Migliore A, Massafra U, Frediani B, Bizzi E, Sinelnikov Yzchaki E, Gigliucci G, Cassol M, Tormenta S
Rheumatology Unit, and Research Center, S. Pietro FBF Hospital, Rome, Italy.
Eur Rev Med Pharmacol Sci. 2017 Apr;21(7):1635-1644.
Several studies on knee osteoarthritis suggest that the intra-articular administration of hyaluronic acid products may be a relevant option in the management of patients with persistent pain. The aim of this study is to report the data of efficacy of US-guided HyalOne®/Hyalubrix® 60 injections in a large population of patients with hip osteoarthritis, repeated at least 2 times per year for up to seven years.
This is a prospective, post-marketing, cohort study. Data were collected from the ANTIAGE registry. Values of Lequesne index, pain VAS, NSAIDs intake, global medical and patients assessments were evaluated every six months from the baseline to the end of the follow-up, seven years later. The inclusion criteria were: age ≥18 years, symptomatic hip osteoarthritis of at least 1-year duration, and up to 84 months of follow-up. All the patients received hyaluronic acid injections at least every six months, using ultrasound guidance to ensure accurate placement.
1022 patients were included in the study. The patients were categorized by age classes, gender, and body mass index (BMI). All the groups show a statistically significant reduction at all time points compared to baseline values of Lequesne index, pain VAS, NSAIDs intake, global medical and patients assessments. There are slight differences in the subgroups of overweighted, obese and over 70 years patients.
Our study supports the clinical efficacy and safety of HyalOne®/Hyalubrix®60 in patients affected by osteoarthritis. This is the first study, reporting on a large cohort of patients in different categories with a long follow-up on seven years. The data confirm the proper use of ultrasound-guided viscosupplementation (VS) as background therapy in the management of hip osteoarthritis.
多项关于膝关节骨关节炎的研究表明，关节腔内注射透明质酸产品可能是治疗持续性疼痛患者的一种有效选择。本研究的目的是报告在大量髋骨关节炎患者中，每年至少重复2次、持续7年的超声引导下注射HyalOne®/Hyalubrix® 60的疗效数据。
这是一项前瞻性、上市后队列研究。数据来自ANTIAGE注册库。从基线到随访结束（7年后），每6个月评估一次Lequesne指数、疼痛视觉模拟评分（VAS）、非甾体抗炎药摄入量、总体医疗评估和患者评估值。纳入标准为：年龄≥18岁、症状性髋骨关节炎病程至少1年、随访时间长达84个月。所有患者至少每6个月接受一次透明质酸注射，采用超声引导以确保准确注射。
1022例患者纳入研究。患者按年龄组、性别和体重指数（BMI）分类。与Lequesne指数、疼痛VAS、非甾体抗炎药摄入量、总体医疗评估和患者评估的基线值相比，所有组在所有时间点均显示出统计学上的显著降低。超重、肥胖和70岁以上患者亚组存在细微差异。
我们的研究支持HyalOne®/Hyalubrix®60对骨关节炎患者的临床疗效和安全性。这是第一项对大量不同类别患者进行长达7年长期随访的研究。数据证实了超声引导下粘弹性补充疗法（VS）作为髋骨关节炎治疗背景疗法的合理应用。
