- Keywords
- PRONTOKET,
- MeSH
- Drug Therapy methods utilization MeSH
- Orthopedic Procedures utilization MeSH
- Surveys and Questionnaires MeSH
- Publication type
- Review MeSH
Cíl: Ukázat možnosti nové aplikační metody estrogenní substituční terapie ve formě trandermálního spreje s dávkováním. Typ studie: Literární přehled. Výsledky: Transdermální sprej obsahuje 1,53 mg estradiolu v jedné dávce. Umožňuje individuální dávkování jednoho až tří střiků. Dosahuje významného snížení frekvence návalů u 85 % uživatelek. Současně má výborný bezpečnostní kardiovaskulární profil. KLÍČOVÁ SLOVA: transdermální sprej, hormonální substituční terapie, klimakterium, tromboembolická nemoc
Objective: To show possibilities of new application method of estrogen replacement therapy – mettered-dose transdermal spray. Design: Review article Results: Transdermal spray contains 1.53 mg estradiol in one dose. It gives possibility of individual aproach in estradiol application 1, 2 or 3 doses daily. About 85% of patients showed the significant reduction of hot flushes. Perfect safety profile is predicted especially in cardiovascular point. KEYWORDS: mettered-dose transdermal spray, hormone replacement therapy, perimenopausal symptoms, tromboembolic desease
- MeSH
- Administration, Cutaneous MeSH
- Estradiol * administration & dosage contraindications therapeutic use MeSH
- Risk Assessment MeSH
- Hormone Replacement Therapy MeSH
- Climacteric * drug effects MeSH
- Humans MeSH
- Hot Flashes drug therapy prevention & control MeSH
- Thromboembolism MeSH
- Check Tag
- Humans MeSH
- Female MeSH
A tutorial and spreadsheet for the validation and bottom-up uncertainty evaluation of quantifications performed by instrumental methods of analysis based on linear weighted calibrations is presented. The developed tool automatically assesses if calibrator values uncertainty is negligible given instrumental signal precision, assesses signal homoscedasticity by the Levene's test, guides the selection of weighting factors and evaluates the fitness of the regression model to define the calibration curve. The spreadsheet allows the use of the linear weighted regression model without the need for collecting many replicate signals of calibrators and sample by taking previously developed detailed models of signal precision variation in the calibration interval after adjustments to the daily precision conditions. This tool was successfully applied to the determination of the mass concentration of Cd, Pb, As, Hg, Co, V and Ni in a nasal spray by ICP-MS after samples dilution and acidification. The developed uncertainty models were checked through the analysis of nasal sprays after spiking with known analyte concentration levels. The metrological compatibility between estimated and reference analyte levels for 95% or 99% confidence level supports uncertainty model adequacy. The spiked samples were quantified from many replicate signals but uncertainty evaluation from duplicate calibrator and sample signals was assessed by randomly selecting calibrators and sample signals and by numerically defining a minimum acceptable success rate of the compatibility tests. The developed model was proven adequate to quantify the uncertainty of the studied measurements.
- MeSH
- Calibration MeSH
- Linear Models MeSH
- Uncertainty MeSH
- Nasal Sprays * MeSH
- Spectrum Analysis MeSH
- Publication type
- Journal Article MeSH
OBJECTIVE: To evaluate the effect of topical haemoglobin spray on treatment response and wound-closure rates in patients with chronic venous leg ulcers. METHOD: A linear regression model was used to forecast healing outcomes over a 12-month period. Simulated data were taken from normal distributions based on post-hoc analysis of a 72-patient study in non-healing and worsening wounds (36 patients receiving standard care and 36 receiving standard care plus topical haemoglobin spray). Using a simulated 25,000 'patients' from each group, the proportion of wound closure over time was projected. RESULTS: Simulation results predicted a 55% wound closure rate at six months in the haemoglobin group, compared with 4% in the standard care group. Over a 12-month simulation period, a 43% overall reduction in wound burden was predicted. With the haemoglobin spray, 85% of wounds were expected to heal in 12 months, compared with 13% in the standard care group. CONCLUSION: Topical haemoglobin spray promises a more effective treatment for chronic venous leg ulcers than standard care alone in wounds that are non-healing or worsening. Further research is required to validate these predictions and to identify achievable outcomes in other chronic wound types.
- MeSH
- Anti-Bacterial Agents administration & dosage MeSH
- Anti-Infective Agents, Local administration & dosage MeSH
- Administration, Topical MeSH
- Varicose Ulcer microbiology therapy MeSH
- Time Factors MeSH
- Chronic Disease MeSH
- Hemoglobins administration & dosage MeSH
- Wound Healing MeSH
- Humans MeSH
- Linear Models MeSH
- Occlusive Dressings * MeSH
- Forecasting MeSH
- Prospective Studies MeSH
- Regression Analysis MeSH
- Models, Statistical MeSH
- Treatment Outcome MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Randomized Controlled Trial MeSH
- Comparative Study MeSH
Inhalační podání suchých práškových částic je využívanou aplikační cestou pro dosažení lokálního i systémového působení léčiv. U plicních onemocnění je žádoucí depozice léčiv v místě účinku. Pro efektivní léčbu jsou tak zásadní parametry inhalovaných částic, a to především jejich velikost, tvar nebo aerosolizační parametry. Vhodných parametrů je možné dosáhnout volbou metody přípravy nebo pomocných látek (nosičů, porogenů nebo aerosolizačních činidel). Cílem experimentu byla příprava jedenácti šarží práškových směsí sprejovým sušením, které se lišily použitým nosičem, množstvím leucinu či porogenu. Cílem bylo optimalizovat složení pro navázání léčiva s ohledem na požadavky pro plicní podání. Připravené částice byly zhodnoceny z hlediska morfologie, tokových vlastností, pórovitosti, geometrického i aerodynamického průměru. Bylo zjištěno, že se zvyšující se koncentrací leucinu se sypná hustota částic snižovala a zároveň rostla hodnota FPF. Stejně tak docházelo i ke snižování MMAD. Jako vhodná se jevila šarže obsahující 15 % leucinu. Při stanovení optimální koncentrace porogenu (hydrogenuhličitan amonný) u manitolových částic dosahovala nejlepších výsledků šarže s jeho 1% zastoupením, vzhledem k vyhovující velikosti částic oproti ostatním šaržím (MMAD 5,92 ± 1,32 μm), vhodné pórovitosti a obecně přijatelné morfologii částic. Za účelem formulace částic s navázaným léčivem by tedy bylo vhodné snížit aerodynamický průměr částic např. úpravou procesních parametrů sprejového sušení.
Inhalation administration of dry powder particles is a common application route to achieve local and systemic drug effects. For pulmonary diseases, the deposition of drugs at the site of action is desirable. Thus, the parameters of the inhaled particles, especially their size, shape, or aerosolization, are essential for effective treatment. Suitable parameters can be achieved by choice of preparation method or excipients (carriers, porogens, or aerosolizing agents). This experiment aimed to prepare 11 batches of powder mixtures by spray drying, which differed in the carrier used and the amount of leucine or porogen. The aim was to optimize the formulation for drug binding concerning the requirements for pulmonary administration. The prepared particles were evaluated in terms of morphology, flow properties, porosity, and geometric and aerodynamic diameter. It was found that with increasing concentration of leucine, the bulk density of the particles decreased while the FPF value increased. Similarly, there was a decrease in MMAD. The batch containing 15% leucine was the most suitable. In determining the optimum porogen concentration for mannitol particles, the batch with its 1% gave the best results due to its adequate particle size compared to the other batches (MMAD 5.92 ± 1.32 μm), suitable porosity, and particle morphology. Thus, to formulate drug-loaded particles, it would be advisable to reduce the aerodynamic diameter of the particles, e.g., by spray drying process parameters.
Cieľ práce: Autori na príklade ošetreného pacienta so zriedkavým poranením vysokotlakovou „striekacou pištoľou“ zdôrazňujú nutnosť cielenej anamnézy, zistenie charakteru, množstva injikovanej tekutiny a iných okolností úrazu. Materiál: V príspevku autori popisujú priebeh liečby 30ročného muža s pracovným úrazom po poranení ruky technickou vodou vysokotlakovým mechanizmom. Autori považujú za významný faktor ovplyvňujúcim konečný funkčný výsledok časový faktor od vzniku úrazu po primerané ošetrenie. Autori v súlade s publikovanými prezentáciami považujú za najdôležitejšiu chirurgickú intervenciu prevedenú skúseným chirurgom. Výsledky: Vyhovujúci funkčný výsledok prezentovaný autormi bol ovplyvnený neagresívnou látkou prenikajúcou do tkaniva a primeraným chirurgickým ošetrením skúseným operatérom. Diskusia: Autori v príspevku prezentujú literárne poznatky o prognostických faktoroch pri poranení, spôsob liečby na dosiahnutie vyhovujúcich funkčných výsledkov. Záver: Zriedkavé poranenie „vysokotlakovou pištoľou“ je závažné poranenie s možnými trvalými následkami u ohrozenej skupiny – mladých ľudí v produktívnom veku. Znalosť nových poznatkov o tomto poranení u lekárov prvého kontaktu, chirurgov umožní znížiť percento funkčných obmedzení po tomto type poranenia.
Aim of the paper: On the grounds of the particular case of a patient being treated for a rare high-pressure injection hand injury, the authors emphasize the necessity of a targeted medical history, detecting the nature and the amount of an injected fluid and other circumstances of an accident. Material: In this paper, the authors describe a course of treatment of a thirty-year-old man who has had an occupational accident in which he has suffered a hand injury caused by a high-pressure water mechanism. They consider a time that goes by from an emergence of the injury to an appropriate treatment being a very important factor influencing the final functional outcome. However, in accordance with published presentations, the authors regard a surgical intervention conducted by an experienced surgeon to be the most important one. Results: A satisfactory functional outcome that the authors present has been influenced by a non-aggressive substance penetrating into the tissue and an appropriate surgical treatment conducted by an experienced surgeon. Discussion: The authors hereby present literary knowledge of prognostic factors in injury and a method of treatment applied to achieve satisfactory functional outcome. Conclusion: A rare high-pressure injection injury is a serious injury with possible permanent effects in a vulnerable group – young people of working age. Awareness of primary care providers and surgeons of new knowledge concerning this type of an injury makes it possible to decrease the functional limitations percentage after suffering such an injury.
- Keywords
- vysokotlaková (vysokotlaká) stříkací pistole,
- MeSH
- Time Factors MeSH
- Adult MeSH
- Humans MeSH
- Hand Injuries * diagnosis etiology surgery MeSH
- Occupational Injuries * diagnosis etiology surgery MeSH
- Subcutaneous Emphysema diagnosis etiology surgery MeSH
- Treatment Outcome MeSH
- Check Tag
- Adult MeSH
- Humans MeSH
- Male MeSH
- Publication type
- Case Reports MeSH
Since the outbreak of the COVID-19 pandemic, the use of hand sanitisers has become an inseparable part of our personal hygiene. However, the short-term effect and the need for frequent application are shortcomings that impair the overall protection. Another aspect is that repeated use of some products (typically alcohol-based) may cause skin irritation or eventually more severe health problems. This work proposes spray-drying as a suitable method for the preparation of swellable chitosan carriers, allowing for encapsulation and sustained release of antibacterial chlorhexidine digluconate as a model active substance. After application to hands, micron-sized particles preferentially accommodate space between epidermal ridges, protected against attrition. Thanks to their small size (d < 10 μm), particles are comfortable to carry since they are not recognisable by somatosensory receptors. The performance of formulations with various amounts of chlorhexidine and cross-linker was tested and compared with selected commercial disinfectants available on the Czech market (ethanol gel and alcoholic solution with chlorhexidine) against E. coli and S. epidermidis. The real-life performance was investigated with twelve volunteers performing various activities for up to 2 h. Finally, a replica of the human index finger with accurately captured micro-topology was proposed and compared with volunteers' fingers concerning the total amount of adhered and detached particles.
- MeSH
- Chlorhexidine MeSH
- Hand Sanitizers * MeSH
- Escherichia coli MeSH
- Ethanol MeSH
- Humans MeSH
- Pandemics MeSH
- Powders MeSH
- Hand microbiology MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
OBJECTIVE: The aim of this study was to evaluate the use of novel estradiol metered-dose transdermal spray (EMDTS) in the treatment of acute climacteric syndrome. METHODS: A multicenter open-label trial was conducted with a 24-week intervention. EMDTS 1.53 mg was given to symptomatic menopausal women. The Menopause Rating Scale (MRS) was used to assess the climacteric syndrome severity. The Friedman non-parametric test and a post-hoc test with Bonferroni correction were used for statistical evaluation. RESULTS: A total of 132 women were enrolled in 20 centers, of whom 123 (93.2%) completed the study. The average age of patients was 53.8 years (37-65 years). The study was discontinued by 6.8% of women. The patients were checked at the beginning of the study, and after 12 and 24 weeks. There was a statistically significant drop (p < 0.001) in MRS values both after 12 and 24 weeks of therapy. The average MRS values improved by 66.2% between the first and the third visits. The most significant improvement was manifested in patients with initial moderate climacteric syndrome (70.9%). CONCLUSION: This study confirms that application of EMDTS offers a novel treatment option for climacteric symptoms.
- MeSH
- Administration, Cutaneous MeSH
- Adult MeSH
- Estradiol administration & dosage MeSH
- Estrogen Replacement Therapy * MeSH
- Middle Aged MeSH
- Humans MeSH
- Menopause drug effects MeSH
- Hot Flashes drug therapy MeSH
- Aged MeSH
- Severity of Illness Index MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial MeSH
- Multicenter Study MeSH
- Geographicals
- Czech Republic MeSH
Importance: Controlled studies have shown short-term efficacy of esketamine for treatment-resistant depression (TRD), but long-term effects remain to be established. Objective: To assess the efficacy of esketamine nasal spray plus an oral antidepressant compared with an oral antidepressant plus placebo nasal spray in delaying relapse of depressive symptoms in patients with TRD in stable remission after an induction and optimization course of esketamine nasal spray plus an oral antidepressant. Design, Setting, and Participants: In this phase 3, multicenter, double-blind, randomized withdrawal study conducted from October 6, 2015, to February 15, 2018, at outpatient referral centers, 705 adults with prospectively confirmed TRD were enrolled; 455 entered the optimization phase and were treated with esketamine nasal spray (56 or 84 mg) plus an oral antidepressant. After 16 weeks of esketamine treatment, 297 who achieved stable remission or stable response entered the randomized withdrawal phase. Interventions: Patients who achieved stable remission and those who achieved stable response (without remission) were randomized 1:1 to continue esketamine nasal spray or discontinue esketamine treatment and switch to placebo nasal spray, with oral antidepressant treatment continued in each group. Main Outcomes and Measures: Time to relapse was examined in patients who achieved stable remission, as assessed using a weighted combination log-rank test. Results: Among the 297 adults (mean age [SD], 46.3 [11.13] years; 197 [66.3%] female) who entered the randomized maintenance phase, 176 achieved stable remission; 24 (26.7%) in the esketamine and antidepressant group and 39 (45.3%) in the antidepressant and placebo group experienced relapse (log-rank P = .003, number needed to treat [NNT], 6). Among the 121 who achieved stable response, 16 (25.8%) in the esketamine and antidepressant group and 34 (57.6%) in the antidepressant and placebo group experienced relapse (log-rank P < .001, NNT, 4). Esketamine and antidepressant treatment decreased the risk of relapse by 51% (hazard ratio [HR], 0.49; 95% CI, 0.29-0.84) among patients who achieved stable remission and 70% (HR, 0.30; 95% CI, 0.16-0.55) among those who achieved stable response compared with antidepressant and placebo treatment. The most common adverse events reported for esketamine-treated patients after randomization were transient dysgeusia, vertigo, dissociation, somnolence, and dizziness (incidence, 20.4%-27.0%), each reported in fewer patients (<7%) treated with an antidepressant and placebo. Conclusions and Relevance: For patients with TRD who experienced remission or response after esketamine treatment, continuation of esketamine nasal spray in addition to oral antidepressant treatment resulted in clinically meaningful superiority in delaying relapse compared with antidepressant plus placebo. Trial Registration: ClinicalTrials.gov identifier: NCT02493868.
- MeSH
- Antidepressive Agents administration & dosage adverse effects pharmacology MeSH
- Administration, Intranasal MeSH
- Administration, Oral MeSH
- Depressive Disorder, Treatment-Resistant drug therapy MeSH
- Depressive Disorder, Major drug therapy MeSH
- Adult MeSH
- Double-Blind Method MeSH
- Outcome Assessment, Health Care * MeSH
- Remission Induction MeSH
- Ketamine administration & dosage adverse effects pharmacology MeSH
- Drug Therapy, Combination MeSH
- Middle Aged MeSH
- Humans MeSH
- Nasal Sprays MeSH
- Secondary Prevention * MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
