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骨粗鬆症性椎体圧迫骨折（OVCF）患者の治療における片側と両側の経皮的弯曲術の比較：システマティックレビューとメタアナリシス
Comparison of unilateral versus bilateral percutaneous kyphoplasty for the treatment of patients with osteoporosis vertebral compression fracture (OVCF): a systematic review and meta-analysis.
PMID: 26814475 DOI: 10.1007/s00586-016-4395-6.
抄録
目的:
OVCF治療のための片側からのアプローチと両側からのアプローチの間で、短期および長期の臨床転帰、手術時間、修復率、ポリメチルメタクリレート（PMMA）の注入量、合併症、X線照射頻度を比較すること。
PURPOSE: To compare the short- and long-term clinical outcomes, operation times, restoration rate, dosage of polymethylmeth-acrylate (PMMA) injected, complications and X-rays exposure frequency between unilateral and bilateral kyphoplasty approaches for the treatment of OVCF.
研究デザイン:
システマティックレビューとメタアナリシス。
STUDY DESIGN: Systematic review and meta-analysis.
方法:
2015年4月までに発表された無作為化または非無作為化比較試験で、OVCFの治療に対する片側性PKPと両側性PKPを比較したものを、Cochrane Controlled Trial Register、PubMed、MEDLINE、EMBASE、Web of Science、OVIDで包括的に検索して取得した。除外基準は、腫瘍性病因（転移または骨髄腫）、感染症、神経圧迫症候群、侵襲性・変性疾患、外傷性骨折、再手術、神経学的欠損、著しい側湾症、脊椎狭窄症を有する患者とした。主要エンドポイントは、手術時間、術後短期および長期のVisual Analogue Scale（VAS）スコア、術後短期のOswestry Disability Index（ODI）、修復率、PMMA注入量、セメント漏れ、X線曝露頻度、術後隣接レベル骨折であった。
METHODS: Randomized or non-randomized controlled trials published up to April 2015 that compared the unilateral and bilateral PKP for the treatment of OVCF were acquired by a comprehensive search in the Cochrane Controlled Trial Register, PubMed, MEDLINE, EMBASE, Web of Science, OVID. Exclusion criteria were patients with neoplastic etiology (metastasis or myeloma), infection, neural compression syndrome, invasive and degenerative disease, traumatic fracture, re-operation, neurological deficits, significant scoliosis and spinal stenosis. The main end points included: operation times, the short- and long-term postoperative Visual Analogue Scale (VAS) scores, the short-term postoperative Oswestry Disability Index (ODI), restoration rate, dosage of PMMA injected, cement leakage, X-ray exposure frequency and postoperative adjacent-level fractures.
結果:
428名の患者を対象とした8件の研究がメタ解析に含まれた。平均手術時間は片側の群が両側の群に比べて短かった［P＜0.05、加重平均差（WMD）-19.74（-30.56、-8.92）］。両群間の術後短期VASスコア[P>0.05, WMD 0.03 (-0.34, 0.40)]、両群間の術後長期VASスコア[P>0.05, WMD 0.01 (-0.42, 0.45)]、術後短期ODI[P>0.05, WMD -0.33 (-2.36, 1.69)]に有意差は認められなかった。片側からのアプローチでは、二足歩行アプローチよりもPMMAの投与量が有意に少なかった[P<0.05, WMD -1.56 (-1.59, -1.16)]。両側アプローチ群の修復率は片側アプローチ群よりも高かった[P<0.05, WMD -7.82 (-12.23, -3.41)]。セメント漏出リスク比[P>0.05、RR 0.86（0.36、2.06）]と術後隣接レベル骨折リスク比[P>0.05、RR 0.91（0.25、3.26）]には両法間で有意差はなかった。X線被曝頻度の平均値は、片側群の方が両側群よりも高かった［P＜0.05、WMD -5.69（-10.67、-0.70）］。
RESULTS: A total of 8 studies involving 428 patients were included in the meta-analysis. The mean operative time was shorter in the unilateral groups compared with the bilateral groups [P < 0.05, weighted mean difference (WMD) -19.74 (-30.56, -8.92)]. There was no significant difference in the short-term postoperative VAS scores [P > 0.05, WMD 0.03 (-0.34, 0.40)], the long-term postoperative VAS scores between them [P > 0.05, WMD 0.01 (-0.42, 0.45)] and the short-term postoperative ODI [P > 0.05, WMD -0.33 (-2.36, 1.69)] between the two groups. The unilateral approaches required significantly less dosage of PMMA than the bipedicular approaches did [P < 0.05, WMD -1.56 (-1.59, -1.16)]. The restoration rate in the bilateral groups was higher than the unilateral groups [P < 0.05, WMD -7.82 (-12.23, -3.41)]. There was no significant difference in the risk ratio of cement leakage [P > 0.05, RR 0.86 (0.36, 2.06)] and postoperative adjacent-level fractures [P > 0.05, RR 0.91 (0.25, 3.26)] between the two methods. The mean X-ray exposure frequency in the unilateral groups was greater than the bilateral groups [P < 0.05, WMD -5.69 (-10.67, -0.70)].
結論:
OVCFの治療にはどちらのアプローチが良いかについては明確な結論は出ていない。片側PKPは両側PKPに比べて手術時間が短く、X線照射回数やPMMAの投与量が少ないことが特徴であった。両者の間には短期・長期の臨床転帰や合併症に明らかな違いはなかった。しかし、片側からのPKPよりも両側からのPKPの方が修復率は高かった。しかし、質の高いエビデンスが不足していることから、将来的にどちらの手術法がOVCFの治療に適しているかを判断するためには、質の高いランダム化比較試験の実施が必要であり、より多くの合併症を分析する必要があると考えられる。
CONCLUSIONS: A definitive verdict could not be reached regarding which approach is better for the treatment of OVCF. Although unilateral PKP was associated with shorter operative time, less X- ray exposure frequency and dosage of PMMA than bilateral PKP. There was no apparent difference in the short- and long-term clinical outcomes and complications between them. However, bilateral PKP approaches were higher than unilateral PKP in term of the restoration rate. But on account of lack of some high-quality evidence, we hold that amounts of high-quality randomized controlled trials should be required and more complications should be analysed to resolve which surgical approach is better for the treatment of OVCF in the future.