Nakano Yuki, Mitsuboshi Satoru, Tada Kazuhiro, Masutani Kosuke
Department of Pharmacy, Saiseikai Futsukaichi Hospital, Fukuoka, Japan.
Department of Pharmacy, Kaetsu Hospital, Niigata, Japan.
J Pharm Health Care Sci. 2024 Jun 8;10(1):30. doi: 10.1186/s40780-024-00351-z.
Based on several case reports and observational studies, there is a growing concern regarding the potential association between roxadustat, a hypoxia-inducible factor prolyl-hydroxylase inhibitor, and suppression of thyroid function. In this systematic review and meta-analysis (PROSPERO: CRD42023471516), we aimed to evaluate the relationship between roxadustat use and suppression of thyroid function.
We conducted a comprehensive search of MEDLINE via PubMed, ClinicalTrials.gov, and the Cochrane Central Register of Controlled Trials databases using the search term "roxadustat" to identify all relevant studies. The study population comprised adults with renal anemia who participated in a randomized controlled trial or observational study, with roxadustat as the intervention and a placebo or erythropoiesis-stimulating agent (ESA) as the comparator. The primary outcome was suppression of thyroid function and the secondary outcome was hypothyroidism. A meta-analysis was conducted using the DerSimonian-Laird random effects model based on the size of the intention-to-treat population, and the odds ratio (OR) and 95% confidence interval (CI) were calculated. Two reviewers independently screened the articles, extracted data, and assessed studies using the ROBINS-I tool.
Of the six studies eligible for inclusion, a meta-analysis was performed using data from two observational studies comparing roxadustat and ESA. The meta-analysis showed that the incidence of suppression of thyroid function was significantly higher with roxadustat use than with ESA use (OR: 6.45; 95% CI: 3.39-12.27; I = 12%). Compared with ESA, roxadustat seemed to potentially increase the risk for suppression of thyroid function in patients with renal anemia.
Our findings highlighted the importance of monitoring thyroid function in patients treated with roxadustat. The results of this review may enhance the safety of using roxadustat to treat renal anemia through advance recognition of the risk for suppression of thyroid function.
基于多项病例报告和观察性研究，人们越来越关注缺氧诱导因子脯氨酰羟化酶抑制剂罗沙司他与甲状腺功能抑制之间的潜在关联。在这项系统评价和荟萃分析（国际前瞻性系统评价注册库：CRD42023471516）中，我们旨在评估使用罗沙司他与甲状腺功能抑制之间的关系。
我们通过PubMed、ClinicalTrials.gov和Cochrane对照试验中央注册库数据库，使用检索词“罗沙司他”对MEDLINE进行了全面检索，以识别所有相关研究。研究人群包括参与随机对照试验或观察性研究的成年肾性贫血患者，以罗沙司他作为干预措施，以安慰剂或促红细胞生成剂（ESA）作为对照。主要结局是甲状腺功能抑制，次要结局是甲状腺功能减退。基于意向性治疗人群的规模，使用DerSimonian-Laird随机效应模型进行荟萃分析，并计算比值比（OR）和95%置信区间（CI）。两名评审员独立筛选文章、提取数据，并使用ROBINS-I工具评估研究。
在六项符合纳入标准的研究中，使用两项比较罗沙司他和ESA的观察性研究的数据进行了荟萃分析。荟萃分析表明，使用罗沙司他时甲状腺功能抑制的发生率显著高于使用ESA时（OR：6.45；95%CI：3.39-12.27；I² = 12%）。与ESA相比，罗沙司他似乎可能增加肾性贫血患者甲状腺功能抑制的风险。
我们的研究结果强调了在接受罗沙司他治疗的患者中监测甲状腺功能的重要性。本综述的结果可能通过提前识别甲状腺功能抑制风险来提高使用罗沙司他治疗肾性贫血的安全性。
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