Inhaler yatsopano yapakamwa imatha kulowa m'malo mwa jakisoni wa insulin kwa odwala matenda ashuga

Alfred E. Mann (wapampando ndi Mtsogoleri wamkulu wa MannKind) ndi gulu lake la okonza zachipatala akuyesetsa kuti athetse mavuto a odwala matenda a shuga. Kumayambiriro kwa chaka chino, a Mannkind adatulutsa cholembera pakamwa cha insulin chotchedwa Afrezza. Inhaler yaing'ono yam'thumba yam'thumba imatha kugwiritsidwa ntchito m'malo mwa jakisoni wa insulin pakati pa odwala matenda ashuga.

Kuopsa kwa matenda a shuga

Pafupifupi anthu 29.1 miliyoni aku America ali ndi matenda a shuga, malinga ndi kafukufukuyu 2014 National Diabetes Report. Izi zikufanana ndi 9.3% ya anthu aku US. Mwa anthu 29 miliyoni omwe ali ndi matenda a shuga pakadali pano, 8.1 miliyoni sakudziwika. Ziwerengerozi zimakhala zochititsa mantha kwambiri munthu akazindikira kuti anthu oposa 27.8 peresenti ya anthu omwe ali ndi matenda a shuga sadziwa za matenda awo.

Matenda a shuga atsimikizira kuti ndi matenda oopsa omwe amakhudza kwambiri moyo wa odwala omwe ali nawo. Chiwopsezo cha kufa kwa akuluakulu omwe ali ndi shuga ndi wamkulu kuposa 50%, malinga ndi National Diabetes Report. Pafupifupi odwala 73,000 amayenera kudulidwa chiwalo chifukwa cha matenda awo. Chiwopsezo cha matenda a shuga ndi chenicheni, ndipo kupeza chithandizo choyenera komanso chothandiza cha matendawa ndikofunikira. Matenda a shuga anali achisanu ndi chiwiri omwe amayambitsa imfa ku United States mu 2010, ndikupha miyoyo ya odwala 69,071.

Kulemera kwa matenda a shuga sikukhudza okhawo omwe apezeka ndi matendawa. Malinga ndi Center of Disease Control and Prevention (CDC) 86 miliyoni, opitilira 1 mwa 3 aku America pakadali pano ali ndi matenda a shuga. Pakadali pano, anthu 9 mwa 10 aku America sadziwa kuti ali ndi matenda a shuga, 15-30% ya anthu omwe ali ndi matenda ashuga adzakhala ndi matenda amtundu wa 2 mkati mwa zaka zisanu.

Kuopsa kwa matenda a shuga pamodzi ndi ziwerengero zoopsa zomwe zimanyamula zimapangitsa kuti Mann apangidwe, Afrezza, akhale oyenera komanso okopa kwa iwo omwe ali kale ndi matenda a shuga 1 kapena 2. Mwa kuwongolera kuchuluka kwa shuga m'magazi, izi zitha kuthandiza wodwala kukhala ndi moyo wabwinobwino wokhala ndi matenda ashuga.

Kodi phindu lake ndi lotani?

Ubwino wa Afrezza ndi chiyani? Ndi chiyani chomwe chimasiyanitsa ndi jakisoni wa insulin? Awa ndi mafunso omwe adayankhidwa pakulankhula kwa Mann, pa John Hopkins School of Medicine.

Ponena za mmene inhaler ya ufa wa insulini imagwirira ntchito, Mann anafotokoza kuti: “Timatsanzira zimene kapamba weniweni amachita, timakwera kwambiri [insulini] m’mphindi 12 mpaka 14 m’magazi... yapita m’maola atatu.” Izi ndi zazifupi poyerekezera kuvomereza kwabwino kwa insulin Health.com, insulin yochepa chabe iyenera kumwedwa pakati pa mphindi makumi atatu mpaka ola limodzi kuti wodwala adye, ndipo imachuluka pambuyo pa maola awiri kapena anayi. 

Mann akupitiriza kunena kuti, "Ndi insulini yomwe imakhazikika mukamaliza kudya yomwe imayambitsa pafupifupi mavuto onse a insulin. Ndi hyperinsulinemia, hyperinsulinemia imayambitsa hypoglycemia, chifukwa cha hypoglycemia muyenera kukweza kuchuluka kwa shuga. Pakalipano mukudya zokhwasula-khwasula tsiku lonse, ndipo chiwindi chanu chikutulutsa glucose kuti musalowe mu coma, ndipo ndizomwe zimayambitsa kuwonda kwa matenda a shuga, zimangoyamba ndikupitirira mpaka kalekale chifukwa mulibe prandial. insulin. "

Zonena izi za Mann zokhudzana ndi Afrezza, zimagwirizana ndi zotsatira za kafukufuku wapadziko lonse lapansi adachitidwa pa odwala a shuga amtundu wa 2 ochokera ku United States, Brazil, Russia ndi Ukraine. Ofufuza adamaliza mu kafukufuku woyendetsedwa ndi akhungu awiri, oyendetsedwa ndi placebo kuti odwala omwe adapatsidwa Afrezza, anali olemera pang'ono, ndipo adawona kuchepa kwakukulu kwa kuchuluka kwa shuga m'magazi a postprandial.

Kulengeza Afrezza

Poyesa kuphunzitsa odwala ndi ogwira ntchito zachipatala zaubwino wa Afrezza, MannKind yapereka mapaketi a zitsanzo za 54,000 kwa asing'anga. Pochita izi, MannKind akuyembekeza kuti izi zipanga 2016 yopindulitsa komanso yopindulitsa kwa odwala matenda ashuga, komanso kampani. Popereka zitsanzo zamapaketi, zimapanga ubale wolimba pakati pa Afrezza ndi akatswiri azachipatala, zomwe zidzalolanso MannKind kukhazikitsa semina yamaphunziro a udokotala, komanso kuphatikiza Afrezza mu Sanofi's Coach - pulogalamu yaulere ya odwala matenda ashuga.

Tsogolo la Afrezza likuwoneka lowala kwambiri kuposa kale lake lalifupi. Chiyambireni kukhazikitsidwa kwa Afrezza pa February 5, 2015, inhaler ya insulin idangobweretsa ndalama zokwana $ 1.1 miliyoni. Izi zidadzetsa kukayikira pakati pa omwe ali ku Wall Street omwe amawoneka kuti ali ndi mwayi waukulu pazachipatala ichi.

Kuyamba kwachuma kwaulesi kwa Afrezza, kungayambitsidwenso ndi odwala omwe amayenera kuwunika asanalembedwe Afrezza. Odwala ayenera kukayezetsa ntchito ya m'mapapo (spirometry), kuti adziwe ngati mankhwalawa angagwiritsidwe ntchito ndi omwe ali ndi vuto la m'mapapo.

Nkhani zaumwini za Afrezza

Zinthu zazikulu zanenedwa ndi odwala matenda ashuga omwe adalembedwa ndikumwa mankhwala ndi Afrezza monga gwero lawo loyamba la insulin. Mawebusayiti monga Afrezzauser.com asonyeza kukondwera kwawo ndi mankhwalawa. Makanema ambiri a YouTube ndi masamba a Facebook atuluka m'miyezi ingapo yapitayo, akufotokoza kusintha kwa thanzi chifukwa cha insulin inhaler.

Eric Finar, yemwe ali ndi matenda a shuga a mtundu woyamba kwa zaka 1, wakhala akulankhula momveka bwino pothandizira Afrezza. Finar wayikapo ma YouTube ambiri mavidiyo okhudza ubwino wathanzi la Afrezza, ndipo amati HbA1c yake (muyeso wa shuga wa nthawi yayitali m'magazi), yatsika kuchokera ku 7.5% mpaka 6.3%, HbA1c yake yotsika kwambiri, kuyambira kugwiritsa ntchito Afrezza. Finar akuyembekeza kutsitsa HbA1c yake mpaka 5.0% popitiliza kugwiritsa ntchito Afrezza.

Kupanga njira ina

Mwa kupanga chidziwitso pakati pa odwala ndi akatswiri azachipatala, tsogolo likuwoneka lowala kwa Afrezza. Anthu ambiri omwe ali ndi matenda a shuga amatha kugwiritsa ntchito njira ina ya insulini, zomwe zimathandizira kuwongolera thanzi. Izi zidzatsimikiziranso kukhala chithandizo chamankhwala kwa odwala matenda ashuga omwe amawopa singano, kapena amazengereza kumwa mankhwala pamaso pa anthu asanadye.

Malinga ndi Chikalata cha FDA, “Chigawo chimodzi mwa zitatu cha opereka chithandizo chamankhwala akunena kuti odwala awo ogwiritsira ntchito insulin akuda nkhaŵa ndi jakisoni wawo; chiwerengero chofanana cha anthu…akunena kuti amawaopa. Kusamvera ... ndi vuto mwa onse odwala T1DM (mtundu 1 shuga mellitus) ndi T2DM, monga momwe zimasonyezedwera ndi kuletsa mlingo pafupipafupi kapena kusabaya jakisoni wa insulin.