He Yumei, Li Wei, Zhu He, Han Sheng
International Research Center for Medicinal Administration, Peking University, Beijing, China.
School of Pharmaceutical Sciences, Peking University, Beijing, China.
Front Pharmacol. 2023 Jul 5;14:1175310. doi: 10.3389/fphar.2023.1175310. eCollection 2023.
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. 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. 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. We found that Bailing capsules may be a cost-effective treatment choice for patients with diabetic nephropathy in the Chinese population.
糖尿病肾病是一种主要的微血管并发症，也是糖尿病患者终末期肾病的主要原因。百令胶囊对糖尿病肾病的治疗效果已经得到证实；然而，百令胶囊的成本效益仍存在争议。本研究旨在从中国医疗保健系统的角度评估百令胶囊联合西药与单纯西药治疗糖尿病肾病的成本效益。建立了马尔可夫模型来模拟患者20年的疾病进程。临床疗效数据来自一项荟萃分析，并基于微观模拟估计转移概率。直接成本和效用值从中国药品招标数据库（https://www.shuju.menet.com.cn）和已发表的文献中收集。测量了增量成本效益比（ICER），并进行了单向和概率敏感性分析以观察模型稳定性。共选择了34项涉及3444例糖尿病肾病患者的随机对照试验进行荟萃分析。与单纯西药相比，加用百令胶囊可使质量调整生命年（QALY）增加0.39，额外成本为人民币24721元，每获得一个QALY的ICER为人民币63001元。该ICER低于愿意支付的阈值人民币80976元（中国人均国内生产总值）。敏感性分析证实了结果的可靠性和稳定性。我们发现，对于中国人群中的糖尿病肾病患者，百令胶囊可能是一种具有成本效益的治疗选择。
