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伊古曲妥单抗治疗肾移植后矿物质和骨代谢紊乱的疗效:一项初步研究。

Efficacy of iguratimod on mineral and bone disorders after kidney transplantation: a preliminary study.

机构信息

Department of Urology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.

Department of Urology, The Second Affiliated Hospital of Nanjing Medical University, Nanjing, China.

出版信息

Ren Fail. 2023;45(2):2256418. doi: 10.1080/0886022X.2023.2256418. Epub 2023 Oct 31.

Abstract

BACKGROUND

Iguratimod has been shown to promote bone formation and inhibit bone resorption in rheumatoid arthritis patients. We aimed to explore its effect on bone metabolism and vascular calcification (VC) in kidney transplant recipients (KTRs).

METHODS

A analysis was conducted among the subjects in our previous randomized clinical trial (NCT02839941). Forty-three KTRs completing bone metabolism 52 weeks after enrollment were selected for this analysis, among whom 27 patients received VC examinations. In the iguratimod group, iguratimod (25 mg twice daily) was added adjuvant to the traditional triple regimen. At the 52-week follow-up, the following parameters were assessed: serum calcium, phosphorus, 25-hydroxyvitamin D, intact parathyroid hormone (iPTH), bone alkaline phosphatase (BALP), osteocalcin, type I collagen N-terminal peptide (NTx), type I collagen C-terminal peptide (CTx), bone mineral density (BMD) of the femoral neck and lumbar spine, coronary artery calcification (CAC) and thoracic aortic calcification (TAC). Bone metabolic and VC indices were compared between the two groups using the independent samples t test and Wilcoxon nonparametric test.

RESULTS

At 52 weeks after enrollment, the iguratimod group had lower osteocalcin ( = 0.010), BALP ( = 0.015), NTx ( = 0.007), CTx ( = 0.012), CAC ( = 0.080) and TAC scores ( = 0.036) than the control group. There was no significant difference in serum calcium, phosphorus, 25-hydroxyvitamin D, iPTH and BMD between the groups. Iguratimod could reduce bone turnover markers (BTMs) at both high and low iPTH levels. The adverse effect of iguratimod was mild and tolerable.

CONCLUSION

Iguratimod is safe, can reduce BTMs and may could attenuate VC in the first year after KT.

摘要

背景

依拉佤替在类风湿关节炎患者中表现出促进骨形成和抑制骨吸收的作用。我们旨在探讨其在肾移植受者(KTR)中的骨代谢和血管钙化(VC)的影响。

方法

对我们之前的随机临床试验(NCT02839941)中的受试者进行分析。在入组后 52 周完成骨代谢检查的 43 名 KTR 被纳入本分析,其中 27 名患者接受了 VC 检查。在依拉佤替组中,依拉佤替(每日 2 次,每次 25mg)被添加到传统三联方案中作为辅助治疗。在 52 周随访时,评估以下参数:血清钙、磷、25-羟维生素 D、全段甲状旁腺激素(iPTH)、骨碱性磷酸酶(BALP)、骨钙素、I 型胶原 N 端肽(NTx)、I 型胶原 C 端肽(CTx)、股骨颈和腰椎骨密度(BMD)、冠状动脉钙化(CAC)和胸主动脉钙化(TAC)。采用独立样本 t 检验和 Wilcoxon 非参数检验比较两组间的骨代谢和 VC 指标。

结果

入组后 52 周时,依拉佤替组的骨钙素( = 0.010)、BALP( = 0.015)、NTx( = 0.007)、CTx( = 0.012)、CAC( = 0.080)和 TAC 评分( = 0.036)低于对照组。两组间血清钙、磷、25-羟维生素 D、iPTH 和 BMD 无显著差异。依拉佤替可降低高和低 iPTH 水平的骨转换标志物(BTMs)。依拉佤替的不良反应轻微且可耐受。

结论

依拉佤替安全,可降低 BTMs,并可能在 KT 后 1 年内减轻 VC。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fd94/11001337/21a59bde0c0e/IRNF_A_2256418_F0001_B.jpg

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