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Donepezil hydrochloride is a specific and reversible inhibitor of acetylcholinesterase, the predominant cholinesterase in the brain. Donepezil hydrochloride is in vitro over 1000 times more potent an inhibitor of this enzyme than of butyrylcholinesterase, an enzyme that is present mainly outside the central nervous system.
In patients with Alzheimer’s Dementia participating in clinical trials, administration of single daily doses of 5 mg or 10 mg of donepezil hydrochloride produced steady-state inhibition of acetylcholinesterase activity (measured in erythrocyte membranes) of 63.6% and 77.3%, respectively when measured post dose. The inhibition of acetylcholinesterase (AChE) in red blood cells by donepezil hydrochloride has been shown to correlate to changes in ADAS-cog, a sensitive scale which examines selected aspects of cognition. The potential for donepezil hydrochloride to alter the course of the underlying neuropathology has not been studied. Thus Alzepil cannot be considered to have any effect on the progress of the disease.
Efficacy of treatment with donepezil has been investigated in four placebo-controlled trials, 2 trials of 6-month duration and 2 trials of 1-year duration.
In the 6 months clinical trial, an analysis was done at the conclusion of donepezil treatment using a combination of three efficacy criteria: the ADAS-Cog (a measure of cognitive performance), the Clinician Interview Based Impression of Change with Caregiver Input (a measure of global function) and the Activities of Daily Living Subscale of the Clinical Dementia Rating Scale (a measure of capabilities in community affairs, home and hobbies and personal care).
Translation - Lithuanian Farmakoterapinė grupė vaistai nuo demencijos, ATC kodas N06DA02.
Donepezilo hidrochloridas yra specifinis grįžtamas acetilcholinesterazės inhibitorius, daugiausia smegenų cholinesterazės. Donepezilo hidrochloridas in vitro 1000 kartų stipriau slopina šį fermentą, negu butirilcholinesterazę, kuri daugiausi yra ne centrinėje nervų sistemoje.
Pacientams, sergantiems Alzheimerio liga, kurie dalyvavo klinikiniuose tyrimuose, paskyrus vieną 5 ar 10 mg donepezilo hidrochlorido paros dozę acetilcholinesterazės aktyvumas buvo stabiliai nuslopintas (matuojant eritrocitų membranose) atitinkamai 63,6% ir 77,3%, kai buvo matuota po dozės pavartojimo. Acetilcholinesterazės (AchE) slopinimas donepezilio hidrochloridu eritrocituose siejosi su ALVS-kog (Alzheimerio ligos vertinimo skalės kognityvine dalimi), jautria skale, kurioje atsispindi atskiri pažinimo (kognityviniai) aspektai. Donepezilio hidrochlorido galimybė pakeisti pagrindinės neuropatologijos eigą nebuvo tirta. Taigi, negalima tvirtinti, kad Alzepil turi kokį nors poveikį ligos progresavimui.
Gydymo donepezilu veiksmingumas buvo tirtas keturiuose placebu kontroliuojamuose tyrimuose, kurių 2 truko 6 mėnesius ir 2 1 metus
6 mėnesių trukmės tyrime gydymo donepezilu analizės išvados buvo padarytos remiantis trimis veiksmingumo kriterijais: ALVS-kog (pažinimo mastas), klinicisto apklausa, pagrįsta matomais pokyčiais ir slaugytojo informacija (visų funkcijų mastas) ir klinikinės demencijos vertinimo skalės kasdieninio aktyvumo rodikliais (visuomeninės veiklos, savęs aptarnavimo, mėgstamos ir namų veiklos mastas).
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Years of experience: 15. Registered at ProZ.com: Mar 2008.
Microsoft Excel, Microsoft Word, Powerpoint, Trados Studio, Wordfast
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CV available upon request
Bio
More than 10 years experience of pharmaceutical, clinical trial and general medical texts translation from English to Lithuanian, and from Russian to Lithuanian, performing quality review of documents of medical products applied for centralized procedure to EMEA.
Keywords: medicine, cardiology, pharmacy, pharmaceuticals, health care, clincal trials, biology
