Department of Pharmacy, The Third Hospital of Hebei Medical University, 139 Ziqiang Road, Qiaoxi District, Shijiazhuang, 050051, Hebei Province, China.
Department of Chinese Pharmacy, Hebei Maternity Hospital, 27 Shifeng Road, Qiaoxi District, Shijiazhuang, 050051, Hebei Province, China.
Int Urol Nephrol. 2021 May;53(5):985-997. doi: 10.1007/s11255-020-02693-7. Epub 2021 Jan 3.
Anemia is a common complication for patients with kidney disease. Roxadustat is an oral hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitor (PHI), which is a newly approved oral drug for anemia. We performed this study to build evidence regarding efficacy and safety of roxadustat in kidney disease patients with or without dialysis.
We searched the databases of PubMed, Embase, Cochrane library and clinicaltrials.gov from the inception to July 20, 2020. The randomized controlled trials (RCTs) which compared roxadustat with placebo or other therapies in the treatment of anemia in kidney disease patients were included. Data were extracted from eligible studies and pooled in a meta-analysis model using RevMan5.3 and stata13.0 software.
Eight RCTs with 1010 patients were included in our analysis. We found that roxadustat significantly increased hemoglobin (Hb) level (1.10 g/dL, 95% CI [0.52 g/dL, 1.67 g/dL], p = 0.0002), total iron-binding capacity (TIBC) (58.71 µg/dL, 95% CI [44.10 µg/dL, 73.32 µg/dL], p < 0.00001), iron level (9.28 µg/dL, 95% CI [0.11 µg/dL, 18.45 µg/dL], p = 0.05) compared with control group in kidney disease patients. In addition, our result showed that a significant reduction in hepcidin level (- 31.96 ng/mL, 95% CI [- 35.05 ng/mL, - 28.87 ng/mL], p < 0.00001), ferritin (- 44.82 ng/mL, 95% CI [- 64.42 ng/mL, - 25.23 ng/mL], p < 0.00001) was associated with roxadustat. No difference was found between roxadustat and control group in terms of oral iron supplementation, adverse events (AEs), serious adverse events (SAEs), infection, myocardial infraction, stroke, heart failure and death.
Roxadustat has higher mean Hb level than placebo or EPO. Due to the short follow-up period and the lack of critical data, more RCTs are needed to prove long-term safety and effectiveness of roxadustat in the future.
贫血是肾病患者的常见并发症。罗沙司他是一种口服低氧诱导因子（HIF）脯氨酰羟化酶抑制剂（PHI），是一种新批准的用于治疗贫血的口服药物。我们进行这项研究是为了提供罗沙司他在有或无透析的肾病患者中的疗效和安全性证据。
我们从数据库中检索了PubMed、Embase、Cochrane 图书馆和 clinicaltrials.gov 从成立到 2020 年 7 月 20 日。纳入比较罗沙司他与安慰剂或其他疗法治疗肾病患者贫血的随机对照试验（RCT）。使用 RevMan5.3 和 stata13.0 软件从合格研究中提取数据并进行荟萃分析。
我们的分析纳入了 8 项 RCT，共 1010 名患者。我们发现罗沙司他显著增加血红蛋白（Hb）水平（1.10g/dL，95%CI[0.52g/dL，1.67g/dL]，p=0.0002），总铁结合能力（TIBC）（58.71μg/dL，95%CI[44.10μg/dL，73.32μg/dL]，p<0.00001），铁水平（9.28μg/dL，95%CI[0.11μg/dL，18.45μg/dL]，p=0.05）与对照组相比，肾病患者。此外，我们的结果显示，铁调素水平显著降低（-31.96ng/mL，95%CI[-35.05ng/mL，-28.87ng/mL]，p<0.00001），铁蛋白（-44.82ng/mL，95%CI[-64.42ng/mL，-25.23ng/mL]，p<0.00001）与罗沙司他有关。罗沙司他与对照组在口服铁补充剂、不良事件（AE）、严重不良事件（SAE）、感染、心肌梗死、中风、心力衰竭和死亡方面无差异。
罗沙司他的平均血红蛋白水平高于安慰剂或 EPO。由于随访时间短且缺乏关键数据，未来需要更多的 RCT 来证明罗沙司他的长期安全性和有效性。
