Abstract
BackgroundTangshen Formula (TSF) is a traditional Chinese medicine for the treatment of diabetic kidney disease (DKD). Liver-type fatty acid binding protein (L-FABP) is expressed in various tissues, including the kidney, where it is known as urinary L-FABP. Other studies demonstrated that urinary L-FABP may be a useful biomarker for monitoring DKD. This post-hoc analysis and cross-sectional study evaluated the changes in urinary L-FABP in DKD patients treated with TSF and conventional medicine.MethodsPost-hoc analysis was conducted on a multicenter, randomized, double-blind, placebo-controlled trial. A total of 180 participants with DKD including 98 with microalbuminuria and 82 with macroalbuminuria were enrolled in the original study. In addition to conventional treatment, 122 participants were randomly assigned to receive TSF and 58 to receive placebo. After 24-weeks of treatment, the intention-to-treat population in microalbuminuria stage was 56 in the TSF group and 25 in the placebo group, and in the macroalbuminuria stage 42 and 19, respectively. The primary outcome in the original trial was urinary protein level. In the current study, urinary and plasma L-FABP levels were measured in 30 microalbuminuria patients (15 in the TSF group and 15 in the placebo group) and 30 macroalbuminuria patients (15 in the TSF group and 15 in the placebo group). In addition, another 30 patients with normoalbuminuria (urinary albumin excretion rate (UAER) < 20 μg/min) were recruited for the cross-sectional study.Results(1) In microalbuminuria patients, UAER in the TSF group displayed a significant decrease after 24 weeks of treatment (P = 0.045). Levels of urinary L-FABP in the TSF group were markedly lower than in the placebo group after 12 and 24 weeks (P = 0.004 and P = 0.047, respectively). (2) In macroalbuminuria patients, 24-h urinary protein levels decreased significantly compared with baseline in the TSF group at week 12 (P = 0.042) and week 24 (P = 0.041). The TSF group showed a significant decrease in urinary L-FABP after 12 and 24 weeks (P = 0.036 and P = 0.046, respectively). (3) Levels of urinary L-FABP increased markedly, correlating with severity of DKD. L-FABP in patients with normoalbuminuria, microalbuminuria, and macroalbuminuria were 5.9 (5.2, 7.8) μg/ml, 11.4 (6.8, 13.4) μg/ml and 18.5 (10.9, 23.4) μg/ml, respectively (P = 0.000).ConclusionsTSF combined with conventional therapy appeared to be effective in reducing urinary protein and urinary L-FABP. Urinary L-FABP levels appear to be associated with the severity of DKD.Trial registrationChinese Clinical Trial Registry ChiCTR-TRC-10000843. Registered 15 April 2010.
Highlights
Tangshen Formula (TSF) is a traditional Chinese medicine for the treatment of diabetic kidney disease (DKD)
Effects of TSF on renal function indices and urinary and plasma Liver-type fatty acid binding protein (L-FABP) levels in DKD patients with microalbuminuria There was no statistical differences in levels of serum creatinine (Scr), blood urea nitrogen (BUN), urinary albumin excretion rate (UAER), estimated glomerular filtration rate (eGFR) between the TSF group and the placebo group in participants with microalbuminuria at baseline (P = 0.136, P = 0.295, P = 0.975, P = 0.242, respectively), 12 weeks (P = 0.817, P = 0.080, P = 0.979, P = 0.713, respectively) and 24 weeks (P = 0.343, P = 0.484, P = 0.385, P = 0.697, respectively)
Levels of Scr declined and eGFR was increased over baseline in the TSF group without significant difference
Summary
Tangshen Formula (TSF) is a traditional Chinese medicine for the treatment of diabetic kidney disease (DKD). Liver-type fatty acid binding protein (L-FABP) is expressed in various tissues, including the kidney, where it is known as urinary L-FABP. Other studies demonstrated that urinary L-FABP may be a useful biomarker for monitoring DKD. This post-hoc analysis and cross-sectional study evaluated the changes in urinary L-FABP in DKD patients treated with TSF and conventional medicine. Clinical studies have demonstrated that increased urinary liver-type fatty acid binding protein (L-FABP), which is expressed in the proximal tubules in the human kidney, is associated with the severity and clinical prognosis of DKD [10]. An accumulating number of interventional studies have reported that urinary L-FABP responds to renoprotective treatment [12,13,14]
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.