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Clinical Biochemistry Sep 2019Replacements are required for the WHO International Standards (IS) for free PSA, coded 96/668 and total PSA (90:10), coded 96/670, which were established in 1999 to...
OBJECTIVES
Replacements are required for the WHO International Standards (IS) for free PSA, coded 96/668 and total PSA (90:10), coded 96/670, which were established in 1999 to support efforts to harmonise PSA assays and address non-equimolarity. An important consideration is that the introduction of the replacements should have minimal impact on PSA measurements.
DESIGN AND METHODS
We report the development of a replacement strategy, informed by field assessment of preparations through an external quality assessment scheme and the subsequent evaluation of the candidate ISs in worldwide collaborative studies.
RESULTS
By immunoassay, data from participants confirmed the value assigned to the current standards. Robust geometric mean estimates of the free PSA content of the candidate replacement for 96/668 coded 17/102 was 0.533 μg/ampoule (n = 21). The ratio of the content estimates of 17/102:96/668 was 0.516 (GCV 12.5%, n = 21). Robust geometric mean estimates of the total PSA content of the candidate replacement for 96/670, coded 17/100, was 0.505 μg/ampoule (n = 22). The ratio of the content estimates of 17/100:96/670 was 0.490 (GCV 5.3%, n = 22). Through concomitant measurement of a panel of 15 representative patient samples, the candidate ISs were shown to exhibit commutability with patient samples that was comparable with that of the current ISs.
CONCLUSION
On the basis of these results, the preparations coded 17/102 and 17/100 were established by the WHO Expert Committee on Biological Standardization as the 2nd ISs for free and total PSA (PSA-ACT+free PSA) respectively, with assigned contents of 0.53 μg/ampoule and 0.50 μg/ampoule.
Topics: Humans; Prostate-Specific Antigen; Reference Standards; World Health Organization
PubMed: 31295477
DOI: 10.1016/j.clinbiochem.2019.07.007 -
International Journal of Environmental... Sep 2022Sharp injuries are a serious issue among healthcare workers (HCWs). The aim of the study was to examine the frequency of sharps injuries among nurses (who have the most...
Sharp injuries are a serious issue among healthcare workers (HCWs). The aim of the study was to examine the frequency of sharps injuries among nurses (who have the most frequent contact with infectious material) when using devices with and without safety features, then to analyse the factors associated with such injuries and to compare the risk of injuries with safety engineered devices (SEDs) and non-safety engineered devices (non-SEDs). An online cross-sectional survey was completed between October 2021 and March 2022 by 280 nurses. The incidence of exposure to sharp injury during their professional life was 51.4%. The percentage of nurses experiencing a sharp injury in the year preceding the study was 29% and 9.6% for superficially and deep injury, respectively. Ampoules and conventional hollow-bore needles caused the most injuries (25.92% and 22.64% of nurses in the last year). Factors including sex (males), age and seniority (elderly), education (higher), work exhaustion and being left-handed were associated with the occurrence of conventional hollow-bore needle injuries. In the case of SEDs: age, seniority and right/left-handed were the most frequent risk factors associated with the occurrence of sharp injuries. SEDs injuries were much less frequent than non-SEDs. There was a significant difference between the risk of injuries with safety and non-safety needles, central cannulas and ampoules. Fisher's exact test (-value = 0.000) and positive Spearman's rho statistics (0.2319, -value = 0.0001) confirmed that in accredited hospitals, the availability of safety needles was higher. Almost half of the nurses ( = 115, 41.07%) stated that staff had little influence on the type of medical sharp instruments supplied. To reduce the risk of nurse injuries, access to medical devices with safe protection mechanisms should be ensured, the use of sharp instruments should be limited where possible, managers should consult nurses regarding the choice of safe devices, and training programs on the proper use of SEDs should be available.
Topics: Aged; Cross-Sectional Studies; Disease Susceptibility; Health Personnel; Humans; Male; Needlestick Injuries; Poland; Protective Devices
PubMed: 36141587
DOI: 10.3390/ijerph191811315 -
Antioxidants (Basel, Switzerland) May 2021This study investigated the effects of an aronia juice-based food supplement on background and total DNA strand breaks in whole blood, and on HO-induced DNA strand...
BACKGROUND
This study investigated the effects of an aronia juice-based food supplement on background and total DNA strand breaks in whole blood, and on HO-induced DNA strand breaks in isolated peripheral blood lymphocytes.
METHODS
Ninety-one healthy volunteers were randomly selected to consume either the food supplement (2 × 25 mL drinking ampules, = 45) or no supplement ( = 46) daily for eight weeks.
RESULTS
Background DNA strand breaks decreased significantly after four and eight weeks of supplement consumption, compared to baseline ( < 0.05), but the overall effect was low, and neither group showed a decrease in total DNA strand breaks. Conversely, supplement consumption clearly reduced HO-induced DNA strand breaks ex vivo ( < 0.001), with statistically significant reductions after four and eight weeks, compared to the control group ( < 0.05).
CONCLUSIONS
Thus, although consuming antioxidant supplements might produce only marginal immediate benefits under healthy conditions, potential preventive effects warrant further investigation.
PubMed: 34071817
DOI: 10.3390/antiox10060857 -
Archives of Plastic Surgery Nov 2017Polydeoxyribonucleotide (PDRN) is known to have anti-inflammatory and angiogenic effects and to accelerate wound healing. The aim of this study was to investigate...
BACKGROUND
Polydeoxyribonucleotide (PDRN) is known to have anti-inflammatory and angiogenic effects and to accelerate wound healing. The aim of this study was to investigate whether PDRN could improve peripheral tissue oxygenation and angiogenesis in diabetic foot ulcers.
METHODS
This was a prospective randomized controlled clinical trial. Twenty patients with a non-healing diabetic foot ulcer were randomly distributed into a control group (n=10) and a PDRN group (n=10). Initial surgical debridement and secondary surgical procedures such as a split-thickness skin graft, primary closure, or local flap were performed. Between the initial surgical debridement and secondary surgical procedures, 0.9% normal saline (3 mL) or PDRN was injected for 2 weeks by the intramuscular (1 ampule, 3 mL, 5.625 mg, 5 days per week) and perilesional routes (1 ampule, 3 mL, 5.625 mg, 2 days per week). Transcutaneous oxygen tension (TcPO) was evaluated using the Periflux System 5000 with TcPO/CO unit 5040 before the injections and on days 1, 3, 7, 14, and 28 after the start of the injections. A pathologic review (hematoxylin and eosin stain) of the debrided specimens was conducted by a pathologist, and vessel density (average number of vessels per visual field) was calculated.
RESULTS
Compared with the control group, the PDRN-treated group showed improvements in peripheral tissue oxygenation on day 7 (P<0.01), day 14 (P<0.001), and day 28 (P<0.001). The pathologic review of the specimens from the PDRN group showed increased angiogenesis and improved inflammation compared with the control group. No statistically significant difference was found between the control group and the PDRN group in terms of vessel density (P=0.094). Complete healing was achieved in every patient.
CONCLUSIONS
In this study, PDRN improved peripheral tissue oxygenation. Moreover, PDRN is thought to be effective in improving inflammation and angiogenesis in diabetic foot ulcers.
PubMed: 29076318
DOI: 10.5999/aps.2017.00801 -
Anesthesia, Essays and Researches 2017Anesthetic drugs and material wastage are common in operation rooms (ORs). In this era of escalating health-care expenditure, cost reduction strategies are highly...
BACKGROUND AND OBJECTIVES
Anesthetic drugs and material wastage are common in operation rooms (ORs). In this era of escalating health-care expenditure, cost reduction strategies are highly relevant. The aim of this study was to assess the amount of daily intravenous anesthetic drug wastage from major ORs and to estimate its financial burden. Any preventive measures to minimize drug wastage are also looked for.
METHODS
It was a prospective study conducted at the major ORs of a tertiary care hospital after getting the Institutional Research Committee approval. The total amount of all drugs wasted at the end of a surgical day from each major OR was audited for five nonconsecutive weeks. Drug wasted includes the drugs leftover in the syringes unutilized and opened vials/ampoules. The total cost of the wasted drugs and average daily loss were estimated.
RESULTS
The drugs wasted in large quantities included propofol, thiopentone sodium, vecuronium, mephentermine, lignocaine, midazolam, atropine, succinylcholine, and atracurium in that order. The total cost of the wasted drugs during the study period was Rs. 59,631.49, and the average daily loss was Rs. 1987.67. The average daily cost of wasted drug was maximum for vecuronium (Rs. 699.93) followed by propofol (Rs. 662.26).
INTERPRETATION AND CONCLUSIONS
Financial implications of anesthetic drug wastage can be significant. Propofol and vecuronium contributed maximum to the financial burden. Suggestions for preventive measures to minimize the wastage include education of staff and residents about the cost of drugs, emphasizing on the judicial use of costly drugs.
PubMed: 28663611
DOI: 10.4103/0259-1162.186596 -
Cureus Jan 2020Human factors and systems factors can affect surgical performance, including the operating room (OR) environment, teamwork and communication, technology and equipment,...
Human factors and systems factors can affect surgical performance, including the operating room (OR) environment, teamwork and communication, technology and equipment, tasks and workload factors, and organizational variables. Patient safety is a new healthcare discipline that emphasizes the reporting, analysis, and prevention of medical errors that often lead to adverse healthcare events. We are highlighting a potential error and hazardous situation, which may occur due to the difficulty in reading the embossed letters of some ampoules because of the typeface of these ampoules. This problem is particularly important in the ORs, which require special sterile conditions. We are adding a simple step to help in the differentiation between plastic, embossed ampoules. This simple and easy-to-do step makes it possible for accurate and correct identification, without jeopardizing the safety of the patients and health care professionals.
PubMed: 31929959
DOI: 10.7759/cureus.6592 -
European Journal of Pharmaceutical... Aug 2022'Aseptic handling is the procedure to enable sterile products to be made ready to administer using closed systems' (EU Resolution CM/Res(2016)2). Microbiological...
INTRODUCTION
'Aseptic handling is the procedure to enable sterile products to be made ready to administer using closed systems' (EU Resolution CM/Res(2016)2). Microbiological controls are an important part of the overall assurance of process and product quality of aseptic handling. They consist of the End-of-Session Broth Test (ESBT) using Tryptone Soya Broth, Microbiological Monitoring (MM) using Ø 55- and 90-mm agar plates and a periodical Operator Broth Transfer Validation Test (OBTVT) using Tryptone Soya Broth. This study describes the results of these controls over a 7-year period, involving between 44 and 49 pharmacies (mostly hospital pharmacies). All pharmacies use a web-based programme for processing, evaluation and assessing microbiological controls ('Microbio'). Aggregated results in Microbio are used for benchmarking and feedback information.
OBJECTIVE
The objective of this study is to analyse the results of the 7-year period and to develop methods for assessing of, and determining realistic limits for, microbiological controls during aseptic handling. As secondary objective the role of Microbio is highlighted.
RESULTS AND DISCUSSION
Results of ESBT are expressed as Contamination Rate (CR), which is the percentage of units filled in a process simulation that are positive for microbial growth after incubation. Compared with the first 3 years of the study, the results in the last 4 years were significantly better: mean CRs are 0.20 and 0.11, respectively (p-value <0.01). For assessing CRs of ESBT, the approach 'the more frequent samples with growth, the stronger the corrective actions' was adopted. Levels of investigative and corrective actions, based on the 95% Upper Confidence Limit, are suggested. Microbiological Monitoring (MM) during aseptic handling into a laminar airflow cabinet or safety cabinet consists of settle plates, glove prints, contact plates of the worktop and surface bioburden determination of disinfected ampoules and vials. The results are expressed as the Contamination Recovery Rate (CRR), which is the rate at which MM samples contain any level of contamination. During the study period, the results of glove prints and contact plates improved substantially. The most probable explanation of this finding is improved disinfection procedures of the gloved hands, the worktop inside LAF/SC and the ampoules and vials. Results of settle plates did not change. There were too few results available to evaluate the surface bioburden of disinfected ampoules and vials. Benchmarking and feedback information from Microbio may have contributed to the improved ESBT and MM results. Results of the Operator Broth Transfer Validation Test (OBTVT) are expressed as Contamination Rate (CR). The target is zero samples with growth (CR = 0). The overall CR result over the study period is 0.50%. This is worse than ESBT (overall CR is 0.14%). This is probably due to the high number of critical steps in OBTVT compared to ESBT.
CONCLUSION
Results of microbiological controls improved during the study period. Realistic limits as well as methods for assessing ESBT and MM results are given and discussed.
Topics: Drug Contamination; Hospitals; Pharmacies
PubMed: 35640785
DOI: 10.1016/j.ejps.2022.106228 -
Journal of Cosmetic Dermatology Sep 2022Peptide-C ampoules (PC) contain peptides, 10% of vitamin C, hyaluronic acid, and Vichy volcanic mineralizing water. (Observational Study)
Observational Study
INTRODUCTION
Peptide-C ampoules (PC) contain peptides, 10% of vitamin C, hyaluronic acid, and Vichy volcanic mineralizing water.
AIMS
To assess the effectiveness and tolerability of PC.
PATIENTS AND METHODS
An observational study conducted in 9 countries in women ≥30 years old with signs of facial skin aging (grade >0 for forehead and/or crow's feet wrinkles and bothered by skin quality). Investigator assessments and subject questionnaires were performed at initial visit and Day 30 after application of PC twice daily for 28 days. Tolerance was assessed throughout the study.
RESULTS
Effectiveness and safety were analyzed in 1382 and 1742 subjects, respectively. Most subjects (mean age 48.5 ± 8.6 years) had skin phototype II or III (91.7%) and dry or combination skin (63.9%). PC was used as a standalone care or prior to a planned procedure (70%), or after a procedure (30%). Between baseline and Day 30, 63% and 64% of all subjects (N = 1360) had an improvement in forehead wrinkles and crow's feet wrinkles, respectively. Skin hydration improved in 67.3% of subjects. According to investigator and subject assessments, skin quality, skin radiance, skin aging signs, wrinkles, complexion, and skin pores significantly improved by Day 30. Similar results were observed for subgroup analyses when PC was used as standalone skin care or after a procedure. Tolerance of PC was rated as good to very good by 97.7% of subjects.
CONCLUSIONS
Peptide-C ampoules is effective in reducing visible signs of skin aging, and well tolerated, when used alone or as an adjunct to anti-aging procedures.
Topics: Adult; Ascorbic Acid; Female; Humans; Hyaluronic Acid; Middle Aged; Peptides; Skin Aging; Water
PubMed: 35064615
DOI: 10.1111/jocd.14733 -
Turkish Journal of Emergency Medicine 2020Succinylcholine is a short-acting depolarizing neuromuscular blocking agent. We describe a case where the above drug was employed for self-harm by a health-care worker....
Succinylcholine is a short-acting depolarizing neuromuscular blocking agent. We describe a case where the above drug was employed for self-harm by a health-care worker. The patient, a 28-year-old female, was brought to the emergency department (ED) in impending respiratory arrest and altered mental status. On arrival, she had hypoxia, bradycardia, and hypotension. Although the cause for rapid deterioration in this patient was unknown, the ED physician still went ahead by resuscitating the patient's airway, breathing, and circulation. During the course of resuscitation, information was received that an empty ampoule of succinylcholine was recovered from her bathroom. Further clinical examination and laboratory investigations led the treating physicians to suspect deliberate intravenous injection of succinylcholine. She was mechanically ventilated and monitored in the critical care unit. Targeted temperature management was initiated in the ED and was continued for 24 h. The patient was discharged from the hospital without any neurological deficits after 4 days. Patients with acute poisoning are one of the major encounters in ED, and this case highlights the possibility of anesthetic drug misuse in any health-care workers coming to the ED with sudden cardiac arrest, altered sensorium, or abnormal vitals. This is the first report describing the survival of a patient following intentional succinylcholine injection for self-harm.
PubMed: 33089028
DOI: 10.4103/2452-2473.297468 -
Cureus Sep 2022Recurrent episodes of hypoglycemia are uncommon in non-diabetic patients. The workup investigation must confirm hypoglycemia and distinguish between endogenous versus...
Recurrent episodes of hypoglycemia are uncommon in non-diabetic patients. The workup investigation must confirm hypoglycemia and distinguish between endogenous versus exogenous hyperinsulinism. Simultaneous measurements of plasma glucose, insulin, C-peptide, and a screen for oral hypoglycemic agents should be performed. According to the results, further imaging studies may be necessary. A 43-year-old woman suffering from recurrent hypoglycemia presented to the emergency room (ER) with a hypoglycemic coma. She has had multiple episodes of documented hypoglycemia for the last 13 years. The case was initially investigated, and laboratory studies revealed endogenous hyperinsulinism. Screening for sulfonylureas, anti-insulin and anti-insulin receptor antibodies were negative. Body imaging and positron emission tomography (PET) with Ga-DOTANOC did not show evidence of an insulinoma. The patient was submitted to a pancreatectomy, which revealed nesidioblastosis in the histologic examination. Since then, the patient became hyperglycemic but the insulin doses were progressively reduced until new episodes of hypoglycemia recurred and the insulin was stopped. Again, inappropriately high levels of insulin were found at the time of hypoglycemic episodes. Computed tomography (CT) and PET scans did not find evidence of an insulinoma. A C-peptide was later found to be negative and insulin ampoules were found in her possession, making a diagnosis of a factitious disorder. Although rare, factious disorders are frequently overlooked and challenging to diagnose. Since they are very resource and time-consuming, self-inflicted illnesses should always be considered and ruled out beforehand.
PubMed: 36225520
DOI: 10.7759/cureus.28876