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评估他克莫司治疗膜性肾病的疗效和安全性:182例患者的回顾性研究结果

Evaluating Efficacy and Safety of Tacrolimus Treatment in Membranous Nephropathy: Results of a Retrospective Study of 182 Patients.

作者信息

Liang Shuang, Liang Yan-Jun, Li Zhao, Wang Yong, Guo Xin-Ru, Zhang Chao-Yang, Zhang Chun, Wu Jie, Wang Xiao-Long, Li Yi-Sha, Cai Guang-Yan, Chen Xiang-Mei

机构信息

Department of Nephrology, First Medical Center of Chinese PLA General Hospital, Nephrology Institute of the Chinese People's Liberation Army, State Key Laboratory of Kidney Diseases, National Clinical Research Center for Kidney Diseases, Beijing Key Laboratory of Kidney Disease Research, Beijing, People's Republic of China.

Haikou People's Hospital Affiliated to Xiangya School of Medicine, Haikou, People's Republic of China.

出版信息

Ther Clin Risk Manag. 2023 Apr 12;19:351-360. doi: 10.2147/TCRM.S399218. eCollection 2023.

Abstract

PURPOSE

Tacrolimus is recommended by KDIGO Clinical Practice Guidelines as an initial therapy for the treatment of membranous nephropathy (MN). However, little is known about the factors that influence response and recurrence of the disease after tacrolimus therapy, and there are limited data regarding the duration of tacrolimus treatment. Here, we present a real-world retrospective cohort study of 182 MN patients treated with tacrolimus, aiming to assess the efficacy and safety of tacrolimus in the treatment of MN.

PATIENTS AND METHODS

The clinical data of 182 patients with MN treated with tacrolimus and followed up for at least one year were analyzed retrospectively for the efficacy and safety of tacrolimus.

RESULTS

The mean follow-up period was 27.3 (19.3-41.6) months. A total of 154 patients (84.6%) achieved complete or partial remission, and 28 patients (15.4%) did not. Multivariate Cox regression analysis showed that male and higher baseline BMI were independently associated with lower, while higher serum albumin was associated with higher probability of remission. Among the responders, 56 patients (36.4%) relapsed. After adjustments for age and sex, Cox regression analysis revealed that the longer period of full-dose tacrolimus was administered, the lower the incidence of relapse. However, high levels of serum creatinine and proteinuria at the onset of tacrolimus discontinuation were risk factors for relapse. During the treatment of tacrolimus, a decline in renal function (≥50% increase in serum creatinine after the onset of tacrolimus treatment) was the most common adverse reaction, observed in 20 (11.0%) patients, followed by elevated blood glucose and infection, but the latter two occurred mostly during treatment with tacrolimus plus corticosteroids.

CONCLUSION

Tacrolimus is effective in the treatment of MN, but the relapse rate is high. Clinical studies with larger sample sizes are needed to further explore the use of tacrolimus in the treatment of membranous nephropathy.

摘要

目的

KDIGO临床实践指南推荐他克莫司作为膜性肾病(MN)治疗的初始疗法。然而,关于影响他克莫司治疗后疾病反应和复发的因素知之甚少,且关于他克莫司治疗持续时间的数据有限。在此,我们开展了一项针对182例接受他克莫司治疗的MN患者的真实世界回顾性队列研究,旨在评估他克莫司治疗MN的疗效和安全性。

患者与方法

回顾性分析182例接受他克莫司治疗且随访至少1年的MN患者的临床资料,以评估他克莫司的疗效和安全性。

结果

平均随访期为27.3(19.3 - 41.6)个月。共有154例患者(84.6%)实现完全或部分缓解,28例患者(15.4%)未缓解。多因素Cox回归分析显示,男性和较高的基线体重指数与缓解概率较低独立相关,而较高的血清白蛋白与缓解概率较高相关。在缓解者中,56例患者(36.4%)复发。在对年龄和性别进行调整后,Cox回归分析显示,他克莫司全剂量给药时间越长,复发率越低。然而,停用他克莫司时血清肌酐和蛋白尿水平较高是复发的危险因素。在他克莫司治疗期间,肾功能下降(他克莫司治疗开始后血清肌酐升高≥50%)是最常见的不良反应,20例(11.0%)患者出现,其次是血糖升高和感染,但后两者大多发生在他克莫司联合糖皮质激素治疗期间。

结论

他克莫司治疗MN有效,但复发率较高。需要更大样本量的临床研究来进一步探索他克莫司在膜性肾病治疗中的应用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e650/10106312/d503e5816b8a/TCRM-19-351-g0001.jpg

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