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中国高尿酸血症痛风患者中选择的通用与原研非布司他片的临床与经济学评价比较:一项真实世界多中心回顾性研究。

Comparison of clinical and economic evaluation between selected generic and original febuxostat tablets in Chinese gout patients with hyperuricemia: A real-world multicenter retrospective study.

机构信息

Department of Pharmacy, Peking University People's Hospital, Beijing, China.

Department of Pharmacy, Beijing Tsinghua Changgung Hospital, Beijing, China.

出版信息

Medicine (Baltimore). 2024 Jan 26;103(4):e37081. doi: 10.1097/MD.0000000000037081.

Abstract

Generic febuxostat tablets were listed in China's third-round centralized drug procurement program. However, there are no sufficient data available on the use of febuxostat in a real-world setting. This study aimed to compare the efficacy, safety, and cost of selected generic febuxostat with original febuxostat in primary gout and hyperuricemia. Medical records at 3 tertiary hospitals from January 2014 to February 2022 were retrospectively analyzed. Propensity score matching was used to balance the distribution of baseline characteristics. The proportion of patients achieving target serum uric acid (SUA) levels at 12 weeks, the percent changes from baseline in SUA, adverse drug reactions, and the cost of febuxostat therapy were assessed. A total of 221 patients were recruited and 57 pairs of patients were 1:1 matched in the 2 groups. There was no statistically significant difference in the proportion of patients achieving a target SUA levels below 300 μmol/L, the percent changes of SUA decreased from baseline, and the incidence of adverse drug reactions between the 2 groups (all P > .05). The daily febuxostat cost in the generic group were significantly lower than that in original group (P < .05). Based on the results of this study, the clinical efficacy of selected generic febuxostat is comparable to that of original febuxostat for gout with hyperuricemia. No serious adverse reactions were reported in the 2 groups, and generic febuxostat is more economical than the original febuxostat.

摘要

仿制非布司他片剂被列入中国第三轮国家药品集中采购目录。然而,目前关于仿制非布司他在真实世界中的应用还缺乏足够的数据。本研究旨在比较选定的仿制非布司他与原研非布司他在原发性痛风和高尿酸血症中的疗效、安全性和成本。回顾性分析了 2014 年 1 月至 2022 年 2 月 3 家三级医院的病历。采用倾向评分匹配来平衡基线特征的分布。评估了 12 周时达到目标血清尿酸(SUA)水平的患者比例、SUA 从基线的变化百分比、药物不良反应以及非布司他治疗的成本。共纳入 221 例患者,在两组中按 1:1 比例进行了 57 对患者的 1:1 匹配。两组在达到 SUA 目标水平低于 300μmol/L的患者比例、SUA 从基线下降的百分比以及药物不良反应的发生率方面均无统计学差异(均 P>.05)。在通用组中,非布司他的每日费用明显低于原研组(P<.05)。基于本研究结果,选定的仿制非布司他的临床疗效与原研非布司他相当,用于治疗伴有高尿酸血症的痛风。两组均未报告严重不良反应,而且仿制非布司他比原研非布司他更经济。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3177/10817005/c97e1ad12c53/medi-103-e37081-g001.jpg

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