092	多中心	Ⅲ期	150	151	101（67.3）	107（70.9）	64.6±11.7	64.9±10.1
AKIZAWA^[10]	2019	日本	NCT01964196	多中心	Ⅲ期	13	43	10（76.9）	26（60.5）	64.4±8.7	61.9±10.6
CHEN^[11]	2019	中国	NCT02652806	多中心	Ⅲ期	204	100	126（61.8）	58（58.0）	47.6±11.7	51.0±11.8
CHEN^[12]	2017	中国	NCT01596855	多中心	Ⅱ期	74	22	45（60.4）	13（59.1）	50.0±12.8	53.8±10.0
PROVENZANO^[13]	2016	美国	NCT01147666	多中心	Ⅱ期	41	13	27（66.0）	9（69.0）	55.8±13.4	59.5±10.1
PROVENZANO^[13]	2016	美国	NCT01147666	多中心	Ⅱ期	67	23	45（67.0）	14（61.0）	56.9±12.1	57.0±11.6
第一作者	基线血红蛋白（g/dl）		干预措施		罗沙司他剂量	干预时间（周）	结局指标
第一作者	试验组	对照组	试验组	对照组	罗沙司他剂量	干预时间（周）	结局指标
AKIZAWA^[9]	11.00±0.56	11.00±0.60	罗沙司他	ESAs	70 mg、100 mg，TIW	24	①②③④⑤⑥⑦⑧
AKIZAWA^[10]	9.35±0.75	10.85±0.54	罗沙司他	ESAs	50 mg、70 mg，TIW；70 mg、100 mg，TIW	24	①②③④⑤⑦⑧
CHEN^[11]	10.40±0.70	10.50±0.70	罗沙司他	ESAs	100 mg（体质量45~<60 kg）、120 mg（体质量≥60 kg）	26	①②③④⑤⑥⑦⑧
CHEN^[12]	10.80±0.70	10.60±1.00	罗沙司他	ESAs	1.1~1.8 mg/kg、1.5~3.0 mg/kg、1.7~2.3 mg/kg，TIW	6	①②③④⑤⑥⑦⑧
PROVENZANO^[13]	11.30±0.60	11.50±0.60	罗沙司他	ESAs	1.0 mg/kg、1.5 mg/kg、1.8 mg/kg、2.0 mg/kg，TIW	6	①②③⑤⑥⑦⑧
PROVENZANO^[13]	11.20±0.70	11.20±1.00	罗沙司他	ESAs	1.0 mg/kg、1.5 mg/kg、1.8 mg/kg、2.0 mg/kg，TIW	19	①②③⑤⑥⑦⑧

Effectiveness and Safety of Roxadustat for Renal Anemia in Dialysis-dependent Chronic Kidney Disease: a Meta-analysis

罗沙司他治疗血液透析患者肾性贫血的有效性和安全性Meta分析

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