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Advanced Healthcare Materials Sep 2023Efforts aimed at exploring economical and efficient vaccination have taken center stage to combat frequent epidemics worldwide. Various vaccines have been developed for... (Review)
Review
Efforts aimed at exploring economical and efficient vaccination have taken center stage to combat frequent epidemics worldwide. Various vaccines have been developed for infectious diseases, among which nucleic acid vaccines have attracted much attention from researchers due to their design flexibility and wide application. However, the lack of an efficient delivery system considerably limits the clinical translation of nucleic acid vaccines. As mass vaccinations via syringes are limited by low patient compliance and high costs, microneedles (MNs), which can achieve painless, cost-effective, and efficient drug delivery, can provide an ideal vaccination strategy. The MNs can break through the stratum corneum barrier in the skin and deliver vaccines to the immune cell-rich epidermis and dermis. In addition, the feasibility of MN-mediated vaccination is demonstrated in both preclinical and clinical studies and has tremendous potential for the delivery of nucleic acid vaccines. In this work, the current status of research on MN vaccines is reviewed. Moreover, the improvements of MN-mediated nucleic acid vaccination are summarized and the challenges of its clinical translation in the future are discussed.
Topics: Humans; Immunization; Vaccination; Skin; Vaccines; Drug Delivery Systems; Nucleic Acid-Based Vaccines; Needles; Nucleic Acids; Administration, Cutaneous
PubMed: 37115817
DOI: 10.1002/adhm.202300339 -
Emerging Microbes & Infections Dec 2023Immunization during pregnancy (IP) against pertussis is recommended in many countries to protect infants. Although maternal antibodies can influence the infants'...
Immunization during pregnancy (IP) against pertussis is recommended in many countries to protect infants. Although maternal antibodies can influence the infants' antibody responses to primary vaccinations, their effect on the development of functional antibodies and B cells remain poorly studied. We investigated the maternal immune response to IP and the effect of IP and pre-existing antibodies on infants' primary vaccine responses in an open-label, non-randomized trial. Forty-seven mothers received tetanus-diphtheria-acellular pertussis (Tdap) vaccine during pregnancy, and 22 mothers were included as controls. Sixty-nine infants received primary doses of DTaP at three and five months of age. Geometric mean concentrations of antibodies to pertussis toxin, filamentous haemagglutinin, pertactin, diphtheria, and tetanus toxins, pertussis toxin neutralizing antibodies (PTNAs), and plasma and memory B-cell frequencies were studied at delivery, and at three, five and six months. Levels of antibodies, PTNAs, and frequencies of memory B-cells were significantly increased at delivery and up to six months after in mothers with IP compared to those without IP (all < 0.05, except for PT-specific memory B-cells). In vaccinated pregnant women, high pre-existing antibody levels were positively correlated with higher antibody responses after IP. IP blunted the infants' antibody and plasma B-cell responses to all vaccine antigens, except for tetanus toxin. This blunting effect was the strongest in infants with high concentrations of maternal antibodies. In conclusion, IP resulted in significantly higher concentrations of antibodies in infants up to three months of age (all < 0.05); but was associated with blunting of various infants' vaccine responses.
Topics: Humans; Infant; Female; Pregnancy; Diphtheria-Tetanus-acellular Pertussis Vaccines; Whooping Cough; Pertussis Toxin; Diphtheria; Antibodies, Bacterial; Vaccination; Immunization
PubMed: 37060181
DOI: 10.1080/22221751.2023.2204146 -
International Journal of Clinical... Jun 2024Although the clinical role of protein convertase subtilisin kexin type 9 (PCSK9) inhibitors for cholesterol management is increasing, the post-marketing period of use is... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
Although the clinical role of protein convertase subtilisin kexin type 9 (PCSK9) inhibitors for cholesterol management is increasing, the post-marketing period of use is short compared to other lipid-lowering drugs, so there is still insufficient evidence for their efficacy and safety. In this meta-analysis, we evaluated preventive effects of stroke and cardiovascular (CV) events using evolocumab and alirocumab.
MATERIALS AND METHODS
We assessed the relative risk of stroke and CV events after alirocumab or evolocumab treatment in individuals with or without clinical CV diseases compared with that in controls. In addition, we evaluated the relative risk of hemorrhagic stroke.
RESULTS
A total of 25 articles were included (median of study duration = 52 weeks). The risk of stroke was significantly decreased after treatment with alirocumab or evolocumab (primary prevention in patients without CV diseases: RR = 0.733; 95% CI, 0.618 - 0.870; secondary prevention in patients with CV diseases: RR = 0.703; 95% CI, 0.562 - 0.880). The risk of CV events also significantly decreased in patients treated with alirocumab or evolocumab (primary prevention: RR = 0.818; 95% CI, 0.777 - 0.861; secondary prevention: RR = 0.725; 95% CI, 0.578 - 0.910). The relative risk of hemorrhagic stroke was not significantly different between PCSK9 inhibitor-treated patients and controls (RR = 1.041; 95% CI, 0.690 - 1.573).
CONCLUSION
Our findings indicate that evolocumab and alirocumab are significantly effective without increasing the risk of hemorrhagic stroke. Based on this, the PCSK9 inhibitors can be highly recommended for cholesterol management.
Topics: Humans; Antibodies, Monoclonal, Humanized; Anticholesteremic Agents; Cardiovascular Diseases; PCSK9 Inhibitors; Primary Prevention; Proprotein Convertase 9; Randomized Controlled Trials as Topic; Secondary Prevention; Stroke; Treatment Outcome
PubMed: 38529927
DOI: 10.5414/CP204506 -
BMJ Open Dec 2023Atherosclerotic cardiovascular disease (ASCVD) was the main cause of death in Germany in 2021, with major risk factors (ie, hypertension, diabetes, dyslipidaemia,...
INTRODUCTION
Atherosclerotic cardiovascular disease (ASCVD) was the main cause of death in Germany in 2021, with major risk factors (ie, hypertension, diabetes, dyslipidaemia, obesity and certain lifestyle factors) being highly prevalent. Preventing ASCVD by assessment and modification of these risk factors is an important challenge for general practitioners. This study aims to systematically review and synthesise recent recommendations of national and international guidelines regarding the primary prevention of ASCVD in adults in primary care.
METHODS AND ANALYSIS
We will conduct a systematic review of clinical practice guidelines (CPGs) to evaluate primary prevention strategies for ASCVD. CPGs will be retrieved from MEDLINE and the Turning Research Into Practice database, guideline-specific databases and websites of guidelines-producing societies, with searches limited to publications from 2016 onwards. We will include CPGs in English, Spanish, German or Dutch languages that provide evidence-based recommendations for ASCVD prevention. The study population will include adults without diagnosed ASCVD. Two independent reviewers will assess guideline eligibility and quality by means of the mini-checklist MiChe, and extract study characteristics and relevant recommendations for further consistency analysis. A third reviewer will resolve disagreements. Findings will be presented as a narrative synthesis and in tabular form.
ETHICS AND DISSEMINATION
This review does not require ethical approval. Our systematic review will inform the CPG of the German College of General Practitioners and Family Physicians on the primary prevention of ASCVD. The review results will also be disseminated through publications in peer-reviewed journals and presentations at local, national and international conferences.
PROSPERO REGISTRATION NUMBER
CRD42023394605.
Topics: Humans; Cardiovascular Diseases; Delivery of Health Care; Risk Factors; Atherosclerosis; Primary Prevention; Primary Health Care; Systematic Reviews as Topic
PubMed: 38070923
DOI: 10.1136/bmjopen-2023-074788 -
Diabetes Care Dec 2023We examined guideline-directed statin intensity (GDSI) use and atherosclerotic cardiovascular disease (ASCVD) outcomes in patients with diabetes across a contemporary...
OBJECTIVE
We examined guideline-directed statin intensity (GDSI) use and atherosclerotic cardiovascular disease (ASCVD) outcomes in patients with diabetes across a contemporary health care system.
RESEARCH DESIGN AND METHODS
Patients without preexisting ASCVD were categorized by diabetes status and 10-year ASCVD risk (borderline [5-7.4%], intermediate [7.5-19.9%], high [≥20%]). Mean ±SD time to start of or change to GDSI was calculated. Incident ASCVD and all-cause mortality association, stratified by ASCVD risk, was calculated using Cox regression.
RESULTS
Among 282,298 patients, 28,807 (10.2%) had diabetes and 253,491 (89.8%) did not. Only two-thirds of intermediate- and high-risk patients with diabetes were receiving GDSI therapy at 5-year follow-up. In fully adjusted models, patients with diabetes not taking a statin (vs. GDSI) had a significantly higher risk of stroke and mortality in the intermediate- and high-risk groups (hazard ratio for mortality 1.81 [95% CI 1.58-2.07] vs. 1.41 [1.26-1.57]; P for interaction < 0.01).
CONCLUSIONS
Significant gaps remain in GDSI use for high-risk patients with diabetes, conferring an increased risk of ASCVD outcomes and all-cause mortality.
Topics: Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Cardiovascular Diseases; Diabetes Mellitus; Atherosclerosis; Primary Prevention; Risk Factors
PubMed: 37851356
DOI: 10.2337/dc23-0816 -
Trauma, Violence & Abuse Oct 2023Intimate partner violence (IPV) affects the health of women across the globe, with the greatest burden encountered by women in low- and middle-income countries (LMICs).... (Review)
Review
Intimate partner violence (IPV) affects the health of women across the globe, with the greatest burden encountered by women in low- and middle-income countries (LMICs). This scoping review aims to summarize and critically examine primary prevention interventions addressing IPV perpetration by men and boys in LMICs and identify gaps in the evidence base. PubMed, EMbase, and PsychINFO were searched for articles published between January 2001 and October 2020 that examined the efficacy of primary prevention interventions to prevent IPV perpetration by men/boys in LMICs and reported on a quantitative outcome examining IPV perpetration. Data on study population, setting and design, intervention components, evaluation methods, and outcomes were extracted, and study quality was assessed using the Effective Public Health Practice Project tool. Of 8,392 articles, 16 intervention studies met inclusion criteria. All 16 were of moderate or weak quality. The majority were conducted in Africa, delivered by peers, theoretically grounded, and included content to challenge IPV acceptance and gender norms. Half demonstrated intervention efficacy in prevention of IPV perpetration; these studies tended to intervene at multiple levels of the Socio-Ecological Model, be delivered over a minimum of eight sessions, and utilize a validated IPV measure to assess intervention impact. In conclusion, the field of IPV perpetration prevention research in LMICs is rapidly evolving, with many interventions demonstrating promise. Future intervention studies should consider expanding to LMICs outside Africa, targeting school-age youth, exploring whether shorter intervention durations are effective, and addressing the methodological shortcomings noted in the quality assessment.
Topics: Adolescent; Adult; Humans; Male; Africa; Developing Countries; Intimate Partner Violence; Primary Prevention
PubMed: 35511498
DOI: 10.1177/15248380221097441 -
Heart (British Cardiac Society) Aug 2023To evaluate the effects of fixed dose combination (FDC) medications on cardiovascular outcomes in different age groups in an individual participant meta-analysis of... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To evaluate the effects of fixed dose combination (FDC) medications on cardiovascular outcomes in different age groups in an individual participant meta-analysis of three primary prevention randomised trials.
METHODS
Participants at intermediate risk (17.7% mean 10-year Framingham Cardiovascular Risk Score), randomised to FDC of two or more antihypertensives and a statin with or without aspirin, or to their respective control, were followed up for 5 years. Age groups were <60, 60-65 and ≥65 years. The primary outcome was cardiovascular death, myocardial infarction, stroke or revascularisation. Cox proportional HRs and 95% CIs were computed within each age group.
RESULTS
The primary outcome risk was reduced by 37% (3.3% in FDC vs 5.2% in control (HR 0.63; 95% CI 0.54 to 0.74)) in the total population of 18 162 participants with larger benefits in older groups (HR 0.58; 95% CI 0.42 to 0.78, 60 to 65 years) and (HR 0.57; 95% CI 0.47 to 0.70, ≥65 years), as were their numbers needed to treat to avoid one primary outcome: 53 and 33, respectively. The primary outcome risk was reduced in the two oldest groups with FDC with aspirin (n=8951) by 54% and 54%, and without aspirin (n=12 061) by 34% and 38%. Dizziness, the most frequent FDC adverse effects, was higher in participants aged <65 years. Aspirin was not associated with significant bleeding excess.
CONCLUSIONS
In participants with intermediate cardiovascular risk, FDCs produce larger cardiovascular benefits in older individuals, which appear greater with aspirin.
TRIAL REGISTRATION NUMBER
HOPE-3, NCT00468923; TIPS-3, NCT016464137; PolyIran, NCT01271985.
Topics: Aged; Humans; Antihypertensive Agents; Aspirin; Cardiovascular Diseases; Drug Combinations; Hemorrhage; Myocardial Infarction; Primary Prevention; Stroke; Randomized Controlled Trials as Topic
PubMed: 37258095
DOI: 10.1136/heartjnl-2022-322278 -
World Journal of Urology Dec 2023To investigate the association between low-dose aspirin use for primary prevention and self-reported kidney stones prevalence in the 40-79 years old population.
OBJECTIVE
To investigate the association between low-dose aspirin use for primary prevention and self-reported kidney stones prevalence in the 40-79 years old population.
METHODS
We conducted a cross-sectional study based on the United States population data from the National Health and Nutrition Examination Survey 2011-2018. Baseline demographical and clinical data were collected. The univariate and multivariate regression was performed to identify confounding factors and assess the relationship between aspirin use for primary prevention and the prevalence of self-reported kidney stones. A propensity-score matching was used to identify patients with similar baseline characteristics to adjust for the bias caused by confounding factors.
RESULTS
A total of 10,256 low-dose aspirin-use participants were included in this study. 10.4% of participants reported a history of kidney stones, and 18.5% reported a continuous use of low-dose prophylactic aspirin. Multivariate logistic regression analysis showed that low-dose preventive aspirin use had significantly increased the odds of self-reported kidney stones (OR = 1.245; 95% CI: 1.063-1.459; p = 0.007). In subgroup analysis, this finding was primarily limited to males (OR = 1.311), non-hypertensive participants (OR = 1.443), diabetic participants (OR = 1.380), and older (60 ≤ Age < 80) (OR = 1.349). The propensity-score matched analyses supported this result after adjusting for the bias caused by potential confounders (OR = 1.216; 95% CI: 1.011-1.462; p = 0.038).
CONCLUSION
In this study, there exists a significant relationship between low-dose aspirin for primary prevention and self-reported kidney stones, primarily among males, no hypertensive participants, diabetics, or older adults. Further studies are needed to elucidate the mechanisms underlying these findings in the future.
Topics: Male; Humans; United States; Aged; Adult; Middle Aged; Cross-Sectional Studies; Self Report; Nutrition Surveys; Aspirin; Kidney Calculi; Diabetes Mellitus; Hypertension; Primary Prevention
PubMed: 37838641
DOI: 10.1007/s00345-023-04657-9 -
Circulation Journal : Official Journal... Jun 2024
Topics: Humans; Aged, 80 and over; Primary Prevention; Defibrillators, Implantable; Aged; Age Factors
PubMed: 38763734
DOI: 10.1253/circj.CJ-24-0310 -
The American Journal of Cardiology Nov 2023
Meta-Analysis
Topics: Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Anthracyclines; Randomized Controlled Trials as Topic; Heart Diseases; Antibiotics, Antineoplastic; Primary Prevention; Cardiotoxicity
PubMed: 37683579
DOI: 10.1016/j.amjcard.2023.08.123