ObjectiveTo investigate whether there is an association of the triglyceride-to-HDL cholesterol (TG:HDL-C) ratio with cardiovascular risk factors and early signs of vascular damage in obese ...prepubertal children.Design and methodsIn 50 obese (27 boys, 7.8±1.4 years) and 37 normal-weight (20 boys; 7.3±1.5 years) prepubertal children, anthropometric measurements, oxidative stress markers (urinary isoprostanes (PGF2α (prostaglandin F2α)), soluble receptor for advanced glycation end-products (sRAGE)) and insulin sensitivity (homeostasis model assessment of insulin resistance (HOMA-IR) and whole-body insulin sensitivity index (WBISI)) were evaluated. Lipids profile was assessed and the TG:HDL-C ratio was calculated. In addition, high-resolution ultrasound was performed to assess carotid intima-media thickness (cIMT).ResultsObese children showed significantly higher values of the TG:HDL-C ratio (1.9±1.1 vs 1.2±0.6, P=0.002) compared with controls. After dividing the population in tertiles of the TG:HDL-C ratio (<1.04, 1.04–1.67, >1.67), cIMT (P=0.0003), and HOMA-IR (P=0.0001) progressively increased from the lower to the upper tertile, whereas WBISI (P=0.0003) and sRAGE (P=0.05) progressively decreased. In a regression model, the TG:HDL ratio was significantly and positively associated with cIMT (r=0.493; P=0.0005). A cutoff point for TG:HDL-C ratio of 1.12 had 81% sensitivity and 49% specificity in the identification of children with cIMT values in the upper quartile (Area under the curve values from receiver operating characteristic curves=0.633±0.065, P=0.045).ConclusionThis study confirms the reliability of the TG:HDL-C ratio as a useful marker of cardiovascular risk. Interestingly, our results underline that the TG:HDL-C ratio is directly related with early signs of vascular damage already present in prepubertal children.
Background and Objectives: This study aimed to assess the effectiveness and costs associated with pharmacokinetics-driven (PK) prophylaxis based on the myPKFiT® device in patients affected by ...hemophilia A (HA) in Italy. Materials and Methods: An observational retrospective study was conducted in three Italian hemophilia centers. All patients with moderate or severe HA, aged ≥ 18 years, capable of having PK estimated using the myPKFiT device, and who had had a clinical visit between 1 November 2019 and 31 March 2022 were included. Differences in clinical, treatment, health resources, and cost data were assessed comparing post-PK prophylaxis with pre-PK. The incremental cost-effectiveness ratio (ICER) was estimated as cost (EUR) per bleed avoided. Results: The study enrolled 13 patients with HA. The mean annual bleeding rate decreased by −1.45 (−63.80%, p = 0.0055) after the use of myPKFiT®. Overall, the consumption of FVIII IU increased by 1.73% during follow-up compared to the period prior the use of the myPKFiT. Prophylaxis based on the myPKFiT resulted in an ICER of EUR 5099.89 per bleed avoided. Conclusions: The results of our study support the idea that the use of PK data in clinical practice can be associated with an improvement in the management of patients, as well as clinical outcomes, with a reasonable increase in costs.
(1) Background: new generations of rFVIII products offered the possibility to improve personalized therapeutic approaches, reducing the number of infusions or increasing the protection against ...bleeding risk. The aim of this study was to assess the effectiveness of prophylaxis with BAY 81-8973 (octocog alfa, Kovaltry®, Bayer Pharma AG) in the real-world setting and its impact on FVIII consumption compared to previous standard half-life treatments. (2) Methods: a retrospective observational study was conducted in five Italian Haemophilia Centers. Patients with haemophilia A under prophylactic treatment with BAY 81-8973 for at least one year, and previously on prophylaxis with a different product were included in the study. Annual bleeding rate (ABR) and annual FVIII consumption were compared. (3) Results: forty-four patients were included in the study. After switching to BAY 81-8973, ABR was significantly reduced (1.76 vs. 0.23; p = 0.015), the percentage of patients with zero bleeds increased from 54.6% to 84.1% (p = 0.003), and the overall FVIII consumption decreased by 25,542 (−7.2%, p = 0.046) IU per patient-year. Patients treated every 3 days or 2 times per week increased from 0% to 27.3%. (4) Conclusion: our results suggest that prophylaxis with BAY 81-8973 can improve clinical outcomes and reduce FVIII consumption, in the real-world practice, compared with the previous prophylaxis regimen with standard half-life products.
Objective To report a case of bilateral ovarian pregnancy in a young patient who had previously undergone intrauterine insemination (IUI) and controlled ovarian stimulation (COS). Design Case report. ...Setting University hospital. Patient(s) A 34-year-old woman who had previously undergone IUI and COS. Intervention(s) Emergency exploratory laparotomy for circulatory collapse. About 350 mL of bloody fluid was collected in the pelvic cavity. The left ovary was about 6 cm in diameter and was completely involved by a darkish hemorrhagic ovarian mass; the right ovary was involved by a 4-cm mass. A left ovariectomy and a partial resection of the right ovary with preservation of two-thirds of ovarian tissue was performed. Main Outcome Measure(s) IUI and COS outcome. Result(s) The pathologic diagnosis was considered, and bilateral ovarian pregnancy was confirmed according to the diagnostic criteria described by Spiegelberg. Conclusion(s) Diagnosis of primary ovarian pregnancy is very difficult because of its rarity and asymptomatic state before rupture. However, early diagnosis is fundamental to avoid more serious complications and an emergency invasive procedure.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
FuseNGO is a relatively new device consisting of a prefilled dual-chamber syringe (DCS) that was recently introduced for the reconstitution of recombinant factor VIII. Herein, the DCS device was ...assessed using five questionnaires with the primary aim of evaluating patient perceptions and preferences.
An observational, non-interventional, longitudinal study on 86 patients with a confirmed diagnosis of hemophilia A was carried out at 21 sites in Italy. Each patient underwent a baseline visit and final study visit within 3-6 months. Patients were administered five questionnaires: HemoPREF; Treatment Satisfaction Questionnaire for Medication (TSQM); VeritasPRO; Hemophilia Well-being Index (HWBI); Work Productivity and Activity Impairment Questionnaire (WPAI) + Classroom Impairment Questions (CIQ): Hemophilia Specific (HS).
Compared to baseline, scores for HemoPREF were higher at follow-up; significant increases in the percentage of positive responses were seen for all questions regarding the ease of use (
<0.05). The mean time needed for the reconstruction of the device at baseline was 11 minutes (range 1-30 minutes), which decreased to 6 minutes (range 30 seconds to 25 minutes) at follow-up. All scores in the TSQM indicated good satisfaction with the device. Patients reported an adherence of >70% in the VeritasPRO questionnaire, and the majority of patients reported in the HWBI that hemophilia A did not affect their lives in a significant way. The perceived level of overall impairment was 30% as reported in the WPAI + CIQ: HS, indicating little impairment. There were no safety concerns.
Considering patient-reported outcomes, the DCS device was associated with easier preparation, storage, disposal of equipment, and overall use. Of particular note, preparation times were reduced by around 50%. The majority of patients were satisfied with the device and overall adherence scores were high. Considering these results, the device has the potential to increase adherence to therapy and, possibly, reduce healthcare costs.
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IZUM, KILJ, NUK, PILJ, PNG, SAZU, UL, UM, UPUK
Background: This study evaluated the effectiveness, safety, and possible changes in bowel symptoms after multicompartment prolapse surgery by comparing two different surgical approaches, transvaginal ...mesh surgery with levatorplasty (TVMLP) and robot-assisted sacrocolpopexy (RSC). Methods: All patients underwent pelvic (POP-Q staging system) and rectal examination to evaluate anal sphincter tone in the lithotomy position with the appropriate Valsalva test. The preoperative evaluation included urodynamics and pelvic magnetic resonance defecography. Patient Global Impression of Improvement (PGI-I) at follow-up measured subjective improvement. All patients completed Agachan–Wexner’s questionnaire at 0 and 12 months of follow-up to evaluate bowel symptoms. Results: A total of 73 cases were randomized into the RSC group (36 cases) and TVMLP group (37 cases). After surgery, the main POP-Q stage in both groups was stage I (RCS 80.5% vs. TVMLP 82%). There was a significant difference (p < 0.05) in postoperative anal sphincter tone: 35%. The TVMLP group experienced a hypertonic anal sphincter, while none of the RSC group did. Regarding subjective improvement, the median PGI-I was 1 in both groups. At 12 months of follow-up, both groups exhibited a significant improvement in bowel symptoms. Conclusions: RSC and TVMLP successfully corrected multicompartment POP. RSC showed a greater improvement in the total Agachan–Wexner score and lower bowel symptoms.
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