{"id":581717,"date":"2026-06-02T13:01:45","date_gmt":"2026-06-02T11:01:45","guid":{"rendered":"https:\/\/pharma-hemp.com\/?p=581717"},"modified":"2026-06-02T13:01:45","modified_gmt":"2026-06-02T11:01:45","slug":"klinicna-studija-cbd-in-epilepsija-pri-otrocih","status":"publish","type":"post","link":"https:\/\/pharma-hemp.com\/sl\/klinicna-studija-cbd-in-epilepsija-pri-otrocih\/","title":{"rendered":"Klini\u010dna \u0161tudija: CBD in epilepsija pri otrocih"},"content":{"rendered":"<p><em>Vsak proizvajalec govori o kakovosti. Mi smo jo dali izmeriti, na pediatri\u010dni kliniki.<\/em><\/p>\n<table style=\"height: 196px;\" width=\"1066\">\n<tbody>\n<tr>\n<td width=\"602\"><strong>Kaj boste izvedeli?<\/strong><\/p>\n<p><em>\u2022\u00a0 Kako je potekala neodvisna, dvojno slepa klini\u010dna \u0161tudija o ekstraktih konoplje pri otrocih z rezistentno epilepsijo na Pediatri\u010dni kliniki UKC Ljubljana.<\/em><\/p>\n<p><em>\u2022\u00a0 Zakaj je GMP certifikacija pogoj za sodelovanje v resni klini\u010dni \u0161tudiji, in kaj pomeni za kakovost.<\/em><\/p>\n<p><em>\u2022\u00a0 Kaj klini\u010dna opa\u017eanja in meta-analiza (<a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/30258398\/\">Pamplona, 2018<\/a>) ka\u017eejo o razliki med \u010distim CBD in polnospektralnim ekstraktom.<\/em><\/p>\n<p><em>\u2022\u00a0 Kak\u0161na je bila vloga PharmaHempa pri \u0161tudiji.<\/em><\/p>\n<p>&nbsp;<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><em>Trg konopljinih izdelkov je poln trditev, ki jih nih\u010de ne preverja. Mi smo se odlo\u010dili za nasprotno pot.<\/em><\/p>\n<p>O kakovosti svojih izdelkov je enostavno govoriti. Bistveno te\u017eje \u2014 in bistveno bolj povedno \u2014 je financirati neodvisno klini\u010dno \u0161tudijo, ki kakovost dejansko izmeri. To je pot, ki smo jo pri PharmaHempu izbrali.<\/p>\n<p>Na Oddelku za pediatri\u010dno nevrologijo Pediatri\u010dne klinike UKC Ljubljana je potekala randomizirana, dvojno slepa klini\u010dna \u0161tudija. Ekipa izku\u0161enih zdravnikov \u2014 prof. dr. Damjan Osredkar, prof. dr. David Neubauer in dr. Neli Bizjak skupaj s kolegi z In\u0161tituta za biokemijo in molekularno genetiko Medicinske fakultete \u2014 je iskala odgovor na vpra\u0161anje, ki v medicini ostaja odprto: ali je polnospektralni ekstrakt konoplje pri zdravljenju rezistentne epilepsije pri otrocih res u\u010dinkovitej\u0161i od \u010distega CBD-ja?<\/p>\n<p>PharmaHemp je za to \u0161tudijo doniral ekstrakt konoplje. Brez tr\u017enih pogojev, brez vpliva na rezultate. Samo prepri\u010danje, da kakovost prestane preizkus neodvisne znanosti \u2014 in da tak preizkus sploh mora obstajati.<\/p>\n<h2>Kaj je \u0161tudija dejansko merila?<\/h2>\n<p>V \u0161tudiji so sodelovali otroci med 2. in 18. letom starosti s farmakorezistentno epilepsijo \u2014 kar pomeni, da vsaj dve standardni protiepilepti\u010dni zdravili nista pomagali. Primarno vpra\u0161anje je bilo jasno: kateri pripravek bolj zmanj\u0161a frekvenco napadov?<\/p>\n<table style=\"height: 224px;\" width=\"668\">\n<tbody>\n<tr>\n<td width=\"301\"><strong>SKUPINA A<\/strong><\/td>\n<td width=\"301\"><strong>SKUPINA B<\/strong><\/td>\n<\/tr>\n<tr>\n<td width=\"301\"><strong>Izolirani CBD<\/strong><\/p>\n<p>2 mg\/kg \u2192 do 8 mg\/kg dvakrat dnevno<\/td>\n<td width=\"301\"><strong>Polnospektralni ekstrakt CBD:THC 10:1<\/strong><\/p>\n<p>Titriran glede na odmerek THC (0,08\u20130,32 mg\/kg dvakrat dnevno)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\" width=\"602\"><em>Obe skupini sta prejemali oljne kapljice z enakim videzom in okusom \u2014 dvojno slepo.<\/em><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<p>Ta primerjava ni naklju\u010dna \u2014 sodi v klini\u010dno logiko stopnjevanja zdravljenja, od izoliranega CBD prek \u0161irokospektralnega do polnospektralnega ekstrakta 10:1, kot jo je prof. Neubauer predstavil na <em>prvem slovenskem kongresu o klini\u010dnem zdravljenju s kanabinoidi<\/em>.<\/p>\n<h2>GMP certifikacija: vstopnica za resno medicino<\/h2>\n<p>Ekstrakt za skupino B je moral priti od GMP certificiranega proizvajalca. In to ni bila zgolj formalnost.<\/p>\n<p>GMP (Good Manufacturing Practice) pomeni: dokumentirana sledljivost vsake serije, standardizirani postopki proizvodnje, neodvisna laboratorijska analiza vsebnosti in \u010distosti. Brez tega eti\u010dna komisija ne bi odobrila \u0161tudije \u2014 ker brez standardizirane kakovosti enostavno ne more\u0161 vedeti, ali u\u010dinek izvira iz zdravilne u\u010dinkovine ali iz nenadzorovane variabilnosti v sestavi.<\/p>\n<p>PharmaHemp je ta standard izpolnil. Na\u0161 ekstrakt je bil podlaga za skupino B \u2014 in to je dejstvo, ki govori samo zase.<\/p>\n<p><em>Isti GMP standard, ki je bil pogoj za sodelovanje v \u0161tudiji \u2014 dokumentirana sledljivost vsake serije, neodvisna analiza \u010distosti \u2014 ni rezerviran za to \u0161tudijo. Je temelj vsega, kar proizvedemo. Ekstrakt v skupini B ni bil posebna serija; bil je na\u0161a rutina.<\/em><\/p>\n<p>\u2192 <a href=\"https:\/\/pharma-hemp.com\/sl\/our-lab\/\">Na\u0161i certifikati kakovosti, vklju\u010dno z GMP<\/a><\/p>\n<h2>Kaj klini\u010dna praksa ka\u017ee?<\/h2>\n<p>Klini\u010dna opa\u017eanja ekipe prof. Neubauerja so dosledna: pri otrocih, ki se niso odzivali na \u010disti CBD, je dodajanje nizkih odmerkov THC \u2014 v varnem razmerju 10:1 \u2014 pri mnogih prineslo vidno izbolj\u0161anje. Ne samo pri epilepti\u010dnih napadih. Tudi pri vedenju, spanju in kognitivnih funkcijah.<\/p>\n<p>Pri teh otrocih \u010disti CBD (skupina A) ni zado\u0161\u010dal. Pri skupini B \u2014 polnospektralnem ekstraktu \u2014 je izbolj\u0161anje pri mnogih zajelo \u0161tiri podro\u010dja hkrati, ne le napade:<\/p>\n<p><strong>Pogostost napadov\u00a0\u00a0<\/strong><\/p>\n<p><strong>Vedenje\u00a0 <\/strong><\/p>\n<p><strong>Spanje\u00a0 <\/strong><\/p>\n<p><strong>Kognitivne funkcije<\/strong><\/p>\n<p>Razlaga le\u017ei v entourage efektu: sinergiji med CBD, THC in ostalimi fitokanabinoidi \u2014 CBG, CBN, terpeni, flavonoidi. Meta-analiza Pamplona in sodelavcev (<em>Frontiers in Neurology<\/em>, 2018) je pokazala, da so pacienti, zdravljeni z ekstrakti bogatimi s CBD, za primerljivo terapevtsko izbolj\u0161anje potrebovali povpre\u010dno \u0161tirikrat ni\u017eji odmerek kot tisti s \u010distim CBD-jem \u2014 ob hkrati bolj\u0161em varnostnem profilu.<\/p>\n<table style=\"height: 182px;\" width=\"817\">\n<tbody>\n<tr>\n<td width=\"602\">\n<h2><strong>4\u00d7\u00a0 ni\u017eji odmerek<\/strong><\/h2>\n<h4><em>za primerljivo terapevtsko izbolj\u0161anje \u2014 ob hkrati bolj\u0161em varnostnem profilu.<\/em><\/h4>\n<h4>Vir: meta-analiza Pamplona et al., Frontiers in Neurology, 2018. (Ni rezultat te \u0161tudije \u2014 lo\u010dena raziskava.)<\/h4>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h2>Zakaj nam je to pomembno?<\/h2>\n<p>Vsaka molekula v na\u0161ih pripravkih ima svojo zgodbo. Ampak najbolj\u0161i na\u010din, da to zgodbo povemo, ni oglas \u2014 je raziskava.<\/p>\n<p>Verjamemo v transparentnost in v kakovost, ki jo je mogo\u010de preveriti. Donacija za to \u0161tudijo ni bila marketin\u0161ka poteza \u2014 bila je logi\u010dno nadaljevanje tega, v kar verjamemo: da resna medicina potrebuje resne podatke, in da je na\u0161a vloga pri tem, da ji zagotovimo kakovostno izhodi\u0161\u010de.<\/p>\n<p>Veseli nas, da smo del te zgodbe.<\/p>\n<p><em>Ta ekstrakt ne nastaja le za raziskave. Polnospektralni konopljin ekstrakt je osnova izdelkov PharmaHemp \u2014 pripravljen v isti proizvodnji in po istih standardih kakovosti, kot jih je zahtevala \u0161tudija.<\/em><\/p>\n<table style=\"height: 123px;\" width=\"1050\">\n<tbody>\n<tr>\n<td width=\"602\">\n<h4><em>Ko izbirate med konopljinimi izdelki, izbirate tudi, komu zaupate glede kakovosti, ki je sami ne morete preveriti. Mi smo svojo dali preveriti drugim \u2014 najstro\u017ejim.<\/em><\/h4>\n<p><strong>\u2192 <\/strong><a href=\"https:\/\/pharma-hemp.com\/sl\/our-lab\/\"><strong>Spoznajte standarde, po katerih nastajajo na\u0161i izdelki.<\/strong><\/a><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h2>Pogosta vpra\u0161anja &#8211; FAQ<\/h2>\n<h4>Kaj je polnospektralni ekstrakt konoplje?<\/h4>\n<p><em>Polnospektralni ekstrakt vsebuje celoten naravni profil rastline \u2014 poleg CBD \u0161e druge fitokanabinoide, terpene in flavonoide \u2014 za razliko od izoliranega (\u010distega) CBD, ki vsebuje le eno u\u010dinkovino.<\/em><\/p>\n<h4>Kaj je entourage efekt?<\/h4>\n<p><em>Gre za sinergijo, pri kateri naravne spojine konoplje skupaj delujejo druga\u010de kot vsaka zase. Meta-analiza Pamplona et al. (Frontiers in Neurology, 2018) je pokazala primerljivo izbolj\u0161anje ob povpre\u010dno 4\u00d7 ni\u017ejem odmerku v primerjavi s \u010distim CBD.<\/em><\/p>\n<h4>Kaj pomeni GMP certifikacija?<\/h4>\n<p><em><a href=\"https:\/\/pharma-hemp.com\/sl\/gmp-certifikat-kaj-pomeni-za-kakovost-tvojega-cbd-izdelka\/\">GMP (Good Manufacturing Practice)<\/a> pomeni dokumentirano sledljivost vsake serije, standardizirane postopke in neodvisno laboratorijsko analizo \u010distosti \u2014 pogoj, brez katerega eti\u010dna komisija \u0161tudije ne bi odobrila.<\/em><\/p>\n<h4>Kak\u0161na je bila vloga PharmaHempa v \u0161tudiji?<\/h4>\n<p><em>PharmaHemp je za \u0161tudijo doniral polnospektralni ekstrakt, brez tr\u017enih pogojev in brez vpliva na rezultate.<\/em><\/p>\n<p><em>Avtorica \u010dlanka:<\/em><br data-start=\"55\" data-end=\"58\" \/><strong data-start=\"58\" data-end=\"82\">dr. Marjeta \u010cesen <\/strong><\/p>\n<p>Chief Regulatory Affairs Officer, PharmaHemp\u00ae<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Vsak proizvajalec govori o kakovosti. Mi smo jo dali izmeriti, na pediatri\u010dni kliniki. Kaj boste izvedeli? \u2022\u00a0 Kako je potekala neodvisna, dvojno slepa klini\u010dna \u0161tudija o ekstraktih konoplje pri otrocih z rezistentno epilepsijo na Pediatri\u010dni kliniki UKC Ljubljana. \u2022\u00a0 Zakaj je GMP certifikacija pogoj za sodelovanje v resni klini\u010dni \u0161tudiji, in kaj pomeni za kakovost. [&#8230;]\n","protected":false},"author":24456,"featured_media":581730,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[140],"tags":[],"class_list":["post-581717","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-recovery-sl"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Klini\u010dna \u0161tudija: CBD in epilepsija pri otrocih - Pharma Hemp<\/title>\n<meta name=\"description\" content=\"Klini\u010dna \u0161tudija o uporabi CBD in \u0161irokospektralnega konopljinega ekstrakta pri otrocih z epilepsijo. 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