2022-03-01·Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica
[Clinical comprehensive evaluation of Huangkui Capsules in treatment of chronic kidney diseases].
作者: Zhi-Fei Wang ; Qiang Zhang ; Yan-Ming Xie
Based on Guidelines for the Management of Clinical Comprehensive Evaluation of Drugs(trial version 2021), this study aims to sort out the clinical evidence of Huangkui Capsules(HC) in the treatment of chronic kidney diseases in aspects of safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine( "6+1" dimensions) from real-world data, secondary literature evaluations, questionnaires, and public data, with the methods in evidence-based medicine, epidemiology, pharmacoeconomics, and health technology. Furthermore, with multi-criteria decision analysis(MCDA) model and CSC v2.0, the clinical value of the medicine is comprehensively assessed. All the above are to highlight the advantages and characteristics of HC and lay a basis for scientific decision-making by the medical management department. The dimensions are graded A, B, C, or D. According to the conclusions from phase Ⅳ clinical trial, spontaneous reporting system(SRS), systematic review and Meta-analysis, acute toxicity and long-term toxicity tests, it mainly results in the adverse reactions of nausea, abdominal distension, vomiting, pruritus, rash, and good prognosis in patients. According to the available research, the safety evidence is sufficient and the risk is controllable, so the safety of this medicine is grade B. According to Meta-analysis, HC in combination with conventional drugs in the treatment of chronic kidney disease is superior to conventional drugs alone in reducing urinary protein, serum creatinine concentration, and blood urea nitrogen. In addition, HC combined angiotensin receptor blocker(ARB) or angiotensin converting enzyme inhibitor(ACEI) is outstanding in improving total clinical effective rate, reducing 24 h urinary protein quantity, urinary albumin excretion rate, serum creatinine concentration, triglyceride, and total cholesterol in the treatment of diabetic nephropathy as compared with ARB or ACEI alone. As for chronic nephritis, the application together with ARB or ACEI can raise the total effective rate, reduce 24 h urinary protein content, serum creatinine concentration, and blood urea nitrogen, and delay the progress of the disease. HC boasts high-quality evidence in treating chronic kidney disease, diabetic nephropathy, and chronic nephritis. It has obvious clinical significance in treating chronic kidney disease and thus its efficacy in this aspect is grade B. It has outstanding clinical significance for diabetic nephropathy and chronic nephritis and corresponding and the effectiveness is grade A. As for the pharmacoeconomic value, HC combined with ARB or ACEI is more economical in the treatment of chronic kidney disease than Bailing Capsules combined with ARB or ACEI, with high-quality evidence, and thus the economy of the formula is grade B. HC is a key solution to the high urinary protein in patients with hypotension and chronic kidney disease. The innovation is evidenced by the methods to ensuring drug supply, community-level supply, drug safety, effectiveness, and reasonable price, as wells as the aspects of enterprise philosophy, equipment management, research and development in process and technology, enterprise management and marketing. Thus, the prescription is grade A in innovation. The suitability, as evidenced in drug administration, technical management, drug storage, information service, and medication, is grade B. The course of the medicine is affordable, and it is accessible in a wide range of areas and hospitals. Thus, the accessibility is grade A. HC was developed from an in-hospital preparation, with application in numerous patients and thus large-scale real-world data. As a result, HC is grade B in terms of characteristics of traditional Chinese medicine. After comprehensive evaluation, the clinical value of HC in treating chronic kidney disease is class B, and that for diabetic nephropathy and chronic nephritis is class A. The result is of great reference value for the basic clinical medication management.
2022-01-01·Evidence-based complementary and alternative medicine : eCAM
Clinical Efficacy of Huangkui Capsule plus Methylprednisolone in the Treatment of Nephropathy and the Effect on Urinary Protein and Serum Inflammatory Factors in Patients.
作者: Weibo Wan ; Jingjing Zhou ; Rong Lu ; Chaoyang Wang ; Shuli Hu ; Mei Liu ; Rong Xiong ; Jing Kuang ; Xuepeng Fan
The study aimed to assess the clinical efficacy of Huangkui capsule plus methylprednisolone in the treatment of nephropathy and the effect on urinary protein and serum inflammatory factors in patients.
Between June 2017 and July 2020, 90 patients with nephropathy admitted to our hospital were recruited after assessment of eligibility and assigned via the random number table method (1 : 1) to receive either methylprednisolone tablets (observation group) or methylprednisolone tablets plus Huangkui capsules (experimental group). All eligible patients were also given dipyridamole and valsartan. Outcome measures included clinical efficacy, urine protein, hematuria, serum inflammatory factor levels, and adverse reactions.
A higher clinical efficacy was observed in the experimental group versus the observation group (P < 0.05). Huangkui capsules resulted in significantly lower levels of urine protein and hematuria in the experimental group versus the observation group after treatment (P < 0.05). The serum tumor necrosis factor-α (TNF-α), interleukin (IL)-6, and monocyte chemoattractant protein-1 (MCP-1) levels in the experimental group were significantly lower than those in the observation group after treatment (P < 0.05). Huangkui capsules plus methylprednisolone were associated with a lower incidence of adverse events versus methylprednisolone (P < 0.05).
The clinical efficacy of Huangkui capsule plus methylprednisolone in the treatment of patients with nephropathy is remarkable. It can effectively mitigate the inflammatory responses and enhance renal function, with reliable clinical safety, so it is worthy of clinical application.