Real-World Effects of Chinese Herbal Medicine for Idiopathic Membranous Nephropathy (REACH-MN): Protocol of a Registry-Based Cohort Study.

Real-World Effects of Chinese Herbal Medicine for Idiopathic Membranous Nephropathy (REACH-MN): Protocol of a Registry-Based Cohort Study.
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中草药治疗特发性膜性肾病的真实疗效(REACH-MN):一项基于注册的队列研究方案。

DOI:
10.3389/fphar.2021.760482
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发表时间:
2021
影响因子:
5.6
通讯作者:
Bao K
Bao K
中科院分区:
医学2区
文献类型:
--
作者:
Yang L;Chen X;Li C;Xu P;Mao W;Liang X;Zuo Q;Ma W;Guo X;Bao K

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导论:中药治疗特发性膜性肾病(IMN)在临床试验中获得了一些令人鼓舞的发现,但由于中药治疗方案复杂,难以在日常临床实践中得到验证。该登记的主要目的是提供用于管理IMN的治疗模式的描述,并评估中国IMN患者的日常实践中的临床缓解情况。方法和分析:这是一项前瞻性多中心队列研究,将从中国11个肾脏学中心招募2000名患有IMN的成人,无论尿蛋白水平如何。参与者将被随访至少2年。主要结果是入组后24个月的综合缓解(完全缓解或部分缓解)。次要终点是完全缓解、部分缓解、缓解时间、无反应、复发、蛋白尿、肾小球滤过率的年变化、PLA2R抗体和肾小球滤过率降低40%、血清肌酐翻倍、终末期肾病和死亡的综合终点。倾向得分分析将用于匹配和调整。伦理与传播:本研究已获得广东省中医医院伦理委员会(BF2020-094-01)批准。这项研究的结果将发表在国内和国际同行评议的期刊上,并在科学会议上发表。研究者将通过健康教育告知参与者和其他IMN患者研究结果。研究注册:ChiCTR2000033680(前瞻性注册)。
Introduction: Some encouraging findings of Chinese herbal medicine (CHM) in management of idiopathic membranous nephropathy (IMN) obtained in the setting of clinical trials are hard to validate in the daily clinical practice due to a complicated treatment scenario of CHM in practice. The primary objective of this registry is to provide a description of treatment patterns used in management of IMN and assess clinical remission in daily practice in a Chinese population sample with IMN. Methods and analysis: This is a prospective, multicenter cohort which will comprise 2000 adults with IMN regardless of urinary protein levels that will be recruited from 11 nephrology centers across China. The participants will be followed for up to at least 2 years. Primary outcome is composite remission (either complete remission or partial remission) 24 months after enrolment. The secondary outcomes are complete remission, partial remission, time to remission, no response, relapse, proteinuria, annual change of glomerular filtration rate, antibodies against PLA2R, and composite endpoint of 40% reduction of glomerular filtration rate, doubling of serum creatinine, end-stage renal disease, and death. Propensity score analysis will be used for matching and adjustment. Ethics and dissemination: This study has been approved by the Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine (BF2020-094-01). Results of the study will be published in both national and international peer-reviewed journals, and presented at scientific conferences. Investigators will inform the participants as well as other IMN patients of the findings via health education. Study registration: ChiCTR2000033680 (prospectively registered).
DOI: 10.1155/2018/5854710
发表时间: 2018
期刊: Evidence-based complementary and alternative medicine : eCAM
影响因子: --
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DOI: 10.2215/cjn.11761116
发表时间: 2017-06-01
影响因子: 9.8
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通讯作者: Couser, William G.