{"id":3094,"date":"2022-03-30T12:46:26","date_gmt":"2022-03-30T09:46:26","guid":{"rendered":"https:\/\/www.chemi-pharm.com\/?p=3094"},"modified":"2022-03-30T14:17:42","modified_gmt":"2022-03-30T11:17:42","slug":"bioblock-sars-cov-2-vastaseid-veise-antikehi-sisaldav-ninasprei-on-taiendav-kaitsemeede-takistamaks-viiruse-levikut","status":"publish","type":"post","link":"https:\/\/test2.chemi-pharm.com\/et\/bioblock-sars-cov-2-vastaseid-veise-antikehi-sisaldav-ninasprei-on-taiendav-kaitsemeede-takistamaks-viiruse-levikut\/","title":{"rendered":"BIOBLOCK\u00ae NINASPREI RAHULOLU-UURINGU \u00dcLEVAADE"},"content":{"rendered":"
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Wuhanist 31. detsembril 2019. a. alguse saanud koroonaviiruse SARS<\/em>-CoV-<\/em>2 pandeemia on tekitanud olukorra, mis sunnib otsima v\u00f5imalikult t\u00f5husaid meetmeid selle viiruse ohjamiseks. BioBlocki ninasprei ei asenda vaktsineerimist, ka\u0308tepesu vo\u0303i maski kandmist, vaid on lisavahend viiruse nakkusahelate katkestamisel. Artiklis antakse lu\u0308hiu\u0308levaade BioBlocki ninasprei kasutajate rahulolu-uuringust.<\/p>\n

Kiiresti eskaleerunud tervishoiu kriis sundis m\u00f5tlema uusi lahendusi ning Tartu \u00dclikooli tehnoloogiainstituudi emeriitprofessori Mart Ustavi eestvedamisel alustati Eestis unikaalse ninasprei v\u00e4lja t\u00f6\u00f6tamisega. Ninasprei BioBlock\u00ae on SARS-CoV-2 vastaseid antikehi sisaldav preparaat. See on looduslik toode, mis p\u00e4rineb h\u00fcperimmuniseeritud veiste ternespiimast, kus loomadel on tekitatud immuunvastus SARS-CoV-2 ogavalgu vastu. In vitro testid on n\u00e4idanud, et toode takistab SARS-CoV-2 viirusosakeste sisenemist rakkudesse (VIIDE). Samuti on edasised uuringud t\u00f5estanud, et ninasprei pakub kaitset nii algse Wuhani kui ka India p\u00e4ritolu delta ja kappa viirust\u00fcvede ning Suurbritannia, L\u00f5una-Aafrika ja Brasiilia t\u00fcvede vastu (Kangro et al 2021).<\/p>\n

BioBlock\u00ae ei ole oma olemuselt ravim, vaid lokaalselt manustatav viirusevastane toode, mis toimib ninaneelu limaskestadel neutraliseerides viiruseosakesed ja blokeerides viiruse rakkudesse sisenemist. Toodet soovitatakse kasutada t\u00e4iskasvanutel lisa kaitsemeetmena nt olukordades kui sotsiaalne distantseerumine ei ole v\u00f5imalik. Aga ka koduses olukorras kui ollakse l\u00e4hikontaktne v\u00f5i juba viirusesse nakatunud eesm\u00e4rgiga piirata koroonaviiruse levikut. Ninaspreid on soovitatav piserdada m\u00f5lemasse ninas\u00f5\u00f5rmesse enne ja p\u00e4rast rahvarohkes kohas k\u00e4imist. Lastel kasutades v\u00f5i\u00a0 raseduse ja rinnaga toitmise ajal soovitatakse eelnevalt konsulteerida tervishoiut\u00f6\u00f6tajatel. Toode ei sobi piimavalkude vastase allergia korral (eriti alla 6 a. lastel) v\u00f5i koostisosade suhtes tundlikkuse korral.<\/p>\n

Toote kontseptsioon ja arendus on valminud koost\u00f6\u00f6s Tartu \u00dclikooli (Tehnoloogiainstituut, Farmaatsia instituut, Bio- ja siirdemeditsiini instituut), Eesti Maa\u00fclikooli (Veterinaarmeditsiini ja loomakasvatuse instituut), O\u00dc Teadus ja Tegu, Icosagen Cell Factory O\u00dc ja AS Chemi-Pharm partneritega. Toote tehnoloogia on patenteeritud USA patendiameti poolt ja Eesti Terviseametilt on saadud luba BioBlocki\u00ae tootmiseks ja m\u00fc\u00fcgiks. Kuna hetkel puudub Eestis meditsiiniseadmena registreerimise v\u00f5imalus, on toote turustamine ja turul olemine koosk\u00f5las Eesti nelja riigi ametiga (Terviseamet, Ravimiamet, Tarbijakaitse ja Tehnilise J\u00e4relevalve Amet, P\u00f5llumajandus- ja Toiduamet).<\/p>\n

Metoodika ja tulemused<\/em><\/strong><\/p>\n

Kasutajatelt esmase tagasiside saamiseks jagati BioBlock\u00ae ninaspreid 100-le inimesele koos palvega vastata k\u00fcsimustikule, millele vastamise link anti kaasa koos toodet tutvustava infoga. Uuritavateks olid vabatahtlikud, kes olid n\u00f5us toodet kasutama ja andma tagasisidet. K\u00fcsimustikule vastati ajavahemikul 11.03\u221213.05.2021. Eraldi meeldetuletust vastamiseks ei saadetud.<\/p>\n

K\u00fcsimustikule vastas 30 inimest (15 naist ja 15 meest). Vastajad olid keskmise vanusega 47 aastat, vahemikus 24\u221264 aastat. Kaasuvatest haigustest esines kolmel diabeet, kahel astma ja kahel s\u00fcdame-veresoonkonna haigus ning \u00fcks rasedusega vastaja. 67% (20\/30st) kaasuvaid haiguseid ei esinenud.<\/p>\n

Vastajad olid toodet kasutanud keskmiselt 10 p\u00e4eva (mediaan 6, vahemikus 1\u221252 p\u00e4eva). Neli uuritavat ei kasutanud ninaspreid k\u00fcsimustikule vastamise ajal. P\u00f5hjused, millal otsustati kasutada ninaspreid, oli ligi kolmandikel juhtudel seotud t\u00f6\u00f6 erip\u00e4raga, aga ka reisimise ja \u00fcrituste k\u00fclastustega seoses (joonis 1). Veel toodi v\u00e4lja riskigruppi kuulumist, ennetaval eesm\u00e4rgil kasutamist. Samuti ma\u0308rgiti p\u00f5hjusena, et toode lisab kindlustunnet.<\/p>\n

\"\"<\/p>\n

Joonis 1. Bioblock ninasprei kasutamise p\u00f5hjused (n=30), %.<\/p>\n

Andmete kogumise ajal ei raporteeritud \u00fchtegi nakatumist SARS-CoV-2 BioBlock\u00ae kasutamise foonil. K\u00fcsimustikule vastamise hetkel raporteeris respiratoorseid s\u00fcmptome (nohu, k\u00f6ha) kolm uuritavat, kellest kaks oli nakatunud koroonaviirusesse vahetult enne ninasprei kasutamisega alustamist. Lisaks mainis kaks inimest v\u00e4simust, \u00fcks peavalu ja \u00fcks nahal\u00f6\u00f6be tekkimist k\u00fcsimustikule vastamise ajal. 70%-l\u00a0 (21\/30), kes kasutasid k\u00fcsitluse hetkel ninaspreid ei esinenud sel perioodil \u00fchtegi s\u00fcmptomi. Vabas vormis esitatud kommentaaridena toodi v\u00e4lja, et toodet on lihtne kasutada, puudub ebameeldiv l\u00f5hn ja maitse, teeb hingamise kergemaks ning kasutaks ka edaspidi nakatumise ennetamiseks.<\/p>\n

Arutelu ja kokkuv\u00f5te<\/em><\/strong><\/p>\n

SARS-CoV-2 p\u00f5hjustatud infektsioonid j\u00e4\u00e4vad t\u00f5en\u00e4oliselt p\u00fcsima aastateks, millega inimkonnal tuleb paratamatult kohaneda. Selleks on oluline leida v\u00f5imalikult t\u00f5hus nakatumist piiravate meetmete kogum. \u00dcheks viiruse nakkusahela katkestamise mehhanismiks on kasutada antikehasid, millel \u00a0on v\u00f5ime neutraliseerida viirust sisenedes peremeesrakku ja selle l\u00e4bi v\u00e4ltida nakatumist. Inimeselt p\u00e4rinevad antikehad on ravimid ja kuuluvad ravimite tootmist reguleerivate \u00f5igusaktide alla. Alternatiivina saab kasutada efektiivselt neutraliseerivate antikehade puhastamist teistelt liikidelt. Seda ideed on rakendatud Bioblock`i v\u00e4lja arendamisel ning preparaat sisaldab h\u00fcperimmuniseeritud lehmade ternespiimast puhastatud immuunglobuliine ehk antikehasid, mis suudavad blokeerida ja neutraliseerida SARS-CoV-2 ogavalgu. Toote turule tulemisega on paralleelselt toimunud toote edasine arendus uute viirust\u00fcvede vastu ja hetkel k\u00e4ivad \u00a0testid omikroni t\u00fcvega.<\/p>\n

Antud kasutaja tagasiside k\u00fcsitluse puuduseks on uuritavate v\u00e4ike arv, samas andmekogumise hetkel oli eesm\u00e4rk saada kiiresti esmast tagasisidet, mida see uuring ka andis. P\u00f5hjalikuma \u00fclevaate saamiseks on kindlasti vajalik metoodiliselt teistsugune l\u00e4henemine.<\/p>\n

Positiivne on see, et tootega rahulolu ja talutavus oli v\u00e4ga hea ning toote kasutamise foonil ei olnud \u00fchtegi koroonaviirusesse nakatumise juhtu. K\u00f5rvaltoimete puudumist kinnitab ka kliiniline uuring 16 terve vabatahtliku hulgas (Planken et al 2021). Samuti on n\u00fc\u00fcdseks, turule tulemisest kuni november 2021, kasutanud toodet hinnanguliselt ligi 150\u00a0000 inimest, teadaolevalt ilma \u00fchegi t\u00f5sise k\u00f5rvaltoimeta. Samas on oluline meeles pidada, et k\u00f5ige t\u00f5husama kaitse tagab mitme meetme koos kasutamine. BioBlock ninasprei ei asenda vaktsineerimist, ega k\u00e4tepesu v\u00f5i maski kandmist, vaid on lisameede viiruse nakkusahelate katkestamisel.<\/p>\n

Tervet artiklit saab lugeda SIIT<\/a><\/p>\n

Artikli ilmumist toetas AS Chemi-Pharm<\/p>\n

Kasutatud kirjandus:
\nKangro K,\u00a0 Kura\u0161in M, Gildemann K, et al. Colostrum Derived Antibodies Against SARS-CoV-2 Show Great Potential to Serve as a Prophylactic Agent. Preprint, doi: https:\/\/doi.org\/10.1101\/2021.06.08.21258069<\/a><\/p>\n

Planken A, Plaas M, \u2026 BioMask: Clinical Trial of BioBlock\u00ae Nasal Spray Containing Anti-SARSCoV-2 Antibodies Derived from Bovine Colostrum https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04916574<\/a><\/p>\n

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SIGRID VOROBJOV uuringu koordinaator<\/p>\n

KONSTANTIN REBROV a\u0308riarendusjuht, AS Chemi-Pharm<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n <\/div>\n <\/div>\n <\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":2848,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_uag_custom_page_level_css":"","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","ngg_post_thumbnail":0,"footnotes":""},"categories":[10],"tags":[],"class_list":["post-3094","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uudised-est"],"acf":[],"yoast_head":"\nBIOBLOCK\u00ae NINASPREI RAHULOLU-UURINGU \u00dcLEVAADE - Chemi-Pharm<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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