腰椎圧迫骨折にセメント注入は無効？

圧迫骨折で入院してくるヒトは後を絶たないが、時々聞かれるのはセメントのことだ。テレビでは一時効果が華々しく報じられたから。

・・・・・脊椎圧迫骨折患者209人を対象とした椎体形成術に関する2件の無作為化プラセボ対照試験のデータを用いて、疼痛に対する同手術の有効性をメタアナリシスで検討。発症後6週間以内または重度の疼痛（10点評価で8点以上）の両サブグループとも、1カ月時の疼痛および身体障害の各スコアの平均変化に、介入群と対照群で大きな差は見られなかった。・・・・

との報告である。余り期待しないほうがよいということかもしれないが、とても残念である。残念だ。

BMJ 2011; 343:d3952 doi: 10.1136/bmj.d3952 (Published 12 July 2011)

Cite this as: BMJ 2011; 343:d3952

Effectiveness of vertebroplasty using individual patient data from two randomised placebo controlled trials: meta-analysis

OPEN ACC

1. Margaret P Staples, biostatistician1,
2. David F Kallmes, professor2,
3. Bryan A Comstock, operations director3,
4. Jeffrey G Jarvik, professor of radiology and neurological surgery and director4,
5. Richard H Osborne, professor of public health and director5,
6. Patrick J Heagerty, professor6,
7. Rachelle Buchbinder, director and professor1

Abstract

Objective To determine whether vertebroplasty is more effective than placebo for patients with pain of recent onset (≤6 weeks) or severe pain (score ≥8 on 0-10 numerical rating scale).

Design Meta-analysis of combined individual patient level data.

Setting Two multicentred randomised controlled trials of vertebroplasty; one based in Australia, the other in the United States.

Participants 209 participants (Australian trial n=78, US trial n=131) with at least one radiographically confirmed vertebral compression fracture. 57 (27%) participants had pain of recent onset (vertebroplasty n=25, placebo n=32) and 99 (47%) had severe pain at baseline (vertebroplasty n=50, placebo n=49).

Intervention Percutaneous vertebroplasty versus a placebo procedure.

Main outcome measure Scores for pain (0-10 scale) and function (modified, 23 item Roland-Morris disability questionnaire) at one month.

Results For participants with pain of recent onset, between group differences in mean change scores at one month for pain and disability were 0.1 (95% confidence interval −1.4 to 1.6) and 0.2 (−3.0 to 3.4), respectively. For participants with severe pain at baseline, between group differences for pain and disability scores at one month were 0.3 (−0.8 to 1.5) and 1.4 (−1.2 to 3.9), respectively. At one month those in the vertebroplasty group were more likely to be using opioids.

Conclusions Individual patient data meta-analysis from two blinded trials of vertebroplasty, powered for subgroup analyses, failed to show an advantage of vertebroplasty over placebo for participants with recent onset fracture or severe pain. These results do not support the hypothesis that selected subgroups would benefit from vertebroplasty.