I-oral inhaler entsha ingase ithathele indawo imijovo ye-insulin ezigulini ezinesifo sikashukela

U-Alfred E. Mann (usihlalo kanye no-CEO we-MannKind) kanye nethimba lakhe labathuthukisi bezokwelapha benza umzamo oqinile wokudambisa imithwalo yeziguli ezinesifo sikashukela. Ngasekuqaleni kwalo nyaka, iMannkind yakhipha i-oral insulin inhaler ebizwa ngokuthi i-Afrezza. I-inhaler yomlomo elingana nephakethe encane ingasetshenziswa esikhundleni somjovo we-insulin phakathi kweziguli ezinesifo sikashukela.

Izingozi zesifo sikashukela

Bangu-29.1 million abantu baseMelika abanesifo sikashukela, ngokusho kombiko Umbiko Kazwelonke Wesifo Sikashukela ka-2014. Lokhu kulingana ne-9.3% yabantu base-U.S. Kwabangu-29 million abaphila nesifo sikashukela njengamanje, bangu-8.1 million abangakatholakali. Lezo zinombolo ziyethusa kakhulu lapho umuntu ebona ukuthi ngaphezu kwengxenye eyodwa kwezine (27.8%) yabantu abaphila nesifo sikashukela abasazi ukugula kwabo.

Isifo sikashukela sibonakale siyisifo esiyingozi esithinta kakhulu impilo yeziguli ezinaso. Amathuba okufa kwabantu abadala abanesifo sikashukela angaphezulu kuka-50%, ngokombiko we-National Diabetes Report. Iziguli ezilinganiselwa ku-73,000 kudingeke ukuthi zinqunywe isitho ngenxa yokugula kwazo. Usongo lwesifo sikashukela lungokoqobo, futhi ukuthola ukwelashwa okufanele nokusebenzayo kwalesi sifo kubalulekile. Isifo sikashukela saba yimbangela yesikhombisa yokufa kwabantu e-United States ngo-2010, sathatha izimpilo zeziguli ezingama-69,071.

Imithwalo yesifo sikashukela ngeke ithinte kuphela labo okutholakala ukuthi banalesi sifo njengamanje. Ngokusho kwe Centre of Disease Control and Prevention (CDC) izigidi ezingama-86, ngaphezu kwe-1 kwabangu-3 baseMelika njengamanje abanesifo sangaphambi kwesifo sikashukela. Njengamanje i-9 kwabayi-10 baseMelika abazi ukuthi bane-prediabetes, i-15-30% yabantu abane-prediabetes bazoba nesifo sikashukela sohlobo 2 phakathi neminyaka emihlanu.

Izingozi zesifo sikashukela kanye nezibalo ezishaqisayo ezizithwalayo zenza ukusungulwa kukaMann, i-Afrezza, kuhambisane futhi kuhehe kulabo asebevele benesifo sikashukela sohlobo loku-1 noma lwe-2. Ngokulawula amazinga kashukela aphezulu, lokhu kungasiza isiguli ukuba siphile impilo evamile enesifo sikashukela.

Ziyini izinzuzo?

Yiziphi izinzuzo ze-Afrezza? Yini eyenza ihluke kumjovo we-insulin? Lena imibuzo eyaphendulwa ngesikhathi senkulumo kaMann, eJohn Hopkins School of Medicine.

Mayelana nokuthi impushana ephefumula i-insulin eyimpuphu isebenza kanjani, uMann wachaza “Silingisa lokho okwenziwa amanyikwe wangempela, sifinyelela inani eliphakeme [i-insulin] emizuzwini eyi-12 kuya kweyi-14 egazini... Ukuvunyelwa kwe-insulin okujwayelekile Health.comI-insulin esebenza isikhathi esifushane kufanele iphuzwe phakathi kwemizuzu engamashumi amathathu nehora ngaphambi kokudla kwesiguli, futhi ifinyelela umkhawulo ngemuva kwamahora amabili kuya kwamane. 

UMann uqhubeka athi, “Yileyo insulin ehlala ingapheli ngemva kokugaya ukudla ebangela cishe zonke izinkinga ngokwelashwa kwe-insulin. Idala i-hyperinsulinemia, i-hyperinsulinemia idala i-hypoglycemia, ngenxa ye-hypoglycemia kufanele ukhuphule izinga le-glucose esheshayo. Okwamanje udla ama-snacks usuku lonke, isibindi sakho sikhipha i-glucose ukuze ungangeni kwi-coma, futhi yilokho okubangela ukukhuluphala kwesifo sikashukela, siqala futhi siqhubeke unomphela ngoba awunayo i-prandial. insulin. "

Lezi zimangalo zikaMann mayelana ne-Afrezza, zihambisana ne okutholakele ocwaningweni lwamazwe ngamazwe kwenziwa ezigulini ezinesifo sikashukela sohlobo 2 ezivela e-United States, Brazil, Russia nase-Ukraine. Abacwaningi baphethe ocwaningweni olulawulwa yi-placebo oluyi-double blind-blind, ukuthi iziguli ezanikezwa i-Afrezza, zazingaphansi kokuthola isisindo esincane, futhi zabona ukwehla okukhulu kumazinga kashukela wegazi we-postprandial.

Ishicilela i-Afrezza

Emizamweni yokufundisa iziguli nabasebenzi bezokwelapha ngezinzuzo ze-Afrezza, iMannKind ilethe amasampula amaphakethe angama-54,000 kodokotela. Ngokwenza kanjalo, u-MannKind uthemba ukuthi lokhu kuzodala inzuzo ka-2016 enenzuzo eyengeziwe ezigulini ezinesifo sikashukela, kanye nenkampani. Ngokuletha amasampula amaphakethe, kwakha ubuhlobo obuqinile phakathi kwe-Afrezza nochwepheshe bezokwelapha, okuzophinde kuvumele iMannKind ukuthi isungule uchungechunge lwesemina yemfundo yodokotela, kanye nokuhlanganisa i-Afrezza ku-Sanofi's Coach - uhlelo lokulawula isifo sikashukela samahhala ezigulini.

Ikusasa le-Afrezza libonakala likhanya kakhulu kunesikhathi esifushane sayo. Selokhu yethulwa i-Afrezza ngoFebhuwari 5, 2015, i-insulin inhaler ingenise imali eyizigidi eziyi-1.1 kuphela. Lokhu kudale ukungabaza phakathi kwalabo abakuWall Street abebebukeka bezuza amaphuzu aphezulu kulokhu kusungulwa kwezokwelapha.

Isiqalo esintekenteke sezimali se-Afrezza, singase futhi sibhekiselwe ezigulini ezihlolwayo okufanele zidlule ngaphambi kokuthi zinikezwe i-Afrezza. Iziguli kumele zihlolwe ukusebenza kwamaphaphu (i-spirometry), ukuze kutholakale ukuthi umuthi ungasetshenziswa yini yilabo abanesimo samaphaphu esivele sikhona.

Ama-akhawunti womuntu siqu we-Afrezza

Izinto ezinkulu ziye zashiwo iziguli ezinesifo sikashukela eziye zanqunywa futhi zelapha nge-Afrezza njengomthombo wazo oyinhloko we-insulin. Amawebhusayithi afana Afrezzauser.com baye bazwakalisa ukujabula kwabo ngalesi sidakamizwa. Inqwaba yamavidiyo e-YouTube namakhasi e-Facebook avele ezinyangeni ezimbalwa ezedlule, echaza ukuthuthuka kwezempilo ngenxa ye-insulin inhaler.

U-Eric Finar, onesifo sikashukela sohlobo loku-1 iminyaka engu-22, ubelokhu ephumela obala ekusekeleni kwakhe i-Afrezza. U-Finar uthumele i-YouTube eminingi amavidiyo mayelana nezinzuzo zezempilo ze-Afrezza, futhi uthi i-HbA1c yakhe (isilinganiso samazinga kashukela wesikhathi eside egazini), selokhu yehla isuka ku-7.5% yaya ku-6.3%, i-HbA1c yakhe ephansi kunazo zonke, kusukela esebenzise i-Afrezza. U-Finar uthemba ukuthi uzophinde ehlise i-HbA1c yakhe ibe ngu-5.0% ngokuqhubeka nokusebenzisa i-Afrezza.

Ukudala enye indlela

Ngokudala ukuqwashisa phakathi kweziguli nochwepheshe bezokwelapha, ikusasa libonakala liqhakazile ku-Afrezza. Abaningi abanesifo sikashukela bangasebenzisa i-insulin ehlukile, okusiza ukuthuthukisa imiphumela yezempilo. Lokhu kuzophinde kube yintuthuko yezempilo kulabo abanesifo sikashukela abesaba izinaliti, noma abamanqikanqika ukulapha esidlangalaleni ngaphambi kokudla.

Ngokombiko othile Idokhumenti ye-FDA, “Ingxenye eyodwa kwezintathu yabo bonke abahlinzeki bezempilo ibika ukuthi iziguli zabo ezisebenzisa i-insulin zikhathazekile ngemijovo yazo; inani elifanayo labantu ... libika ukuthi liyabesaba. Ukungathobeli ... kuyinkinga kuzo zombili iziguli ze-T1DM (uhlobo loku-1 lwesifo sikashukela) kanye ne-T2DM, njengoba kuphawulwa ukuncishiswa kaningi komthamo noma ukungafaki imijovo ye-insulin ngokungagunci.”