痹祺胶囊治疗膝骨关节炎的有效性和安全性：一项随机对照试验方案。
Efficacy and safety of Biqi capsule in the treatment of knee osteoarthritis: A protocol of a randomized controlled trial.
机构信息
Henan Medical College.
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China.
出版信息
Medicine (Baltimore). 2021 Apr 23;100(16):e25476. doi: 10.1097/MD.0000000000025476.
BACKGROUND
Knee osteoarthritis (KOA) is a chronic and degenerative bone and joint disease, with KOA, cartilage degeneration, destruction and subchondral bone remodeling as the main pathological features. Its clinical symptoms are knee pain, swelling, limited activity, and long course of disease can cause joint deformities. At present, the early treatment of Western medicine is mainly the use of nonsteroidal drugs for anti-inflammation and removing pain, but because the efficacy of these drugs is unstable, the disease is easy to repeat after treatment, and the clinical effect is not good. Although Biqi capsule has advantages in the treatment of KOA, there is a lack of standard clinical studies to verify it, so the purpose of this randomized controlled study is to evaluate the efficacy and safety of Biqi capsule in the treatment of KOA.
METHODS
This is a prospective randomized controlled trial to study the efficacy and safety of Biqi capsule in the treatment of KOA. The patients were randomly divided into a treatment group and a control group according to 1:1. Among them, treatment group: Biqi capsule combined with diclofenac sodium sustained release tablets; Control group: Diclofenac sodium sustained-release tablets alone. Both groups were treated with standard treatment for 2 weeks and were followed up for 30 days to pay attention to the efficacy and safety indexes. Observation indicators included: the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Hospital for Special Surgery Knee Score (HSS), liver and kidney function, adverse reactions, and so on. SPSS 25.0 software is used for data analysis.
DISCUSSION
This study will evaluate the efficacy and safety of Biqi capsule in the treatment of KOA, and the results of this experiment will provide a clinical basis for Biqi capsule in the treatment of KOA.
TRIAL REGISTRATION
OSF Registration number: DOI 10.17605/OSF.IO/6HB9D.
背景
膝骨关节炎（KOA）是一种慢性退行性骨关节病，以 KOA、软骨退变、破坏和软骨下骨重塑为主要病理特征。其临床症状为膝关节疼痛、肿胀、活动受限，病程长可导致关节畸形。目前，西医的早期治疗主要是使用非甾体类药物抗炎止痛，但由于这些药物疗效不稳定，治疗后疾病容易复发，临床效果不佳。虽然芪七胶囊在治疗 KOA 方面具有优势，但缺乏标准的临床研究来验证，因此本随机对照研究旨在评价芪七胶囊治疗 KOA 的疗效和安全性。
方法
这是一项前瞻性随机对照试验，研究芪七胶囊治疗 KOA 的疗效和安全性。患者按照 1：1 随机分为治疗组和对照组，其中治疗组：芪七胶囊联合双氯芬酸钠缓释片；对照组：双氯芬酸钠缓释片单独使用。两组均给予标准治疗 2 周，并随访 30 天，注意疗效和安全性指标。观察指标包括：WOMAC（西安大略和麦克马斯特大学骨关节炎指数）、HSS（特种外科医院膝关节评分）、肝肾功能、不良反应等。采用 SPSS 25.0 软件进行数据分析。
讨论
本研究将评价芪七胶囊治疗 KOA 的疗效和安全性，该实验结果将为芪七胶囊治疗 KOA 提供临床依据。
试验注册
OSF 注册号：DOI 10.17605/OSF.IO/6HB9D。
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