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硫酸羟氯喹治疗低危 PLAR 相关膜性肾病的单中心、开放标签、随机、对照研究。

A single-center, open label, randomized, controlled study of hydroxychloroquine sulfate in the treatment of low risk PLAR-associated membranous nephropathy.

机构信息

Department of Nephrology & Rheumatology, People's Hospital of Shapingba District, Chongqing University Shapingba Hospital, School of Medicine,Chongqing University, Chongqing, China.

Department of Nephrology, The First Hospital Affiliated to Army Medical University, Chongqing, China.

出版信息

BMC Nephrol. 2024 Jul 19;25(1):230. doi: 10.1186/s12882-024-03670-3.

Abstract

OBJECTIVE

To evaluate the efficacy and safety of hydroxychloroquine sulfate (HCQ) in the treatment of low risk phospholipase A receptor (PLAR)-associated membranous nephropathy (MN).

METHODS

A total of 110 patients with low risk PLAR-associated MN were included in the study. Patients who met the inclusion and exclusion criteria were assigned randomly to two groups: the HCQ treatment group and the control group. The control group received standard supportive treatment according to the guidelines, while the HCQ treatment group received HCQ in addition to the supportive treatment. The clinical data of the patients were analyzed, with comparisons made at baseline and during the six-month follow-up period. Any adverse reactions were recorded.

RESULTS

The baseline data were comparable between the HCQ treatment group and the control group. At the end of the six-month follow-up period, the reductions in urine protein excretion and serum PLAR antibody titer were more notable in the HCQ treatment group than those in the control group, with these differences being statistically significant (p < 0.05). Compared to the control group, the HCQ treatment group had fewer patients who were converted from low risk to moderate-to-high risk (p = 0.084). There were also no severe adverse reactions in the HCQ treatment group.

CONCLUSION

In patients with low risk PLAR-associated MN, adequate supportive therapy combined with HCQ is superior to supportive therapy alone in controlling proteinuria and reducing serum PLAR antibody titers. Additionally, our study demonstrated that the incidence of adverse reactions did not increase.

TRIAL REGISTRATION

This study was registered in the Chinese Clinical Trial Registry (Registration No.: ChiCTR1900021757, Date of registration: 2019-03-08).

摘要

目的

评估硫酸羟氯喹(HCQ)治疗低风险磷脂酶 A 受体(PLAR)相关膜性肾病(MN)的疗效和安全性。

方法

本研究共纳入 110 例低风险 PLAR 相关 MN 患者。符合纳入和排除标准的患者被随机分为两组:HCQ 治疗组和对照组。对照组根据指南接受标准支持治疗,而 HCQ 治疗组在支持治疗的基础上接受 HCQ 治疗。分析患者的临床资料,在基线和 6 个月随访期间进行比较。记录任何不良反应。

结果

HCQ 治疗组和对照组的基线数据无差异。在 6 个月随访期末,HCQ 治疗组的尿蛋白排泄和血清 PLAR 抗体滴度降低更明显,差异具有统计学意义(p < 0.05)。与对照组相比,HCQ 治疗组从低危转为中高危的患者更少(p = 0.084)。HCQ 治疗组也没有严重的不良反应。

结论

在低风险 PLAR 相关 MN 患者中,充分的支持治疗联合 HCQ 优于单纯支持治疗,可更好地控制蛋白尿和降低血清 PLAR 抗体滴度。此外,我们的研究表明不良反应发生率并未增加。

试验注册

本研究在中国临床试验注册中心注册(注册号:ChiCTR1900021757,注册日期:2019-03-08)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9d45/11264965/db591ef757e6/12882_2024_3670_Fig1_HTML.jpg

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