Moderní medicína se opírá o dùkazy z rùzných typù výzkumných studií. Aèkoliv se výsledky randomizovaných kontrolovaných studií považují za zlatý standard pro klinické rozhodování, observaèní studie, jsou-li správnì uspoøádány a kvalifikovanì „èteny“, poskytují nepostradatelné informace pro klinickou praxi. Observaèní studie skýtají ale mnohá úskalí, mezi která patøí pøedevším pøítomnost systematického zkreslení, jež mùže ovlivnit výsledky studie a snižovat jejich platnost. Tento èlánek vysvìtluje základní metodologické koncepty, s nimiž by se mìl lékaø seznámit, aby dokázal správnì interpretovat výsledky observaèních studií.
The modern medicine relies on evidence from different types of scientific studies. Even though the results of randomized controlled trials are considered as a gold standard for clinical decision-making, observational studies, if well conducted and critically interpreted, provide useful information for the clinical practice. Observational studies are plaqued with methodological challenges, in particular the presence of bias, that can affect the results of the studies and decrease their validity. This article explains basic methodological concepts that a physician should get aquainted with in order to be able to interpret the results of observational studies.
- Keywords
- misklasifikace, výběrové zkreslení,
- MeSH
- Estrogen Replacement Therapy statistics & numerical data adverse effects MeSH
- Confounding Factors, Epidemiologic * MeSH
- Myocardial Ischemia MeSH
- Evidence-Based Medicine MeSH
- Postmenopause MeSH
- Observational Studies as Topic * MeSH
- Randomized Controlled Trials as Topic MeSH
- Reproducibility of Results * MeSH
- Risk Factors MeSH
- Research Design MeSH
- Bias * MeSH
- Publication type
- Research Support, Non-U.S. Gov't MeSH
- Review MeSH
Osteoporóza je nejčastějším metabolickým onemocněním skeletu, které vede ke zvýšenému riziku zlomenin. Ve farmakoterapii osteoporózy se používají přípravky snižující kostní resorpci či stimulující kostní novotvorbu. Jedná se především o bisfosfonáty, dále je v terapii využíván denosumab, stroncium ranelát a deriváty parathormonu, určitou roli v terapii osteoporózy hraje i hormonální substituční terapie a léčba tibolonem a raloxifenem.
Osteoporosis is the most common metabolic bone disease which leads to an increased risk of fractures. The products which reduce bone resorption or stimulate bone formation are used in therapy. Bisphosponates are mainly used, besides them therapy with denosumab, stroncium ranelate and parathormon is used in osteoporosis treatment. Hormonal therapy, tibolone and raloxifen play some role in osteoporosis treatment.
- MeSH
- Diphosphonates therapeutic use MeSH
- Estrogen Replacement Therapy methods statistics & numerical data trends MeSH
- Antibodies, Monoclonal, Humanized therapeutic use MeSH
- Bone Density Conservation Agents therapeutic use MeSH
- Clinical Trials as Topic statistics & numerical data MeSH
- Humans MeSH
- Norpregnenes therapeutic use MeSH
- Osteoporotic Fractures prevention & control MeSH
- Osteoporosis * drug therapy therapy MeSH
- Parathyroid Hormone therapeutic use MeSH
- Osteoporosis, Postmenopausal drug therapy therapy MeSH
- Raloxifene Hydrochloride therapeutic use MeSH
- Strontium therapeutic use MeSH
- Thiophenes therapeutic use MeSH
- Calcium, Dietary therapeutic use MeSH
- Vitamin D therapeutic use MeSH
- Check Tag
- Humans MeSH
- Female MeSH
- Publication type
- Review MeSH
Ciele štúdie. Epidemiologické údaje ukazujú, že riziko vzniku depresie u žien v období perimenopauzy je vyššie ako v ostatnej populácii. Estrogen môže byť účinný pri ľahkej a stredne ťažkej depresii, pri ťažkej depresii sa odporúčajú antidepresíva. Cieľom retrospektívnej klinickej štúdie bolo vyhodnotiť klinické charakteristiky a zmapovať terapeutické postupy u hospitalizovaných žien s depresívnymi poruchami. Súbor a metodika: Vyhodnocovali sme chorobopisy žien, ktoré boli hospitalizované na Psychiatrickej klinike SZU Ružinov v období 2008-2011. Identifikovali sme 155 žien 45ročných a starších a 44 mladších žien s rôznymi formami depresie. U každej pacientky sme zaznamenávali formu depresie, závažnosť depresívnej epizódy, demografické charakteristiky, začiatok depresívnej poruchy, gynekologickú anamnézu, somatickú a psychiatrickú komorbiditu, psychofarmakoterapiu a hormonálnu liečbu. Výsledky: V súbore žien > 45 rokov sa najčastejšie vyskytovala F33 - rekurentná depresia (62 %). U 70% žien bola aktuálna depresívna epizóda ťažká alebo ťažká s psychotickými príznakmi. U 41% žien sa prvá epizóda depresie manifestovala vo vekom rozmedzí 45-54 rokov, v perimenopauze. Kombinácie psychofarmák boli indikované u 76% žien, najčastejšia kombinácia bola antidepresíva a antipsychotiká (u 54 % žien). Všetky ženy užívali antidepresíva, najčastejšie duloxetín, vyše polovica žien užívala antipsychotiká, najčastejšie olanzapín. Hormonálna substitučná liečba sa zistila len u 2 % žien. Záver: Terapeutické stratégie, ktoré sme na základe zdravotnej dokumentácie identifikovali v súbore hospitalizovaných žien 45ročných a starších, odrážajú súčasné trendy v oblasti farmakoterapie depresie.
Background and objective: Epidemiological data show that the risk of development of depression in women during menopausal transition is higher than in other population. Estrogen may be useful for mild and moderate depression, antidepressants are recommended for sever depression. The aim of the retrospective clinical study was to evaluate clinical characteristics and therapeutic strategies in hospitalized women with depressive disorders. Sets and methods: We evaluated all case - records of women hospitalized in Psychiatric department of University hospital in Bratislava-Ružinov between the years 2008 and 2011. We identified 155 women over 44 years of age and 44 younger women with various forms of depression. In each woman we recorded the form of depression, the severity of depressive episode, demographic characteristics, the onset of depressive disorder , somatic and psychiatric comorbidity, pharmacotherapy and hormonal treatment. Results: The most frequent diagnosis in women over 44 years of age was F33 - recurrent depression (62 %). The current episode of depression, sever or sever with psychotic features was present in 70 % of women. In 41 % of women, the onset of depressive disorder occurred between 45 and 54 years of age (in perimenopause). All women took antidepressants, duloxetine being the most frequent, more than half of women took antipsychotics, the most frequent being olanzapine. Combinations of psychopharmacs were indicated in 76 % of women, the most frequent combination was antidepressants and antipsychotics (54 %). The hormonal replacement therapy was detected only in 2 % of women. Conclusion: Therapeutic strategies detected on the basis of case-records in the group of women over 44 years of age reflect current trends in area of psychopharmacology of depression.
- Keywords
- duloxetine,
- MeSH
- Antidepressive Agents therapeutic use MeSH
- Antipsychotic Agents therapeutic use MeSH
- Citalopram therapeutic use MeSH
- Depressive Disorder * drug therapy MeSH
- Adult MeSH
- Estrogen Replacement Therapy statistics & numerical data MeSH
- Drug Therapy * methods MeSH
- Hospitalization statistics & numerical data MeSH
- Inpatients psychology statistics & numerical data MeSH
- Drug Therapy, Combination methods MeSH
- Middle Aged MeSH
- Humans MeSH
- Menopause psychology MeSH
- Adolescent MeSH
- Young Adult MeSH
- Perimenopause * psychology MeSH
- Retrospective Studies MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Severity of Illness Index MeSH
- Thiophenes therapeutic use MeSH
- Age of Onset MeSH
- Age Factors MeSH
- Age Distribution MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Adolescent MeSH
- Young Adult MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
The aim of this work is to give summary of changes in recommendation for hormone replacement therapy (HT) and cardiovascular prevention during last decade. Conclusions from observational studies demonstrated a positive effect of HT in both the primary and secondary prevention of coronary heart disease (CHD). But large randomized trials failed to prove this positive effect; on the contrary, the cardiovascular risk was increased in the beginning of therapy. But estrogen arm of Women's Health Initiative (WHI) show neutral influence and the Estrogen in the Prevention of Atherosclerosis Trial (EPAT) indicate possible positive effects of some HT regimens. Also reanalysis of WHI in age-related groups show the window of opportunity. The prevention of CHD was excluded from possible indications of HT. Many questions regarding optimal choice in the individual treatment strategies have been raised. HT in its individualized form remains the first choice therapy for the acute climacteric syndrome, for the prevention and the therapy of urogenital atrophy and prevention of osteoporosis. Early start of HT has neutral or slightly positive effect on cardiovascular prevention.
- MeSH
- Time Factors MeSH
- Estrogen Replacement Therapy statistics & numerical data MeSH
- Estrogens administration & dosage MeSH
- Climacteric * MeSH
- Coronary Disease epidemiology prevention & control MeSH
- Middle Aged MeSH
- Humans MeSH
- Progestins administration & dosage MeSH
- Risk Factors MeSH
- Aged MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- MeSH
- Estrogen Replacement Therapy statistics & numerical data MeSH
- Hormone Replacement Therapy statistics & numerical data MeSH
- Humans MeSH
- Menopause drug effects MeSH
- Joint Diseases prevention & control MeSH
- Osteoarthritis MeSH
- Arthritis, Rheumatoid MeSH
- Lupus Erythematosus, Systemic MeSH
- Check Tag
- Humans MeSH
- Female MeSH
- MeSH
- Estrogen Replacement Therapy methods statistics & numerical data utilization MeSH
- Hormone Replacement Therapy methods statistics & numerical data utilization MeSH
- Humans MeSH
- Melanoma epidemiology etiology MeSH
- Skin Aging ethnology pathology MeSH
- Aging physiology MeSH
- Check Tag
- Humans MeSH
- Female MeSH
Východisko. Cílem studie bylo zjistit změny plazminogen activator inhibitor – 1(PAI-1) jako biochemického rizikového faktoru pro kardiovaskulární nemoci při různých aplikačních formách časně zahájené estrogenní substituční terapie. Metody a výsledky. V prospektivní randomizované 12týdenní intervenční studii byl v cross-over designu podáván estradiol perorálně v dávce 2 mg denně nebo transdermálně v dávce 0,05 mg denně. Zařazeno bylo 45 zdravých postmenopauzálních žen do 12 týdnů od odstranění dělohy a vaječníků (chirurgické kastrace). Studii dokončilo 41 žen a jejich data byla analyzována. Průměrný věk byl 49±6 let. PAI-1 bylo stanoveno bio imunoassay (ChromolyzeTM PAI-1). Po perorální estrogenní terapii hladina PAI-1 signifikantně (p=0,001) klesla z 11,39±12,02 IU/l na 5,0±5,27 IU/l. Tyto změny jsou významné i ve srovnání s nesignifikantními změnami po transdermální léčbě. Závěry. Perorální terapie významně snížila hladiny PAI-1 ve srovnání s transdermální. Tyto změny jsou z pohledu kardiovaskulárního rizika příznivé.
Background. The purpose of the present study was to determine changes of plasminogen activator inhibitor – 1 (PAI-1) as biochemical cardiovascular risk factor during the use of different administration methods in the early estrogen replacement therapy. Methods and Results. In a 12-week prospective, randomized, interventional, cross-over trial, oestradiol was administered orally in a dose of 2 mg daily or transdermally in a dose of 0.05 mg daily. Forty-five healthy postmenopausal women were included into the study within 12 weeks after the hysterectomy and ovariectomy (surgical castration). Forty-one women completed the study and their data were analyzed. The average age was of 49±6 years. PAI-1 was determined by bioimmunoassay (ChromolyzeTM PAI-1). The PAI-1 level decreased statistically significantly (p = 0.001) after the oral oestrogen therapy from 11.39±12.02 IU/l to 5.0±5.27 IU/l. Changes are also significant compared with non-significant changes after the transdermal therapy. Conclusions. The oral therapy reduced statistically significantly PAI-1 levels compared with the transdermal method of administration. This change is beneficial from the view of cardiovascular risk.
- MeSH
- Administration, Oral MeSH
- Biomarkers analysis blood MeSH
- Adult MeSH
- Estradiol administration & dosage pharmacology therapeutic use MeSH
- Estrogen Replacement Therapy methods statistics & numerical data utilization MeSH
- Plasminogen Inactivators analysis diagnostic use metabolism MeSH
- Data Interpretation, Statistical MeSH
- Cardiovascular Diseases etiology prevention & control MeSH
- Humans MeSH
- Prospective Studies MeSH
- Randomized Controlled Trials as Topic statistics & numerical data MeSH
- Risk Factors MeSH
- Treatment Outcome MeSH
- Check Tag
- Adult MeSH
- Humans MeSH
- Female MeSH
- MeSH
- Estrogen Replacement Therapy statistics & numerical data MeSH
- Hormone Replacement Therapy statistics & numerical data MeSH
- Myocardial Ischemia epidemiology pathology prevention & control MeSH
- Clinical Trials as Topic statistics & numerical data MeSH
- Humans MeSH
- Postmenopause drug effects MeSH
- Primary Prevention MeSH
- Risk Factors MeSH
- Secondary Prevention MeSH
- Check Tag
- Humans MeSH
- Female MeSH
- MeSH
- Adult MeSH
- Estrogen Replacement Therapy methods statistics & numerical data trends MeSH
- Contraceptives, Oral, Combined therapeutic use MeSH
- Bone Density drug effects MeSH
- Middle Aged MeSH
- Humans MeSH
- Menopause drug effects MeSH
- Menstruation Disturbances drug therapy MeSH
- Osteoporosis epidemiology drug therapy prevention & control MeSH
- Aged MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Aged MeSH
- Female MeSH
