I-Ectopic ibhekisela kunento noma izicubu zomuntu ezakhayo noma ezitholakala lapho zingekho khona. Ukubunjwa kwe-Ectopic bone ukubeka phansi amathambo amathambo amasha (ngenqubo ebizwa ngokuthi i-ossification) ezindaweni, futhi, lapho le nto engeyona eyakhe. Le nqubo ye-ossification yenziwa ngamaseli abizwa ngama-osteoblasts.
Igama elithi ectopic livela kumaGreki, futhi lisho ukuthi "kude nendawo." Isichazamazwi salo, okuyinto ithambo elithi "orthotopic" - eliphinde lisuka esiGrekini - libhekisela ethanjeni elakhiwe endaweni yalo elungile, ngokusho kukaScott, et.
i-al., kusihloko sabo esithi "Ukubukeza Okufushane Kwamamodeli E-Ectopic Bone Formation." Lesi sihloko sanyatheliswa kumagazini ka-Mashi 2012, iStem Cells Development.
Ukwakheka kwe-Ectopic bone kungaba khona lapho uzalwa, kungenxa yezinhlobo zezakhi zofuzo noma ukuphakama njengenkinga yezimo ezithile zezokwelapha ezifana ne-paraplegia kanye / noma ukulimala okubuhlungu (ukubiza nje ezimbalwa.) Scott, et. al. ithi ukubunjwa kwe-ectopic bone kucatshangwa ukuthi kubangelwa ukuvuvukala kwendawo okulandelwa ukuhlanganiswa kwamaseli angama-skeletal progenitor. Ngokwesayithi leBoston Children's Hospital, i-progenitor cell isifana nesitembu se-stem ngaphandle kokuthi sinomkhawulo ngokwemigomo yamaseli angaba yiyo uma ehlukana. Ama-cell progenitor avela kuma-stem cells kepha akuzona amangqamuzana amancane ase-stem.
I-Ectopic Bone Formation Ngenxa Yokuhlinzwa Kwamazinyo
Scott, et. al, uthi iziguli ezingafika ku-10% ezihlinzwa ngokungahambi kahle - nokuhlinzwa kwangemuva ziwela kuleli qembu - zizokwakha i-ectopic bone formulation.
Emgodleni, igama elithi "i-ectopic bone formation" ngezinye izikhathi lisetshenziselwa ukuchaza izicubu ezingafunwa amathambo ezitholakala emgodini womgogodla . Ngo-2002, i-FDA ivume amaprotheni amathambo okwenziwa yi-Medtronic okuthiwa i-Infuse ukuze isebenziswe ekuhlinzekeni kwe-lumbar spine. I-criteria yokusetshenziswa echazwe yi-FDA yayicacile kakhulu: Njengethambo lokuxhunyelelwa kwezinga elilodwa le-Anterior Lumbar Interbody Fusion (ALIF) ngaphakathi kwesistimu ye-Lumbar Tapered Fusion Device (LT-Cage.) Whew!
Kodwa ngemva kokuvunyelwa, odokotela abaningi abahlinzayo baqala ukusebenzisa le "off-label," okusho ngezinhloso ngaphandle kwalokho okuvunyelwe yi-FDA. Ukusetshenziswa kwelebuli okungenayo kuhlanganiswe ukuhlinzekwa komgogodla womlomo wesibeletho okwaholela "eziningana ezenzakalweni," noma i-AE ibikwa ku-FDA. Ukubunjwa kwamathambo e-Ectopic kwakungenye ye-AE, kodwa uhlu luhlanganisa nezinye izinto ezinzima kakhulu ezifana ne- arachnoiditis, ukwanda kwezinkinga ze-neurological, ukubuyiswa kabusha kwe-ejaculation, umdlavuza nokuningi. Akunhle!
Ukuphikisana okuxilisayo
Umbiko wezokubuka oMilwaukee Journal of Sentinal, olandelele le ndaba kusukela ngo-2011 (futhi uyaqhubeka ukwenza kanjalo), uthi emasontweni emvivinyo lokuqala lomtholampilo we-Infuse, ukutholakala kwe-ectopic bone kwatholakala ku-70% weziguli zesifundo. Ezinye zalezi ziguli zidinga ukuhlinzwa okulodwa noma ngaphezulu ukulungisa ithambo elingadingeki kanye / noma izinkinga zezokwelapha ezavela kuwo.
Ekubuyekezeni kwakhe kobufakazi obushicilelwe ngo-2013 lwe- Surgery Neurology International , u-Epstein waqhathanisa imboni engu-13 eyathuthukisa izifundo kwezinye izici ezashicilelwa emaphephandabeni, kanye namaphepha e-FDA nolwazi olulondolozwe emininingwaneni yolwazi. Ubika ukuthi uthole "imicimbi engavunyelwe engashicilelwe kanye nokungahambisani kwangaphakathi" nezifundo zokungena.
Uphinde ubike ukuthi izingosi ezingamaphesenti angu-40 ezithintekayo zavela ku-ALIF (ukukhishwa kwentamo "ye-off-label" eyenziwe,) enezela ukuthi ezinye zalezi zenzakalo zazisongela ukuphila.
Phakathi naleso sikhathi, i-Milwaukee Journal Sentinel ibika ukuthi iMedtronic noma ingabe ingakaze ibike imiphumela emibi ku-FDA embikweni ka-2004 obhalwe odokotela abaxhasiwe nge-Medtronic. I-MJS ithi "odokotela abhale iphephandaba lika-2004 bazoqhubeka bezothola izigidi zamaRandi ngezinkokhelo nezinye izinkokhelo ezivela eMedtronic."
NgoMeyi ka-2014, i-MJS ilandele le nkulumo ngenye indaba ethi Medtronic ivumile ukukhokhela izigidi ezingu-22 zamaRandi ukuxazulula izimangalo eziyi-1000 ngokumelene ne-Infuse yazo.
Le ndaba nayo yathi uMedtronic ubeka eceleni i $ 140 ukumboza izimangalo ezilindelekile.
Imithombo:
Isibhedlela sezingane saseBoston. Yiziphi amaCentgenitor Amaseli? Ikhasi le-Stem Cells 101 ikhasi. Iwebhusayithi yeBoston Children's Hospital. Ifinyelele ngo-Dec 2015.
Epstein, N. Izinkinga ngenxa yokusetshenziswa kwe-BMP / INFUSE ekuhlinzekeni komgogodla: Ubufakazi buqhubeka nokuphakama. Surg Neurol Int. 2013: Ukutholakala ngoDisemba 2015.
UFauber, J., Infuse okukhulunywe ngawo emathunjini aphutha amathambo. Okuqhamuka uma udla imishanguzo. Umbiko we-Journal Sentinel Watchdog. I-Journal Interactive. Juni 2011.
UFauber, J. Medtronic ukukhokha imali eyizigidi ezingama-22 ukuxazulula izimangalo zomthetho mayelana nomkhiqizo we-spie. Imibiko yokubuka. Milwaukee Wisconsin Journal Sentinel. Meyi 6, 2014.
UScott, M., A., Levi, B., ASkarinam, A., Nguyen, A., Rackohn, T., Ting, K, Soo, C., Ukubuyekezwa okufushane kwamaModeli e-Ectopic Bone Formation. Ama-Stem Amaseli Dev. 2012 uMashi 20; 21 (5): 655-667.