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两种不同剂型的线性透明质酸治疗膝骨关节炎患者的疗效和安全性比较

Comparative Efficacy and Safety of Two Different Formulations of Linear Hyaluronic Acid in Patients with Knee Osteoarthritis.

作者信息

Rania Vincenzo, Vocca Cristina, Marcianò Gianmarco, Caroleo Maria Cristina, Muraca Lucia, Toraldo Emanuele, Greco Francesca, Palleria Caterina, Emerenziani Gian Pietro, Gallelli Luca

机构信息

Operative Unit of Pharmacology and Pharmacovigilance, "Renato Dulbecco" University Hospital, 88100 Catanzaro, Italy.

Department of Health Science, University Magna Graecia of Catanzaro, 88100 Catanzaro, Italy.

出版信息

Pharmaceuticals (Basel). 2025 Jul 19;18(7):1065. doi: 10.3390/ph18071065.

Abstract

: Knee osteoarthritis (OA) is defined by articular cartilage loss, increased discomfort, and functional restrictions. Changes in lifestyle, painkillers, intra-articular injections, and, as a last resort, surgery are all part of clinical therapy. In this setting, intra-articular injections of hyaluronic acid (HA) represent a relevant and diffused therapeutic option. : A prospective observational study was performed from October 2024 to May 2025 in 70 patients with knee OA. HA was administered in three intra-articular injections and was followed up at 3 and 6 months from the last injection. Knee Injury and Osteoarthritis Outcome Score (KOOS) was evaluated as primary outcome measure; Visual Analogue Scale (VAS), time up and go test, six-minute walking test, general health assessment with 36-Item Short Form Health Survey (SF-36), Zung's Self-Rating Anxiety Scale (Zung SAS), and Zung's Self-Rating Depression Scale (Zung SDS) as secondary outcome measures. : We observed a statistically significant improvement in clinical scores at 3 months in both HA formulations compared to the control group. No relevant side effects were described during the study. : Hyalubrix 30 mg/2 mL and DIART 1.8%/2 mL are two safe and effective therapeutic options to manage knee OA, offering benefits in pain control, functionality and emotional wellness.

摘要

膝关节骨关节炎(OA)的定义为关节软骨丧失、不适感增加和功能受限。生活方式改变、止痛药、关节内注射以及作为最后手段的手术都是临床治疗的一部分。在这种情况下,关节内注射透明质酸(HA)是一种相关且广泛应用的治疗选择。

2024年10月至2025年5月,对70例膝关节OA患者进行了一项前瞻性观察研究。HA通过三次关节内注射给药,并在最后一次注射后的3个月和6个月进行随访。膝关节损伤和骨关节炎结局评分(KOOS)被评估为主要结局指标;视觉模拟量表(VAS)、起立行走测试、六分钟步行测试、采用36项简短健康调查问卷(SF - 36)进行的总体健康评估、zung氏自评焦虑量表(zung SAS)和zung氏自评抑郁量表(zung SDS)作为次要结局指标。

与对照组相比,我们观察到两种HA制剂在3个月时临床评分有统计学意义的改善。研究期间未描述相关副作用。

Hyalubrix 30 mg/2 mL和DIART 1.8%/2 mL是治疗膝关节OA的两种安全有效的治疗选择,在疼痛控制、功能和情绪健康方面具有益处。

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