一種被稱作Charite的人造椎間盤（Charite Disc）最近推向市場(chǎng)，使用它替代發(fā)生損傷或者退行性病變的椎間盤，從而發(fā)揮治療重度下腰部疼痛的作用。這是美國(guó)食品和藥品管理局（the U.S. Food and Drug Administration，F(xiàn)DA）批準(zhǔn)的首類產(chǎn)品。
位于德克薩斯州普萊諾時(shí)（Plano, TX, USA）的后背研究院（The Texas Back Institute，TBI）是美國(guó)第一個(gè)進(jìn)行人造椎間盤置換術(shù)的醫(yī)學(xué)中心。TBI是美國(guó)國(guó)立研究機(jī)構(gòu)15個(gè)臨床中心之一。
治療下腰部疼痛最常采用的外科手術(shù)方式是脊柱融合術(shù)，可以有效地緩解疼痛，但是卻極大地限制了腰部的運(yùn)動(dòng)幅度，并且增大了融合部位上方和下方的受力程度。比較人工椎間盤置換術(shù)與脊柱融合術(shù)的臨床試驗(yàn)發(fā)現(xiàn)：Charite椎間盤置換術(shù)的患者能夠維持或者增加了運(yùn)動(dòng)幅度，疼痛減輕較快，術(shù)后恢復(fù)也較快。患者對(duì)手術(shù)感到滿意。手術(shù)過程通常只需60-90分鐘。
TBI院長(zhǎng)Scott Blumenthal博士是該試驗(yàn)的首席研究員，他指出：“迄今為止，通過椎間盤融合減輕疼痛的脊柱手術(shù)會(huì)限制了脊柱的運(yùn)動(dòng)幅度。現(xiàn)在是第一次，我們能夠在緩解患者下腰部疼痛的同時(shí)保留脊柱的運(yùn)動(dòng)功能”。Charite人造椎間盤是美國(guó)DePuy (DePuy，Inc.，Raynham，MA，USA)公司的產(chǎn)品。

Charite Disc Treats Low Back Pain

An artificial disc called Charite treats severe low back pain by replacing a damaged or worn-out spinal disc with an artificial one. The disc is the first such device to be cleared by the U.S. Food and Drug Administration (FDA).
The Texas Back Institute (TBI, Plano, TX, USA) was the first center to perform artificial disc surgery in the United States. TBI was one of 15 clinical sites in the national investigational study.
Lumbar spinal fusion, the most common surgical treatment for low back pain or degenerative disc disease, is effective in reducing pain but may significantly limit range of motion and put extra stress on discs above and below the fusion site. In trials comparing artificial disc replacement with spinal fusion surgery, Charite patients maintained or improved their range of motion, experienced pain relief sooner, had a quicker recovery, and were more satisfied with the procedure. The procedure generally takes about 60-90 minutes.
“Until now, spine surgery relieved pain by fusing discs, limiting motion,” noted Scott Blumenthal, M.D., principal investigator in the trial and president of TBI. “Now, for the first time, we can relieve pain and preserve motion.” The Charite disc is the product of DePuy, Inc. (Raynham, MA, USA)。