Treatment of diabetic nephropathy with Tripterygium wilfordii Hook F extract: a prospective, randomized, controlled clinical trial

Journal of Translational Medicine

Zhihong Liu¹  Mingjun Shi¹  Haitao Zhang¹  Jinhua Hou¹  Bo Jin¹  Shijun Li¹  Honglang Xie¹  Yongchun Ge¹ 

[1] Reasch Institute of nephrology, Jinling Hospital, Nanjing University school of medicine, Nanjing, China

关键词: Angiotensin II receptor blocker (ARB);    Tripterygium wilfordii Hook F (TwHF);    Proteinuria;    Diabetic nephropathy;    Type 2 diabetes mellitus;   

Others  :  827502
DOI  :  10.1186/1479-5876-11-134

 received in 2013-02-27, accepted in 2013-05-17,  发布年份 2013

【 摘 要 】

Background

Diabetic nephropathy (DN) is the most common cause of end-stage renal failure. Although angiotensin II receptor blockers (ARBs) can be used to attenuate proteinuria in DN patients, their efficacy remains limited. This clinical trial aimed to evaluate the efficacy of Tripterygium wilfordii Hook F (TwHF) extract in the treatment of type 2 diabetes mellitus (DM)-induced nephropathy.

Methods

A total of 65 DN patients with proteinuria levels ≥ 2.5 g/24 h and serum creatinine levels < 3 mg/dl were enrolled in this six-month, prospective, randomized, controlled study. The patients were randomized into treatment groups that received either 120 mg of TwHF extract per day for three months, followed by 60 mg per day for three more months, or 160 mg of valsartan daily for six months. The urinary protein and estimated glomerular filtration (eGFR) level were measured at one, three, and six months after the commencement of treatment. The primary measure of treatment efficacy was a reduction in the 24-h urine protein level between baseline and the end of the study, and the secondary measure of treatment efficacy was a reduction in the eGFR value.

Results

At the end of the treatment period, the mean urine protein level in the TwHF group was dramatically decreased (4.99 ± 2.25 g/24 h vs 2.99 ± 1.81 g/24 h, p < 0.01), with decreases at one, three, and six months of 32.9%, 38.8%, and 34.3%, respectively. In contrast, the proteinuria in the valsartan group was not significantly attenuated, and the decreases in urine protein levels at treatment months one, three, and six were 1.05%, 10.1%, and -11.7%, respectively. The mean decrease in eGFR in the valsartan group was greater than that in the TwHF group (26.4% vs. 13.7%, respectively; p =0.067).

Conclusions

TwHF extract can reduce the urine protein level of DN patients and represents a novel, potentially effective, and safe drug for the treatment of DN patients with proteinuria.

Trial registration

ClinicalTrials.gov: NCT00518362

【 授权许可】

   
2013 Ge et al.; licensee BioMed Central Ltd.

【 图 表 】

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