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Economic evaluation of bailing capsules for patients with diabetic nephropathy in China.

ABSTRACT: Background: Diabetic nephropathy is a major microvascular complication and the main cause of end-stage renal disease in diabetic patients. The therapeutic effects of Bailing capsules for diabetic nephropathy have already been demonstrated; however, the cost-effectiveness of Bailing capsules remains controversial. This study aimed to evaluate the cost-effectiveness of Bailing capsules combined with Western medicine compared with Western medicine alone in diabetic nephropathy from a Chinese healthcare system perspective. Methods: A Markov model was established to simulate the disease process of patients over a 20-year period. Clinical efficacy data were obtained from a meta-analysis, and transition probability was estimated based on microsimulation. Direct costs and utility values were collected from the Chinese Drug Bidding Database (https://www.shuju.menet.com.cn) and published literature. The incremental cost-effectiveness ratio (ICER) was measured, and one-way and probabilistic sensitivity analyses were performed to observe model stability. Results: A total of 34 randomized controlled trials involving 3,444 patients with diabetic nephropathy were selected for the meta-analysis. Compared to Western medicine alone, the addition of Bailing capsules resulted in an increase of 0.39 quality-adjusted life-years (QALYs) and additional costs of Chinese Yuan (CNY) 24,721, yielding an ICER of CNY 63,001 per QALY gained. The ICER was lower than the threshold of willingness-to-pay of CNY 80,976 (The GDP per Capita in China). The reliability and stability of the results were confirmed by the sensitivity analysis. Conclusion: We found that Bailing capsules may be a cost-effective treatment choice for patients with diabetic nephropathy in the Chinese population.

SUBMITTER: He Y

PROVIDER: S-EPMC10354420 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature

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Economic evaluation of bailing capsules for patients with diabetic nephropathy in China.

He Yumei Y Li Wei W Zhu He H Han Sheng S

Frontiers in pharmacology 20230705

<b>Background:</b> Diabetic nephropathy is a major microvascular complication and the main cause of end-stage renal disease in diabetic patients. The therapeutic effects of Bailing capsules for diabetic nephropathy have already been demonstrated; however, the cost-effectiveness of Bailing capsules remains controversial. This study aimed to evaluate the cost-effectiveness of Bailing capsules combined with Western medicine compared with Western medicine alone in diabetic nephropathy from a Chinese ...[more]

PMID: 37475712

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Project description:BackgroundDiabetic nephropathy (DN) is a prevalent and debilitating disease that represents the leading cause of chronic kidney disease which imposes public health challenges Tongmai Jiangtang capsule (TMJT) is commonly used for the treatment of DN, albeit its underlying mechanisms of action are still elusive.MethodsThis study retrieved databases to identify the components and collect the targets of TMJT and DN. Target networks were constructed to screen the core components and targets. Samples from the GEO database were utilized to perform analyses of targets and immune cells and obtain significantly differentially expressed core genes (SDECGs). We also selected a machine learning model to screen the feature genes and construct a nomogram. Furthermore, molecular docking, another GEO dataset, and Mendelian randomization (MR) were utilized for preliminary validation. We subsequently clustered the samples based on SDECG expression and consensus clustering and performed analyses between the clusters. Finally, we scored the SDECG score and analyzed the differences between clusters.ResultsThis study identified 13 SDECGs between DN and normal groups which positively regulated immune cells. We also identified five feature genes (CD40LG, EP300, IL1B, GAPDH, and EGF) which were used to construct a nomogram. MR analysis indicated a causal link between elevated IL1B levels and an increased risk of DN. Clustering analysis divided DN samples into four groups, among which, C1 and CI were mainly highly expressed and most immune cells were up-regulated. C2 and CII were the opposite. Finally, we found significant differences in SDECG scores between C1 and C2, CI and CII, respectively.ConclusionTMJT may alleviate DN via core components (e.g. Denudatin B, hancinol, hirudinoidine A) targeting SDECGs (e.g. SRC, EGF, GAPDH), with the involvement of feature genes and modulation of immune and inflammation-related pathways. These findings have potential implications for clinical practice and future investigations.

Project description:BackgroundThe epidemic of diabetic nephropathy (DN) has been paralleled by rapid increases in both obesity and diabetes in China. The aim of this study was to investigate the natural history of DN and the association of obesity and renal function with diabetes.MethodsIn total, 264 patients with renal biopsy-confirmed DN were examined from 2002 to 2008 and followed up to June 2008 in our institute. Among these, 129 patients were classified into a Kidney Disease Outcomes Quality Initiative (K/DOQI) stage I subgroup. Weight status, clinico-histopathological features, the development of end-stage renal disease (ESRD) and increased proteinuria were evaluated at the baseline of biopsy and during the follow up. Lean, overweight and obese phenotypes were defined as body mass index (BMI) less than 25 kg/m2, 25-28 kg/m2, and more than 28 kg/m2 over, respectively.ResultsIn the patients with renal biopsy-confirmed DN, BMI was 25.5 ± 3.39 kg/m2, with 122 (46.2%), 83 (31.4%) and 59 (22.3%) having lean, overweight and obese phenotypes, respectively. Mean proteinuria was 3.09 ± 2.32 g/24 h, serum creatinine was 2.02 ± 2.02 mg/dL, and creatinine clearance rate (Ccr) was 96.0 ± 54.0 mL/min/1.73 m2. Compared with obese patients, lean patients had a lower Ccr, a higher percentage of anemia, more renal lesions and higher risk for ESRD (HR = 1.812, P = 0.048). The weight in obese patients decreased significantly after 27 months, and lean patients had a longer duration of diabetes than obese patients. Regarding patients at K/DOQI stage I, patients with DN showed similar duration of diabetes regardless of weight status. Minimal weight loss was recorded in obese patients during follow-up, and they exhibited greater glomerular hyperfiltration and higher risk for increased proteinuria (HR = 2.872, P = 0.014) than lean patients.ConclusionsIn China, obesity is common in DN patients undergoing biopsy. Initial high levels of proteinuria and subsequent weight loss are the major characteristics of the natural course of DN. Obesity contributed to increased proteinuria at an early stage, while the lean phenotype was associated with ESRD development, especially at the later stages.

Project description:Validation of predicted gene expression of human mesangial cells after 24h Tacrolimus stimulus Objective: To evaluate tacrolimus as therapeutic option for diabetic nephropathy (DN) based on molecular profile and network-based molecular model comparisons. Materials and Methods: We generated molecular models representing pathophysiological mechanisms of DN and tacrolimus mechanism of action (MoA) based on literature derived data and transcriptomics datasets. Shared enriched molecular pathways were identified based on both model datasets. A newly generated transcriptomics dataset studying the effect of tacrolimus on mesangial cells in vitro was added to identify mechanisms in DN pathophysiology. We searched for features in interference between the DN molecular model and the tacrolimus MoA molecular model already holding annotation evidence as diagnostic or prognostic biomarker in the context of DN. Results: Thirty nine molecular features were shared between the DN molecular model, holding 252 molecular features and the tacrolimus MoA molecular model, holding 209 molecular features, with six additional molecular features affected by tacrolimus in mesangial cells. Significantly affected molecular pathways by both molecular model sets included cytokine-cytokine receptor interactions, adherens junctions, TGF-beta signaling, MAPK signaling, and calcium signaling. Molecular features involved in inflammation and immune response contributing to DN progression were significantly downregulated by tacrolimus (e.g. the tumor necrosis factor alpha (TNF), interleukin 4, or interleukin 10). On the other hand, pro-fibrotic stimuli being detrimental to renal function were induced by tacrolimus like the transforming growth factor beta 1 (TGFB1), endothelin 1 (EDN1), or type IV collagen alpha 1 (COL4A1). Conclusion: Patients with DN and elevated TNF levels might benefit from tacrolimus treatment regarding maintaining GFR and reducing inflammation. TGFB1 and EDN1 are proposed as monitoring markers to assess degree of renal damage. Next to this stratification approach, the use of drug combinations consisting of tacrolimus in addition to ACE inhibitors, angiotensin receptor blockers, TGFB1- or EDN1-receptor antagonists might warrant further studies. comparison of gene expression of human mesangial cells after 24h Tacrolimus vs. Ctrl; 4 independent experiments were conducted (4xTacrolimus 24h and 4x ctrl. 24h with Drug solvent (DMSO))

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Economic evaluation of bailing capsules for patients with diabetic nephropathy in China.

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Economic evaluation of bailing capsules for patients with diabetic nephropathy in China.

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