This retrospective cohort study evaluated the risk of maternal safety outcomes, including preterm birth, following prefusion F protein (RSVpreF) during pregnancy compared with an unvaccinated cohort using large-scale real-world data. Propensity score matching was performed to compare the risks of preterm delivery, hypertensive disorder of pregnancy (HDP), gestational diabetes (GDM), oligohydramnios, placental abruption, intrauterine growth restriction (IUGR), and intrauterine fetal death (IUFD) to calculate the odds ratio (OR). Following the propensity score matching, 11,265 and 11,265 pregnant women with and without RSVpreF vaccination were included, respectively. After matching, the ORs in the vaccinated group compared with the unvaccinated group were 0.98 [0.84–1.14], p = 0.789; 1.01 [0.96–1.08], p = 0.644; 0.98 [0.90–1.06], p = 0.570; 0.77 [0.63–0.95], p = 0.015; 0.99 [0.77–1.27], p = 0.949; 0.94 [0.86–1.03], p = 0.189; and 0.68 [0.38–1.22], p = 0.189 for pre-term delivery, HDP, GDM, oligohydramnios, placental abruption, IUGR, and IUFD, respectively. Maternal RSV vaccination did not increase the risk of selected maternal outcome events. However, further safety monitoring with larger sample size is required to detect rare events or small risk differences.
OBJECTIVE:To determine safety and efficacy of exclusive human milk diet (EHMD) for very low birth weight (VLBW, <1500 g) infants. DESIGN:Prospective, controlled, open trial of VLBW infants randomized to EHMD (mother's own milk [MOM]/donor milk [DM] with human milk-based fortifiers) or Standard Diet (MOM/DM with cow milk-based fortifier/formula). Outcomes included superiority of weight gain velocity from birth to 34 weeks gestational age, time to full feeds, and safety. RESULT:In total, 147 infants received EHMD (n = 77) or Standard Diet (n = 70). The EHMD group had superior mean weight gain velocity versus the Standard Diet (13.44 vs 11.96 g/kg/day, p = 0.006) and earlier mean time to full feeds (20.0 vs 25.9 days, p = 0.03); adverse events were not significantly different (32.5% vs 21.4%, p = 0.13). CONCLUSION:EHMD is viable for management of VLBW infants, providing improved growth without reduced safety. TRIAL REGISTRATION AND ID:Japan Registry of Clinical Trials: jRCT2031210384.
Introduction: Multidisciplinary education has been shown to slow the progression of chronic kidney disease (CKD) and reduce cardiovascular (CV) risk, although its effects depend partly on patient characteristics. The aim of this study was to assess how patients categorized on the basis of estimated glomerular filtration rate (eGFR) responded to multidisciplinary education in terms of cardiorenal outcomes. Methods: In this retrospective cohort study, we included 447 CKD patients who received multidisciplinary education between January 1, 2013, and December 31, 2020, at Nara Prefecture General Medical Center. Exposure was four categories according to eGFR slopes before and after multidisciplinary education. The primary outcomes were renal events defined as the composite of dialysis initiation, transplantation, and 30% eGFR decline, and CV events defined as the composite of heart failure requiring hospitalization, coronary or leg revascularization, cardiac sudden death, and stroke. Results: Multidisciplinary education decreased the median eGFR slope from -5.00 to -0.65 mL/min/1.73 m2/year. In fully adjusted models, the hazard ratios (95% confidence intervals) for total renal events relative to slow-slow eGFR decline were 1.02 (0.50-2.06) for fast-slow decline, 5.30 (2.82-9.97) for slow-fast decline, and 7.53 (4.02-14.1) for fast-fast decline. Only fast-fast eGFR decline was associated with a high risk of CV events. Subgroup analyses showed similar trends. Fast decline after education was independently associated with increased proteinuria and decreased hemoglobin levels. Conclusions: Fast eGFR decline after but not before multidisciplinary education was significantly associated with renal and CV events in CKD patients. Attention should be paid to CKD patients with limited benefit from multidisciplinary education.
In the era of disease-modifying therapy (DMT), almost all patients with spinal muscular atrophy (SMA) type I treated after onset, but before 6 months of age, develop early-onset, rapidly progressive scoliosis by 2 years of age, despite improvements in their motor function. Seven symptomatic patients with SMA type I who were treated before the age of 6 months were included in this retrospective observational study. Scoliosis had developed in all patients by 27 months of age. Among them, the patients who could stand with support or independently (standing patients; n = 3) tended to present with more progressive scoliosis than the sitters (n = 4). All standing patients demonstrated thoracic hyperkyphosis before or at the time of their scoliosis diagnosis. Despite receiving DMT, these patients continued to show residual key manifestations of SMA type I. Chronic difficulty maintaining posture due to trunk muscle weakness in the lying, sitting, or standing position was considered to be the main contributor to the development and progression of the scoliosis. The development and progression of such scoliosis, which begins in infancy, may be related to inappropriate postural management, which is not currently recognized as such by clinicians, caregivers, or guardians. In this population, it is important to closely monitor patients for such scoliosis from soon after the diagnosis of SMA. As this type of scoliosis progresses rapidly during the early developmental stage, when surgery is not possible, it is necessary to establish a proactive non-surgical management strategy for it.
Partially covered self-expandable metallic stents (PCSEMSs) used for endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) provide favorable patency and low migration risk; however, reintervention (RI) remains challenging. We retrospectively evaluated the outcomes of RI after EUS-HGS with PCSEMS placement in 108 patients with malignant biliary obstruction treated between January 2016 and December 2024. Causes of recurrent biliary obstruction (RBO), RI techniques, and post-RI outcomes were analyzed. The median age of patients was 77 years, with pancreatic cancer being the most common (n = 62). RBO occurred in 25 (23
