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

蘇淑芬(Shu-Fen Su) ； 吳孟珊(Meng-Shan Wu) ； 林英超(Ying-Chao Lin)

《澄清醫護管理雜誌》 14卷1期 (2018/01) Pp. 39-51

摘要

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 surgery patients），I：ISOBAR動態內固定裝置（ISOBAR semi-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。

關鍵字

ISOBAR動態內固定裝置 ； 腰椎退化性疾病 ； 腰椎融合手術 ； 疼痛 ； 失能 ； 合併症

並列摘要

Lumbar spine fusion surgery is often used for the treatment of lumbar spine degenerative disease but easily induces adjacent segment disease around the surgical segment. The ISOBAR Semi-rigid Device is designed to reduce pain, improve disability, and prevent complications, but its effectiveness remain uncertain. This systemic review aimed to investigate the effectiveness of the ISOBAR Semi-rigid Device on pain, disability, and complications in patients with lumbar degenerative disease who underwent lumbar fusion surgery. Electronic databases, including Cochrane Library, PubMed, Medline, CINAHL, ProQuest, CEPS (Chinese Electronic Periodical Services), and CJFD (China Academic Journals Full-text Database), were searched. The languages of publication were restricted to Chinese and English. Only studies published after 1997 were included. The keywords used referenced the PICO format, including P: lumbar fusion surgery patients, I: ISOBAR semi-rigid device, C: lumbar fusion surgery, and O: pain, disability, and complications. Experimental, quasi-experimental, and cohort studies were included in this review study. The Critical Appraisal Skills Programme was used to appraise the quality of the reviewed studies. Eighteen studies with 982 patients with lumbar spine degenerative diseases were included in the systematic review. Results showed that the use of the ISOBAR Semi-rigid Device in the patients who underwent lumbar fusion surgery could decrease 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 of this review are limited in study design, small sample size, and disease severity, the exact effect on the prevention of adjacent segment disease is difficult to infer. We suggest that larger, longitudinal, and transnational randomized studies are necessary to identify the most effective device for lumbar fusion surgery.

並列關鍵字

ISOBAR semi-rigid device ； Lumbar degenerative disease ； Lumbar spine fusion surgery ； Pain ； Disability ； Complication