一项关于关节内透明质酸钠治疗骨关节炎关节的临床疗效和安全性的前瞻性观察研究。

A prospective observational study of the clinical efficacy and safety of intra-articular sodium hyaluronate in synovial joints with osteoarthritis.

机构信息

Physical and Rehabilitation Medicine Chair, Tor Vergata University, Rome, Italy.

出版信息

Eur J Phys Rehabil Med. 2011 Sep;47(3):407-15.

PMID:21946401

Abstract

BACKGROUND

Clinical trials have demonstrated the safety and efficacy of hyaluronic acid-based products for the treatment of synovial joints affected by osteoarthritis (OA), but data from observational studies of normal medical practice are sparse.

AIM

This study investigated the safety and efficacy of intra-articular (IA) sodium hyaluronate (MW 1500-2000 KDa; Hyalubrix®) in the treatment of synovial joint OA.

DESIGN

This is prospective, and observational study.

SETTING

This study was carried out at 47 specialist centers for physiatrists, orthopedics and rheumatology in Italy; the enrolled population, 1266 outpatient, was predominantly female (66%, 840/1266), with a mean age of 66 years, and a mean weight of 74 kg.

POPULATION

The Participants with OA received IA injections of the study treatment (2 mL) once per week for 3 weeks. The knee was the joint most commonly affected by OA (right knee 802/1266 [63%]; left knee 598/1266 [47%]), and the longest median duration of disease occurred in the carpal joint (right carpal joint 40 months; left carpal joint 60 months).

METHODS

The primary endpoints were tolerability and details of usage of the IA sodium hyaluronate syringe device. Efficacy parameters included assessment of self-reported pain via the Visual Analogue Scale (VAS), and evaluation of motor function via the Health Assessment Questionnaire (HAQ). Quality of life (QoL) was assessed using the Euro QoL questionnaire (Clinical Trial Registration Number: ISRCTN 42690497).

RESULTS

Data from 1266 participants were collected. The adverse event (AE) rate was 0.8% (95% CI, 0.4 to 1.5). Thirteen AEs were reported, 12 of which were mild or moderate in severity. Only one participant discontinued study treatment following an AE. No serious adverse events occurred. Coadministration of local anesthetic was required by up to 10% of patients. Statistically significant improvements in VAS, HAQ and EuroQoL were recorded in multiple joints (P<0.0001 for each).

CONCLUSION

The study treatment was safe and well tolerated.

CLINICAL REHABILITATION IMPACT

. The study treatment reduced pain, improved mobility, and increased QoL in participants with OA.

摘要

背景

临床试验已经证明了基于透明质酸的产品在治疗受骨关节炎（OA）影响的滑液关节方面的安全性和有效性，但来自常规医疗观察研究的数据却很少。

目的

本研究旨在调查关节内（IA）注射透明质酸钠（MW 1500-2000 KDa；Hyalubrix®）治疗滑液关节 OA 的安全性和疗效。

设计

这是一项前瞻性、观察性研究。

设置

该研究在意大利的 47 家物理治疗师、骨科和风湿病专家中心进行；纳入的 1266 名门诊患者主要为女性（66%，840/1266），平均年龄为 66 岁，平均体重为 74 公斤。

人群

OA 患者每周接受一次研究治疗（2 mL），共 3 周。膝关节是最常受 OA 影响的关节（右膝 802/1266[63%]；左膝 598/1266[47%]），而腕关节的疾病最长中位持续时间（右腕关节 40 个月；左腕关节 60 个月）。

方法

主要终点是关节内注射透明质酸钠注射器装置的耐受性和使用细节。疗效参数包括通过视觉模拟量表（VAS）评估自我报告的疼痛，以及通过健康评估问卷（HAQ）评估运动功能。使用 EuroQoL 问卷（临床试验注册号：ISRCTN42690497）评估生活质量（QoL）。

结果

共收集了 1266 名参与者的数据。不良事件（AE）发生率为 0.8%（95%CI，0.4 至 1.5）。报告了 13 例 AEs，其中 12 例为轻度或中度。只有一名参与者因 AE 而停止了研究治疗。没有发生严重不良事件。多达 10%的患者需要联合使用局部麻醉剂。在多个关节中，VAS、HAQ 和 EuroQoL 均有显著改善（P<0.0001）。