Ectopic Bone Formation le Khohlano ea Medtronic

Ectopic e bua ka ntho kapa lisele tsa motho tse hlahisang kapa tse teng moo e seng tsa eona. Ectopic bone sebopeho ke ho behoa ha motsoako o mocha oa masapo (ka mokhoa o bitsoang ossification) libakeng, hape, moo boitsebiso bona bo seng ba bona. Ts'ebetso ena ea ho tlosa lihlahisoa e etsoa ke lisele tse bitsoang osteoblasts.

Lentsoe ectopic le tsoa ho Bagerike, 'me le bolela "hole le sebaka." Tlhaloso ea eona, e leng bone "orthotopic" bone - hape e tsoang ho Segerike - e bolela lesapo le thehiloeng sebakeng sa lona se nepahetseng sa tlhaho, ho latela Scott, et et.

al., sehloohong sa bona se nang le sehlooho se reng "Tlhahlobo e Khutšoanyane ea Mefuta ea Ectopic Bone Formation." Sehlooho sena se ile sa hatisoa makasineng ea March 2012, Stem Cells Development.

Ectopic bone sebopeho se ka ba teng ha a tsoaloa, e bakoa ke liphatsa tsa lefutso kapa li hlahe e le tlhaloso ea maemo a itseng a bongaka a kang paraplegia le / kapa kotsi e bohloko (ho bolela tse seng kae feela) Scott, et. al. bolela hore ectopic bone sebopeho ho nahanoa hore e bakiloe ke ho ruruha hoa moo ho lateloa ke pokello ea lisele tsa masapo a masapo. Ho ea ka websaeteng ea Boston Children's Hospital, sele e tsoetseng pele e tšoana le seleng ea stem ntle le hore e fokotsehile ka mefuta ea lisele e ka ba eona ha e arohana. Lisele tse tsoelang pele li tsoa liseleng tsa stem empa ha li li-cell stem tse khōlō.

Ectopic Bone Formation ka Lebaka la Bopaki ba Meriana

Scott, le. al, a re bakuli ba ka bang 10% ba kenang opereishene e hlaselang - 'me ka mor'a moo opereishene ea morao e kena sehlopheng sena - e tla hlahisa ectopic bone sebopeho.

Mokokotlong, lentsoe "ectopic bone formulation" ka linako tse ling le sebelisoa ho hlalosa lisele tse sa batleheng tsa masapo tse fumanoang mokokotlong oa mokokotlo . Ka 2002, FDA e lumeletse protheine ea lesapo e entsoeng ke Medtronic e bitsoang Infuse bakeng sa tšebeliso ea ho buuoa ka sekhahla sa luru. Mokhoa oa ho sebelisa o boletsoeng ke FDA o ne o totobetse haholo: Joaloka lesapo le kenngoa litekong tse lekanang tsa Anterior Lumbar Interbody Fusion (ALIF) ka har'a tsamaiso ea Lumbar Fusion Device (LT-Cage.) Whew!

Empa hang ka mor'a tumello eo, lingaka tse ngata tsa ho buuoa li ile tsa qala ho sebelisa boitsebiso bo reng "se-off-label," e bolelang ka merero e meng ntle le e amoheletsoeng ke FDA. Ho sebelisa li-label ho ne ho kenyelelitsoe opereishene ea mokokotlo ea mokokotlo e ileng ea baka "liketsahalo tse mpe," kapa AE tse tlalehoang ho FDA. Ectopic bone sebopeho e ne e le e 'ngoe ea AE, empa lenane le kenyeletsa tse ling tse lintho tse tebileng joaloka arachnoiditis, eketseha methapo ea kelello, ho tsosolosa ejaculation, kankere le ho feta. Hase ntle!

Khohlano ea Medtronic

Tlaleho ea Milwaukee Journal Sentinal Watchdog Report, e latetseng pale ena ho tloha ka 2011 (mme e ntse e tsoela pele ho etsa joalo), e re ka mor'a libeke tsa teko ea pele ea lithethefatsi bakeng sa Infuse, ectopic bone formation e fumanoe ho 70% ba bakuli ba thuto. Ba bang ba bakuli bana ba ne ba hloka ho etsa opereishene e le 'ngoe kapa ho feta ho lokisa lesapo le sa batleheng le / kapa mathata a bongaka a hlahileng ho lona.

Tlhahlobisong ea hae ea bopaki bo phatlalalitsoeng Bukeng ea International Surgery Neurology International ea 2013, Epstein e ile ea bapisa le indasteri e 13 e hlahisitse lithuto tsa lithuto tse ling tse ileng tsa hatisoa likoranteng, hammoho le litokomane tsa FDA le tlhahisoleseding e fumanehang ka boitsebiso. O tlaleha hore o fumana "liketsahalo tse sa hlahisoang tse sa hlahisoang le tse sa lumellaneng ka hare" le lithuto tsa Infuse.

O boetse o tlaleha hore liketsahalo tse bohloko tse 40% li ne li bakoa ke ALIF ("ho tlosoa" le "opereishene" ea molala e entsoeng ka hlooho e ileng ea etsoa,) a phaella ka hore tse ling tsa liketsahalo tsena li ne li beha bophelo kotsing.

Ho sa le joalo, Milwaukee Journal Sentinel e tlaleha hore Medtronic e tlaleha kapa e sa ka ea tlaleha liphello tse bohloko ho FDA tlalehong ea 2004 e ngotsoeng ke lingaka tse tšehetsoeng ke Medtronic. MJS e re "lingaka tse ngotseng pampiri ea 2004 li ne li tla tsoela pele li amohela liranta tse limilione ka liphallelo le lichelete tse ling tse tsoang Medtronic."

Ka Mantaha oa 2014, MJS e ile ea latela pale ena ka sehlooho se seng se re Medtronic o lumetse ho lefa $ 22 limilione ho rarolla liqoso tse 1000 khahlanong le tsa bona.

Pale ena e boetse e boletse hore Medtronic e behella ka thōko $ 140 bakeng sa ho koahela "lipolelo tse lebeletsoeng."

Lisebelisoa:

Sepetlele sa Bana sa Boston. Li progenitor Cells ke eng? Lihlopha tsa batho ba baholo ba Stem 101. Websaeteng ea Boston Children's Hospital. E fihlile ka 2015.

Epstein, N. Mathata ka lebaka la tšebeliso ea BMP / INFUSE ka ho buuoa ka mokokotlo: Bopaki bo tsoela pele ho phahama. Surg Neurol Int. 2013: Fihletsoeng ka 2015.

Fauber, J., Infuse e hlalositsoeng ka masapo a bohloko a bakuli. Litla-morao. Tlaleho ea Journal of Sentinel Watchdog. Litaba tsa ho buisana. June 2011.

Fauber, J. Medtronic ho lefa $ 22 limilione ho rarolla liqoso tsa molao ka lebaka la sehlahisoa sa spie. Litlaleho tsa Masoko. Milwaukee Wisconsin Journal Sentinel. La 6 May, 2014.

Scott, M., A., Levi, B., ASkarinam, A., Nguyen, A., Rackohn, T., Ting, K., Soo, C., Tlhahlobo e Khutšoanyane ea Mefuta ea Ectopic Bone Formation. Li-cell Stem Dev. 2012 Mar 20; 21 (5): 655-667.