{"id":6691,"date":"2023-10-23T22:24:17","date_gmt":"2023-10-23T19:24:17","guid":{"rendered":"https:\/\/www.chemi-pharm.com\/?p=6691"},"modified":"2023-10-26T15:28:19","modified_gmt":"2023-10-26T12:28:19","slug":"bioblock-ninasprei-kliinilise-uuringu-tulemused","status":"publish","type":"post","link":"https:\/\/test2.chemi-pharm.com\/et\/bioblock-ninasprei-kliinilise-uuringu-tulemused\/","title":{"rendered":"BIOBLOCK\u00ae NINASPREI KLIINILISE UURINGU TULEMUSED"},"content":{"rendered":"\n<p><strong><em>Randomiseeritud, kontrollitud, topeltpime kontseptsiooni t\u00f5estamise uuring hindamaks BioBlock\u00ae ninasprei efektiivsust COVID-19 nakkuse ennetamisel ning ohutust tervete vabatahtlike seas<\/em><\/strong><\/p>\n\n\n\n<p>Eesti teadlaste ja tootjate poolt loodud SARS-CoV-2 vastaseid antikehi sisaldava BioBlock<sup>\u00ae <\/sup>ninaspreiga viidi l\u00e4bi kliiniline uuring, et hinnata selle efektiivsust SARS-CoV-2 viirusnakkuse ennetamisel ning ohutust 18-70 aastaste tervete vabatahtlike seas. <a><\/a><a>Tartu \u00dclikooli poolt teostatud <\/a>uuringus osales 852 inimest, kellest 816 uuringu l\u00f5petasid. Uuringu vahetulemuste protokoll n\u00e4itab, et BioBlocki r\u00fchmas oli nakatunuid ligi kaks korda v\u00e4hem kui platseebo grupis (5 nakatunut BioBlocki r\u00fchmas 406 uuritavatest vs 9 nakatunut platseebo grupis 410 uuritavatest). Seega on t\u00e4heldatav tendents BioBlock<sup>\u00ae<\/sup> ninasprei kaitsvale toimele.<\/p>\n\n\n\n<p><a>Tartu \u00dclikooli kliiniliste uuringute keskus<\/a>e uuringu vahearuande anal\u00fc\u00fcs n\u00e4itab, et BioBlock<sup>\u00ae<\/sup>i preparaat oli uuritavatele h\u00e4sti talutav. K\u00f5rvaltoimete esinemise sagedus oli nii BioBlock<sup>\u00ae<\/sup>i saanute kui platseebot saanute hulgas sarnane ning kummaski uuringur\u00fchmas ei esinenud t\u00f5siseid k\u00f5rvaltoimeid.<\/p>\n\n\n\n<p>Uuringu tulemuste statistilise v\u00e4\u00e4rtuse t\u00f5stmiseks oleks vajalik uuritavate arvu suurendada, eeldusel, et suureneb ka koroonaviirusesse nakatunute hulk. Uuringuga j\u00e4tkamiseks 2025. aasta juuli l\u00f5puni on olemas Tartu \u00dclikooli inimuuringute eetika komitee koosk\u00f5lastus (nr. 381\/M-8).<\/p>\n\n\n\n<p>Vahearuande tulemused on esitatud US FDA-le ning on protokolli registreerimise ja tulemuste s\u00fcsteemi poolt (PRS) \u00fclevaatamisel. Detailsed tulemused muutuvad k\u00e4ttesaadavaks US FDA kliinilise uuringu registreerimise veebilehel p\u00e4rast PRS-i \u00fclevaatamist.<\/p>\n\n\n\n<p>Chemi-Pharm tellis kliinilise uuringu koost\u00f6\u00f6s Tartu \u00dclikooli rahvatervishoiu \u2013 ja peremeditsiini instituudi ning T\u00dc KMI ja Kliinikumi kliiniliste uuringute keskusega, Meliva Qvalitas AS-iga ja Icosagen Cell Factory O\u00dcga.<\/p>\n\n\n\n<p><strong>T\u00f5estatud toimega antikehad<\/strong><\/p>\n\n\n\n<p>BioBlock\u00ae ninaspreis olevad SARS-CoV-2 vastased antikehad on juba enne eespool kirjeldatud kliinilist uuringut p\u00f5hjalikult <em>in-vitro<\/em> testitud ja tulemused teadusartiklina publitseeritud <sup>[1]<\/sup>.<br>Katsed on t\u00f5estanud antikehade toimet algsetele ja ka praegu levivatele muteerunud viirust\u00fcvedele (sh. omikron B.1.1.529 ja selle alavormid XBB 1.5, BA.1, BA.2, BA.4, BA.5, BA.2.75.2, BA.2.3.20, BQ.1.1). BioBlock\u00ae ninaspreid ja selles olevaid antikehi arendatakse ja testitakse regulaarselt vastavalt globaalsele situatsioonile ja viiruse muteerumisele.<\/p>\n\n\n\n<p><strong>J\u00e4reldused ja soovitused<\/strong><\/p>\n\n\n\n<p>Viirushooaja elavnemine suurendab t\u00f5en\u00e4oliselt ka koroonaviirusesse nakatunute hulka.<\/p>\n\n\n\n<p>K\u00f5ikide teostatud uuringute tulemused n\u00e4itavad, et BioBlock<sup>\u00ae<\/sup> on praegusel viirushooajal oluline ja ohutu lisakaitsemeede. Soovitame seda kasutada olukordades, kus sotsiaalne distantseerumine on keeruline: kodus, t\u00f6\u00f6l, koolis, treeningutel, transpordivahendites, avalikel ning seltskonna\u00fcritustel.<\/p>\n\n\n\n<p><em>[1] BioBlock\u00ae ninaspreis olevad SARS-CoV-2 vastaste antikehade ja nende efektiivsuse kohta oleme 2022 aastal publitseerinud teadusartikli PLOS ONE teadusajakirjas:<\/em><\/p>\n\n\n\n<p><a href=\"https:\/\/journals.plos.org\/plosone\/article?id=10.1371\/journal.pone.0268806\">https:\/\/journals.plos.org\/plosone\/article?id=10.1371\/journal.pone.0268806<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"Randomiseeritud, kontrollitud, topeltpime kontseptsiooni t\u00f5estamise uuring hindamaks BioBlock\u00ae ninasprei efektiivsust COVID-19 nakkuse ennetamisel ning ohutust tervete vabatahtlike seas Eesti teadlaste ja tootjate poolt loodud SARS-CoV-2 vastaseid antikehi sisaldava BioBlock\u00ae ninaspreiga viidi l\u00e4bi kliiniline uuring, et hinnata selle efektiivsust SARS-CoV-2 viirusnakkuse ennetamisel ning ohutust 18-70 aastaste tervete vabatahtlike seas. Tartu \u00dclikooli poolt teostatud uuringus osales 852 [&hellip;]","protected":false},"author":7,"featured_media":6692,"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-6691","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uudised-est"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>BIOBLOCK\u00ae NINASPREI KLIINILISE UURINGU TULEMUSED - 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\" href=\"https:\/\/test2.chemi-pharm.com\/et\/bioblock-ninasprei-kliinilise-uuringu-tulemused\/\" \/>\n<meta property=\"og:locale\" content=\"et_EE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"BIOBLOCK\u00ae NINASPREI KLIINILISE UURINGU TULEMUSED - Chemi-Pharm\" \/>\n<meta property=\"og:description\" content=\"Randomiseeritud, kontrollitud, topeltpime kontseptsiooni t\u00f5estamise uuring hindamaks BioBlock\u00ae ninasprei efektiivsust COVID-19 nakkuse ennetamisel ning ohutust tervete vabatahtlike seas Eesti teadlaste ja tootjate poolt loodud SARS-CoV-2 vastaseid antikehi sisaldava BioBlock\u00ae ninaspreiga viidi l\u00e4bi kliiniline uuring, et hinnata selle efektiivsust SARS-CoV-2 viirusnakkuse ennetamisel ning ohutust 18-70 aastaste tervete vabatahtlike seas. 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