Pan Hejing, Li Xuanlin, Wu Shan, Zhou Donghai, Guan Haojie, Wu Haoyu, Wang Qiao, Tang Yujun, Hu Xuanming, Wang Meijiao, Zhou Mingqian, Huang Runyue, Liu Lei, Chen Yaolong, Wen Chengping, Huang Lin
College of Basic Medical Science, Zhejiang Chinese Medical University, Hangzhou, China.
the First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China.
PLoS One. 2025 Jul 9;20(7):e0327864. doi: 10.1371/journal.pone.0327864. eCollection 2025.
Gout, a prevalent metabolic rheumatic disease, arises from the accumulation of monosodium urate (MSU) crystals in joints, directly associated with hyperuricemia. Long-term or lifelong urate-lowering therapy (ULT) stands as the primary management strategy. However, there is a significant risk of gout flares during ULT, and current methods have drawbacks, including side effects. Previous research has suggested a potential benefit of the Qu-zhuo Tong-bi formula (QTF) in the treatment and prevention of gout. This study aims to evaluate the effectiveness and safety of QTF in reducing gout flares during ULT.
This is a multi-center, randomized, double-blind, placebo, parallel-controlled clinical trial conducted in four hospitals in Zhejiang Province, China. A total of 144 patients, aged 18-80 years, will be randomly allocated to either the intervention group (QTF + febuxostat) or the control group (placebo + febuxostat) for a 12-week treatment period. The primary outcome measure is the frequency of gout flares. Secondary outcome measures include the time from the patient's enrollment to the first occurrence of gout flare (in days), duration of gout flare (in days), health assessment questionnaire disability index (HAQ-DI), pain level (visual analog scale - VAS), rate of achieving target uric acid levels. Occurrences of adverse events, and results from electrocardiograms and laboratory tests, will be monitored.
The findings from this study will offer valuable evidence supporting the efficacy of the QTF in reducing gout flares during ULT.
ChiCTR20084417 Register on May 16, 2024.
痛风是一种常见的代谢性风湿疾病，由关节中尿酸钠（MSU）晶体的积累引起，与高尿酸血症直接相关。长期或终身降尿酸治疗（ULT）是主要的治疗策略。然而，ULT期间痛风发作的风险很高，并且目前的方法存在包括副作用在内的缺点。先前的研究表明，祛浊通痹方（QTF）在痛风的治疗和预防方面具有潜在益处。本研究旨在评估QTF在ULT期间减少痛风发作的有效性和安全性。
这是一项在中国浙江省四家医院进行的多中心、随机、双盲、安慰剂平行对照临床试验。总共144名年龄在18至80岁之间的患者将被随机分配到干预组（QTF + 非布司他）或对照组（安慰剂 + 非布司他），进行为期12周的治疗。主要结局指标是痛风发作的频率。次要结局指标包括从患者入组到首次痛风发作的时间（以天为单位）、痛风发作的持续时间（以天为单位）、健康评估问卷残疾指数（HAQ-DI）、疼痛程度（视觉模拟量表 - VAS）、达到目标尿酸水平的比率。将监测不良事件的发生情况以及心电图和实验室检查结果。
本研究的结果将为支持QTF在ULT期间减少痛风发作的疗效提供有价值的证据。
ChiCTR20084417 于2024年5月16日注册。
