Z\u00e1jem o v\u00fdzkum Pinealonu u lid\u00ed vzrostl s rostouc\u00edm z\u00e1jmem o bioregula\u010dn\u00ed peptidy a intervence podporuj\u00edc\u00ed zdrav\u00e9 st\u00e1rnut\u00ed. P\u0159i hodnocen\u00ed dostupn\u00fdch \u00fadaj\u016f je v\u0161ak t\u0159eba m\u00edt na pam\u011bti, \u017ee klinick\u00e9 d\u016fkazy u lid\u00ed z\u016fst\u00e1vaj\u00ed omezen\u00e9. A\u010dkoli bylo publikov\u00e1no n\u011bkolik studi\u00ed na lidech, datab\u00e1ze d\u016fkaz\u016f je mnohem men\u0161\u00ed ne\u017e u v\u011bt\u0161iny konven\u010dn\u00edch farmaceutick\u00fdch terapi\u00ed.<\/p>\n
Jednou z hlavn\u00edch studi\u00ed na lidech, kterou provedl Meshchaninov a spol., bylo zapojeno 32 dosp\u011bl\u00fdch ve v\u011bku 41 a\u017e 83 let s chronickou polymorbiditou a organick\u00fdm syndromem mozku v remisi (1). V\u00fdzkumn\u00edci hodnotili vliv Pinealonu a dal\u0161\u00edho peptidov\u00e9ho bioregul\u00e1toru, Vesugenu, na biomarkery biologick\u00e9ho st\u00e1rnut\u00ed a ukazatele funk\u010dn\u00edho stavu organismu.<\/p>\n
V\u011bdci zaznamenali, \u017ee Pinealon vyvol\u00e1val v\u00fdznamn\u00e9 anabolick\u00e9 \u00fa\u010dinky a byl spojen se zlep\u0161en\u00edm aktivity centr\u00e1ln\u00edho nervov\u00e9ho syst\u00e9mu (CNS) a funkce n\u011bkolika d\u016fle\u017eit\u00fdch org\u00e1n\u016f (1). Podle autor\u016f studie tyto zm\u011bny odpov\u00eddaly zpomalen\u00ed ukazatel\u016f biologick\u00e9ho st\u00e1rnut\u00ed. V\u00fdzkumn\u00edci dosp\u011bli k z\u00e1v\u011bru, \u017ee Pinealon vykazuje jak neuroprotektivn\u00ed, tak geroprotektivn\u00ed vlastnosti, kter\u00e9 mohou podporovat zdrav\u00e9 st\u00e1rnut\u00ed a udr\u017een\u00ed funk\u010dn\u00ed zdatnosti u star\u0161\u00edch osob.<\/p>\n
V\u00fdzkum zahrnoval tak\u00e9 hodnocen\u00ed mnoha bun\u011b\u010dn\u00fdch a metabolick\u00fdch marker\u016f souvisej\u00edc\u00edch se st\u00e1rnut\u00edm. A\u010dkoli Pinealon vykazoval p\u0159\u00edzniv\u00fd vliv na funk\u010dn\u00ed v\u00fdsledky, v\u011bdci poznamenali, \u017ee jeho geroprotektivn\u00ed \u00fa\u010dinky se zd\u00e1ly b\u00fdt o n\u011bco m\u00e9n\u011b v\u00fdrazn\u00e9 ne\u017e \u00fa\u010dinky pozorovan\u00e9 u Vesugenu ve stejn\u00e9 studii (1). Navzdory tomu auto\u0159i pova\u017eovali Pinealon za potenci\u00e1ln\u00ed neuroprotektivn\u00ed a geroprotektivn\u00ed peptid, kter\u00fd si zaslou\u017e\u00ed dal\u0161\u00ed hodnocen\u00ed u star\u0161\u00ed populace.<\/p>\n
Napriek t\u00fdmto s\u013eubn\u00fdm zisteniam je potrebn\u00e9 vzia\u0165 do \u00favahy nieko\u013eko obmedzen\u00ed. \u0160t\u00fadia zah\u0155\u0148ala relat\u00edvne mal\u00fd po\u010det \u00fa\u010dastn\u00edkov, nemala rozsiahly rozsah potrebn\u00fd na vyvodenie jednozna\u010dn\u00fdch klinick\u00fdch z\u00e1verov a zamerala sa na \u0161pecifick\u00fa skupinu pacientov (1). Na potvrdenie t\u00fdchto v\u00fdsledkov je potrebn\u00e9 \u010fal\u0161ie v\u00fdskumn\u00e9 \u00fasilie s v\u00e4\u010d\u0161ou a rozmanitej\u0161ou popul\u00e1ciou.<\/p>\n
V sou\u010dasnosti neexistuj\u00ed rozs\u00e1hl\u00e9 multicentrick\u00e9 randomizovan\u00e9 kontrolovan\u00e9 studie hodnot\u00edc\u00ed Pinealon pro zhor\u0161en\u00ed kognitivn\u00edch funkc\u00ed, Alzheimerovu chorobu, zdrav\u00e9 st\u00e1rnut\u00ed ani pro jin\u00e9 klinick\u00e9 indikace. Podobn\u011b prohled\u00e1v\u00e1n\u00ed ve\u0159ejn\u011b dostupn\u00fdch datab\u00e1z\u00ed klinick\u00fdch studi\u00ed nazna\u010duje relativn\u011b mal\u00fd po\u010det registrovan\u00fdch studi\u00ed se zapojen\u00edm lid\u00ed ve srovn\u00e1n\u00ed s podrobn\u011bji studovan\u00fdmi terapeutick\u00fdmi slou\u010deninami.<\/p>\n
Obecne dane z bada\u0144 z udzia\u0142em ludzi nazna\u010duj\u00ed, \u017ee Pinealon m\u016f\u017ee ovlivnit funkci centr\u00e1ln\u00edho nervov\u00e9ho syst\u00e9mu a biomarkery souvisej\u00edc\u00ed s biologick\u00fdm st\u00e1rnut\u00edm. Dostupn\u00e9 klinick\u00e9 \u00fadaje v\u0161ak z\u016fst\u00e1vaj\u00ed p\u0159edb\u011b\u017en\u00e9 a jsou zapot\u0159eb\u00ed dal\u0161\u00ed, dob\u0159e navr\u017een\u00e9 klinick\u00e9 studie, ne\u017e bude mo\u017en\u00e9 vyvodit kone\u010dn\u00e9 z\u00e1v\u011bry o jeho \u00fa\u010dinnosti, bezpe\u010dnosti a terapeutick\u00e9m potenci\u00e1lu u lid\u00ed.<\/p>\n
Dostupn\u00e1 data moment\u00e1ln\u011b nazna\u010duj\u00ed, \u017ee Pinealon je obecn\u011b dob\u0159e sn\u00e1\u0161en jak v experiment\u00e1ln\u00edch studi\u00edch na zv\u00ed\u0159atech, tak v omezen\u00e9m po\u010dtu dosavadn\u00edch studi\u00ed na lidech. Jeliko\u017e v\u0161ak klinick\u00e1 data od lid\u00ed z\u016fst\u00e1vaj\u00ed relativn\u011b \u0159\u00eddk\u00e1, jeho celkov\u00fd bezpe\u010dnostn\u00ed profil je\u0161t\u011b nebyl pln\u011b charakterizov\u00e1n, zejm\u00e9na s ohledem na dlouhodob\u00e9 u\u017e\u00edv\u00e1n\u00ed.<\/p>\n
Nejcenn\u011bj\u0161\u00ed \u00fadaje o bezpe\u010dnosti poch\u00e1zej\u00ed ze studie proveden\u00e9 Meshchaninovem a spolupracovn\u00edky, kter\u00e1 zahrnovala 32 dosp\u011bl\u00fdch ve v\u011bku 41 a\u017e 83 let s chronickou polymorbiditou a organick\u00fdm mozkov\u00fdm syndromem v remisi (1). V\u011bdci zaznamenali zlep\u0161en\u00ed funkce centr\u00e1ln\u00edho nervov\u00e9ho syst\u00e9mu a biomarker\u016f biologick\u00e9ho st\u00e1rnut\u00ed bez zji\u0161t\u011bn\u00ed v\u00fdznamn\u00fdch bezpe\u010dnostn\u00edch probl\u00e9m\u016f b\u011bhem studie. D\u016fle\u017eit\u00e9 je, \u017ee Pinealon se nezd\u00e1l negativn\u011b ovliv\u0148ovat kondenzaci chromozom\u016f, co\u017e vedlo autory k z\u00e1v\u011bru, \u017ee peptid vykazuje bezpe\u010dnost na \u00farovni genetick\u00e9 stability bun\u011b\u010dn\u00e9ho j\u00e1dra za zkouman\u00fdch podm\u00ednek (1).<\/p>\n
V\u00fdzkumy na zv\u00ed\u0159atech a bu\u0148k\u00e1ch rovn\u011b\u017e poukazuj\u00ed na p\u0159\u00edzniv\u00fd bezpe\u010dnostn\u00ed profil. Studie hodnot\u00edc\u00ed vliv Pinealonu na oxida\u010dn\u00ed stres, p\u0159e\u017eit\u00ed neuron\u016f a kognitivn\u00ed funkce obvykle prok\u00e1zaly ochrann\u00e9, nikoli \u0161kodliv\u00e9 \u00fa\u010dinky (2\u20134). V experiment\u00e1ln\u00edch modelech Pinealon sni\u017eoval oxida\u010dn\u00ed po\u0161kozen\u00ed, omezoval akumulaci reaktivn\u00edch forem kysl\u00edku, zlep\u0161oval \u017eivotaschopnost neuron\u016f a sni\u017eoval nekr\u00f3zu bun\u011bk, a to bez zn\u00e1mek v\u00fdznamn\u00e9 toxicity p\u0159i zkouman\u00fdch d\u00e1vk\u00e1ch (2,3).<\/p>\n
I p\u0159es slibn\u00e9 v\u00fdsledky je t\u0159eba vz\u00edt v \u00favahu n\u011bkolik v\u00fdznamn\u00fdch omezen\u00ed. Studie na lidech jsou st\u00e1le omezen\u00e9 po\u010dtem \u00fa\u010dastn\u00edk\u016f a d\u00e9lkou trv\u00e1n\u00ed, co\u017e zt\u011b\u017euje identifikaci vz\u00e1cn\u00fdch ne\u017e\u00e1douc\u00edch \u00fa\u010dink\u016f a pln\u00e9 posouzen\u00ed dlouhodob\u00e9 bezpe\u010dnosti. Nav\u00edc dosud nebyla provedena \u017e\u00e1dn\u00e1 rozs\u00e1hl\u00e1 randomizovan\u00e1 kontrolovan\u00e1 studie navr\u017een\u00e1 specificky pro hodnocen\u00ed bezpe\u010dnosti.<\/p>\n
V d\u016fsledku toho dlouhodob\u00fd bezpe\u010dnostn\u00ed profil Pinealonu z\u016fst\u00e1v\u00e1 nejist\u00fd. Ot\u00e1zky t\u00fdkaj\u00edc\u00ed se chronick\u00e9ho u\u017e\u00edv\u00e1n\u00ed, opakovan\u00fdch l\u00e9\u010debn\u00fdch cykl\u016f, mo\u017en\u00fdch interakc\u00ed s l\u00e9ky a pou\u017eit\u00ed ve specifick\u00fdch populac\u00edch nebyly v rozs\u00e1hl\u00fdch klinick\u00fdch studi\u00edch \u0159\u00e1dn\u011b prozkoum\u00e1ny. Jedinci s ji\u017e existuj\u00edc\u00edmi zdravotn\u00edmi probl\u00e9my by se m\u011bli p\u0159ed zv\u00e1\u017een\u00edm u\u017eit\u00ed jak\u00e9hokoli experiment\u00e1ln\u00edho peptidu poradit s kvalifikovan\u00fdm zdravotnick\u00fdm pracovn\u00edkem.<\/p>\n
Na z\u00e1klad\u011b v sou\u010dasnosti dostupn\u00fdch \u00fadaj\u016f se Pinealon jev\u00ed jako dob\u0159e tolerovan\u00fd v podm\u00ednk\u00e1ch studi\u00ed a nebyly identifikov\u00e1ny \u017e\u00e1dn\u00e9 v\u00fdznamn\u00e9 bezpe\u010dnostn\u00ed sign\u00e1ly v publikovan\u00fdch studi\u00edch. Omezen\u00fd rozsah studi\u00ed na lidech v\u0161ak znamen\u00e1, \u017ee p\u0159ed formulac\u00ed komplexn\u00edch z\u00e1v\u011br\u016f o bezpe\u010dnosti jsou nutn\u00e9 dal\u0161\u00ed klinick\u00e9 studie.<\/p>\n
Mnoho lid\u00ed, kte\u0159\u00ed hledaj\u00ed informace o Pinealonu, se sna\u017e\u00ed zjistit, zda byl schv\u00e1len americk\u00fdm \u00da\u0159adem pro kontrolu potravin a l\u00e9\u010div (FDA) a zda je v USA pova\u017eov\u00e1n za schv\u00e1len\u00fd l\u00e9k. Na z\u00e1klad\u011b sou\u010dasn\u00fdch regula\u010dn\u00edch informac\u00ed nebyl Pinealon schv\u00e1len FDA pro l\u00e9\u010dbu, prevenci ani diagnostiku jak\u00e9hokoli onemocn\u011bn\u00ed.<\/p>\n
Prohled\u00e1v\u00e1n\u00ed ve\u0159ejn\u011b dostupn\u00fdch datab\u00e1z\u00ed FDA t\u00fdkaj\u00edc\u00edch se l\u00e9k\u016f neukazuje Pinealon jako schv\u00e1len\u00fd l\u00e9k na p\u0159edpis. Podobn\u011b se Pinealon nenach\u00e1z\u00ed v datab\u00e1zi Drugs@FDA jako schv\u00e1len\u00fd terapeutick\u00fd produkt. To znamen\u00e1, \u017ee Pinealon nepro\u0161el rozs\u00e1hl\u00fdm procesem regula\u010dn\u00edho posouzen\u00ed, kter\u00fd je vy\u017eadov\u00e1n pro z\u00edsk\u00e1n\u00ed farmaceutick\u00e9ho schv\u00e1len\u00ed ve Spojen\u00fdch st\u00e1tech.<\/p>\n
M\u00edsto toho je Pinealon obecn\u011b pova\u017eov\u00e1n za experiment\u00e1ln\u00ed bioregula\u010dn\u00ed peptid nebo v\u00fdzkumn\u00fd peptid. V\u011bt\u0161ina v sou\u010dasnosti dostupn\u00fdch v\u011bdeck\u00fdch d\u016fkaz\u016f poch\u00e1z\u00ed z laboratorn\u00edch studi\u00ed, studi\u00ed na zv\u00ed\u0159atech a omezen\u00e9ho po\u010dtu studi\u00ed na lidech prov\u00e1d\u011bn\u00fdch p\u0159ev\u00e1\u017en\u011b v Rusku a v\u00fdchodn\u00ed Evrop\u011b (1\u20134). A\u010dkoli tyto studie prok\u00e1zaly potenci\u00e1ln\u011b prosp\u011b\u0161n\u00e9 biologick\u00e9 \u00fa\u010dinky, nejsou dostate\u010dn\u00e9 k tomu, aby ospravedlnily schv\u00e1len\u00ed FDA nebo zavedly uzn\u00e1van\u00e9 l\u00e9\u010debn\u00e9 indikace.<\/p>\n
Niezatwierdzenie przez FDA automaticky neznamen\u00e1, \u017ee dan\u00e1 slou\u010denina nevykazuje biologickou aktivitu. Znamen\u00e1 to v\u0161ak, \u017ee v r\u00e1mci regula\u010dn\u00edho procesu FDA nebyl p\u0159edlo\u017een a schv\u00e1len dostatek d\u016fkaz\u016f o jej\u00ed bezpe\u010dnosti, \u00fa\u010dinnosti, kvalit\u011b v\u00fdroby a klinick\u00fdch p\u0159\u00ednosech.<\/p>\n
V\u011bdci nad\u00e1le zkoumaj\u00ed Pinealon pro jeho potenci\u00e1ln\u00ed vyu\u017eit\u00ed v oblasti neuroprotekce, kognitivn\u00edch funkc\u00ed, regulace oxida\u010dn\u00edho stresu a zdrav\u00e9ho st\u00e1rnut\u00ed. Tyto oblasti v\u0161ak z\u016fst\u00e1vaj\u00ed experiment\u00e1ln\u00ed a v sou\u010dasn\u00e9 dob\u011b \u017e\u00e1dn\u00fd hlavn\u00ed regula\u010dn\u00ed org\u00e1n neuzn\u00e1v\u00e1 Pinealon jako schv\u00e1lenou terapii pro neurologick\u00e9 poruchy, onemocn\u011bn\u00ed souvisej\u00edc\u00ed s v\u011bkem ani pro \u017e\u00e1dn\u00e9 jin\u00e9 l\u00e9ka\u0159sk\u00e9 indikace.<\/p>\n
Vzhledem k tomu je t\u0159eba Pinealon v sou\u010dasn\u00e9 dob\u011b pova\u017eovat za experiment\u00e1ln\u00ed slou\u010deninu, nikoli za schv\u00e1len\u00fd farmaceutick\u00fd produkt. Z\u00e1jemci o Pinealon by si m\u011bli b\u00fdt v\u011bdomi toho, \u017ee tvrzen\u00ed o jeho terapeutick\u00fdch \u00fa\u010dinc\u00edch jsou zalo\u017eena p\u0159ev\u00e1\u017en\u011b na preklinick\u00fdch \u00fadaj\u00edch a omezen\u00e9m po\u010dtu studi\u00ed na lidech, nikoli na zaveden\u00e9m regula\u010dn\u00edm schv\u00e1len\u00ed.<\/p>\n
Obsah je v\u00fdhradn\u011b pro vzd\u011bl\u00e1vac\u00ed a informativn\u00ed \u00fa\u010dely a nem\u011bl by b\u00fdt interpretov\u00e1n jako l\u00e9ka\u0159sk\u00e1 rada, diagn\u00f3za, l\u00e9\u010dba nebo odborn\u00e9 doporu\u010den\u00ed. Pinealon nebyl schv\u00e1len americk\u00fdm \u00da\u0159adem pro kontrolu potravin a l\u00e9\u010div (FDA), Evropskou l\u00e9kovou agenturou (EMA) ani v\u011bt\u0161inou dal\u0161\u00edch regula\u010dn\u00edch org\u00e1n\u016f pro l\u00e9\u010dbu poklesu kognitivn\u00edch funkc\u00ed, neurologick\u00fdch poruch, onemocn\u011bn\u00ed souvisej\u00edc\u00edch s v\u011bkem nebo jak\u00fdchkoli jin\u00fdch l\u00e9ka\u0159sk\u00fdch indikac\u00ed. V\u011bt\u0161ina dostupn\u00fdch \u00fadaj\u016f poch\u00e1z\u00ed z preklinick\u00fdch studi\u00ed a omezen\u00e9ho po\u010dtu studi\u00ed na lidech, z nich\u017e mnoh\u00e9 zahrnovaly mal\u00e9 kohorty \u00fa\u010dastn\u00edk\u016f. Dal\u0161\u00ed, dob\u0159e navr\u017een\u00e9 klinick\u00e9 studie jsou nezbytn\u00e9 k lep\u0161\u00edmu stanoven\u00ed \u00fa\u010dinnosti, bezpe\u010dnosti, dlouhodob\u00fdch \u00fa\u010dink\u016f a potenci\u00e1ln\u00edch terapeutick\u00fdch p\u0159\u00ednos\u016f Pinealon v r\u016fzn\u00fdch populac\u00edch.<\/p>\n
(1)<\/strong> Meshchaninov, V. N., Tkachenko, E. L., Zharkov, S. V., Gavrilov, I. V., & Katyreva, Y. E. (2015). Vliv syntetick\u00fdch peptid\u016f na st\u00e1rnut\u00ed pacient\u016f s chronickou polymorbiditou a syndromem organick\u00e9ho po\u0161kozen\u00ed centr\u00e1ln\u00edho nervov\u00e9ho syst\u00e9mu v remisi<\/em>. Pokroky v gerontologii, 28<\/em>(1), 62\u201367.<\/span> (2)<\/strong> Arutjunjan, A. V., Kozinov\u00e1, L. S., Stvolinskij, S. L., Bulyginov\u00e1, E. R., Ma\u0161kinov\u00e1, A. P., & Chavinson, V. K. (2012). Pinealon chr\u00e1n\u00ed potkany po narozen\u00ed p\u0159ed prenat\u00e1ln\u00ed hyperhomocysteinemi\u00ed<\/em>. International Journal of Peptides, 2012<\/em>, 109757. https:\/\/doi.org\/10.1155\/2012\/109757<\/a><\/span> (3)<\/strong> Khavinson, V., Ribakova, Y., Trofimova, S., et al. (2011). Pinealon zvy\u0161uje \u017eivotaschopnost bun\u011bk potla\u010den\u00edm hladiny voln\u00fdch radik\u00e1l\u016f a aktivac\u00ed prolifera\u010dn\u00edch proces\u016f<\/em>. Rejuvenation Research, 14<\/em>(5), 517\u2013523. https:\/\/doi.org\/10.1089\/rej.2011.1172<\/a><\/span> (4)<\/strong> Khavinson, V., Ilina, A., Kraskovskaya, N., Linkova, N., Kolchina, N., Mironova, E., Erofeev, A., & Petukhov, M. (2021). Neuroprotektivn\u00ed \u00fa\u010dinky tripeptid\u016f \u2013 epigenetick\u00fdch regul\u00e1tor\u016f na my\u0161\u00edm modelu Alzheimerovy choroby<\/em>. Farmacie, 14<\/em>(6), 515. https:\/\/doi.org\/10.3390\/ph14060515<\/a><\/span> V\u00fdzkum Pinealonu u lid\u00ed. Z\u00e1jem o v\u00fdzkum Pinealonu u lid\u00ed vzrostl spolu s rostouc\u00edm z\u00e1jmem o bioregula\u010dn\u00ed peptidy a intervence podporuj\u00edc\u00ed zdrav\u00e9 st\u00e1rnut\u00ed. P\u0159i hodnocen\u00ed\u2026<\/p>","protected":false},"author":7908,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"footnotes":""},"categories":[253],"tags":[],"class_list":["post-51177","post","type-post","status-publish","format-standard","hentry","category-kategoria-pinealon","beh-no-thumb"],"_links":{"self":[{"href":"https:\/\/bioevidencehub.com\/cs\/wp-json\/wp\/v2\/posts\/51177","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/bioevidencehub.com\/cs\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/bioevidencehub.com\/cs\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/bioevidencehub.com\/cs\/wp-json\/wp\/v2\/users\/7908"}],"replies":[{"embeddable":true,"href":"https:\/\/bioevidencehub.com\/cs\/wp-json\/wp\/v2\/comments?post=51177"}],"version-history":[{"count":0,"href":"https:\/\/bioevidencehub.com\/cs\/wp-json\/wp\/v2\/posts\/51177\/revisions"}],"wp:attachment":[{"href":"https:\/\/bioevidencehub.com\/cs\/wp-json\/wp\/v2\/media?parent=51177"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/bioevidencehub.com\/cs\/wp-json\/wp\/v2\/categories?post=51177"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/bioevidencehub.com\/cs\/wp-json\/wp\/v2\/tags?post=51177"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
PubMed: https:\/\/pubmed.ncbi.nlm.nih.gov\/26390612\/<\/a><\/span><\/p>\n
PubMed: https:\/\/pubmed.ncbi.nlm.nih.gov\/22567179\/<\/a><\/span>
Cel\u00fd text PMC: https:\/\/pmc.ncbi.nlm.nih.gov\/articles\/PMC3342713\/<\/a><\/span><\/p>\n
Odkaz na den\u00edk: https:\/\/journals.sagepub.com\/doi\/abs\/10.1089\/rej.2011.1172<\/a><\/span><\/p>\n
Odkaz na den\u00edk: https:\/\/www.mdpi.com\/1424-8247\/14\/6\/515<\/a><\/span><\/p>","protected":false},"excerpt":{"rendered":"