OSTEOARTHRITIS
A randomized clinical trial to evaluate two doses of an intra-articular injection of LMWF-5A in adults with pain due to osteoarthritis of the knee
This report has been verified
by one or more authors of the
original publication.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2014;2(11):18 PLoS One. 2014 Feb 3;9(2):e87910. doi: 10.1371/journal.pone.0087910. eCollection 2014.329 patients with symptomatic knee osteoarthritis (OA) were randomized to receive either Low Molecular Weight Fraction of 5% human serum albumin (LMWF-5A) or saline vehicle solution, each at a dose of either 4 or 10 mL. The purpose of this study was to determine the analgesic efficacy and safety of LMWF-5A in this study population. Results indicated that both the 4-mL and 10-mL volumes of the LMWF-5A solution were safe and yielded significantly better pain scores, functional outcome, and overall assessment of disease severity, when compared to a saline vehicle solution. These effects were especially pronounced in patients with severe OA, and those who received a prior knee injection.
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
はい = 1
不確実＝0.5
無関係 = 0
いいえ = 0
報告基準評価では、著者が出版物内で試験の方法論的特徴や試験特性を報告する際の透明性を評価します。評価は以下の5つのカテゴリーに分類されます。
4/4
Randomization
3/4
Outcome Measurements
4/4
Inclusion / Exclusion
4/4
Therapy Description
4/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
Fragility Indexは、重要な所見の解釈を助けるツールで、結果の強さの尺度を提供します。Fragility Indexは、その所見が有意でなくなるために、二項対立の結果に追加する必要がある連続した事象の数を表します。数値が小さいほど弱い所見を表し、数値が大きいほど強い所見を表します。
なぜ今この研究が必要なのですか？
The prevalence of knee osteoarthritis (OA) is on the rise. This increase - potentially attributable (in part) to the increasing rates of obesity within the population - in concerning, as knee OA can significantly impact a patient's quality of life. Currently, conservative treatment for this inflammatory condition may include intra-articular corticosteroid or hyaluronan injections, or non-steroidal anti-inflammatory drugs (NSAIDs); however, these approaches are not supported by high-quality evidence. As a result, human serum albumin (HSA) has been proposed as an alternative in the management of knee OA. This study was needed to establish the analgesic efficacy and safety of the Low Molecular Weight Fraction of 5% HSA (LMWF-5A) for the treatment of patients with knee OA.
主な研究課題は何ですか？
Is the Low Molecular Weight Fraction of 5% human serum albumin (LMWF-5A) safe and effective for improving pain, stiffness, function and overall disease severity in patients with knee osteoarthritis?
重要な知見は？
- In general, LMWF-5A improved pain significantly more (-0.93) compared to the control solution (-0.72) (estimated difference: -0.25; 95% CI -0.08 to -0.41; p=0.004). This significant between-group difference was apparent at week 4 (p=0.03), week 6 (p=0.04) and week 12 (p=0.004), but not at weeks 2 (p=0.14), 8 (p=0.06) or 10 (p=0.11).
- Over time ending at week 12, the percentage of pain score reduction was significantly greater when patients were administered LMWF-5A (42.3%) compared to the control solution (31.7%) (p<0.05).
- Compared to patients receiving the saline vehicle solution, those receiving LMWF-5A had significantly superior Patient's Global Assessment (PGA) of disease severity scores (-0.87 vs -0.65; p=0.01), physical function (-0.78 vs -0.64; p=0.04) and pain at rest (-0.91 vs -0.70; p=0.004).
- Whether patients were administered LMWF-5A or the saline vehicle solution, there was no significant difference in the number of acetaminophen pills consumed (median 24.0 vs 34.0; p=0.09), or stiffness (p>0.05).
- In patients with severe OA, LMWF-5A had a significant pain improvement compared to the saline solution (-0.42; 95% CI -0.08 to -0.77; p=0.02). Furthermore, patients who had previously received a knee injection had a significantly better mean pain outcome with LMWF-5A compared to control, whereas this finding was borderline-significant in patients who did not receive a previous injection.
- Between the LMWF-5A and control in injection groups, there were no significant differences in total adverse events (41% vs 47%), treatment-related adverse events (10% vs 13%), or serious adverse events (5% vs 6%). No serious adverse event was considered to be study-related and no deaths occurred.
最も覚えておくべきことは？
In patients with knee osteoarthritis (OA), both the 4-mL and 10-mL volumes of the Low Molecular Weight Fraction of 5% human serum albumin (LMWF-5A) were safe and yielded significantly better pain scores, functional outcome, and overall assessment of disease severity, when compared to a saline vehicle solution. These effects were especially pronounced in patients with severe OA, and those who had received a prior knee injection. Stiffness and the amount of rescue analgesics consumed were not significantly different between groups.
それが私の患者ケアにどのように影響するか？
Results from this study support the administration of a single, intra-articular injection of Low Molecular Weight Fraction of 5% human serum albumin (LMWF-5A) in the treatment of knee osteoarthritis (OA). This finding is promising in patients with severe OA, for whom the only other treatment alternative may be surgical intervention. Additional long-term studies, with larger sample sizes, are needed to confirm these results.
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