Chinese herbal medicine (CHM) might have benefits in patients with non-diabetic chronic kidney disease (CKD), but there is a lack of high-quality evidence, especially in CKD4. This study aimed to assess the efficacy and safety of Bupi Yishen Formula (BYF) vs. losartan in patients with non-diabetic CKD4. This trial was a multicenter, double-blind, double-dummy, randomized controlled trial that was carried out from 11-08-2011 to 07-20-2015. Patients were assigned (1:1) to receive either BYF or losartan for 48 weeks. The primary outcome was the change in the slope of the estimated glomerular filtration rate (eGFR) over 48 weeks. The secondary outcomes were the composite of end-stage kidney disease, death, doubling of serum creatinine, stroke, and cardiovascular events. A total of 567 patients were randomized to BYF (n = 283) or losartan (n = 284); of these, 549 (97%) patients were included in the final analysis. The BYF group had a slower renal function decline particularly prior to 12 weeks over the 48-week duration (between-group mean difference of eGFR slopes: −2.25 ml/min/1.73 m2/year, 95% confidence interval [CI]: −4.03,−0.47), and a lower risk of composite outcome of death from any cause, doubling of serum creatinine level, end-stage kidney disease (ESKD), stroke, or cardiovascular events (adjusted hazard ratio = 0.61, 95%CI: 0.44,0.85). No significant between-group differences were observed in the incidence of adverse events. We conclude that BYF might have renoprotective effects among non-diabetic patients with CKD4 in the first 12 weeks and over 48 weeks, but longer follow-up is required to evaluate the long-term effects.Clinical Trial Registration:http://www.chictr.org.cn, identifier ChiCTR-TRC-10001518.
Bacterial infection, inflammatory disorder, and poor angiogenesis of tissue in chronic wounds are the main reasons why wounds are difficult to heal. In this study, a novel MSN-PEG@AS/BP nano-spray was designed to solve these issues. Astragaloside IV (AS) was loaded in mesoporous silica nanoparticles (MSN) to enhance angiogenesis and regulate inflammation, and the two-dimensional (2D) nanosheet black phosphorus (BP) was used to kill bacteria through a photothermal effect. Under thermal decomposition, the covalent bond of polyethylene glycol (PEG) was broken, releasing AS to promote the proliferation of fibroblasts, the formation of blood vessels, and the resolution of inflammation. AS can promote the polarization of the anti-inflammatory (M2) macrophage phenotype to enhance the deposition of extracellular matrix and the formation of blood vessels. Besides, BP showed a significant photothermal effect and nearly 99.58% of Escherichia coli and 99.13% of Staphylococcus aureus were killed in an antibacterial study. This nano-spray would be a novel therapeutic agent for infected wound treatment.
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