SHOULDER & ELBOW
PTH 1-34 (teriparatide) may not improve healing in proximal humerus fractures
This report has been verified
by one or more authors of the
original publication.
この研究はハイインパクトの可能性があります。
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これにより、臨床的に意義のある研究をより早く認識することが可能になり、読者は将来の診療を形成する可能性が最も高い論文に集中することができます。
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2016;4(10):23 Acta Orthop. 2016 Feb;87(1):79-8240 postmenopausal females patients with proximal humerus fractures were randomized to receive either daily 20ug injections of parathyroid hormone (PTH 1-34) for 4 weeks or a control treatment with no injections. The primary purpose of this study was to determine whether the use of teriparatide (Forteo) was able to accelerate fracture healing. Function and pain outcomes, as well as the use of opioid analgesics, were also compared. The findings of this study indicated no significant differences in pain, opioid or opioid-like consumption, or physical function between both groups, nor were there any signs of accelerated healing through blinded assessment of radiographs after 7 week follow-up.
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。
3/4
Randomization
3/4
Outcome Measurements
3/4
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？
A number of previous research studies have attempted to elucidate a method of accelerating fracture healing and reducing non-unions. Previous therapies that have been investigated include the administration of bisphosphonates, bone morphogenetic proteins (BMPs), and parathyroid hormone (PTH). The use of PTH injections has been reported to be successful in accelerating fracture healing in animals; however, there are a limited number of studies pertaining to the use of PTH injections in humans for fracture healing, thus, warranting the current study.
主な研究課題は何ですか？
In post-menopausal females, were teriparatide injections (20ug) efficacious in improving bone healing of proximal humerus fractures when compared to a non-injection control group at up to 3 months? Additionally, did the use of teriparatide injections improve function, pain, and reduce analgesic use when compared to a non-injection control group at up to 3 months?
重要な知見は？
- Radiologist assumptions were correct for radiological outcomes in 21 of 39 cases, indicating that teriparatide did not provide radiographic signs of enhanced healing according to the authors
- No significant differences were reported between groups for pain at rest at 7 weeks (p=0.4) or at 3 months (p=0.7), for pain during activity at 7 weeks (p=0.5) or at 3 months (p=0.8), or proportion of pain-free individuals at any time point
- No significant differences were reported between groups for medication use, assessed after a median of 18 days of use
- No significant differences were reported between groups for function outcomes as measured with DASH
- One fracture complication was reported in each group
- No adverse events were reported in the control group; however, 6 of 19 patients in the PTH group reported mild adverse events
最も覚えておくべきことは？
In the treatment of proximal humerus fractures, no significant differences were reported in terms of opioid consumption, pain, or functional outcomes between patients who received parathyroid hormone injections and individuals without injection. Additionally, the radiographic analysis did not find evidence of accelerated fracture healing in the group that received parathyroid hormone injections. More mild adverse events were reported in the parathyroid hormone injection group compared to the control group.
それが私の患者ケアにどのように影響するか？
The results of this study suggested that the use of the parathyroid hormone (teriparatide) injections in patients with proximal humerus fractures does not enhance bone healing rates, nor does it improve clinical outcomes compared to controls. The results of this study should be interpreted with caution as the method of radiographic evaluation used was qualitative and non-standardized, making it difficult to draw definitive conclusions regarding the effect of teriparatide on bone healing. Future research should use standardized methods of radiographic evaluation and study the effects of PTH injection in other fracture types.
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