Viscosupplementation for Osteoarthritis of the Knee A Systematic Review of the Evidence
Viscosupplementation for Osteoarthritis of the Knee A Systematic Review of the Evidence
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DOI：
10.2106/jbjs.n.00743
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发表时间：
2015-12-16
影响因子：
5.3
通讯作者：
Cummins, Deborah S.
中科院分区：
文献类型：
--
作者：
Jevsevar, David;Donnelly, Patrick;Cummins, Deborah S.
背景资料：本分析的目的是确定注射用透明质酸（HA）治疗膝关节骨关节炎的临床意义，并评估哪些试验水平因素影响HA对疼痛的总体治疗效果（通过VAS [视觉模拟量表]或WOMAC [西安大略大学和麦克马斯特大学骨关节炎指数]测量）和WOMAC功能和WOMAC僵硬子量表。对PubMed、EMBASE、物理治疗证据数据库和科克伦对照试验中心进行了全面的文献检索，以查找比较HA与对照治疗的随机对照试验，每个亚组至少有30例患者。为了考虑纳入，每篇文章必须将VAS或WOMAC疼痛、WOMAC功能和/或WOMAC僵硬度作为结局，因为已经确定了这些工具的最小重要差异（MID）。对19项试验进行了“最佳证据”系统评价和荟萃分析;由于试验之间的高度异质性，进行了荟萃回归分析，以确定试验特征对疼痛、功能和僵硬的整体HA治疗效果的影响。最一致的发现是双盲，假对照试验的治疗效果比不充分设盲的试验小得多（p < 0.05）。对于双盲试验，疼痛、功能和僵硬的总体治疗效果不到MID的一半。交联HA和随访时间也有显著相关性。然而，交联HA的双盲试验中的效应量仍然不到疼痛和僵硬MID的一半。统计学显着效果的后续持续时间消失时，开放标签试验被删除的analysis.Conclusions：Meta分析的双盲，假对照试验，至少有60例患者没有显示临床上重要的差异，HA治疗安慰剂。当将所有文献加入分析时，总体效果更大，但由于非盲或不适当盲法试验的影响，偏向于更强的治疗效果。
Background: The purpose of this analysis was to determine the clinical significance of injectable hyaluronic acid (HA) in the treatment of knee osteoarthritis, and to assess which trial-level factors influence the overall treatment effect of HA on pain (as measured by a VAS [visual analog scale] or the WOMAC [Western Ontario and McMaster Universities Osteoarthritis Index]) and the WOMAC function and WOMAC stiffness subscales.Methods: A comprehensive literature search of PubMed, EMBASE, the Physiotherapy Evidence Database, and the Cochrane Central Register of Controlled Trials was done to locate randomized controlled trials that compared HA with control treatment and had a minimum of thirty patients per subgroup. To be considered for inclusion, each article had to include VAS or WOMAC pain, WOMAC function, and/or WOMAC stiffness as outcomes because the minimal important difference (MID) has been established for these instruments. A "best-evidence" systematic review and meta-analysis of nineteen trials was performed; because of high heterogeneity among the trials, meta-regression analyses were conducted to determine the influence of trial characteristics on overall HA treatment effects for pain, function, and stiffness.Results: The most consistent finding was that double-blinded, sham-controlled trials had much smaller treatment effects than trials that were not sufficiently blinded (p < 0.05). For double-blinded trials, the overall treatment effect was less than half of the MID for pain, function, and stiffness. Other significant associations were found for cross-linked HAs and follow-up duration. However, the effect sizes among double-blinded trials of cross-linked HAs were still less than half of the MIDs for pain and stiffness. The statistically significant effect of follow-up duration disappeared when the open-label trials were removed from the analysis.Conclusions: Meta-analysis of only the double-blinded, sham-controlled trials with at least sixty patients did not show clinically important differences of HA treatment over placebo. When all literature was added to the analysis, the overall effect was greater but was biased toward stronger treatment effects because of the influence of nonblinded or improperly blinded trials.