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富血小板血浆与传统药物注射治疗膝骨关节炎的临床疗效:一项随机对照试验的研究方案

The Clinical Efficacy of Platelet-Rich Plasma versus Conventional Drug Injection in the Treatment of Knee Osteoarthritis: A Study Protocol for a Randomized Controlled Trial.

作者信息

Ma Qi, Hei Xiaoyan, Zhu Shiqiang, Tian Xinbao, Chen Yundong, Zhu Ning, Zhang Jinchen, Feng Ping, Liu Yujuan, Xing Lijuan, Li Xiaojun, Liu Qiang, Li Fengqiao, Li Xiaolong, Lai Zheying, Lin Ruizhu, Xu Jianfeng

机构信息

General Hospital of Ningxia Medical University, Yinchuan, Ningxia, China.

Clinical College of Ningxia Medical University, Yinchuan, Ningxia, China.

出版信息

Evid Based Complement Alternat Med. 2022 Apr 25;2022:8767137. doi: 10.1155/2022/8767137. eCollection 2022.

Abstract

Knee osteoarthritis is a common chronic degenerative joint disease in middle-aged and elderly people. Intra-articular injection for the treatment of knee osteoarthritis is a regularly utilized nonsurgical treatment in modern medicine. Hyaluronic acid (HA) and platelet-rich plasma (PRP) are two frequently employed intra-articular devices. Hyaluronic acid (HA) is an accepted nonsurgical treatment for symptomatic KOA, and platelet-rich plasma is a popular option in the treatment of KOA in recent years. The purpose of this research is to compare the efficacy and safety of intra-articular injection of platelet-rich plasma (PRP) versus hyaluronic acid (HA) on the pain score scale, knee function, and related inflammatory biomarkers in KOA patients using a clinical randomized controlled trial. Participants are being randomized into either the hyaluronic acid (HA) or into the platelet-rich plasma (PRP) group. All patients receive 4 weeks of treatment (once a week), and well-being support and quadriceps training (3 times a week). The primary outcomes are measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the visual analog scale (VAS). The secondary outcomes include the activities of daily living score, erythrocyte sedimentation rate, C-reactive protein testing, interleukin-6 levels, and X-ray examination. In order to monitor the occurrence of irregularities and abnormalities, patients are assessed at each visit, and restorative treatment is given if necessary. The results of this clinical trial will verify the efficacy of PRP and HA in the treatment of KOA and provide important evidence for the clinical treatment of KOA. The trial was enlisted at the Chinese Clinical Trial Registry on 26 September 2020 (ChiCTR2000038635).

摘要

膝骨关节炎是中老年人常见的慢性退行性关节疾病。关节腔内注射治疗膝骨关节炎是现代医学中常用的非手术治疗方法。透明质酸(HA)和富血小板血浆(PRP)是两种常用的关节腔内注射制剂。透明质酸(HA)是症状性膝骨关节炎公认的非手术治疗方法,富血小板血浆是近年来治疗膝骨关节炎的常用选择。本研究的目的是通过一项临床随机对照试验,比较关节腔内注射富血小板血浆(PRP)与透明质酸(HA)对膝骨关节炎患者疼痛评分、膝关节功能及相关炎症生物标志物的疗效和安全性。参与者被随机分为透明质酸(HA)组或富血小板血浆(PRP)组。所有患者接受4周治疗(每周一次),并给予健康支持和股四头肌训练(每周3次)。主要结局指标采用西安大略和麦克马斯特大学骨关节炎指数(WOMAC)和视觉模拟量表(VAS)进行测量。次要结局指标包括日常生活活动评分、红细胞沉降率、C反应蛋白检测、白细胞介素-6水平及X线检查。为监测异常情况的发生,每次就诊时对患者进行评估,必要时给予恢复性治疗。本临床试验结果将验证PRP和HA治疗膝骨关节炎的疗效,为膝骨关节炎的临床治疗提供重要依据。该试验于2020年9月26日在中国临床试验注册中心注册(ChiCTR2000038635)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8d19/9153935/485316ad2457/ECAM2022-8767137.001.jpg

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