目的 分析人工全椎間盤置換治療退行性腰椎間盤疾病的療效.
方法 計(jì)算機(jī)檢索Cochrane圖書館(2004年第2期)中的臨床對照試驗(yàn)資料庫和Cochrane協(xié)作網(wǎng)背痛專業(yè)試驗(yàn)數(shù)據(jù)庫、MEDLINE(1966～2004)、EMBASE(1980～2004)、中國生物醫(yī)學(xué)文獻(xiàn)光盤數(shù)據(jù)庫(CBMdisk,2003),手工檢索中文文獻(xiàn)(截自2004年6月),并詢問相關(guān)廠家以及研究者.由兩名評價(jià)員獨(dú)立提取資料,并按Cochrane協(xié)作網(wǎng)提供的方法對納入文獻(xiàn)進(jìn)行質(zhì)量評價(jià)和結(jié)果分析.
結(jié)果 共納入3個(gè)RCT,包括152例患者.文獻(xiàn)質(zhì)量評價(jià)結(jié)果顯示,3個(gè)RCT均可能存在選擇性偏倚、實(shí)施偏倚和測量偏倚的高度可能性.其中兩篇使用ProDisc-Ⅱ人工全椎間盤置換,1篇使用SB-Ⅲ人工全椎間盤置換.3個(gè)RCT均未提供詳細(xì)的原始數(shù)據(jù),因此不能進(jìn)行Meta分析.人工全椎間盤置換組病人術(shù)后早期VAS疼痛評分(visual analog scale)和ODI功能評分(oswestry disability index)有改善,但術(shù)后6個(gè)月與融合組無差異.病人滿意率,術(shù)后6個(gè)月人工全椎間盤置換組有優(yōu)于融合組的趨勢.短期隨訪顯示,人工椎間盤能夠保存受累節(jié)段的運(yùn)動功能.兩篇RCT報(bào)告了相關(guān)并發(fā)癥.
結(jié)論 人工全椎間盤置換短期內(nèi)能夠重建退變節(jié)段的高度及生理運(yùn)動功能,但缺乏長期的隨訪,尤其對于能否防止毗鄰節(jié)段的退變?nèi)狈ψC據(jù).尚需更多設(shè)計(jì)嚴(yán)格的研究以增加證據(jù)的強(qiáng)度.
引用本文： 何祖勝,白靖平,錫林寶勒日,金格勒,吳泰相,李 靜. 人工全椎間盤置換治療退行性腰椎間盤疾病的系統(tǒng)評價(jià). 中國循證醫(yī)學(xué)雜志, 2005, 05(2): 136-139. doi: 復(fù)制
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| 13. | McCullen GM, Yuan HA. Artificial disc: current developments in artificial disc replacement[J]. Current Opinion in Orthopaedics, 2003;14(3): 138-143. |
| 14. | Juni P, Altman DG, Egger M. Assessing the quality of controlled clinical trials[J]. BMJ, 2001;323(7 303): 42-46. |
| 15. | McAfee PC, Fedder IL, Saiedy S, Shucosky EM, Cunningham BW. SB-Charité Disc Replacement: Report of 60 Prospective Randomized Cases in a U.S. Center[J]. J Spinal Disord Tech J Spinal Disord Tech, 2003;16(4): 424-433. |
- 1. Folman Y, Lee SH, Silivera JR, Gepstein R. Posterior lumbar interbody fusion for degenerative disc disease using a minimaly invasive B-Twin expandable spinal spacer: a multicenter study[J]. Spinal Disorder&techniques, 2003;16(5): 455-460.
- 2. Chedid KJ, Chedid MK. The "tract" of history in the treatment of lumbar degenerative disc disease[J]. Neurosurg Focus, 2003;16(1): 1-4.
- 3. Hall BB, Asher MA, Zang RH, Quinn LM. The safety and efficacy of the isola spinal implant system for the surgical treatment of degenerative disc disease: d prospective study[J]. Spine, 1996;21(8): 982-994.
- 4. Jack EZ, Paul AA, Scott DB, Keith HB, Alexander RV. What is New in Spine Surgery in Spine Surgery[J]. The Journal Of Bone And Joint Surgery, 2003;85(8): 1 626-1 636.
- 5. Herkowitz HN, Abraham DJ, Albert TJ. Management of degenerative disc disease above an L5-S1 segment requiring arthrodesis [Controversy] [J]. Spine, 1999;24(12): 1 268.
- 6. QI BB, Hansen AY. Artificial disc technology[J]. Neurosurg Focus, 2000;9(4): 1-7.
- 7. Fritzell P, Hagg O, Wessberg P, Nordwall A .Lumbar fusion versus nonsurgical treatment for chronic low back pain: a multicenter randomized controlled trial from the Swedish Lumbar Spine Study Group[J]. Spine, 2001;26(23): 2 521-2 534.
- 8. Resnick DK. Spinal Fusion for Discogenic Back Pain: Patient Selection, Operative Techniques, and Outcomes[J]. Techniques in Neurosurgery, 2003;8(3): 176-190.
- 9. Heary, Robert F. Intradiscal Electrothermal Annuloplasty: The IDET Procedure[J]. Journal of Spinal Disorders, 2001;14(4): 353-360.
- 10. Delamarter RB, Fribourg DM, Kanim LE, Bae H. ProDisc Artificial Total Lumbar Disc Replacement: Introduction and Early Results From the United States Clinical Trial[J]. Spine, 2003;28(20s): s167-s175.
- 11. Zigler JE. Clinical Results with ProDisc: European Experience and U.S. Investigation Device Exemption Study[J]. Spine, 2003;28(20s): s163-s166.
- 12. Cunningham BW, Gordon JD, Dmitriev AE, Hu NB, McAfee PC. Biomechanical Evaluation of Total Disc Replacement Arthroplasty: An In Vitro Human Cadaveric Model[J]. Spine, 2003;28(20s): s110-s117.
- 13. McCullen GM, Yuan HA. Artificial disc: current developments in artificial disc replacement[J]. Current Opinion in Orthopaedics, 2003;14(3): 138-143.
- 14. Juni P, Altman DG, Egger M. Assessing the quality of controlled clinical trials[J]. BMJ, 2001;323(7 303): 42-46.
- 15. McAfee PC, Fedder IL, Saiedy S, Shucosky EM, Cunningham BW. SB-Charité Disc Replacement: Report of 60 Prospective Randomized Cases in a U.S. Center[J]. J Spinal Disord Tech J Spinal Disord Tech, 2003;16(4): 424-433.