ISOBAR動態內固定裝置對腰椎退化行腰椎融合手術患者疼痛、失能及合併症之成效：系統性文獻回顧

Effectiveness of the ISOBAR Semi-rigid Device for Pain, Disability, and Complications in Patients with Lumbar Degenerative Disease who Underwent Lumbar Fusion Surgery: A Systematic Review

腰椎融合術常用來治療腰椎退化性疾病，但易誘發手術鄰近節段病變，故ISOBAR動態內固定裝置被應用於脊椎手術以降低疼痛、改善失能及預防合併症，但成效未有定論。本文以系統性文獻回顧方式，搜尋1997年迄今的中、英文文獻，包括Cochrane、PubMed/Medline、CINAHL、ProQuest、華藝線上圖書館和中國期刊全文資料庫，以PICO建立中、英文關鍵字，P：腰椎融合手術病人（lumbar fusion surgerypatients），I：ISOBAR動態內固定裝置（ISOBARsemi-rigid device），C：傳統融合手術（lumbar fusion surgery），O：疼痛、失能（pain、disability）及合併症（complications）。選取與主題相關之實驗性、類實驗性及世代研究，以CASP做為文獻品質評析工具，以探討ISOBAR動態內固定裝置對腰椎融合術患者疼痛、失能及合併症之成效。文中共納入18篇文獻，982位腰椎融合術患者，分析結果指出ISOBAR可有效減輕患者腰腿痛、下背痛及失能，不會增加合併症，可能影響鄰近節段退化發生率。然所有研究文獻均來自美國及中國，多為非隨機控制實驗，可能因研究設計、個案數少、疾病嚴重度影響，難以推論預防鄰近節退化的成效。建議未來可進行大型跨國長期性研究以確認ISOBAR成效。

Lumbar spine fusion surgery is often used for the treatment of lumbar spinedegenerative disease but easily induces adjacent segment disease around the surgicalsegment. The ISOBAR Semi-rigid Device is designed to reduce pain, improve disability,and prevent complications, but its effectiveness remain uncertain. This systemic reviewaimed to investigate the effectiveness of the ISOBAR Semi-rigid Device on pain, disability,and complications in patients with lumbar degenerative disease who underwent lumbarfusion surgery. Electronic databases, including Cochrane Library, PubMed, Medline,CINAHL, ProQuest, CEPS (Chinese Electronic Periodical Services), and CJFD (ChinaAcademic Journals Full-text Database), were searched. The languages of publication wererestricted to Chinese and English. Only studies published after 1997 were included. Thekeywords used referenced the PICO format, including P: lumbar fusion surgery patients,I: ISOBAR semi-rigid device, C: lumbar fusion surgery, and O: pain, disability, andcomplications. Experimental, quasi-experimental, and cohort studies were included in thisreview study. The Critical Appraisal Skills Programme was used to appraise the quality ofthe reviewed studies. Eighteen studies with 982 patients with lumbar spine degenerativediseases were included in the systematic review. Results showed that the use of theISOBAR Semi-rigid Device in the patients who underwent lumbar fusion surgery coulddecrease the pain of the back and legs, and disability without increasing complications.However, the effect of prevention of adjacent segment disease still needs to be confirmed.All the studies reviewed in the present study originated in American and China.Furthermore, most of the studies were not randomized controlled trials. As the findings ofthis review are limited in study design, small sample size, and disease severity, the exacteffect on the prevention of adjacent segment disease is difficult to infer. We suggest thatlarger, longitudinal, and transnational randomized studies are necessary to identify the mosteffective device for lumbar fusion surgery.