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1.
Adv Ther ; 2024 Apr 15.
Artigo em Inglês | MEDLINE | ID: mdl-38616242

RESUMO

INTRODUCTION: Despite the appearance of off-pump coronary artery bypass grafting (CABG), ischemia-reperfusion injury (IRI) in the perioperative period still arouses concerns of clinicians. Remote ischemic conditioning (RIC) is the process of repeated ischemia and reperfusion in the peripheral vessels, which is proven to reduce IRI in vital organs. However, the effect of RIC in patients undergoing off-pump CABG is still unclear. METHODS: This IMPROVE trial is a national, multicenter, randomized, controlled, open-label, blinded-endpoint clinical trial designed to assess whether RIC intervention can improve short-term prognosis of patients undergoing off-pump CABG. It plans to enroll 648 patients who will be randomly assigned into a RIC group or control group. Patients in the RIC group will receive four cycles of 5 min of pressurization (about 200 mmHg) and 5 min of rest in the 3 days before and 7 days after the surgery. PLANNED OUTCOMES: The primary outcome is the occurrence of major adverse cardiovascular and cerebrovascular events (MACCE) within the 3-month follow-up. MACCE is defined as all-cause death, myocardial infarction, stroke, and coronary revascularization surgery. CLINICAL TRIAL REGISTRATION: NCT06141525 (ClinicalTrials.gov).

2.
Int J Public Health ; 69: 1606378, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38426185

RESUMO

Objectives: Socioeconomic disparities in obesity have been observed in both childhood and adulthood. However, it remains unclear how the role of risk factors influencing these inequalities has evolved over time. Methods: Longitudinal data on 2,866 children and adolescents (6-17 years old) from the China Health and Nutrition Survey were used to track their BMI during childhood, adolescence, and adulthood. Concentration Index was utilized to measure socioeconomic inequalities in obesity, while Oaxaca decomposition was employed to determine the share of different determinants of inequality. Results: The concentration index for obesity during childhood and adulthood were 0.107 (95% CI: 0.023, 0.211) and 0.279 (95% CI: 0.203, 0.355), respectively. Changes in baseline BMI (24.6%), parental BMI (10.4%) and socioeconomic factors (6.7%) were found to be largely responsible for the increasing inequality in obesity between childhood and adulthood. Additionally, mother's education (-7.4%) was found to contribute the most to reducing these inequalities. Conclusion: Inequalities in obesity during childhood and adulthood are significant and growing. Interventions targeting individuals with higher BMI, especially those who are wealthy, can significantly reduce the gap.


Assuntos
Disparidades nos Níveis de Saúde , Perspectiva de Curso de Vida , Criança , Adolescente , Humanos , Obesidade/epidemiologia , Obesidade/etiologia , Fatores Socioeconômicos , Fatores de Risco
3.
JAMA Neurol ; 2024 Mar 11.
Artigo em Inglês | MEDLINE | ID: mdl-38466274

RESUMO

Importance: Dual antiplatelet therapy has been demonstrated to be superior to single antiplatelet in reducing recurrent stroke among patients with transient ischemic attack or minor stroke, but robust evidence for its effect in patients with mild to moderate ischemic stroke is lacking. Objective: To evaluate whether dual antiplatelet therapy is superior to single antiplatelet among patients with mild to moderate ischemic stroke. Design, Setting, and Participants: This was a multicenter, open-label, blinded end point, randomized clinical trial conducted at 66 hospitals in China from December 20, 2016, through August 9, 2022. The date of final follow-up was October 30, 2022. The analysis was reported on March 12, 2023. Of 3065 patients with ischemic stroke, 3000 patients with acute mild to moderate stroke within 48 hours of symptom onset were enrolled, after excluding 65 patients who did not meet eligibility criteria or had no randomization outcome. Interventions: Within 48 hours after symptom onset, patients were randomly assigned to receive clopidogrel plus aspirin (n = 1541) or aspirin alone (n = 1459) in a 1:1 ratio. Main Outcomes and Measures: The primary end point was early neurologic deterioration at 7 days, defined as an increase of 2 or more points in National Institutes of Health Stroke Scale (NIHSS) score, but not as a result of cerebral hemorrhage, compared with baseline. The superiority of clopidogrel plus aspirin to aspirin alone was assessed based on a modified intention-to-treat population, which included all randomized participants with at least 1 efficacy evaluation regardless of treatment allocation. Bleeding events were safety end points. Results: Of the 3000 randomized patients, 1942 (64.6%) were men, the mean (SD) age was 65.9 (10.6) years, median (IQR) NIHSS score at admission was 5 (4-6), and 1830 (61.0%) had a stroke of undetermined cause. A total of 2915 patients were included in the modified intention-to-treat analysis. Early neurologic deterioration occurred in 72 of 1502 (4.8%) in the dual antiplatelet therapy group vs 95 of 1413 (6.7%) in the aspirin alone group (risk difference -1.9%; 95% CI, -3.6 to -0.2; P = .03). Similar bleeding events were found between 2 groups. Conclusions and Relevance: Among Chinese patients with acute mild to moderate ischemic stroke, clopidogrel plus aspirin was superior to aspirin alone with regard to reducing early neurologic deterioration at 7 days with similar safety profile. These findings indicate that dual antiplatelet therapy may be a superior choice to aspirin alone in treating patients with acute mild to moderate stroke. Trial Registration: ClinicalTrials.gov Identifier: NCT02869009.

4.
EClinicalMedicine ; 69: 102486, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38370536

RESUMO

Background: Limited data exists on how early-life weight changes relate to metabolic syndrome (MetS) risk in midlife. This study examines the association between long-term trajectories of body mass index (BMI), its variability, and MetS risk in Chinese individuals. Methods: In the Hanzhong Adolescent Hypertension study (March 10, 1987-June 3, 2017), 1824 participants with at least five BMI measurements from 1987 to 2017 were included. Using group-based trajectory modeling, different BMI trajectories were identified. BMI variability was assessed through standard deviation (SD), variability independent of the mean (VIM), and average real variability (ARV). Logistic regression analyzed the relationship between BMI trajectory, BMI variability, and MetS occurrence in midlife (URL: https://www.clinicaltrials.gov; Unique identifier: NCT02734472). Findings: BMI trajectories were categorized as low-increasing (34.4%), moderate-increasing (51.8%), and high-increasing (13.8%). Compared to the low-increasing group, the odds ratios (ORs) [95% CIs] for MetS were significantly higher in moderate (4.27 [2.63-6.91]) and high-increasing groups (13.11 [6.30-27.31]) in fully adjusted models. Additionally, higher BMI variabilities were associated with increased MetS odds (ORs for SDBMI, VIMBMI, and ARVBMI: 2.30 [2.02-2.62], 1.22 [1.19-1.26], and 4.29 [3.38-5.45]). Furthermore, BMI trajectories from childhood to adolescence were predictive of midlife MetS, with ORs in moderate (1.49 [1.00-2.23]) and high-increasing groups (2.45 [1.22-4.91]). Lastly, elevated BMI variability in this period was also linked to higher MetS odds (ORs for SDBMI, VIMBMI, and ARVBMI: 1.24 [1.08-1.42], 1.00 [1.00-1.01], and 1.21 [1.05-1.38]). Interpretation: Our study suggests that both early-life BMI trajectories and BMI variability could be predictive of incident MetS in midlife. Funding: This work was supported by the National Natural Science Foundation of China No. 82070437 (J.-J.M.), the Clinical Research Award of the First Affiliated Hospital of Xi'an Jiaotong University of China (No. XJTU1AF-CRF-2022-002, XJTU1AF2021CRF-021, and XJTU1AF-CRF-2023-004), the Key R&D Projects in Shaanxi Province (Grant No. 2023-ZDLSF-50), the Chinese Academy of Medical Sciences & Peking Union Medical College (2017-CXGC03-2), and the International Joint Research Centre for Cardiovascular Precision Medicine of Shaanxi Province (2020GHJD-14).

5.
Nutr Res Pract ; 18(1): 98-109, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-38352209

RESUMO

BACKGROUND/OBJECTIVES: The efficacy of Lab4 probiotic and vitamin C combination on the prevention of upper respiratory tract infections (URTIs) was investigated in two studies with children. Our objective was to pool dataset of 57 preschool children from the PROCHILD study (ISRCTN28722693) and the dataset of 50 preschool matched cohort from the PROCHILD-2 study (ISRCTN26587549) to evaluate the impact of probiotic/vitamin C combination on the prevention of upper respiratory tract symptoms and provide a more robust assessment of effect using detailed individual level data. SUBJECTS/METHODS: The children were supplemented daily for 6 months with either the multistrain probiotic (1.25×1010 cfu/tablet consisting of two strains of Lactobacillus acidophilus CUL21 and CUL60, Bifidobacterium bifidum CUL20 and Bifidobacterium animalis subsp. lactis CUL34) plus 50 mg vitamin C or a placebo. RESULTS: In the pooled analysis of the individual participant data (per protocol population), significant reductions were observed for the incidence (-25%; 95% confidence interval [CI], 0.66, 0.85; P < 0.0001) and duration (-14.9 days; 95% CI, -24.8, -5.1; P = 0.0030) of typical URTI symptoms in the active group compared with the placebo. The incidence rates of absenteeism from preschool (IR ratio, 0.75; 95% CI, 0.66, 0.86; P < 0.0001), paediatric visits (IR ratio, 0.56; 95% CI, 0.47; 0.68; P < 0.0001) and antibiotic usage (IR ratio, 0.53; 95% CI, 0.39, 0.71; P < 0.0001) were also significantly reduced. CONCLUSION: The pooled analysis findings of comparable preschool cohorts from two studies indicate that the supplementation with probiotic and vitamin C combination is beneficial in the prevention and management of URTI symptoms.

6.
Nutr J ; 23(1): 8, 2024 Jan 10.
Artigo em Inglês | MEDLINE | ID: mdl-38195532

RESUMO

BACKGROUND: Abnormal blood potassium levels are associated with an increased risk of cardiometabolic diseases and mortality in the general population; however, evidence regarding the association between dyskalemia and mortality among patients with cardiovascular disease (CVD) remains inconclusive. This study aimed to evaluate the association of potassium levels with all-cause and cardiovascular mortality among patients with CVD. METHODS: PubMed, Embase, Web of Science, and Cochrane Library databases were searched up to August 2023 to identify relevant cohort studies among patients with CVD, such as myocardial infarction, stroke, and heart failure. Abnormal potassium levels were considered as hypokalemia or hyperkalemia. The primary outcomes were all-cause mortality based on follow-up length (including in-hospital, short-term and long-term mortality) and cardiovascular mortality. The methodological quality of included studies was assessed by using the Newcastle-Ottawa Scale. The pooled relative risks (RRs) and 95% confidence intervals (CIs) were calculated using random-effects models. Restricted cubic splines were applied to explore the dose-response relationship. RESULTS: Thirty-one cohort studies involving 227,645 participants with an average age of 68.3 years were included in the meta-analysis, all of which achieved moderate to high quality. Hyperkalemia was significantly associated with an approximately 3.0-fold increased risk of all-cause in-hospital mortality (RR:2.78,95CI%:1.92,4.03), 1.8-fold of all-cause short-term mortality (RR:1.80, 95CI%:1.44,2.27), 1.3-fold of all-cause long-term mortality (RR:1.33, 95CI%:1.19,1.48) and 1.2-fold of cardiovascular mortality (RR:1.19, 95CI%:1.04,1.36). Similar positive associations were also observed between hypokalemia and risk of all-cause mortality and cardiovascular mortality. The RRs of all-cause in-hospital, short-term, long-term mortality and cardiovascular mortality with hyperkalemia were attenuated to 2.21 (95CI%:1.60,3.06), 1.46(95CI%:1.25,1.71), 1.23 (95CI%:1.09,1.39) and 1.13 (95CI%:1.00,1.27) when treating hypokalemia together with normokalemia as the reference group. A U-shaped association was observed between potassium levels and mortality, with the lowest risk at around 4.2 mmol/L. CONCLUSIONS: Both hypokalemia and hyperkalemia were positively associated with the risk of mortality in patients with CVD. Our results support the importance of potassium homeostasis for improving the CVD management. REGISTRATION: PROSPERO, CRD42022324337.


Assuntos
Doenças Cardiovasculares , Hiperpotassemia , Hipopotassemia , Humanos , Idoso , Estudos de Coortes , Potássio
7.
PLoS Negl Trop Dis ; 18(1): e0011678, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-38165835

RESUMO

INTRODUCTION: Snakebite is an important public health concern, especially in tropical areas, but the true burden remains unclear due to sub-optimal reporting and over-reliance on health facility-based data. METHODS: A community-based cross-sectional survey was conducted in Samburu County, Kenya from December 2019 to March 2020. Geospatial techniques were used to create a sampling frame of all households in Samburu County and a multistage cluster sampling strategy to select households and recruit study participants. Five year prevalence and mortality rates were estimated, the characteristics and circumstances of snakebite were described, and multilevel logistic regression models were built to identify independent risk factors for snakebite. RESULTS: We recruited 3,610 individuals living in 875 households from 30 clusters. The 5-year prevalence of snakebite was 2.2% (95% CI 1.4%-3.4%), and the 5-year mortality rate was 138 (95% CI 44-322) deaths per 100,000 inhabitants, resulting in an estimated 1,406 snakebites and 88 deaths from snakebites per year in Samburu County. Snakebite incidents often occurred at night between 9pm and 6 am (44%, n = 36), and the participants were mostly walking/playing outdoors (51%, n = 41) or sleeping (32%, n = 27) when they were bitten. Lower household socioeconomic status and smaller numbers of people per house were significant independent risk factors. CONCLUSION: Samburu County has a high snakebite burden and the most victims are bitten while sleeping or walking outdoors at night. Snakebite prevention and health promotion programs in Samburu County, and other endemic regions, need to be contextualised and consider the geographic, seasonal, and temporal specificities found in our study. Our findings also have implications for health care delivery, especially identification of the need for night-time staffing with expertise in snakebite management and antivenom availability to better manage patients and thereby improve outcomes.


Assuntos
Mordeduras de Serpentes , Humanos , Prevalência , Quênia/epidemiologia , Estudos Transversais , Antivenenos , Fatores de Risco
8.
Heliyon ; 10(1): e23354, 2024 Jan 15.
Artigo em Inglês | MEDLINE | ID: mdl-38169906

RESUMO

Background: Due to the limitations of current methods for detecting obstructive coronary artery disease (CAD), many individuals are mistakenly or unnecessarily referred for coronary angiography (CAG). Objectives: Our goal is to create a comprehensive database of heart sounds in CAD and develop accurate deep learning algorithms to efficiently detect obstructive CAD based on heart sound signals. This will enable effective screening before undergoing CAG. Methods: We included 320 subjects suspected of CAD who underwent CAG. We employed advanced filtering techniques and state-of-the-art deep learning models (VGG-16, 1D CNN, and ResNet18) to analyze the heart sound signals and identify obstructive CAD (defined as at least one ≥50 % stenosis). To assess the performance of our models, we prospectively recruited an additional 80 subjects for testing. Results: In the test set, VGG-16 exhibited the highest performance with an area under the ROC curve (AUC) of 0.834 (95 % CI, 0.736-0.930), while ResNet-18 and CNN-7 achieved AUCs of only 0.755 (95 % CI, 0.614-0.819) and 0.652 (95 % CI, 0.554-0.770) respectively. VGG-16 demonstrated a sensitivity of 80.4 % and specificity of 86.2 % in the test set. The combined diagnostic model of VGG and DF scores achieved an AUC of 0.915 (95 % CI: 0.855-0.974), and the AUC for VGG combined with PTP scores was 0.908 (95 % CI: 0.845-0.971). The sensitivity and specificity of VGG-16 exceeded 0.85 in patients with coronary artery occlusion and those with 3 vascular lesions. Conclusions: Our deep learning model, based on heart sounds, offers a non-invasive and efficient screening method for obstructive CAD. It is expected to significantly reduce the number of unnecessary referrals for downstream screening.

9.
BMC Cardiovasc Disord ; 24(1): 62, 2024 Jan 20.
Artigo em Inglês | MEDLINE | ID: mdl-38245724

RESUMO

BACKGROUND: Patients treated with drug-coated balloons (DCB) have the theoretical advantage of adopting a low-intensity antiplatelet regimen due to the absence of struts and polymers. Nevertheless, the optimal antiplatelet strategy for patients undergoing DCB-only treatment remains a topic of debate and has not been investigated in randomized trials. METHODS: The REC-CAGEFREE II is an investigator-initiated, prospective, open-label, multi-center, randomized, non-inferiority trial aimed to enroll 1908 patients from ≥ 40 interventional cardiology centers in China to evaluate the non-inferiority of an antiplatelet regimen consisting of Aspirin plus Ticagrelor for one month, followed by five months Ticagrelor monotherapy, and then Aspirin monotherapy for six months (Experimental group) compared to the conventional treatment of Aspirin plus Ticagrelor for 12 months (Reference group) in patients with acute coronary syndrome (ACS) who have undergone percutaneous coronary intervention (PCI) using paclitaxel-coated balloons (DCB) exclusively. Participants will be randomly assigned to the Experimental or Reference group in a 1:1 ratio. The randomization will be stratified based on the center and the type of lesion being treated (De novo or in-stent restenosis). The primary endpoint is net adverse clinical events (NACE) within 12 months of PCI, which includes the composite of all-cause death, any stroke, any myocardial infarction, any revascularization and Bleeding Academic Research Consortium (BARC) defined type 3 or 5 bleeding. The secondary endpoint, any ischemic and bleeding event, which includes all-cause death, any stroke, MI, BARC-defined type 3 bleeding, any revascularization, and BARC-defined type 2 bleeding events, will be treated as having hierarchical clinical importance in the above order and analyzed using the win ratio method. DISCUSSION: The ongoing REC-CAGEFREE II trial aims to assess the efficacy and safety of a low-intensity antiplatelet approach among ACS patients with DCB. If non-inferiority is shown, the novel antiplatelet approach could provide an alternative treatment for ACS patients with DCB. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04971356.


Assuntos
Síndrome Coronariana Aguda , Intervenção Coronária Percutânea , Acidente Vascular Cerebral , Humanos , Síndrome Coronariana Aguda/terapia , Síndrome Coronariana Aguda/tratamento farmacológico , Aspirina , Quimioterapia Combinada , Hemorragia/induzido quimicamente , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/métodos , Inibidores da Agregação Plaquetária/uso terapêutico , Estudos Prospectivos , Acidente Vascular Cerebral/etiologia , Ticagrelor/uso terapêutico , Resultado do Tratamento , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Multicêntricos como Assunto , Estudos de Equivalência como Asunto
10.
AIDS ; 2024 Mar 07.
Artigo em Inglês | MEDLINE | ID: mdl-38277390

RESUMO

BACKGROUND: Both dolutegravir and efavirenz are known to be effective in pregnancy and post-partum to prevent vertical transmission of HIV and to maintain maternal health. Both drugs have also been associated with neuropsychiatric symptoms. To what extent these symptoms occur in pregnant and post-partum women, however, is not yet known. METHODS: This was a secondary analysis of the DolPHIN2 study, a multicenter randomized trial among women presenting late in pregnancy with untreated HIV- who received either a dolutegravir- or efavirenz- containing regimen. Longitudinal measures of depression, anxiety and sleep quality were analyzed during pregnancy and up to 48 weeks post-partum. RESULTS: Among 268 women median (IQR) Edinburgh Post Natal depression score (EPDS) scores were 8 (3-11) and highest at enrolment. In the dolutegravir -and efavirenz arm, respectively, 23.7% and 25.6% had an EPDS score above 9, indicating possible or probable depression. Abnormal Hospital Anxiety Depression scores (HADS) (above 11) were seen at least once during follow up in 42 of patients (15.7%), although no differences were seen between treatment arms. No association was found between EPDS, suicidality and HADS scores and the assigned regimen (p = 0.93, 0.97 and 0.18 respectively). Median (IQR) Pittsburgh Sleep Quality index (PSQI) scores for dolutegravir- and efavirenz were 6 (5-7) and 5 (5-6.5) respectively, p = 0.70. CONCLUSIONS: No statistically significant differences were observed between efavirenz- or dolutegravir containing regimens. Rates of depression were high, but decreased over the course of time and confirm the need for psychological support after initial HIV diagnosis in pregnancy.

11.
Lancet ; 403(10424): 365-378, 2024 Jan 27.
Artigo em Inglês | MEDLINE | ID: mdl-38224710

RESUMO

BACKGROUND: The efficacy of daily co-trimoxazole, an antifolate used for malaria chemoprevention in pregnant women living with HIV, is threatened by cross-resistance of Plasmodium falciparum to the antifolate sulfadoxine-pyrimethamine. We assessed whether addition of monthly dihydroartemisinin-piperaquine to daily co-trimoxazole is more effective at preventing malaria infection than monthly placebo plus daily co-trimoxazole in pregnant women living with HIV. METHODS: We did an individually randomised, two-arm, placebo-controlled trial in areas with high-grade sulfadoxine-pyrimethamine resistance in Kenya and Malawi. Pregnant women living with HIV on dolutegravir-based combination antiretroviral therapy (cART) who had singleton pregnancies between 16 weeks' and 28 weeks' gestation were randomly assigned (1:1) by computer-generated block randomisation, stratified by site and HIV status (known positive vs newly diagnosed), to daily co-trimoxazole plus monthly dihydroartemisinin-piperaquine (three tablets of 40 mg dihydroartemisinin and 320 mg piperaquine given daily for 3 days) or daily co-trimoxazole plus monthly placebo. Daily co-trimoxazole consisted of one tablet of 160 mg sulfamethoxazole and 800 mg trimethoprim. The primary endpoint was the incidence of Plasmodium infection detected in the peripheral (maternal) or placental (maternal) blood or tissue by PCR, microscopy, rapid diagnostic test, or placental histology (active infection) from 2 weeks after the first dose of dihydroartemisinin-piperaquine or placebo to delivery. Log-binomial regression was used for binary outcomes, and Poisson regression for count outcomes. The primary analysis was by modified intention to treat, consisting of all randomised eligible participants with primary endpoint data. The safety analysis included all women who received at least one dose of study drug. All investigators, laboratory staff, data analysts, and participants were masked to treatment assignment. This trial is registered with ClinicalTrials.gov, NCT04158713. FINDINGS: From Nov 11, 2019, to Aug 3, 2021, 904 women were enrolled and randomly assigned to co-trimoxazole plus dihydroartemisinin-piperaquine (n=448) or co-trimoxazole plus placebo (n=456), of whom 895 (99%) contributed to the primary analysis (co-trimoxazole plus dihydroartemisinin-piperaquine, n=443; co-trimoxazole plus placebo, n=452). The cumulative risk of any malaria infection during pregnancy or delivery was lower in the co-trimoxazole plus dihydroartemisinin-piperaquine group than in the co-trimoxazole plus placebo group (31 [7%] of 443 women vs 70 [15%] of 452 women, risk ratio 0·45, 95% CI 0·30-0·67; p=0·0001). The incidence of any malaria infection during pregnancy or delivery was 25·4 per 100 person-years in the co-trimoxazole plus dihydroartemisinin-piperaquine group versus 77·3 per 100 person-years in the co-trimoxazole plus placebo group (incidence rate ratio 0·32, 95% CI 0·22-0·47, p<0·0001). The number needed to treat to avert one malaria infection per pregnancy was 7 (95% CI 5-10). The incidence of serious adverse events was similar between groups in mothers (17·7 per 100 person-years in the co-trimoxazole plus dihydroartemisinin-piperaquine group [23 events] vs 17·8 per 100 person-years in the co-trimoxazole group [25 events]) and infants (45·4 per 100 person-years [23 events] vs 40·2 per 100 person-years [21 events]). Nausea within the first 4 days after the start of treatment was reported by 29 (7%) of 446 women in the co-trimoxazole plus dihydroartemisinin-piperaquine group versus 12 (3%) of 445 women in the co-trimoxazole plus placebo group. The risk of adverse pregnancy outcomes did not differ between groups. INTERPRETATION: Addition of monthly intermittent preventive treatment with dihydroartemisinin-piperaquine to the standard of care with daily unsupervised co-trimoxazole in areas of high antifolate resistance substantially improves malaria chemoprevention in pregnant women living with HIV on dolutegravir-based cART and should be considered for policy. FUNDING: European and Developing Countries Clinical Trials Partnership 2; UK Joint Global Health Trials Scheme (UK Foreign, Commonwealth and Development Office; Medical Research Council; National Institute for Health Research; Wellcome); and Swedish International Development Cooperation Agency.


Assuntos
Antimaláricos , Artemisininas , Antagonistas do Ácido Fólico , Infecções por HIV , Malária , Piperazinas , Quinolinas , Feminino , Humanos , Lactente , Gravidez , Antimaláricos/efeitos adversos , Quimioprevenção , Antagonistas do Ácido Fólico/uso terapêutico , Infecções por HIV/epidemiologia , Infecções por HIV/prevenção & controle , Infecções por HIV/tratamento farmacológico , Quênia/epidemiologia , Malária/epidemiologia , Malária/prevenção & controle , Malaui/epidemiologia , Placenta , Resultado da Gravidez , Gestantes , Combinação Trimetoprima e Sulfametoxazol/uso terapêutico , Método Duplo-Cego
12.
J Evid Based Med ; 17(1): 119-133, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38205918

RESUMO

OBJECTIVE: Accumulating evidence has demonstrated that fractional flow reserves (FFRs) derived from invasive coronary angiograms (CA-FFRs) and coronary computed tomography angiography-derived FFRs (CT-FFRs) are promising alternatives to wire-based FFRs. However, it remains unclear which method has better diagnostic performance. This systematic review and meta-analysis aimed to compare the diagnostic performances of the two approaches. METHODS: The Cochrane Library, PubMed, Embase, Medline (Ovid), the Chinese China National Knowledge Infrastructure Database (CNKI), VIP, and WanFang Data databases were searched for relevant studies that included comparisons between CA-FFR and CT-FFR, from their respective database inceptions until January 1, 2023. Studies where both noninvasive FFR (including CA-FFR and CT-FFR) and invasive FFR (as a reference standard) were performed for the diagnosis of ischemic coronary artery disease and were designed as prospective, paired diagnostic studies, were pulled. The diagnostic test accuracy method and Bayesian hierarchical summary receiver operating characteristic (ROC) model for network meta-analysis (NMA) of diagnostic tests (HSROC-NMADT) were both used to perform a meta-analysis on the data. RESULTS: Twenty-six studies were included in this NMA. The results from both the diagnostic test accuracy and HSROC-NMADT methods revealed that the diagnostic accuracy of CA-FFR was higher than that of CT-FFR, in terms of sensitivity (Se; 0.86 vs. 0.84), specificity (Sp; 0.90 vs. 0.78), positive predictive value (PPV; 0.83 vs. 0.70), and negative predictive value (NPV; 0.91 vs. 0.89) for the detection of myocardial ischemia. A cumulative ranking curve analysis indicated that CA-FFR had a higher diagnostic accuracy than CT-FFR in the context of this study, with a higher area under the ROC curve (AUC; 0.94 vs. 0.87). CONCLUSIONS: Although both of these two commonly used virtual FFR methods showed high levels of diagnostic accuracy, we demonstrated that CA-FFR had a better Se, Sp, PPV, NPV, and AUC than CT-FFR. However, this study provided only indirect comparisions; therefore, larger studies are warranted to directly compare the diagnostic performances of these two approaches.


Assuntos
Doença da Artéria Coronariana , Estenose Coronária , Reserva Fracionada de Fluxo Miocárdico , Humanos , Estenose Coronária/diagnóstico , Sensibilidade e Especificidade , Estudos Prospectivos , Teorema de Bayes , Metanálise em Rede , Doença da Artéria Coronariana/diagnóstico por imagem , Angiografia Coronária/métodos , Tomografia Computadorizada por Raios X/métodos , Valor Preditivo dos Testes
14.
Diabetes Metab J ; 47(6): 859-868, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-37915187

RESUMO

BACKGRUOUND: Prediabetes leads to declines in physical function in older adults, but the impact of prediabetes progression or regression on physical function is unknown. This study assessed this longitudinal association, with physical function objectivelymeasured by grip strength, walking speed, and standing balance, based on the Health and Retirement Study enrolling United States adults aged >50 years. METHODS: Participants with prediabetes were followed-up for 4-year to ascertain prediabetes status alteration (maintained, regressed, or progressed), and another 4-year to assess their impacts on physical function. Weak grip strength was defined as <26 kg for men and <16 kg for women, slow walking speed was as <0.8 m/sec, and poor standing balance was as an uncompleted fulltandem standing testing. Logistic and linear regression analyses were performed. RESULTS: Of the included 1,511 participants with prediabetes, 700 maintained as prediabetes, 306 progressed to diabetes, and 505 regressed to normoglycemia over 4 years. Grip strength and walking speed were declined from baseline during the 4-year followup, regardless of prediabetes status alteration. Compared with prediabetes maintenance, prediabetes progression increased the odds of developing weak grip strength by 89% (95% confidence interval [CI], 0.04 to 2.44) and exhibited larger declines in grip strength by 0.85 kg (95% CI, -1.65 to -0.04). However, prediabetes progression was not related to impairments in walking speed or standing balance. Prediabetes regression also did not affect any measures of physical function. CONCLUSION: Prediabetes progression accelerates grip strength decline in aging population, while prediabetes regression may not prevent physical function decline due to aging.


Assuntos
Diabetes Mellitus , Estado Pré-Diabético , Masculino , Humanos , Feminino , Estados Unidos/epidemiologia , Idoso , Estado Pré-Diabético/epidemiologia , Estudos Prospectivos , Envelhecimento , Análise de Regressão
15.
Cardiol J ; 2023 Nov 15.
Artigo em Inglês | MEDLINE | ID: mdl-37964648

RESUMO

BACKGROUND: Bivalirudin is associated with fewer major bleeding events than heparin in patients undergoing percutaneous coronary intervention (PCI), but confounding effects of concomitant glycoprotein IIb/IIIa inhibitors, routine femoral artery access, and less potent effects of clopidogrel limits meaningful comparisons. The present study is a systematic review and meta-analysis to compare bivalirudin to heparin in contemporary practice. METHODS: The Cochrane Library, PubMed, EMBASE, and Ovid MEDLINE databases were searched for relevant studies, including comparisons between bivalirudin and heparin in the current medical era from inception to December 23, 2021. Studies reporting incidences of major adverse cardiac events (MACE) and net adverse clinical events (NACE) in patients undergoing PCI and meeting the inclusion criteria were retained. Data extraction was performed by three independent reviewers. RESULTS: The meta-analysis included 8 studies. Compared to heparin, bivalirudin during PCI was associated with a lower NACE risk, lower all-cause death, and similar MACE risk, with a pooled risk ratio of 0.82 (95% confidence interval [CI] 0.69-0.97, p = 0.02), 0.83 (95% CI 0.74-0.94, p = 0.002), and 0.93 (95% CI 0.78-1.10, p = 0.38), respectively. Moreover, the reduction in NACE was mainly attributed to reduced bleeding (22% reduction in the risk of major bleeding, 95% CI 0.63-0.97, p = 0.03). CONCLUSIONS: These findings suggest that bivalirudin use during PCI reduced the risk of NACE and all-cause death but did not reduce the risk of MACE compared with heparin use in PCI. More studies specifically designed for anticoagulation strategies and a personalized anticoagulation regimen to comprehensively balance bleeding and ischemia risks are required.

16.
J Biopharm Stat ; : 1-16, 2023 Nov 10.
Artigo em Inglês | MEDLINE | ID: mdl-37947400

RESUMO

The win ratio method has been increasingly applied in the design and analysis of clinical trials. However, the win ratio method is a univariate approach that does not allow for adjusting for baseline imbalances in covariates, although a stratified win ratio can be calculated when the number of strata is small. This paper proposes an adjusted win ratio to control for such imbalances by inverse probability of treatment weighting (IPTW) method. We derive the adjusted win ratio with its variance and suggest three IPTW adjustments: IPTW-average treatment effect (IPTW-ATE), stabilized IPTW-ATE (SIPTW-ATE) and IPTW-average treatment effect in the treated (IPTW-ATT). The proposed adjusted methods are applied to analyse a composite outcome in the CHARM trial. The statistical properties of the methods are assessed through simulations. Results show that adjusted win ratio methods can correct the win ratio for covariate imbalances at baseline. Simulation results show that the three proposed adjusted win ratios have similar power to detect the treatment difference and have slightly lower power than the corresponding adjusted Cox models when the assumption of proportional hazards holds true but have consistently higher power than adjusted Cox models when the proportional hazard assumption is violated.

17.
EClinicalMedicine ; 65: 102261, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-37860578

RESUMO

Background: High rates of sexual and reproductive health (SRH) harms and interrupted schooling are global challenges for adolescent girls, requiring effective interventions. We assessed the impact of menstrual cups (MCs) or cash transfers conditioned on school attendance (CCTs), or both, on SRH and schooling outcomes in western Kenya. Methods: In this cluster-randomised Cups or Cash for Girls (CCG) trial, adolescent girls in Forms two and three at 96 secondary schools in Siaya County (western Kenya) were randomised to receive either CCT, MC, combined CCT and MC, or control (1:1:1:1) for an average of 30 months. The CCT intervention comprised 1500KES (US$15 in 2016) via a cash card each school trimester. All four treatment groups received puberty and hygiene training. Assenting girls with parent or guardian consent who were post-menarche, not pregnant, area residents, not boarding, and had no disabilities precluding participation were eligible. Socio-behavioural risk factors and incidence of HIV and herpes simplex virus type 2 (HSV-2) were measured annually. School retainment and adverse events were monitored throughout. The primary outcome comprised a composite of incident HIV, HSV-2 and/or all-cause school dropout by school exit examination. The primary analysis was by intention-to-treat (ITT) using generalised linear mixed models, controlling for a priori selected baseline covariates. The trial is registered with ClinicalTrials.gov, NCT03051789. Findings: Between February 28, 2017 and June 30, 2021, 4137 girls (median age 17.1 [interquartile range (IQR): 16.3-18.0]) were enrolled and followed annually until completion of secondary school (median 2.5 years [IQR: 2.4-2.7]); 4106 (99.3%) contributed to the ITT analysis. No differences in the primary composite outcome between intervention and control groups were seen (MC: 18.2%, CCT: 22.1%, combined: 22.1%, control: 19.6%; adjusted risk ratio [aRR]: 0.97, 95% confidence interval 0.76-1.24; 1.14, 0.90-1.45; and 1.13, 0.90-1.43, respectively). Incident HSV-2 occurred in 8.6%, 13.3%, 14.8%, and 12% of the MC, CCT, combined and control groups, respectively (MC: RR: 0.67, 0.47-0.95, p = 0.027; aRR: 0.71, 0.50-1.01, p = 0.057; CCT: aRR: 1.02, 0.73-1.41, p = 0.92; combined aRR: 1.16, 0.85-2.58, p = 0.36). Incident HIV was low (MC: 1.2%, CCT: 1.5%, combined: 1.0%, and control: 1.4%; aRR: 0.88, 0.38-2.05, p = 0.77, aRR: 1.16, 0.51-2.62, p = 0.72, aRR: 0.80, 0.33-1.94, p = 0.62, respectively). No intervention decreased school dropout (MC: 11.2%, CCT: 12.4%, combined: 10.9%, control: 10.5%; aRR: 1.16, 0.86-1.57; 1.23, 0.91-1.65; and 1.06, 0.78-1.44, respectively). No related serious adverse events were seen. Interpretation: MCs, CCTs, or both, did not protect schoolgirls against a composite of deleterious harms. MCs appear protective against HSV-2. Studies of longer follow-up duration with objective measures of health impact are needed in this population. Funding: Department of Health and Social Care, the Foreign, Commonwealth & Development Office, the Medical Research Council and Wellcome.

18.
Crit Rev Food Sci Nutr ; : 1-13, 2023 Oct 03.
Artigo em Inglês | MEDLINE | ID: mdl-37788131

RESUMO

Epidemiological evidence on the association between potassium and cardiometabolic outcomes remains controversial. This study aimed to examine associations of dietary intake and blood and urinary levels of potassium with risk of type 2 diabetes, cardiovascular disease (CVD), and mortality. Relevant prospective studies were retrieved through a comprehensive search of four electronic databases up to July 1, 2023. Random-effects models were used to pool the study-specific relative risks (RRs) and 95% confidence intervals (CIs). Fifty-six studies were included in this meta-analysis. A higher intake of potassium was significantly associated with a 16% lower risk of CVD (RR: 0.84, 95% CI: 0.78-0.90). Similar inverse associations were also observed between potassium intake and mortality. Each 1.0 g/d increment in potassium intake was associated with a decreased risk of CVD (RR: 0.85, 95% CI: 0.80-0.91) and all-cause mortality (RR: 0.93, 95% CI: 0.88-0.99). For blood and urinary potassium levels, higher level of blood potassium increased the risk of all-cause mortality by 23% (RR: 1.23, 95% CI: 1.11-1.36). The association of blood potassium levels with mortality was nonlinear (Pnon-linearit<0.001). However, urinary potassium levels were inversely associated with the risk of all-cause mortality (RR: 0.84, 95% CI: 0.76-0.93). Our findings support the benefits of moderate potassium consumption for primary prevention of chronic diseases and premature death.

19.
BMC Public Health ; 23(1): 1955, 2023 10 09.
Artigo em Inglês | MEDLINE | ID: mdl-37814213

RESUMO

BACKGROUND: The social disparities in obesity may originate in early life or in adulthood, and the associations of socioeconomic position (SEP) with obesity could alter over time. It is unclear how lifetime-specific and life-course SEP influence adult obesity development in China. METHODS: Based on the China Health and Nutrition Survey (CHNS), three SEP-related indicators, including the father's occupational position and the participant's education and occupational position, were obtained. The life-course socioeconomic changes and a cumulative SEP score were established to represent the life-course SEP of the participants in the study. The growth mixture modeling was used to identify BMI trajectories in adulthood. Multinomial logistic regression was adopted to assess the associations between SEP and adult BMI trajectories. RESULTS: A total of 3,138 participants were included in the study. A positive correlation was found between the paternal occupational position, the participants' occupational position, education, and obesity in males, whereas an inverse correlation was observed among females. Males who experienced social upward mobility or remained stable high SEP during the follow-up had 2.31 and 2.52-fold risks of progressive obesity compared to those with a stable-low SEP. Among females, stable high SEP in both childhood and adulthood was associated with lower risks of progressive obesity (OR = 0.63, 95% CI: 0.43-0.94). Higher risks of obesity were associated with the life-course cumulative SEP score among males, while the opposite relationship was observed among females. CONCLUSIONS: The associations between life-course SEP and BMI development trajectories differed significantly by gender. Special emphasis should be placed on males experiencing upward and stable high socioeconomic change.


Assuntos
Obesidade , Classe Social , Adulto , Masculino , Feminino , Humanos , Criança , Índice de Massa Corporal , Estudos de Coortes , Obesidade/epidemiologia , Fatores Socioeconômicos , Fatores de Risco
20.
Lancet ; 402(10409): 1241-1250, 2023 10 07.
Artigo em Inglês | MEDLINE | ID: mdl-37805215

RESUMO

BACKGROUND: In sub-Saharan Africa, health-care provision for chronic conditions is fragmented. The aim of this study was to determine whether integrated management of HIV, diabetes, and hypertension led to improved rates of retention in care for people with diabetes or hypertension without adversely affecting rates of HIV viral suppression among people with HIV when compared to standard vertical care in medium and large health facilities in Uganda and Tanzania. METHODS: In INTE-AFRICA, a pragmatic cluster-randomised, controlled trial, we randomly allocated primary health-care facilities in Uganda and Tanzania to provide either integrated care or standard care for HIV, diabetes, and hypertension. Random allocation (1:1) was stratified by location, infrastructure level, and by country, with a permuted block randomisation method. In the integrated care group, participants with HIV, diabetes, or hypertension were managed by the same health-care workers, used the same pharmacy, had similarly designed medical records, shared the same registration and waiting areas, and had an integrated laboratory service. In the standard care group, these services were delivered vertically for each condition. Patients were eligible to join the trial if they were living with confirmed HIV, diabetes, or hypertension, were aged 18 years or older, were living within the catchment population area of the health facility, and were likely to remain in the catchment population for 6 months. The coprimary outcomes, retention in care (attending a clinic within the last 6 months of study follow-up) for participants with either diabetes or hypertension (tested for superiority) and plasma viral load suppression for those with HIV (>1000 copies per mL; tested for non-inferiority, 10% margin), were analysed using generalised estimating equations in the intention-to-treat population. This trial is registered with ISCRTN 43896688. FINDINGS: Between June 30, 2020, and April 1, 2021 we randomly allocated 32 health facilities (17 in Uganda and 15 in Tanzania) with 7028 eligible participants to the integrated care or the standard care groups. Among participants with diabetes, hypertension, or both, 2298 (75·8%) of 3032 were female and 734 (24·2%) of 3032 were male. Of participants with HIV alone, 2365 (70·3%) of 3365 were female and 1000 (29·7%) of 3365 were male. Follow-up lasted for 12 months. Among participants with diabetes, hypertension, or both, the proportion alive and retained in care at study end was 1254 (89·0%) of 1409 in integrated care and 1457 (89·8%) of 1623 in standard care. The risk differences were -0·65% (95% CI -5·76 to 4·46; p=0·80) unadjusted and -0·60% (-5·46 to 4·26; p=0·81) adjusted. Among participants with HIV, the proportion who had a plasma viral load of less than 1000 copies per mL was 1412 (97·0%) of 1456 in integrated care and 1451 (97·3%) of 1491 in standard care. The differences were -0·37% (one-sided 95% CI -1·99 to 1·26; pnon-inferiority<0·0001 unadjusted) and -0·36% (-1·99 to 1·28; pnon-inferiority<0·0001 adjusted). INTERPRETATION: In sub-Saharan Africa, integrated chronic care services could achieve a high standard of care for people with diabetes or hypertension without adversely affecting outcomes for people with HIV. FUNDING: European Union Horizon 2020 and Global Alliance for Chronic Diseases.


Assuntos
Fármacos Anti-HIV , Diabetes Mellitus , Infecções por HIV , Hipertensão , Feminino , Humanos , Masculino , Fármacos Anti-HIV/uso terapêutico , Diabetes Mellitus/terapia , Diabetes Mellitus/tratamento farmacológico , Infecções por HIV/complicações , Infecções por HIV/epidemiologia , Infecções por HIV/terapia , Hipertensão/terapia , Hipertensão/tratamento farmacológico , Tanzânia/epidemiologia
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