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Pharmeuropa Bio & Scientific Notes 2024The level of anti-D antibodies in human immunoglobulin products for intravenous administration (IVIG) is controlled by the direct haemagglutination method prescribed by...
Determination of procoagulant activity in human normal immunoglobulin preparations for therapeutic use by FXIa chromogenic assay: Evaluation of test kit sensitivity, reference standard performance and product formulation effects on the FXIa assay.
The level of anti-D antibodies in human immunoglobulin products for intravenous administration (IVIG) is controlled by the direct haemagglutination method prescribed by the European Pharmacopoeia (Ph. Eur.) that requires 2 control reference reagents. The World Health Organization (WHO) positive control International Reference Reagent (IRR; 02/228) with a nominal titre of 8 defines the highest acceptable titre, while the negative control preparation (02/226) has a nominal titre of <2. Working reference preparations (04/132 and 04/140) were subsequently established as Biological Reference Preparations (BRPs) for the Ph. Eur., and for distribution by the United States Food and Drug Administration (US FDA) and the National Institute for Biological Standards and Control (NIBSC). Due to diminishing stocks of these working reference preparations across the 3 institutions, a joint international study was organised to establish harmonised replacement batches. Sixteen laboratories contributed data to the study to evaluate positive and negative candidate replacement batches (13/148 and 12/300, respectively) against the WHO positive and negative control IRRs and the current working reference preparations (BRPs). The results show that the candidate reference preparations (13/148 and 12/300) are indistinguishable from the corresponding IRRs and current BRPs. The candidate preparations 13/148 and 12/300 were adopted by the Ph. Eur. Commission as Immunoglobulin (anti-D antibodies test) BRP batch 2 and Immunoglobulin (anti-D antibodies test negative control) BRP batch 2 with nominal haemagglutination titres of 8 and <2, respectively. The same materials were also adopted as NIBSC and US FDA reference preparations, thus ensuring full harmonisation.
Topics: Humans; Reference Standards; Immunoglobulins, Intravenous; Rho(D) Immune Globulin; Chemistry, Pharmaceutical
PubMed: 38949845
DOI: No ID Found -
Drug Safety Jun 2024Seasonal influenza is prevented through annual vaccination, especially in children and older adults. These vaccines are annually updated based on World Health...
BACKGROUND
Seasonal influenza is prevented through annual vaccination, especially in children and older adults. These vaccines are annually updated based on World Health Organization recommendations and require continuous safety monitoring.
OBJECTIVE
We assessed the frequency and severity of adverse events within 7 days of administering GSK's inactivated quadrivalent seasonal influenza vaccine (IIV4) in Belgium, Germany, and Spain during the 2022/2023 influenza season.
METHODS
In this enhanced safety surveillance study, adults who received GSK's IIV4 and parents/guardians/legally acceptable representatives of vaccinated children (aged 6 months-17 years) were invited to complete adverse drug reaction cards reporting adverse events within 7 days post-vaccination.
RESULTS
In total, 1332 participants (53.6% female) received at least one dose of GSK's IIV4, including 43 children who received two doses. Overall, 97.8% of adverse drug reaction cards were completed and returned in the study. All participants in Belgium were adults, while 54.7% and 7.4% in Spain and Germany, respectively, were pediatric participants aged 6 months-17 years. After Dose 1, across all age groups, 49.8% of participants reported at least one adverse event. The most common adverse events (cumulative frequency >5%) following Dose 1 were injection-site pain (37.6%), fatigue (15.0%), headache (13.2%), injection-site swelling (9.3%), myalgia (7.6%), and injection-site erythema (7.4%). Across all countries, adverse events were most common in adults aged 18-65 years (59.7%), followed by those aged 3-17 years (47.0%), >65 years (35.7%), and 6-35 months (23.5%). After Dose 2, 18.6% of participants reported at least one adverse event, with general disorders and administration site conditions again being the most frequent.
CONCLUSIONS
Across all age and risk groups for serious disease, no serious adverse events related to GSK's IIV4 were reported within 7 days post-vaccination. This study supports and confirms the acceptable safety profile of GSK's IIV4 across all recommended age groups.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov number: not applicable.
PubMed: 38949714
DOI: 10.1007/s40264-024-01456-y -
Critical Care Medicine Jul 2024In sepsis treatment, antibiotics are crucial, but overuse risks development of antibiotic resistance. Recent guidelines recommended the use of procalcitonin to guide...
Benefits and Harms of Procalcitonin- or C-Reactive Protein-Guided Antimicrobial Discontinuation in Critically Ill Adults With Sepsis: A Systematic Review and Network Meta-Analysis.
OBJECTIVES
In sepsis treatment, antibiotics are crucial, but overuse risks development of antibiotic resistance. Recent guidelines recommended the use of procalcitonin to guide antibiotic cessation, but solid evidence is insufficient. Recently, concerns were raised that this strategy would increase recurrence. Additionally, optimal protocol or difference from the commonly used C-reactive protein (CRP) are uncertain. We aimed to compare the effectiveness and safety of procalcitonin- or CRP-guided antibiotic cessation strategies with standard of care in sepsis.
DATA SOURCES
A systematic search of PubMed, Embase, CENTRAL, Igaku Chuo Zasshi, ClinicalTrials.gov, and World Health Organization International Clinical Trials Platform.
STUDY SELECTION
Randomized controlled trials involving adults with sepsis in intensive care.
DATA EXTRACTION
A systematic review with network meta-analyses was performed. The Grading of Recommendations, Assessments, Developments, and Evaluation method was used to assess certainty.
DATA SYNTHESIS
Eighteen studies involving 5023 participants were included. Procalcitonin-guided and CRP-guided strategies shortened antibiotic treatment (-1.89 days [95% CI, -2.30 to -1.47], -2.56 days [95% CI, -4.21 to -0.91]) with low- to moderate-certainty evidence. In procalcitonin-guided strategies, this benefit was consistent even in subsets with shorter baseline antimicrobial duration (7-10 d) or in Sepsis-3, and more pronounced in procalcitonin cutoff of "0.5 μg/L and 80% reduction." No benefit was observed when monitoring frequency was less than half of the initial 10 days. Procalcitonin-guided strategies lowered mortality (-27 per 1000 participants [95% CI, -45 to -7]) and this was pronounced in Sepsis-3, but CRP-guided strategies led to no difference in mortality. Recurrence did not increase significantly with either strategy (very low to low certainty).
CONCLUSIONS
In sepsis, procalcitonin- or CRP-guided antibiotic discontinuation strategies may be beneficial and safe. In particular, the usefulness of procalcitonin guidance for current Sepsis-3, where antimicrobials are used for more than 7 days, was supported. Well-designed studies are needed focusing on monitoring protocol and recurrence.
PubMed: 38949476
DOI: 10.1097/CCM.0000000000006366 -
The South African Journal of... Jun 2024Young adults are exposed to high noise levels in leisure venues, which increases their risk of hearing loss, and can affect their quality of life.
BACKGROUND
Young adults are exposed to high noise levels in leisure venues, which increases their risk of hearing loss, and can affect their quality of life.
OBJECTIVES
The aim of this study was to describe the young adults' awareness, attitudes and perceptions towards leisure noise at a university in South Africa.
METHOD
A descriptive cross-sectional study design with quantitative methods of data was considered for this study. Students from first to fourth years in the Education Department of a local university in Durban, South Africa, who were aged 18 years old - 25 years old were invited to participate in an online survey.
RESULTS
Of the 462 participants, most had a general awareness on noise and hearing loss but lacked knowledge on the negative effect of loud noise, with 95.2% using personal listening devices, followed by visiting restaurants and gyms, and 48.3% being unsure if noise can damage hearing permanently. They were unaware of methods to reduce their exposure to noise. A significant relationship between awareness of noise and attitudes (p = 0.029) indicated that the higher the level of awareness regarding leisure noise, the better their attitude and behaviour, thus the lower the risk of hearing loss.
CONCLUSION
The results highlight the need for implementing the World Health Organization (WHO) noise regulations and providing education for this age group to prevent irreversible hearing loss through exposure to leisure noise.Contribution: A national study is recommended to increase research evidence.
Topics: Humans; South Africa; Male; Female; Cross-Sectional Studies; Young Adult; Leisure Activities; Noise; Adult; Hearing Loss, Noise-Induced; Adolescent; Health Knowledge, Attitudes, Practice; Students; Awareness; Surveys and Questionnaires; Universities
PubMed: 38949431
DOI: 10.4102/sajcd.v71i1.1040 -
International Maritime Health 2024The World Health Organization (WHO) reported an estimated 249 million malaria cases globally in 2023, of which 94% were reported from Africa. Tanzania, a Sub-Saharan...
BACKGROUND
The World Health Organization (WHO) reported an estimated 249 million malaria cases globally in 2023, of which 94% were reported from Africa. Tanzania, a Sub-Saharan African country, has an exceptionally high malaria prevalence (3.6 million in 2023). The aim of the present study was to assess malaria prevalence rates in the Arusha Region, northern Tanzania. This region is famous for its national parks and wildlife reserves, and it is visited by thousands of tourists from all over the world each year. The assessment of malaria prevalence in the region is important in the context of the necessity to administer antimalarial chemoprophylaxis to international travellers.
MATERIAL AND METHODS
The study group consisted of 101 people, residents of the Karatu District in the Arusha Region, aged between 1 and 73 years, who volunteered to participate in the screening. Phase I of the study was conducted in July 2022 in the Karatu Lutheran Hospital in Karatu Town (located close to the Ngorongoro Conservation Area and the Serengeti National Park). During this phase a venous blood sample was collected from each patient. The samples were tested for malaria using a rapid diagnostic test (mRDT); the same samples were also used to measure haemoglobin concentration and next they were applied onto the Whatman FTA micro cards for further molecular diagnostics in Poland (phase II).
RESULTS
mRDT detected two (2.0%) infections caused by Plasmodium (the etiological factor of malaria), the molecular tests (RT-PCR) confirmed the two positive results by mRDT but also detected infections in six other samples (7.9% in total). The study found that six patients were infected with the Plasmodium falciparum species, while two other subjects had co-infections (P. falciparum + P. ovale, P. falciparum + P. vivax + P. malariae).
CONCLUSIONS
The study findings confirm the prevalence of malaria in areas located close to national parks in northern Tanzania and support the use of antimalarial chemoprophylaxis in international travellers visiting the area. The present study found co-infections caused by four different species of Plasmodium species which supports the prevalence of different parasitic species in Sub-Saharan Africa and is in line with CDC reports but contrary to WHO reports which estimate that 100% of malaria cases in Sub-Saharan Africa are caused by P. falciparum.
Topics: Humans; Tanzania; Prevalence; Adult; Middle Aged; Adolescent; Male; Female; Child; Aged; Young Adult; Child, Preschool; Malaria; Infant; Antimalarials
PubMed: 38949218
DOI: 10.5603/imh.100440 -
BioRxiv : the Preprint Server For... Jun 2024The World Health Organization identified vitamin A deficiency (VAD) as a major public health issue in low-income communities and developing countries, while additional...
The World Health Organization identified vitamin A deficiency (VAD) as a major public health issue in low-income communities and developing countries, while additional studies have shown dietary VAD leads to various lung pathologies. Once believed to be sterile, research now shows that transient microbial communities exist within healthy lungs and are often dysregulated in patients suffering from malnourishment, respiratory infections, and disease. The inability to parse vitamin A-mediated mechanisms from other metabolic mechanisms in humans with pathogenic endotypes, as well as the lack of data investigating how VAD affects the lung microbiome, remains a significant gap in the field. To address this unmet need, we compared molecular, metatranscriptomic, and morphometric data to identify how dietary VAD affects the lung as well as the lung microbiome. Our research shows structural and functional alterations in host-microbe-diet interactions in VAD lungs compared to vitamin A-sufficient (VAS) lungs; these changes are associated with epithelial remodeling, a breakdown in mucociliary clearance, microbial imbalance, and altered microbial colonization patterns after 8 weeks of vitamin A deficient diet. These findings confirm vitamin A is critical for lung homeostasis and provide mechanistic insights that could be valuable for the prevention of respiratory infections and disease.
PubMed: 38948802
DOI: 10.1101/2024.06.21.600110 -
Turkish Journal of Physical Medicine... Jun 2024The study aimed to determine the rates of adherence to phase 2 components of complex decongestive therapy (CDT) and related factors among patients with postmastectomy...
OBJECTIVES
The study aimed to determine the rates of adherence to phase 2 components of complex decongestive therapy (CDT) and related factors among patients with postmastectomy lymphedema.
PATIENTS AND METHODS
This cross-sectional study included 90 female patients (mean age: 54.4±8.0 years; range, 24 to 65 years) with unilateral postmastectomy lymphedema who completed chemotherapy or radiotherapy and had previously undergone CDT phase 1 at our clinic or elsewhere between May 2018 and May 2019. Patients were included in the study at their usual visit to the lymphedema polyclinic. After physical examination, study questionnaires that involved patients' demographic and clinic data and Lymphedema Quality of Life scores were recorded. Patients who applied CDT phase 2 methods four days a week or more frequently were considered adherent, while those who applied these methods less frequently or who never applied these methods were considered nonadherent. The body mass index (BMI) scores were classified based on the criteria of the World Health Organization.
RESULTS
Lymphedema stages of the patients were Stage I in 33.3% (n=30), Stage II in 60% (n=54), and Stage III in 6.7% (n=6). The rates of adherence were 74.4% (n=67) for skin care, 46.6% (n=42) for compression garment use, 42.2% (n=38) for self-massage, 42.2% (n=38) for exercise, and 18.8% (n=17) for multilayer bandaging. The rate of adherence to the multilayer bandaging method was found to be significantly higher in the obese group (BMI >30) than in the other BMI groups.
CONCLUSION
Patient adherence to CDT phase 2 was not sufficient except for the skin care component. There was a significant relationship between BMI and adherence to multilayer bandaging.
PubMed: 38948639
DOI: 10.5606/tftrd.2024.12178 -
Journal of Family Medicine and Primary... May 2024With the ageing of Indian society, providing a healthy life among older people is a public health precedence. Therefore, beforehand discovery and possible forestalment...
CONTEXT
With the ageing of Indian society, providing a healthy life among older people is a public health precedence. Therefore, beforehand discovery and possible forestalment of frailty may help promote healthy ageing and dwindle the social, mental and financial burden of their families and caregivers.
AIMS
The study aimed to assess the proportion of frailty and its associated factors among the elderly aged 65 years and above in a rural community of West Bengal.
SETTINGS AND DESIGN
A community-based cross-sectional study was conducted among 270 elderlies selected from 15 villages out of a total 64 villages of Singur under the Hooghly District of West Bengal from January 2019 to February 2020.
MATERIALS AND METHODS
Cluster sampling technique was used. Data was collected using a pre-designed, pre-tested structured schedule including Fried frailty phenotype (FFP), geriatric depression scale short form (GDS 15) and mini nutritional assessment (MNA) tool.
STATISTICAL ANALYSIS USED
Associated factors of frailty were assessed by univariate and multivariable logistic regression using SPSS version 16 software and MS Excel 2019.
RESULTS
The proportion of frailty was observed to be 23.7% and that of prefrailty 40.7%. Frailty was significantly associated with increasing age [AOR(CI) 1.2(1.1-1.3)], decreasing years of schooling [AOR(CI) 1.3(1.1-1.5)], loss of spouse [AOR(CI) 4.2(1.2-15.2)], financial dependency [AOR(CI) 19.3(2.7-139.0)], staying at home [AOR(CI) 16.3(2.7-98.2)], presence of anaemia [AOR(CI) 3.6(1.3-9.5)], at risk of malnutrition [AOR(CI) 6.5(1.9-22.3)], increasing number of falls in the last 1 year [AOR(CI) 4.3(1.2-15.6)], presence of 3 or more chronic diseases [AOR(CI) 154.7(12.1-1981.9)] and depression [AOR(CI) 8.3(2.5-27.0)].
CONCLUSION
The burden of frailty among the study population is relatively high. It's an intimidating situation that needs bettered screening provisions for early discovery with special stress on nutritive upliftment. Screening for depression should also be done regularly.
PubMed: 38948626
DOI: 10.4103/jfmpc.jfmpc_1572_23 -
Journal of Family Medicine and Primary... May 2024Following the World Health Organization statement 'Health for all', family medicine is a specialty that provides continuing, comprehensive healthcare to individuals and...
BACKGROUND
Following the World Health Organization statement 'Health for all', family medicine is a specialty that provides continuing, comprehensive healthcare to individuals and their families. Despite that, it is still not yet utilized to its full potential by the developing Middle-Eastern community. The aim of our study is to assess the perception and utilization of family medicine services among Abu Dhabi Island's community.
METHODS
A cross-sectional study was conducted targeting Abu Dhabi Island's community. A representative sample with 95% confidence level and 5% margin of error was calculated taking into consideration the latest report by the Abu Dhabi Statistics Center. A total of 395 adult participants were included in the study, who were asked to fill in an electronic-based validated questionnaire. SPSS software was then used for data analysis.
RESULTS
Majority of participants were UAE nationals (81%) and married (71.1%), with almost equal male (50.4%) to female ratio (49.6%). Participants had positive experiences in primary healthcare (PHC) overall, regardless of their gender, nationality and marital status. Positive experience percentages dropped with higher age and educational level (-value <0.05). A better understanding was noticed among ≥50 years of age with the rightful destination for emergency symptoms (-value <0.05). Participants overall agreed on PHC being the preferred allocation for treatment of fever, body aches and sore throat.
CONCLUSION
Primary healthcare centres were chosen as preferred destinations for emergency and non-emergency cases, as the vast majority had positive experiences when attending them.
PubMed: 38948625
DOI: 10.4103/jfmpc.jfmpc_1736_23 -
Journal of Family Medicine and Primary... May 2024The emergence of the coronavirus in 2019 became a global epidemic disease. According to the World Health Organization, people with a history of chronic diseases such as...
INTRODUCTION
The emergence of the coronavirus in 2019 became a global epidemic disease. According to the World Health Organization, people with a history of chronic diseases such as brain stroke are among the main groups at risk of contracting COVID-19. Therefore, this study was performed with the aim of the determination amount of the frequency of contracting COVID-19 in stroke patients.
MATERIALS AND METHODS
This descriptive-analytical study was conducted on 100 patients with a history of stroke referred to Imam Hossein Hospital in Tehran (Iran) between 2019 and 2022, which had all the inclusion criteria in the study. The demographic information including (gender, weight, height) and clinical information was collected by a researcher-made questionnaire and analyzed by SPSS version 24 software.
RESULTS
The average age of the studied patients was 63 years. Among them, 53 people (53%) were infected with COVID-19. The most of underlying diseases were related to high blood pressure. All cases of stroke in patients with COVID-19 were associated with thrombotic type, and half of the other cases included involvement in large cerebral vessels. Lymphocyte count, CRP, and ESR levels were relatively higher in stroke patients with COVID-19, but there were observed no cases of pleural effusion and pericardial effusion associated with COVID-19 in stroke patients. In all of the patients with COVID-19, pulmonary involvement was observed in the Peripheral/Perihillar area.
DISCUSSION AND CONCLUSION
According to the results and data of this research, the probability of infecting COVID-19 is higher in people with a history of stroke, and these patients have more severe strokes and more mortality than stroke patients without contracting COVID-19.
PubMed: 38948623
DOI: 10.4103/jfmpc.jfmpc_1596_23