PURPOSE: The effect of SAM vaginal gel, a medical device containing adsorptive silicon dioxide and antioxidative sodium selenite and citric acid, on histologically-proven cervical intraepithelial neoplasia type 2 (CIN2) as well as p16 positive CIN1, and on the presence of the onco-marker p16 was investigated. METHODS: 216 women aged 25-60 years were randomized to either receive an intravaginal daily dose of SAM gel for three 28-day periods, or be followed-up without intervention. The primary endpoint was efficacy, defined as a combined histological and cytological regression. At baseline and after 3 months participants had: a guided biopsy including p16 immunohistochemical (IHC) staining, only if a lesion was visible at colposcopy; a cervical smear for cytology, high-risk human papillomavirus (hr-HPV) and a p16/Ki-67 test. At 6 months a further cytology and p16/Ki-67 test was performed. RESULTS: Regression of CIN lesions was observed in 78 out of 108 patients (72.2%) in the SAM gel arm and in 27 out of 108 patients (25.0%) in the control arm. Similarly, the change in the p16/Ki-67 cytological test status was significantly in favor of the treatment arm. The prevalence of hr-HPV decreased significantly (p < 0.001) in the treatment arm, from 87.0% to 39.8%, while it slightly increased in the control arm, from 78.7% to 83.3%. At 6 months the cytological regression in the treatment group and the highly significant effect on p16/Ki-67 was still present. CONCLUSION: SAM vaginal gel enhances the regression of cervical lesions and clears hr-HPV and p16/Ki-67 in smears significantly, thus offering an active non-destructive management to prevent cervical cancer. TRIAL REGISTRATION NUMBER: ISRCTN11009040, date of registration: 10/12/2019; https://doi.org/10.1186/ISRCTN11009040 ; retrospectively registered.
- MeSH
- antigen Ki-67 účinky léků MeSH
- antioxidancia aplikace a dávkování MeSH
- aplikace intravaginální MeSH
- cytodiagnostika MeSH
- dospělí MeSH
- dysplazie děložního hrdla patologie terapie MeSH
- geny p16 MeSH
- infekce papilomavirem terapie virologie MeSH
- inhibitor p16 cyklin-dependentní kinasy účinky léků MeSH
- kolposkopie MeSH
- kyselina citronová aplikace a dávkování MeSH
- lidé středního věku MeSH
- lidé MeSH
- nádorové biomarkery analýza MeSH
- nádory děložního čípku prevence a kontrola MeSH
- oxid křemičitý aplikace a dávkování MeSH
- seleničitan sodný aplikace a dávkování MeSH
- těhotenství MeSH
- vaginální krémy, pěny a želé * MeSH
- vaginální stěr MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- těhotenství MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
PURPOSE: The purpose of this study is to compare the efficacy and tolerability of polyethylene glycol (PEG) to sodium picosulfate/magnesium citrate (SPMC) and low-volume polyethylene glycol/ascorbic acid (PEGA) in a single- or split-dose regimen for colonoscopy bowel preparation. METHODS: This was a prospective, randomized, endoscopist-blinded, multicentre study. Outpatients received either PEG or SPMC or PEGA in a single or a split dose before the colonoscopy. Quality and tolerability of the preparation and complaints during preparation were recorded. RESULTS: Nine hundred seventy-three patients were analysed. Satisfactory bowel cleansing (Aronchick score 1 + 2) was more frequent when a split dose was used irrespective of the solution type (PEG 90.1 vs 68.8%, PEGA 86.0 vs 71.6%, SPMC 84.3 vs 60.2%, p < 0.001). SPMC was the best tolerated followed by PEGA (p < 0.006) and PEG as the worst (p < 0.001). Tolerability did not correlate with the regimen and amount of the solution used. Female gender is associated with a higher incidence of nausea, vomiting and pain (p < 0.029). CONCLUSIONS: Both PEG, PEGA and SPMC are fully comparable in terms of colonic cleansing when used in similar regimens. The split-dose preparation is more effective in all agents. SPMC and PEGA are better tolerated than PEG. The preparation regimen and/or the volume do not affect tolerability.
- MeSH
- citráty aplikace a dávkování škodlivé účinky MeSH
- kolonoskopie * MeSH
- kyselina askorbová aplikace a dávkování škodlivé účinky MeSH
- kyselina citronová aplikace a dávkování škodlivé účinky MeSH
- léčebná irigace škodlivé účinky metody MeSH
- lidé MeSH
- organokovové sloučeniny aplikace a dávkování škodlivé účinky MeSH
- pikoliny aplikace a dávkování škodlivé účinky MeSH
- polyethylenglykoly aplikace a dávkování škodlivé účinky MeSH
- projímadla aplikace a dávkování škodlivé účinky MeSH
- prospektivní studie MeSH
- purgativa aplikace a dávkování škodlivé účinky MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
- Geografické názvy
- Česká republika MeSH
BACKGROUND/AIMS: In recent years, one of technical attempts to improve biocompatibility and tolerability of the hemodialysis procedure is the substitution of acetate in dialysis solution with citrate. The aim of our study was to compare two dialysis solutions: traditional bicarbonate dialysis solution containing acetate (3 mmol/L) (solution A); and (solution C) commercially produced citrate-enriched bicarbonate dialysis solution (0.8 mmol/L citrate). METHODS: Patients from a single hemodialysis center (N=126) were included in the study. Both conventional low-flux hemodialysis and on-line hemodiafiltration procedures were studied. Both dialysis solutions contained identical calcium (1.5 mmol/L) and magnesium (0.5 mmol/L) concentrations. RESULTS: Parathyroid hormone (iPTH) concentration decreased during procedures with solution A by 64%. On the contrary, when solution C was used, iPTH concentration increased insignificantly by 4%. For solution A, serum calcium and magnesium increased during procedures in patients with predialysis concentrations lower than 2.33 and 0.76 mmol/L, respectively. In procedures with dialysis solution C these concentrations were significantly lower: 2.19 mmol/L for Ca and 0.68 mmol/L for Mg. CONCLUSION: Our study clearly shows that the substitution of part of acetate with citrate in dialysis solution significantly influences changes of serum calcium, magnesium and parathyroid hormone concentrations during hemodialysis and hemodiafiltration procedures.
- MeSH
- biologické markery krev MeSH
- dialýza ledvin trendy MeSH
- dialyzační roztoky aplikace a dávkování MeSH
- hořčík krev MeSH
- kohortové studie MeSH
- kyselina citronová aplikace a dávkování MeSH
- lidé středního věku MeSH
- lidé MeSH
- parathormon krev MeSH
- prospektivní studie MeSH
- senioři MeSH
- vápník krev MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
BACKGROUND & AIMS: To compare the efficacy and tolerance of sodium picosulphate/magnesium citrate (PMC) and polyethylene glycol (PEG) in a single or split dose regimen for colonoscopy bowel preparation. METHODS: A prospective, randomized, endoscopist-blinded, multicenter study. The patients were randomly assigned to receive PMC (PMC4/0) or PEG (PEG4/0) in a single dose 4L day before colonoscopy or a split dose 2+2L PMC (PMC2/2) or 3+1L PEG (PEG3/1) one day before and in the morning before the colonoscopy. Each patient was interviewed to determine his/her subjective tolerance of the preparation before the procedure. The quality of bowel cleansing was assessed in a blinded test performed by multiple endoscopists using the Aronchick scale. RESULTS: A total of 600 patients were enrolled, 88.2% were included in the analysis. Satisfactory bowel cleansing (Aronchick score 1 and 2) was significantly more frequent when a split dose was used irrespective of the solution type (81.6% PMC2/2, 87.3% PEG3/1 vs. 73.0% PEG4/0, p = 0.024). In single dose regimens, PMC performed better than PEG (82.6% vs. 73.0%). Single or split dose PMC preparations were comparable. A PMC based solution was generally better tolerated than PEG regardless of the regimen used (p < 0.001). Nausea was reported mostly after the 4L PEG (32.8%, p < 0.001), incontinence after a split PMC dose (34.4%, p = 0.002), and bloating after the 4L PEG (38.0%, p < 0.001). There was no significant difference in the prevalence of vomiting. CONCLUSION: Colonic preparation with PMC yields similar results as a split PEG dose, regardless of whether PMC is administered in single or separate doses. PMC is better tolerated than any PEG-based preparation. A single 4L PEG the day before the colonoscopy is less appropriate for bowel cleansing.
- MeSH
- adherence pacienta MeSH
- citráty aplikace a dávkování škodlivé účinky MeSH
- dospělí MeSH
- fixní kombinace léků MeSH
- jednoduchá slepá metoda MeSH
- kolonoskopie metody MeSH
- kyselina citronová aplikace a dávkování škodlivé účinky MeSH
- lidé středního věku MeSH
- lidé MeSH
- organokovové sloučeniny aplikace a dávkování škodlivé účinky MeSH
- pikoliny aplikace a dávkování škodlivé účinky MeSH
- polyethylenglykoly aplikace a dávkování škodlivé účinky MeSH
- prospektivní studie MeSH
- purgativa aplikace a dávkování škodlivé účinky MeSH
- rozvrh dávkování léků MeSH
- senioři MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
Koncentrace vápníku v dialyzačním roztoku je jedna ze složek, které vytváří celkovou bilanci vápníku v organismu. Nesprávná bilance vápníku může být spoluzodpovědná za zvýšenou morbiditu a mortalitu dialyzovaných pacientů. Volba správné koncentrace vápníku pro dialyzační roztok přitom není jednoduchá - je potřeba ji individualizovat dle stavu a potřeb jednotlivých pacientů se zohledněním užívané terapie a dalších faktorů.
Hemodialysis is an important component of whole-body calcium balance. Inappropriate selection of calcium concentration for dial ysis solution may be responsible for increased morbidity and mortality of hemodialysis patients. Choice of adequate calcium concentr ation is complicated, have to be individualized, and must take into account number of factors including clinical status of the patien t and concomitant medication.
- Klíčová slova
- bilance vápníku, kalcifikace, CKD-MBD, hemodialýza,
- MeSH
- chronické selhání ledvin metabolismus terapie MeSH
- dialýza ledvin metody MeSH
- dospělí MeSH
- financování organizované MeSH
- hemodialyzační roztoky chemie MeSH
- kalcifylaxe diagnóza etiologie MeSH
- kyselina citronová aplikace a dávkování metabolismus MeSH
- lidé MeSH
- parathormon metabolismus MeSH
- sekundární hyperparatyreóza diagnóza etiologie terapie MeSH
- vápník aplikace a dávkování krev metabolismus MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- ženské pohlaví MeSH
- Publikační typ
- kazuistiky MeSH
- přehledy MeSH
BACKGROUND: The efficacy and safety of prostacyclin (PGI2) and citrate (ACD) anticoagulation were observed and compared during continuous haemodiafiltration. METHODS: Mechanically ventilated patients received either the PGI2 analogue epoprostenol (group A, n = 17) in escalating doses of 4.5-10.0 ng.kg(-1).min(-1) in combination with heparin (6 IU.kg(-1).h(-1)) or 2.2% ACD (group B, n = 15). Blood flow was set to match the circuit-filling volume per unit time equal to the intravascular half-life of PGI2. RESULTS: Median filter lifetimes were 26 h (interquartile range 16-37) in group A (39 filters) and 36.5 h (interquartile range 23-50) in group B (56 filters; p < 0.01). In group A, 4 patients (23.5%, p < 0.05) had the dose reduced due to hypotension. The final mean dose of PGI2 was 8.7 +/- 2.4 ng.kg(-1).min(-1). Four patients in group A (23.5%, p < 0.05) were switched to ACD due to a decrease in platelet count. No bleeding episodes, decrease in platelet count or adverse haemodynamic effects were encountered in group B. The cost of epoprostenol plus low dose heparin (EUR 204.73 +/- 53.04) was significantly higher than the cost of ACD-based anticoagulation (EUR 93.92 +/- 45.2, p < 0.05). CONCLUSION: ACD offers longer filter survival, has no impact on platelet count and is less expensive. Increasing the dose of PGI2 up to the average of 8.7 ng.kg(-1).min(-1) did not increase the haemodynamic side effects. (c) 2005 S. Karger AG, Basel
- MeSH
- antikoagulancia aplikace a dávkování ekonomika MeSH
- epoprostenol aplikace a dávkování ekonomika MeSH
- glukosa analogy a deriváty aplikace a dávkování MeSH
- hemodiafiltrace metody normy MeSH
- heparin aplikace a dávkování MeSH
- krvácení prevence a kontrola MeSH
- kyselina citronová aplikace a dávkování MeSH
- lidé středního věku MeSH
- lidé MeSH
- riziko MeSH
- senioři MeSH
- trombocyty účinky léků MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- srovnávací studie MeSH
OBJECTIVE: The (13)C-urea breath test ((13)C-UBT) is the most accurate non-invasive method for diagnosis of Helicobacter pylori infection. However, several methodological issues have not been resolved yet. The aim of this study was to test different protocols of (13)C-UBT to find the optimal test drink and sampling interval. MATERIAL AND METHODS: (13)C-UBT was performed at 3-day intervals in 27 healthy volunteers using citric acid (test A), orange juice (B) and still water (C) as test drinks. Breath samples were collected from time 5 to 60 min. A total number of 2106 breath samples were analysed by isotope ratio mass spectrometry (cut-off value 3.5). RESULTS: Differences in delta values were greater than would be expected by chance (A versus B and A versus C at times 20, 25, 30, 35 and 40 min, p<0.05, Dunnett's method). There were no grey zone- or false-negative results among H. pylori-positive persons in test A at any time, but some were found in tests B and C. Optimal intervals for breath sampling are at times 20 or 25 min after (13)C-urea ingestion. CONCLUSIONS: Citric acid solution as a test drink and 20- or 25-min breath sampling intervals are optimal for the (13)C-UBT in healthy volunteers.
- MeSH
- dechové testy metody MeSH
- dospělí MeSH
- financování organizované MeSH
- Helicobacter pylori enzymologie MeSH
- hmotnostní spektrometrie MeSH
- infekce vyvolané Helicobacter pylori diagnóza MeSH
- izotopy uhlíku MeSH
- kyselina citronová aplikace a dávkování diagnostické užití MeSH
- lidé středního věku MeSH
- močovina diagnostické užití MeSH
- roztoky MeSH
- ureasa metabolismus MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- Publikační typ
- srovnávací studie MeSH
- MeSH
- 1,2-dimethylhydrazin MeSH
- kašel etiologie MeSH
- kyselina citronová aplikace a dávkování MeSH
- morčata MeSH
- ovalbumin aplikace a dávkování MeSH
- rýma MeSH
- zvířata MeSH
- Check Tag
- morčata MeSH
- zvířata MeSH
- Publikační typ
- srovnávací studie MeSH