Sibutsetelo
Kunezinketho eziningi ezikhona manje zokwelapha ukukhuluphala. Lokhu kufaka phakathi ukuguqulwa kokudla nokuphila, izidakamizwa zokulahlekelwa isisindo , namadivaysi nezinqubo ezivela ekuzalweni okugcwele kwe-bariatric kuya kumadivayisi amasha, amancane angenawo amandla.
Ehlobo lika-2016, i-US Food and Drug Administration (FDA) ivume idivayisi yokulahlekelwa isisindo okuthiwa i-AspireAssist, edayiswa yi-Aspire Bariatrics.
Kuyini i-AspireAssist?
I-AspireAssist iyisisindo sokulahlekelwa isisindo esivunyelwe ukwelashwa kokukhuluphala kubantu abadala okungenani abaneminyaka engu-22 ubudala futhi abanesimo somzimba womzimba (BMI) ka-35 kuya ku-55. Idivayisi yenza ukuba abasebenzisi bakwazi ukukhipha ingxenye isisu sabo esiswini esiswini (esaziwa njenge-gastrostomy tube) endlini yangasese ngemva kokudla.
Idivayisi ye-AspireAssist ihloselwe ukusetshenziswa kwesikhathi eside kubantu abadala abafanelekile abangazange bakwazi ukuthola ukulahlekelwa kwesisindo okwanele ngezindlela ezingenasidingo ezifana nezinguquko zokuphila kanye nemithi yokulahlekelwa isisindo.
Indlela Esebenza ngayo
Njengoba kuphawuliwe ngenhla, i-AspireAssist isebenzisa ithubhu evezwe ngokuvulwa esiswini, okuvumela okuqukethwe okungezansi kwesisu emva kokudla. Esifundweni sokuqhutshwa nguSullivan nozakwabo, lokhu kutholakale ekunciphiseni inani eliphelele lamakhalori angenayo ngamaphesenti angaba ngu-30.
Idivayisi ye-AspireAssist iqukethe i-gastrostomy tube, njengoba kuphawuliwe ngenhla, kanye ne-valve ye-port, idivayisi yangaphandle equkethe isixhumi, i-water reservoir, kanye ne-tube yokudonsa nge-clamp.
Emaminithini angaba ngu-20 kuya kwangu-30 emva kokudla, umsebenzisi we-AspireAssist idivaysi ihlanganisa i-gastrostomy tube kudivayisi yangaphandle futhi ivula i-valve ye-port, ngaleyo ndlela ivumela okuqukethwe kwesisu ukuba kungene endlini yangasese ngamandla okuvuthwa.
Kubalulekile ukuthi uqaphele ukuthi ukudla kufanele kuhlolwe kahle ngesikhathi sidlo esandulele ukuze kuhambisane nethubhu yokudonsa, okungamamitha ayisithupha kuphela ububanzi.
Uma amanzi eshiya amanzi, umsebenzisi we-AspireAssist kufanele ahlwithe ithubhu nesisu ngamanzi ahlanzekile, ahlanzekile avela echibini lamanzi eliza nedivaysi.
Yonke inqubo kulinganiselwa ukuthatha cishe imizuzu emihlanu kuya kweyishumi.
Uma ungumsebenzisi wale divayisi, khumbula ukuthi kuzodingeka ukuthi ugcine ama-aphoyintimenti avamile okulandela ukulandelana nodokotela wakho, ngoba isikhangiso kufanele sithathe indawo ngemva kwemijikelezo engu-115 (cishe amaviki ama-5 kuya ku-6).
Kuyadingeka kulezi zivakashi zokulandelela ukuqinisekisa ukuthi idivayisi ye-AspireAssist isebenza kahle. Ubude bhubhu bungadinga ukulungiswa njengoba ulahlekelwa isisindo. Udokotela wakho uzoqhubeka nokunikeza ukwelulekwa kokudla nokuphila ngesikhathi sokuvakashelwa kokulandelela.
Izindleko
Ngokusho kwe-Medical Letter yeDrugs and Therapeutics, ngokusekelwe kolwazi oluvela kumkhiqizi, izindleko ezihlangene zenqubo yokuqala kanye nomnyaka wokuqala wokulandelwa kulindeleke ukuthi zibe ngu-8,000 kuya ku-13,000.
Ukuphumelela
Ku-abstract eshicilelwe ekwengeziwe kumagazini we- Gastroenterology , abacwaningi besilingo se-PATHWAY bathole ukuthi lezo ziguli ezanikezwa ukwelashwa nge-AspireAssist kanye nokululekwa kwezinto zokuphila cishe cishe ngonyaka zithole ukulahlekelwa kwesisindo sezingamaphesenti angu-31.5 esisindo esiningi, uma kuqhathaniswa kuphela Amaphesenti angu-9,8 wesisindo esiningi esilahlekile eqenjini elinikezwe ukwelulekwa kokuphila kuphela.
Iminye imiphumela evela kwizifundo zesikhathi eside ayitholakali, ngakho kunzima ukubona ukuthi imiphumela yesikhathi eside ekulahlekeni kwesisindo kanye nekhwalithi yokuphila yayizoba ne-AspireAssist.
Okuqhamuka uma udla imishanguzo
Esigabeni se-PATHWAY eshiwo ngenhla, okungenani amaphesenti angu-5 weziguli abe nemiphumela emibi ehambisana nedivayisi ye-AspireAssist.
Imiphumela emibi elandelwayo ibandakanya ubuhlungu besisu, isicanucanu kanye / noma ukuhlanza, ukuguqula imikhuba yezinyosi, nokuvuvukala noma ukucasula okuzungeze indawo ye-tube gastrostomy. Eminye imiphumela emibi ephawulwe yayihlanganisa ukutheleleka, ukuphuma kwamanzi, kanye / noma ukukhipha ngaphakathi kokuvulwa kwesisu.
Iningi lala miphumela emibi ibonakala ukuxazulula zingakapheli izinsuku ezingu-30.
Ku-4 kweziguli ezingu-111 eziphathwe i-AspireAssist ekulingweni kwe-PATHWAY, le divayisi yayihlotshaniswa nezenzakalo ezimbi ezimbi, ezifana nesidingo sokuguqula i-tube gastrostomy, ukutheleleka kwesisu, nokulonda.
Ngokuphawulekayo, ekubuyekezweni kwayo kwedivayisi, i-Medical Letter kwiDrugs and Therapeutics yaphetha: "Idivayisi ye-AspireAssist ayinamandla kakhulu kunokuhlinza nge-bariatric ekwelapheni ukukhuluphala futhi ingase iphumelele kwezinye iziguli, kodwa idatha etholakalayo inomkhawulo futhi uhlu lwama-contraindications libanzi. "
Ezinye Izinketho Zedivayisi ye-Weight Loss
Enye idivayisi iye yasemakethe yokwelashwa kokukhuluphala kusukela ngoJanuwari 2015. Le divayisi evunyelwe i-FDA, eyaziwa ngokuthi iMasestro Rechargeable System , isebenza ngokuqondisa indlela yesikhumba phakathi kobuchopho nesisu esisenza ukulawula phezu kwemizwa yindlala nokugcwala . Iqukethe i-generator ye-pulse generator ephindwe kabusha, kanye nomthofu wocingo nama-electrode. Lezi zifakiwe zihlinzekwe ngokuhlinzwa ngaphakathi kwesisu. I-ke ithumela imishanguzo kagesi ku-vagus nerve, esiza ukulawula isisu ekuthumeni futhi ithumele isignali ebuchosheni ukuthi isisu mhlawumbe uzizwa singenalutho noma ugcwele.
Ngokusho kwe-EnteroMedics Inc., inkampani eyenza ukuthi idivaysi, uhlelo lwe-Maestro Rechargeable System luvimbele amasignali ukuthi i-vagus nererve ingayithumela ebuchosheni, ngaleyo ndlela ukunciphisa imizwa yendlala nokwenza iziguli zizwe ziphelile kunokuba zingenjalo.
Ngo-Julayi 28, 2015, i-FDA yamemezela ukuvunyelwa komunye umshini wokwelapha ukukhuluphala: idivayisi ye-balloon yesikhashana eyaziwa ngokuthi i-ReShape Integrated Dual Balloon System (ReShape Dual Balloon.
Njengedivayisi ye-AspireAssist, i-ReShape Dual Balloon idinga inqubo yokugcina i- endoscopic ukufaka idivayisi, efakwe ngaphakathi esiswini ngomlomo nangomlomo. Njengoba kuphawulwe yi-FDA, "Idivaysi ayishintshi noma ishintshe isisu semvelo yesisu," futhi iziguli zikhuthazwa ukuba "zilandele ukudla okuhloswe ngokwemithi nokuzivocavoca ukuze zenze imizamo yabo yokulahlekelwa isisindo" ibuye isetshenziswe ngenkathi isebenzisa idivayisi. Lokhu kusiza ukuqinisekisa ukuthi iziguli ziyakwazi ukugcina ukulahlekelwa kwesisindo uma idivayisi isusiwe.
Le divayisi ihloselwe ukuba yesikhashana futhi, ngokusho kwe-FDA, kufanele isuswe izinyanga eziyisithupha ngemuva kokuthi ifakwe kuqala.
Kucatshangwa ukuthi i-ReShape Dual Balloon isebenza ngokuthatha isikhala esiswini, okungenzeka kubangele imizwa yokugcwala, kodwa kungenzeka kube nezinye izindlela zomsebenzi ezingakaqondakali.
Izinketho zokuhlinzekela ukulahlekelwa kwesisindo
Izinketho eziningi ezingavamile nezingokwenkolo ngokuvamile ziwela ngaphansi kwesigaba sokuhlinzwa kwe-bariatric, futhi zingase zibandakanye ukuhlinzwa kwe-gastric bypass, ukubhodla nge-gastric (lap band), kanye ne-gastrectomy yesleedi (umkhonto wesisu), phakathi kwabanye.
Ukuze abe ngumuntu ozobhapathizwa nge-bariatric, umuntu kufanele abe ne-BMI engama-40 noma ngaphezulu, noma i-BMI engama-35 noma ngaphezulu kumuntu oneminye yempilo (eyaziwa ngokuthi "izimo ze-comorbid") ezibangelwa ukukhuluphala. .
Ukuhlinzwa okuthandwa kakhulu kwesisindo kunokwenzeka ukuthi kuyindlela yokwenza umjovo wesisu, noma i-gastrectomy yomkhono. Eqinisweni, ikakhulukazi ngenxa yokusebenza kwayo nokuphepha uma kuqhathaniswa nezinye izinqubo, ngokusho kweBariatric Surgery Source, inqubo yomkhonto wezinyosi manje ibonakala igcwalisa isisu esiswini njengenqubo entsha "yezinga legolide".
Umsebenzi we-sleeve gastrectomy uhlose ukuvumela iziguli ukuba zinciphise ukudla, ngaleyo ndlela zinciphise ukulahlekelwa kwesisindo. Kule nqubo, cishe amaphesenti angama-60 wesisu asusiwe (ngokuvamile ahlelekile ), kangangokuthi ingxenye esele yesisu ithatha ishubhu noma umkhonto.
Ngenxa yokuthi isisu sincane ngemva kokuhlinzwa, isiguli sesisu somzimba esiswini sizozizwa sishesha ngokugcwele futhi sinokudla okuncane. Ngenxa yalezi zizathu, inqubo yemikhono yesisu isaziwa ngokuthi "ukuvimbela" uhlobo lokuhlinzeka nge-bariatric.
Indlela Yokuxoxa Ngodokotela Wakho
Uma unesithukuthezi futhi uzizwa usuvele uzame ukhetho oluningana lwezokwelapha kanye nezinguquko zokudla nokuphila, futhi lezi zingakakisebenzeli, zixoxisane nodokotela wakho okunye okunye. Kubalulekile ukucabanga okuningi nokucatshangelwa kunoma isiphi isinqumo sokuqhubeka nokuhlinzekwa okukhethiwe, ikakhulukazi ukuhlinzekwa kwesisindo noma inqubo.
Udokotela wakho angakhuluma nawe ukuthi yiziphi izinketho ezingahle zibe yinto enhle kuwe njengomuntu ngamunye, unikezwe i-BMI yakho kanye nezinye izifo ezingapheli ongase ube nazo. Kule ngxoxo, nonke ningakwazi ukukala ubuhle nokuziqhenya kwanoma yikuphi ukuhlinzeka isisindo sokulahlekelwa isisindo noma inqubo.
Kubuye kubaluleke kakhulu ukuthi uqiniseke ukuthi uxoxisana futhi uyazi ngemiphumela emibi yanoma iyiphi inqubo, ukuhlinzwa noma idivayisi oyicabangayo, ngoba ukhetho ngalunye luya nemiphumela emibi eminye, okunye okungahle kwenzeke.
Ngakolunye uhlangothi, uma ungumuntu omele ukhetho lokuhlinzwa kwesisindo noma inqubo, futhi unolwazi futhi ulungele ukulandelela neqembu lakho lezokwelapha noma elihlinzayo ngezikhathi ezihleliwe ngokulandela inqubo, ukuhlinzwa kwesisindo-ukulahlekelwa ingaba nezinzuzo eziningi zezempilo, kubandakanya ukwelashwa kwesifo sikashukela kanye negazi eliphezulu kanye nokunciphisa ingozi yesifo senhliziyo.
Imithombo:
I-AspireAssist-idivayisi entsha yokulahlekelwa isisindo. I-Med Lett Izidakamizwa Ther. 2016; 58: 109-110.
Durkin M. Ukulinganisa okukhethwa kukho ukuhlinzeka nge-bariatric. I-ACP Internist 2016; 36 (1): 1.
I-FDA News Release. I-FDA ivumela idivayisi ye-balloon yesikhashana engeyona yokuhlinzwa ukuphatha ukukhuluphala. Kufinyelelwe ku-intanethi ku- http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm456296.htm ngoJulayi 29, 2015.
Sullivan S, Stein R, Jonnalagadda S, Mullady D. Edmundowicz S. Ukwelashwa kokuphefumula kubangela ukulahlekelwa isisindo ezifundweni ezikhulu kakhulu: isifundo somqhubi. I-Gastroenterology. 2013; 145: 1245.
Thompson CC et al. I-AspireAssist iyithuluzi eliphumelelayo ekwelapheni iklasi II kanye nokukhuluphala kwesigaba III: imiphumela yecwaningo lomtholampilo lonyaka owodwa. I-Gastroenterology. 2016; 150 (suppl1): S86, abstract 381.