"NR8466"
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OBJECTIVES: The main objective was to evaluate the effect of five second-generation antipsychotics (amisulpride, quetiapine, olanzapine, risperidone, and zotepine) on prolactinaemia during 6 week therapy in 433 female in-patients with mainly schizophrenic disorders. Secondary objectives included identification of dynamics of change in serum prolactin levels and correlations of changes of prolactinaemia with some demographic and clinical parameters. METHODS: The trial was a prospective, open-label, single-center one with a flexible dosing of SGAs. The therapeutic effect of SGAs was assessed by a change of scores of CGI-S and CGI-I scales from a baseline to the endpoint. Blood samples were taken in the morning under fasting condition. RESULTS: Amisulpride and risperidone increased prolactinaemia significantly in 100% of patients, as early as after week 1 of the therapy. Quetiapine and zotepine relatively reduced prolactinaemia significantly, as early as from week 1 of the quetiapine treatment. Olanzapine led to a transient mild prolactin elevation. The much lower prevalence of hyperprolactinaemia over 2 000 mIU/l differentiates olanzapine from amisulpride and risperidone. Prolactin elevation did not correlate with age, menopausal condition, therapeutic efficacy, antipsychotic daily dose, serum levels of lipids and glucose. There was significant correlation with first vs. subsequent psychotic episodes, weight, EPS and serum levels of thyroid hormones. CONCLUSION: Amisulpride and risperidone had marked and early prolactin elevating effects, requiring, therefore, more frequent monitoring of prolactinaemia and associated undesirable effects and risks than olanzapine, quetiapine and zotepine.
- MeSH
- antipsychotika škodlivé účinky terapeutické užití MeSH
- benzodiazepiny MeSH
- dospělí MeSH
- financování organizované MeSH
- hyperprolaktinemie chemicky indukované krev MeSH
- klinické zkoušky jako téma MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- neparametrická statistika MeSH
- prolaktin krev MeSH
- prospektivní studie MeSH
- risperidon škodlivé účinky terapeutické užití MeSH
- schizofrenie farmakoterapie komplikace MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- sulpirid analogy a deriváty škodlivé účinky MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- srovnávací studie MeSH
Závěrečná zpráva o řešení grantu Interní grantové agentury MZ ČR
Přeruš. str. : il.,tab. ; 30 cm
Cílem projektu je zjistit biologickou aktivitu hyperprolaktinémie po antipsychoticích druhé generace a případný vývoj tolerance k ní. Do studie bude zařazeno minimálně 120 nemocných, kteří budou léčeni po 12 měsíců. Biologická aktivita prolaktinémie budesledována pomocí koncentrací estradiolu, FSH a LH a výskytu endokrinních a sexuálních nežádoucích účinků. Výsledky budou podkladem pro doporučení či omezení terapie antipsychotiky druhé generace.; The aim of the project is to establish biological activity of hyperprolactinaemia induced by antipsychotics of the IInd generation and to study a potential development of tolerance to it. The trial will include at least 120 patients to be treated for 12months. Biological activity of prolactinaemia will be monitored through monitoring estradiol, FSH and LH concentrations and distribution of endocrine and sexual undesirable effects. The results will serve as a basis for recommending or constraining treatment with antipsychotics of the IInd generation.
- MeSH
- antipsychotika farmakokinetika MeSH
- hyperprolaktinemie chemicky indukované MeSH
- nemoci endokrinního systému chemicky indukované MeSH
- sexuální dysfunkce psychické chemicky indukované MeSH
- Konspekt
- Psychiatrie
- NLK Obory
- psychofarmakologie
- psychiatrie
- sexuologie
- NLK Publikační typ
- závěrečné zprávy o řešení grantu IGA MZ ČR