Abstract
BACKGROUND: To systematically evaluate the efficacy and safety of Huangkui capsule (HKC) in the treatment of diabetic nephropathy (DN). METHODS: A computerized search of 8 online databases, CNKI, VIP, WANGFANG, CBM, ChiCTR, Embase, PubMed, and Cochrane Library, was conducted from the time of database construction to June 23, 2023, and randomized controlled trials of HKC for the treatment of DN were included according to the predefined screening criteria. Literature quality was evaluated with the help of Cochrane Risk of Bias Assessment Tool, and data were analyzed by STATA/MP17 and RevMan 5.3 software. RESULTS: A total of 1543 articles were retrieved, and 45 studies were finally included, all in Chinese, with a total sample size of 4297 cases, including 2168 cases in the experimental group and 2129 cases in the control group, and the quality of all the included studies was generally low. Meta-analysis showed that (1) efficacy: effective rate: [relative risk = 1.24, 95% confidence interval (CI) (1.20, 1.29), P < .001], SCR: [standard mean difference (SMD) = -1.19, 95% CI (-1.47, -0.91), P < .001], 24 h-UTP: [SMD = -1.27, 95% CI (-1.66, -0.88), P < .001]. Other renal function, glucose metabolism, lipid metabolism, and inflammatory factors related indicators improved compared with the control group. But in the outcome index of estimated glomerular filtration rate, the addition of HKC did not have an advantage over conventional treatment alone. Estimated glomerular filtration rate: [SMD = -0.21, 95% CI (-0.80, 0.39), P = .50]. (2) Safety: There was no statistical significance in the incidence of adverse reactions between the study group with the addition of HKC and the control group. CONCLUSION: The clinical efficacy and safety of DN treated with the combination of HKC is better than that of conventional western medicine alone, but to better evaluate the efficacy and safety of HKC as an adjunctive intervention for DN, more rigorously designed large-sample, multicenter randomized controlled trials are needed to provide evidence support in the future.