Zilin Long , Houyu Zhao , Yueqi Yin , Yexiang Sun , Peng Shen , Hongbo Lin , Junchang Liu , Siyan Zhan , Zhiqin Jiang , Feng Sun
{"title":"中草药治疗高尿酸血症的临床疗效和安全性:一项回顾性现实世界研究。","authors":"Zilin Long , Houyu Zhao , Yueqi Yin , Yexiang Sun , Peng Shen , Hongbo Lin , Junchang Liu , Siyan Zhan , Zhiqin Jiang , Feng Sun","doi":"10.1016/j.phymed.2025.157231","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Hyperuricemia (HUA) has become a bothersome health problem that cannot be ignored. An increasing number of patients with HUA seek Chinese herbal medicine (CHM) as an alternative or complementary treatment. However, there was a lack of real-world evidence on the long-term impact of CHM in HUA populations.</div></div><div><h3>Purpose</h3><div>This study aimed to explore the clinical outcomes and safety of CHM among individuals with HUA in mainland China.</div></div><div><h3>Study design</h3><div>A population-based, active-comparator new-user designed cohort study of patients with HUA was performed using the Yinzhou Regional Health Care Database (YRHCD).</div></div><div><h3>Methods</h3><div>A cox model with propensity score matching was applied to estimate the hazard ratio (HR) of the association between the use of CHM and gouty arthritis (GA). Various subgroup analyses and multiple sensitivity analyses were also performed to demonstrate the robustness of results. The secondary outcomes were drug-induced liver injury (DILI) risk and gouty nephropathy (GN) risk.</div></div><div><h3>Results</h3><div>A total of 40 653 patients with HUA were included from the YRHCD between 2015 and 2024, among whom 35 511 participants were CHM users and 5 142 were benzbromarone (BBR) users. In the primary analysis, the incidence of GA was 34.43 per 1 000 person-years for CHM users and 58.00 per 1 000 person-years for BRR users, respectively. CHM users appeared to have a 43 % reduction in risk of developing GA compared with BBR users with an HR of 0.57 [95 %CI 0.50, 0.65]. In addition, there was comparable safety in DILI between CHM users and BBR users (HR 1.18 [95 % CI 0.93, 1.49]). The results were generally consistent in various subgroup analyses and sensitivity analyses.</div></div><div><h3>Conclusion</h3><div>CHM users improved clinical outcomes in patients with HUA and was safe, which can be a promising complementary therapy for HUA patients.</div></div>","PeriodicalId":20212,"journal":{"name":"Phytomedicine","volume":"148 ","pages":"Article 157231"},"PeriodicalIF":8.3000,"publicationDate":"2025-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Clinical outcomes and safety of Chinese herbal medicine in the treatment of hyperuricemia: A retrospective real-world study\",\"authors\":\"Zilin Long , Houyu Zhao , Yueqi Yin , Yexiang Sun , Peng Shen , Hongbo Lin , Junchang Liu , Siyan Zhan , Zhiqin Jiang , Feng Sun\",\"doi\":\"10.1016/j.phymed.2025.157231\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><div>Hyperuricemia (HUA) has become a bothersome health problem that cannot be ignored. An increasing number of patients with HUA seek Chinese herbal medicine (CHM) as an alternative or complementary treatment. However, there was a lack of real-world evidence on the long-term impact of CHM in HUA populations.</div></div><div><h3>Purpose</h3><div>This study aimed to explore the clinical outcomes and safety of CHM among individuals with HUA in mainland China.</div></div><div><h3>Study design</h3><div>A population-based, active-comparator new-user designed cohort study of patients with HUA was performed using the Yinzhou Regional Health Care Database (YRHCD).</div></div><div><h3>Methods</h3><div>A cox model with propensity score matching was applied to estimate the hazard ratio (HR) of the association between the use of CHM and gouty arthritis (GA). Various subgroup analyses and multiple sensitivity analyses were also performed to demonstrate the robustness of results. The secondary outcomes were drug-induced liver injury (DILI) risk and gouty nephropathy (GN) risk.</div></div><div><h3>Results</h3><div>A total of 40 653 patients with HUA were included from the YRHCD between 2015 and 2024, among whom 35 511 participants were CHM users and 5 142 were benzbromarone (BBR) users. In the primary analysis, the incidence of GA was 34.43 per 1 000 person-years for CHM users and 58.00 per 1 000 person-years for BRR users, respectively. CHM users appeared to have a 43 % reduction in risk of developing GA compared with BBR users with an HR of 0.57 [95 %CI 0.50, 0.65]. In addition, there was comparable safety in DILI between CHM users and BBR users (HR 1.18 [95 % CI 0.93, 1.49]). The results were generally consistent in various subgroup analyses and sensitivity analyses.</div></div><div><h3>Conclusion</h3><div>CHM users improved clinical outcomes in patients with HUA and was safe, which can be a promising complementary therapy for HUA patients.</div></div>\",\"PeriodicalId\":20212,\"journal\":{\"name\":\"Phytomedicine\",\"volume\":\"148 \",\"pages\":\"Article 157231\"},\"PeriodicalIF\":8.3000,\"publicationDate\":\"2025-09-09\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Phytomedicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0944711325008700\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CHEMISTRY, MEDICINAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Phytomedicine","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0944711325008700","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CHEMISTRY, MEDICINAL","Score":null,"Total":0}
引用次数: 0
摘要
背景:高尿酸血症(HUA)已成为一个不容忽视的健康问题。越来越多的HUA患者寻求中草药作为替代或补充治疗。然而,缺乏真实世界的证据表明CHM对HUA人群的长期影响。目的:本研究旨在探讨中国大陆HUA患者使用CHM的临床结局和安全性。研究设计:使用鄞州地区卫生保健数据库(YRHCD)对HUA患者进行了一项基于人群的、活跃的比较器新用户设计的队列研究。方法:采用倾向评分匹配的cox模型估计CHM使用与痛风性关节炎(GA)相关性的风险比(HR)。还进行了各种亚组分析和多重敏感性分析,以证明结果的稳健性。次要结局是药物性肝损伤(DILI)风险和痛风性肾病(GN)风险。结果:2015年至2024年,YRHCD共纳入40653例HUA患者,其中35,511例为CHM使用者,5142例为苯溴马龙(BBR)使用者。在初步分析中,CHM使用者GA发病率为34.43 / 1000人-年,BRR使用者GA发病率为58.00 / 1000人-年。与BBR使用者相比,CHM使用者发生GA的风险降低了43%,HR为0.57 [95% CI 0.50, 0.65]。此外,CHM使用者和BBR使用者DILI的安全性相当(HR 1.18 [95% CI 0.93, 1.49])。各亚组分析和敏感性分析结果基本一致。结论:中草药可改善HUA患者的临床预后,且安全,是一种有希望的HUA患者补充治疗方法。
Clinical outcomes and safety of Chinese herbal medicine in the treatment of hyperuricemia: A retrospective real-world study
Background
Hyperuricemia (HUA) has become a bothersome health problem that cannot be ignored. An increasing number of patients with HUA seek Chinese herbal medicine (CHM) as an alternative or complementary treatment. However, there was a lack of real-world evidence on the long-term impact of CHM in HUA populations.
Purpose
This study aimed to explore the clinical outcomes and safety of CHM among individuals with HUA in mainland China.
Study design
A population-based, active-comparator new-user designed cohort study of patients with HUA was performed using the Yinzhou Regional Health Care Database (YRHCD).
Methods
A cox model with propensity score matching was applied to estimate the hazard ratio (HR) of the association between the use of CHM and gouty arthritis (GA). Various subgroup analyses and multiple sensitivity analyses were also performed to demonstrate the robustness of results. The secondary outcomes were drug-induced liver injury (DILI) risk and gouty nephropathy (GN) risk.
Results
A total of 40 653 patients with HUA were included from the YRHCD between 2015 and 2024, among whom 35 511 participants were CHM users and 5 142 were benzbromarone (BBR) users. In the primary analysis, the incidence of GA was 34.43 per 1 000 person-years for CHM users and 58.00 per 1 000 person-years for BRR users, respectively. CHM users appeared to have a 43 % reduction in risk of developing GA compared with BBR users with an HR of 0.57 [95 %CI 0.50, 0.65]. In addition, there was comparable safety in DILI between CHM users and BBR users (HR 1.18 [95 % CI 0.93, 1.49]). The results were generally consistent in various subgroup analyses and sensitivity analyses.
Conclusion
CHM users improved clinical outcomes in patients with HUA and was safe, which can be a promising complementary therapy for HUA patients.
期刊介绍:
Phytomedicine is a therapy-oriented journal that publishes innovative studies on the efficacy, safety, quality, and mechanisms of action of specified plant extracts, phytopharmaceuticals, and their isolated constituents. This includes clinical, pharmacological, pharmacokinetic, and toxicological studies of herbal medicinal products, preparations, and purified compounds with defined and consistent quality, ensuring reproducible pharmacological activity. Founded in 1994, Phytomedicine aims to focus and stimulate research in this field and establish internationally accepted scientific standards for pharmacological studies, proof of clinical efficacy, and safety of phytomedicines.