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POLYACRYLAMIDE HYDROGEL VERSUS HYALURONIC ACID IN KNEE OSTEOARTHRITIS: A SUBGROUP ANALYSIS OF A RANDOMIZED STUDY

医学 沃马克 骨关节炎 超重 随机对照试验 透明质酸 统计显著性 子群分析 重复措施设计 体质指数 内科学 物理疗法 方差分析 外科 荟萃分析 病理 替代医学 统计 解剖 数学
作者
Henning Bliddal,Jannie Beier,Andreas Hartkopp,Philip G. Conaghan,Marius Henriksen
标识
DOI:10.1302/1358-992x.2023.13.081
摘要

Abstract Introduction The effectiveness of single intra-articular injections of polyacrylamide hydrogel (iPAAG) and hyaluronic acid (HA) was compared in subgroups of participants from an RCT based on baseline age, BMI or Kellgren-Lawrence (KL) grade. Methodology 239 participants were randomised to 6 mL iPAAG (Arthrosamid; n=119) or 6 mL HA (Synvisc-One; n=120). Participants continued analgesics (except 48 hours prior to visits) and non-pharmacological therapy. Topical therapies and intra-articular corticosteroids were not allowed. Pre-specified subgroup analyses (age: <70 years, ≥70 years; BMI: normal, overweight, obese; KL grade: 2, 3, 4, 2–3) of change from baseline in WOMAC pain subscale at 52 weeks were based on the least squares means for the treatment-by-week interaction effect using a mixed model for repeated measurement with a restricted maximum likelihood-based approach. Results Across all patients, change from baseline in WOMAC pain subscale in the iPAAG group was non-inferior to HA at 26 weeks and approached superiority (p=0.0572) at 52 weeks. Treatment differences for change from baseline in WOMAC pain subscale in favour of iPAAG over HA were statistically significant for the age <70 years (p=0.019), BMI normal (p=0.011) and KL grade 2–3 (p=0.033) subgroups. Treatment differences for all other subgroups favoured iPAAG, except for KL grade 4 which favoured HA, without reaching statistical significance. Conclusion iPAAG approached superiority to HA across all participants at 52weeks, but demonstrated statistical superiority in participants with normal BMI, participants <70 years old or participants with KL score 2–3. iPAAG represents a useful alternative to HA for the treatment of knee OA.

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