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Tripterygium wilfordii Hook F Treatment for Stage IV Diabetic Nephropathy: Protocol for a Prospective, Randomized Controlled Trial
المؤلفون المشاركون
Lengnan, Xu
Ban, Zhao
Haitao, Wang
Lili, Liu
Aiqun, Chen
Huan, Wang
Ping, Zeng
Yonghui, Mao
المصدر
العدد
المجلد 2020، العدد 2020 (31 ديسمبر/كانون الأول 2020)، ص ص. 1-9، 9ص.
الناشر
Hindawi Publishing Corporation
تاريخ النشر
2020-06-10
دولة النشر
مصر
عدد الصفحات
9
التخصصات الرئيسية
الملخص EN
Background.
Diabetic nephropathy (DN) is a major cause of chronic kidney disease (CKD).
There are no effective treatments to prevent or reverse the progression of DN.
A preliminary study showed that Tripterygium glycosides from Tripterygium wilfordii Hook F (TwHF) with valsartan decrease proteinuria in patients with DN.
Objectives.
The objective of the present study is to investigate the efficacy and safety of Tripterygium glycosides from TwHF, a traditional Chinese medicine, for the treatment of DN.
Methods and Analysis.
This is a prospective, single-center randomized controlled trial.
Seventy participants diagnosed with DN were recruited and randomized 1 : 1 to two groups: (1) angiotensin receptor blocker (ARB) combined with TwHF and (2) ARB-only.
The treatment period is 48 weeks.
The primary endpoint is 24 h proteinuria decreased level (reduction of 30% vs.
baseline) after 48 weeks of treatment.
The secondary endpoints are (1) all-cause and cardiovascular-related mortality, (2) development of ESRD (serum creatinine>530.4 μmol/L or estimated glomerular filtration rate eGFR<15 mL/min/1.73 m2), (3) the need for renal replacement therapy, and (4) increased serum creatinine (2-fold higher than the baseline value or ≥442 μmol/L, with confirmation of the initial results after 4 weeks).
A health economics analysis will be carried out.
Discussion.
A meta-analysis of RCTs carried out in patients with stage 4 (Mogensen classification) diabetic CKD showed that TwHF combined with an ARB was more effective than an ARB alone when considering 24 h proteinuria and serum albumin, but with an increase in adverse event (AE) frequency of 8%.
This is a prospective clinical trial that may provide information on a safe and effective novel method for the treatment of DN, especially for patients with macroproteinuria.
Ethics and Dissemination.
The protocol is approved by the ethics committee of Beijing Hospital (2016BJYYEC-059-02).
The results will be disseminated through peer-reviewed publications and international conferences.
This trial is registered with ChiCTR-IOR-17010623.
نمط استشهاد جمعية علماء النفس الأمريكية (APA)
Lengnan, Xu& Ban, Zhao& Haitao, Wang& Lili, Liu& Aiqun, Chen& Huan, Wang…[et al.]. 2020. Tripterygium wilfordii Hook F Treatment for Stage IV Diabetic Nephropathy: Protocol for a Prospective, Randomized Controlled Trial. BioMed Research International،Vol. 2020, no. 2020, pp.1-9.
https://search.emarefa.net/detail/BIM-1138004
نمط استشهاد الجمعية الأمريكية للغات الحديثة (MLA)
Lengnan, Xu…[et al.]. Tripterygium wilfordii Hook F Treatment for Stage IV Diabetic Nephropathy: Protocol for a Prospective, Randomized Controlled Trial. BioMed Research International No. 2020 (2020), pp.1-9.
https://search.emarefa.net/detail/BIM-1138004
نمط استشهاد الجمعية الطبية الأمريكية (AMA)
Lengnan, Xu& Ban, Zhao& Haitao, Wang& Lili, Liu& Aiqun, Chen& Huan, Wang…[et al.]. Tripterygium wilfordii Hook F Treatment for Stage IV Diabetic Nephropathy: Protocol for a Prospective, Randomized Controlled Trial. BioMed Research International. 2020. Vol. 2020, no. 2020, pp.1-9.
https://search.emarefa.net/detail/BIM-1138004
نوع البيانات
مقالات
لغة النص
الإنجليزية
الملاحظات
Includes bibliographical references
رقم السجل
BIM-1138004
قاعدة معامل التأثير والاستشهادات المرجعية العربي "ارسيف Arcif"
أضخم قاعدة بيانات عربية للاستشهادات المرجعية للمجلات العلمية المحكمة الصادرة في العالم العربي
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