Priano Ferdinando
Centro Ortopedico "Policlinico di Monza," Ospedale S.M. Misericordia, Albenga, Italy.
Joints. 2017 Jul 28;5(2):79-84. doi: 10.1055/s-0037-1603677. eCollection 2017 Jun.
The aim of the study was to evaluate the clinical effects of HYADD® 4, an hydrogel based on a hyaluronic acid derivative, in patients with symptomatic knee osteoarthritis, on symptoms, and joint function. This retrospective study of patients with Kellgren-Lawrence grade II to IV knee osteoarthritis (American College of Rheumatology criteria) enrolled patients who had received two infiltrations of HYADD® 4, (24 mg/3 mL) 1 week apart, and evaluated: pain at rest, pain with movement, change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score; change in nonsteroidal anti-inflammatory drugs (NSAIDs)/acetaminophen use; satisfaction with therapy; tolerability. Study duration was 6 months for all predefined endpoints, with a 6-month extension for pain symptoms only. After 6 months, all predefined endpoints were evaluable in 698 of 937 enrolled patients (74.5%). Mean WOMAC scores were reduced by 56.3% from baseline ( < 0.05). NSAIDs/acetaminophen use ≥2 times/week (48.8% of patients at baseline) was substantially reduced after 1 month and was 19.6% after 6 months. After 6 months, 85.6% of patients were satisfied about efficacy. There were no significant adverse effects. The effect on resting pain was rapid, strong, and lasting: reduction from baseline was 45.1% at 1 month ( < 0.05), 56.8% at 6 months ( < 0.05), and 53.6% at 12 months ( < 0.05). Pain on moving was reduced by 47.4% after 6 months ( < 0.05) and 46.0% after 12 months ( < 0.05), results at 6 and 12 months were similar. HYADD® 4 is a new-generation hyaluronic acid with distinctive viscoelastic and rheological properties. In patients with mild-to-severe knee OA (Kellgren-Lawrence grades II-IV), two consecutive infiltrations 1 week apart reduced WOMAC scores and NSAIDs/acetaminophen consumption for at least 6 months. In a subpopulation ( = 106), efficacy on pain lasted approximately 12 months. Adverse events were reported in 11.2% of patients; the most frequent were arthralgias. No cases of allergic reactions or systemic effects were recorded. Level IV, retrospective case series.
本研究旨在评估基于透明质酸衍生物的水凝胶HYADD® 4对有症状的膝关节骨关节炎患者的症状及关节功能的临床效果。
这项针对凯尔格伦-劳伦斯分级为II至IV级膝关节骨关节炎（美国风湿病学会标准）患者的回顾性研究，纳入了接受两次间隔1周的HYADD® 4（24毫克/3毫升）注射的患者，并评估了：静息痛、运动痛、西安大略和麦克马斯特大学骨关节炎指数（WOMAC）评分变化；非甾体抗炎药（NSAIDs）/对乙酰氨基酚使用情况的变化；对治疗的满意度；耐受性。所有预定义终点的研究持续时间为6个月，仅疼痛症状延长6个月。
6个月后，937名入组患者中的698名（74.5%）所有预定义终点均可评估。WOMAC平均评分较基线降低了56.3%（P < 0.05）。每周使用NSAIDs/对乙酰氨基酚≥2次（基线时48.8%的患者）在1个月后大幅减少，6个月后为19.6%。6个月后，85.6%的患者对疗效满意。未出现显著不良反应。对静息痛的影响迅速、强烈且持久：1个月时较基线降低45.1%（P < 0.05），6个月时降低56.8%（P < 0.05），12个月时降低53.6%（P < 0.05）。运动痛在6个月后降低了47.4%（P < 0.05），12个月后降低了46.0%（P < 0.05），6个月和12个月的结果相似。
HYADD® 4是一种具有独特粘弹性和流变学特性的新一代透明质酸。在轻至重度膝关节骨关节炎（凯尔格伦-劳伦斯分级II - IV级）患者中，间隔1周连续两次注射可降低WOMAC评分以及NSAIDs/对乙酰氨基酚的消耗量，至少持续6个月。在一个亚组（n = 106）中，对疼痛的疗效持续约12个月。11.2%的患者报告了不良事件；最常见的是关节痛。未记录到过敏反应或全身效应的病例。
IV级，回顾性病例系列。
