Wang Hui, Huang Ke, Wang Chun, Chen Chunyan, Fang Hui, Cao Jin
Department of Nephrology, China Coast Guard Hospital of the People's Armed Police Force, Jiaxing, China.
Department of Nephrology, Zhejiang Chinese Medical University Affiliated Jiaxing TCM Hospital, Jiaxing, China.
Ann Palliat Med. 2021 Apr;10(4):4736-4746. doi: 10.21037/apm-21-456.
Chronic kidney disease is a global public health problem, anemia is the most common complication of chronic kidney disease. Roxadustat is a new drug that can be used to treat renal anemia by oral administration.
We conducted a comprehensive computerized search of the China Knowledge Network (CNKI), VIP (VIP), Wanfang, China Biomedical (CBM), PubMed, Embase, and the Cochrane Library databases. We collected clinical randomized controlled trials (RCTs) published on roxadustat in the treatment of anemia of kidney disease. According to the inclusion and exclusion criteria, the included studies were subject to screening and quality evaluation, and RevMan 5.3 software was used for meta-analysis.
A total of 7 RCTs involving 997 patients with anemia of kidney disease were included. The results of meta-analysis showed that compared with the treatment effect of the erythropoietin (EPO) group, in the roxadustat group there were significant increases in the amount of hemoglobin [mean difference (MD) =11.70, 95% confidence interval (CI): 0.41 to 22.99, P=0.04], hemoglobin overall response rate [odds ratio (OR) =1.97, 95% CI: 1.7 to 3.33, P=0.01], serum iron [standardized mean difference (SMD) =0.39, 95% CI: 0.23 to 0.55, P<0.00001], transferrin saturation (MD =6.09, 95% CI: 5.36 to 6.82, P<0.0001), transferrin (MD =0.36, 95% CI: 0.28 to 0.44, P<0.00001], total iron binding capacity (SMD =0.63, 95% CI: 0.47 to 0.79, P<0.00001) and significantly reduced hepcidin (MD =-29.04, 95% CI: -51.61 to -6.47, P=0.01). There was no significant difference in adverse reactions between groups (OR =1.06, 95% CI: 0.30 to 3.74, P=0.93).
Roxadustat can effectively improve the anemia status of patients with CKD without increasing adverse reactions. Due to limitations of the number and quality of the included studies, further verification is required through the multi-center, large sample-sized, and high-quality RCTs in the future.
慢性肾脏病是一个全球性的公共卫生问题，贫血是慢性肾脏病最常见的并发症。罗沙司他是一种可通过口服用于治疗肾性贫血的新药。
我们对中国知网（CNKI）、维普（VIP）、万方、中国生物医学文献数据库（CBM）、PubMed、Embase和Cochrane图书馆数据库进行了全面的计算机检索。我们收集了已发表的关于罗沙司他治疗肾性贫血的临床随机对照试验（RCT）。根据纳入和排除标准，对纳入的研究进行筛选和质量评估，并使用RevMan 5.3软件进行荟萃分析。
共纳入7项涉及997例肾性贫血患者的RCT。荟萃分析结果显示，与促红细胞生成素（EPO）组的治疗效果相比，罗沙司他组的血红蛋白量显著增加[平均差（MD）=11.70，95%置信区间（CI）：0.41至22.99，P = 0.04]，血红蛋白总体缓解率[比值比（OR）=1.97，95%CI：1.7至3.33，P = 0.01]，血清铁[标准化平均差（SMD）=0.39，95%CI：0.23至0.55，P<0.00001]，转铁蛋白饱和度（MD =6.09，95%CI：5.36至6.82，P<0.0001），转铁蛋白（MD =0.36，95%CI：0.28至0.44，P<0.00001]，总铁结合力（SMD =0.63，95%CI：0.47至0.79，P<0.00001），且铁调素显著降低（MD = - 29.04，95%CI： - 51.61至 - 6.47，P = 0.01）。两组间不良反应无显著差异（OR =1.06，95%CI：0.30至3.74，P = 0.93）。
罗沙司他可有效改善CKD患者的贫血状况，且不增加不良反应。由于纳入研究的数量和质量存在局限性，未来需要通过多中心、大样本量和高质量的RCT进一步验证。
