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Croatian Medical Journal Aug 2023To assess the quantity and quality of incident reports on medical devices by health care professionals from 2012 to 2021 and evaluate the effect of reporting on...
AIM
To assess the quantity and quality of incident reports on medical devices by health care professionals from 2012 to 2021 and evaluate the effect of reporting on manufacturers' post-market surveillance.
METHODS
Eighty-five incident reports were scored according to a self-developed evaluation system, and categorized as excellent, good, medium, qualified, and unqualified. The completeness of data in critical fields was assessed. For each report, the type and city of the reporter, and medical device risk class were extracted to calculate the frequency of report occurrence per risk class and outcomes for reportable reports.
RESULTS
The number of reports received from health care professionals was low; the highest number of reports in a year was 17. The majority of reports were deemed as unqualified (61.18%) and only 4.71% as excellent. Still, 67.65% of incident reports importantly affected the manufacturer's post-market surveillance, either as added information that contributes to risk monitoring or directly triggering a field safety corrective action.
CONCLUSION
The number of total reports and reports per year shows extensive underreporting in Croatia, and the quality of the provided reports is insufficient.
Topics: Humans; Croatia; Dioctyl Sulfosuccinic Acid; Health Personnel; Phenolphthalein
PubMed: 37654038
DOI: 10.3325/cmj.2023.64.265 -
ACS Omega Jan 2019β-cyclodextrin (β-CD) forms a host-guest inclusion complex with many organic and amphiphilic compounds found in pharmaceutical, textile, cosmetic, food, and personal...
β-cyclodextrin (β-CD) forms a host-guest inclusion complex with many organic and amphiphilic compounds found in pharmaceutical, textile, cosmetic, food, and personal care systems. Therefore, grafting of β-CD onto a cellulose nanocrystal (CNC) offers a possible strategy to use functionalized CNC to complex with surface-active molecules. We have successfully grafted β-CD onto CNCs in a stepwise manner using cyanuric chloride as the linker. The structure of β-CD-grafted CNC (CNC-CD) was characterized by UV-vis and Fourier-transform infrared spectroscopy, and the grafting ratio of β-CD was determined by the phenolphthalein inclusion protocol. Ionic surfactants induced the aggregation of CNC-CDs by forming inclusion complexes with β-CDs on the surface of CNC. The interactions of amphiphilic compounds with CNC-CD were examined by surface tensiometry, conductometric and potentiometric titration, and isothermal titration calorimetry. Mechanisms describing the complex formation between surfactants and CNC-CD were proposed, where an improved understanding of CD interactions with surfactants and lipids would enable better strategies for drug encapsulation and delivery with CDs.
PubMed: 31459458
DOI: 10.1021/acsomega.8b02534 -
Scientific Reports Nov 2023This paper presents comprehensive research of the advantages and applicability of various concrete carbonation detection methods. Employing a combination of...
This paper presents comprehensive research of the advantages and applicability of various concrete carbonation detection methods. Employing a combination of Phenolphthalein indicator (PI), Thermogravimetric analysis (TGA), X-ray phase analysis (XRD), Fourier transform infrared spectroscopy (FTIR), and Quantitative calcium carbonate analysis (CA), a detailed comparison to determine the carbonation depth in the partial carbonation zone of concrete specimens is conducted. Among the quantitative analysis methods, CA measures CaCO content based on chemical reactions, while TGA obtains the concentration distribution of Ca(OH) and CaCO. Among qualitative analysis methods, XRD tested the intensity distribution of Ca(OH) and CaCO, while FTIR traced the characteristic peaks of C-O functional groups in a specific spectral range to determine the depth of carbonation of concrete. Results indicate that the depth of carbonation values measured by CA, TGA, XRDA, and FTIR are 2-3 times higher than those measured by PI. This research may provide valuable insights for the design of carbonation detection in concrete.
PubMed: 37968286
DOI: 10.1038/s41598-023-47443-8 -
F1000Research 2023Dental caries is a major non-communicable disease of public health concern caused due to freely available dietary sugars. We aimed to compare the sugar content and...
Dental caries is a major non-communicable disease of public health concern caused due to freely available dietary sugars. We aimed to compare the sugar content and erosive potential with duration of use and drug classes of orodispersible tablets (ODTs). We conducted an evaluation of the total sugar content (TSC), Potential of Hydrogen (pH), solubility, and Titratable Acidity (TA) of commonly prescribed 62 ODTs. TA was measured by titrating the samples with known amount of. 0.1N sodium hydroxide (NaOH) with phenolphthalein indicator and pH was determined by digital pH meter. TSC was evaluated by phenol sulphuric acid. Solubility was assessed by filtration. Out of the 62 ODTs, majority were Antimicrobials (n=30). One-quarter of the ODTs (26%) had a mean pH below ≤5.5. No significant difference was seen in the mean pH with respect to different drug classes (p=0.082) and duration of use of ODTs. A significant difference was seen in the mean percentage solubility with respect to drug classes (p<0.001). Antimicrobials had the least percentage of solubility as compared to other drug classes. Antiemetics and proton pump inhibitors (24.33 ± 17.34) had significantly higher mean percentage sugar content than Antimicrobials (23.25 ± 17.16). No significant difference was seen in the mean TSC with respect to various drug classes (p=0.718) and between the duration of use of drugs (P=0.568) respectively. No significant difference was seen in the mean percentage TA with respect to drug class (p=0.123) and duration of use of drugs (p=0.424). Overall, we can conclude that one in four ODT formulations had a pH below 5.5 (critical pH). Only one ODT formulation did not have a sugar content. No difference was seen in the mean pH, sugar content, and TA with respect to duration of use of drugs and drug classes.
Topics: Humans; Sugars; Dental Caries; Tablets; Solubility
PubMed: 37089132
DOI: 10.12688/f1000research.130786.2 -
Zhongguo Dang Dai Er Ke Za Zhi =... Jul 2021To study the characteristics of gut microbiota and its association with the activity of β-glucuronidase (β-GD) in neonates with hyperbilirubinemia.
OBJECTIVE
To study the characteristics of gut microbiota and its association with the activity of β-glucuronidase (β-GD) in neonates with hyperbilirubinemia.
METHODS
A total of 50 neonates with hyperbilirubinemia who were admitted in January to December, 2018, were enrolled as the hyperbilirubinemia group, and 30 neonates without hyperbilirubinemia were enrolled as the control group. The 16S rRNA high-throughput sequencing method was used to compare gut microbiota between the two groups. The phenolphthalein-glucuronic acid substrate method was used to measure the activity of β-GD in the intestinal tract of neonates with hyperbilirubinemia before and after treatment.
RESULTS
The comparison of the distribution of gut microbiota at the genus level showed a significant difference in the abundance of 52 bacteria between the hyperbilirubinemia and control groups before treatment ( < 0.05), as well as a significant difference in the abundance of 42 bacteria between the hyperbilirubinemia group on day 3 after treatment and the control group on day 3 after enrollment ( < 0.05). After treatment, the hyperbilirubinemia group had significant reductions in the content of and in the intestinal tract ( < 0.05) and the activity of β-GD in feces ( < 0.05). The activity of β-GD in feces was positively correlated with the abundance of and before and after treatment in the neonates with hyperbilirubinemia (=0.5948-0.7245, < 0.01).
CONCLUSIONS
There are differences in gut microbiota between the neonates with hyperbilirubinemia and those without hyperbilirubinemia. The activity of β-GD in feces is positively correlated with the abundance of and in neonates with hyperbilirubinemia. Gut microbiota may affect the development of neonatal hyperbilirubinemia by regulating the activity of β-GD. The determination and analysis of gut microbiota and β-GD activity may have certain clinical significance for the early assessment of the development of neonatal hyperbilirubinemia.
Topics: Feces; Gastrointestinal Microbiome; Glucuronidase; Humans; Hyperbilirubinemia, Neonatal; Infant, Newborn; RNA, Ribosomal, 16S
PubMed: 34266523
DOI: 10.7499/j.issn.1008-8830.2102039 -
International Journal of Analytical... 2019There has been an increasing interest in the search for colour indicators of natural origin for titrimetric analysis. This is due to some challenges associated with the...
There has been an increasing interest in the search for colour indicators of natural origin for titrimetric analysis. This is due to some challenges associated with the currently used synthetic ones. This study evaluates and validates the acid-base indicator property of plumbagin isolated from Linn. Plumbagin (5-hydroxy-2-methyl-1,4-naphthoquinone) was isolated from the roots of Linn using silica gel chromatography and characterized using spectroscopic methods in comparison with those reported in the literature. Its acid-base indicator property was evaluated alongside phenolphthalein and methyl orange, after it was found to exhibit a sharp change in colour at various pH ranges. The plumbagin indicator was successfully used to assay ibuprofen powder and tablets (400 mg) using the British Pharmacopoeia (2013) method. Data obtained were analyzed statistically by Student's -test and one-way ANOVA in GraphPad Prism (version 5.01, 2010). Analysis of the use of the plumbagin indicator in acid-base titrations between strong acids and strong bases and between weak acids and strong bases has been evaluated and validated according to the ICH guidelines. Plumbagin use in ibuprofen powder and tablets has also been verified. Plumbagin has been validated for use as an indicator suitable for different acid-base titrations and the analysis of ibuprofen.
PubMed: 31531024
DOI: 10.1155/2019/4061927 -
The Turkish Journal of Gastroenterology... Mar 2019Fixed drug eruption (FDE) is a type of drug reaction characterized by localized erythema, hyperpigmentation, and bullous at the same site(s), generally observed... (Review)
Review
Fixed drug eruption (FDE) is a type of drug reaction characterized by localized erythema, hyperpigmentation, and bullous at the same site(s), generally observed following every intake of a causative drug. Delayed-type cellular hypersensitivity (Type IVC) is considered to play a role in FDE etiology. Several antibiotics, barbiturates, oral contraceptives, nonsteroidal anti-inflammatory drugs, laxative-containing phenolphthalein, metronidazole, and quinine are known to be the primary drugs responsible for FDE. Bullous FDE, on the other hand, is a relatively rare form of FDE. Hepatitis B is a significant worldwide health problem, and entecavir is a common nucleoside (deoxyguanosine) analog used for treating hepatitis B; however, it has various side effects, such as lactic acidosis, myalgia, azotemia, hypophosphatemia, headache, diarrhea, pancreatitis, and neuropathy, and, in rare cases, cutaneous drug eruption. Our aim is to present a case of entecavir-associated bullous drug reaction, which has not been reported in the literature. Furthermore, we performed a review of literature to compile previously reported entecavir-associated drug reactions.
Topics: Antiviral Agents; Drug Eruptions; Female; Guanine; Hepatitis B; Hepatitis B virus; Humans; Middle Aged
PubMed: 30459136
DOI: 10.5152/tjg.2018.17887 -
Scientific Reports Nov 2022Factors that increase estrogen or progesterone (P4) action are well-established as increasing breast cancer risk, and many first-line treatments to prevent breast cancer...
Factors that increase estrogen or progesterone (P4) action are well-established as increasing breast cancer risk, and many first-line treatments to prevent breast cancer recurrence work by blocking estrogen synthesis or action. In previous work, using data from an in vitro steroidogenesis assay developed for the U.S. Environmental Protection Agency (EPA) ToxCast program, we identified 182 chemicals that increased estradiol (E2up) and 185 that increased progesterone (P4up) in human H295R adrenocortical carcinoma cells, an OECD validated assay for steroidogenesis. Chemicals known to induce mammary effects in vivo were very likely to increase E2 or P4 synthesis, further supporting the importance of these pathways for breast cancer. To identify additional chemical exposures that may increase breast cancer risk through E2 or P4 steroidogenesis, we developed a cheminformatics approach to identify structural features associated with these activities and to predict other E2 or P4 steroidogens from their chemical structures. First, we used molecular descriptors and physicochemical properties to cluster the 2,012 chemicals screened in the steroidogenesis assay using a self-organizing map (SOM). Structural features such as triazine, phenol, or more broadly benzene ramified with halide, amine or alcohol, are enriched for E2 or P4up chemicals. Among E2up chemicals, phenol and benzenone are found as significant substructures, along with nitrogen-containing biphenyls. For P4up chemicals, phenol and complex aromatic systems ramified with oxygen-based groups such as flavone or phenolphthalein are significant substructures. Chemicals that are active for both E2up and P4up are enriched with substructures such as dihydroxy phosphanedithione or are small chemicals that contain one benzene ramified with chlorine, alcohol, methyl or primary amine. These results are confirmed with a chemotype ToxPrint analysis. Then, we used machine learning and artificial intelligence algorithms to develop and validate predictive classification QSAR models for E2up and P4up chemicals. These models gave reasonable external prediction performances (balanced accuracy ~ 0.8 and Matthews Coefficient Correlation ~ 0.5) on an external validation. The QSAR models were enriched by adding a confidence score that considers the chemical applicability domain and a ToxPrint assessment of the chemical. This profiling and these models may be useful to direct future testing and risk assessments for chemicals related to breast cancer and other hormonally-mediated outcomes.
Topics: United States; Humans; Progesterone; Cheminformatics; Artificial Intelligence; Benzene; Neoplasm Recurrence, Local; Estrogens; Phenols; Phenol; Ethanol; Amines
PubMed: 36450809
DOI: 10.1038/s41598-022-24889-w -
Journal of Nuclear Medicine : Official... Mar 2015We report the design, testing, and in vivo application of pH-sensitive contrast agents designed specifically for Cerenkov imaging. Radioisotopes used for PET emit...
UNLABELLED
We report the design, testing, and in vivo application of pH-sensitive contrast agents designed specifically for Cerenkov imaging. Radioisotopes used for PET emit photons via Cerenkov radiation. The multispectral emission of Cerenkov radiation allows for selective bandwidth quenching, in which a band of photons is quenched by absorption by a functional dye. Under acidic conditions, (18)F-labeled derivatives emit the full spectrum of Cerenkov light. Under basic conditions, the dyes change color and a wavelength-dependent quenching of Cerenkov emission is observed.
METHODS
Mono- and di-(18)F-labeled derivatives of phenolsulfonphthalein (phenol red) and meta-cresolsulfonphthalein (cresol purple) were synthesized by electrophilic fluorination. Cerenkov emission was measured at different wavelengths as a function of pH in vitro. Intramolecular response was measured in fluorinated probes and intermolecular quenching by mixing phenolphthalein with (18)F-FDG. Monofluorocresol purple (MFCP) was tested in mice treated with acetazolamide to cause urinary alkalinization, and Cerenkov images were compared with PET images.
RESULTS
Fluorinated pH indicators were produced with radiochemical yields of 4%-11% at greater than 90% purity. Selective Cerenkov quenching was observed intramolecularly with difluorophenol red or monofluorocresol purple and intermolecularly in phenolphthalein (18)F-FDG mixtures. The probes were selectively quenched in the bandwidth closest to the indicator's absorption maximum (λmax) at pHs above the indicator pKa (the negative logarithm of the acid dissociation constant). Addition of acid or base to the probes resulted in reversible switching from unquenched to quenched emission. In vivo, the bladders of acetazolamide-treated mice exhibited a wavelength-dependent quenching in Cerenkov emission, with the greatest reduction occurring near the λmax. Ratiometric imaging at 2 wavelengths showed significant decreases in Cerenkov emission at basic pH and allowed the estimation of absolute pH in vivo.
CONCLUSION
We have created contrast agents that selectively quench photons emitted during Cerenkov radiation within a given bandwidth. In the presence of a functional dye, such as a pH indicator, this selective quenching allows for a functional determination of pH in vitro and in vivo. This method can be used to obtain functional information from radiolabeled probes using multimodal imaging. This approach allows for the imaging of nonfluorescent chromophores and is generalizable to any functional dye that absorbs at suitable wavelengths.
Topics: Acetazolamide; Animals; Contrast Media; Disease Models, Animal; Fluorine Radioisotopes; Fluorodeoxyglucose F18; Hydrogen-Ion Concentration; Mice; Models, Chemical; Multimodal Imaging; Optics and Photonics; Phenolphthalein; Phenolsulfonphthalein; Photons; Positron-Emission Tomography; Radioisotopes; Radiopharmaceuticals
PubMed: 25655631
DOI: 10.2967/jnumed.114.146605 -
Frontiers in Microbiology 2022The aim of this study was to investigate the effects of subsp VHProbi YB11 (YB11) on attenuating sucralfate-induced constipation in BALB/c mice. The strain of YB11...
INTRODUCTION
The aim of this study was to investigate the effects of subsp VHProbi YB11 (YB11) on attenuating sucralfate-induced constipation in BALB/c mice. The strain of YB11 exhibited favorable tolerance of simulated gastrointestinal (GI) juice. Only 0.42 Log value declined when the live cells of YB11 were co-incubated with simulated GI juice. Meanwhile, this strain also displayed perfect ability to adhere the intestinal epithelium Caco-2 cells with adhesion index of 18.5. 24 of female mice were randomized into four groups.
METHODS
The normal group (NOR) was fed with a normal diet, whereas the placebo group (PLA), positive group (POS), and probiotic group (PRO) were fed with sucralfate to induce constipation. After first successfully establishing the constipation model, groups NOR and PLA received the oral administration of saline solutions. Meanwhile, the POS and PRO groups were orally administered phenolphthalein and YB11 suspensions, respectively. Several indices, including fecal water content, GI transit time, short-chain fatty acids (SCFAs), intestinal neuropeptides level, and histopathology of colonic tissues, were investigated.
RESULTS AND DISCUSSION
Compared with PLA, YB11 had a positive effect in increasing the fecal water content and intestinal peristalsis. Some positive trends, including the acetic and total acids level of fecal samples, and the colonic tissue histopathology, were also observed. Furthermore, YB11 had an ability to upregulate the levels of gut excitatory neuropeptides including motilin, gastrin, and substance P, whereas it downregulated the levels of inhibitory neuropeptides including endothelin-1, somatostatin, and vasoactive intestinal peptide. We conclude that the strain YB11 has a positive impact on improving gastrointestinal mobility and reducing the severity of constipation.
PubMed: 36532450
DOI: 10.3389/fmicb.2022.1040371