•Despite the available treatments, relief of symptoms of vulvovaginal atrophy in postmenopausal women remains unsatisfactory.•A better knowledge of the association between treatments, quality of life ...and symptoms may help disease management.•Postmenopausal women with vulvovaginal atrophy receiving treatment complained of higher number and more severe symptoms.•Women on systemic treatment had fewer and milder symptoms and presented with better vaginal and vulvar health.•The treatment of vulvovaginal atrophy should be initiated at early stages of the disease to prevent irreversible changes.
To evaluate the association between treatments for vulvovaginal atrophy (VVA) and symptom frequency and severity, quality of life (QoL) and sexual functioning in postmenopausal women.
Cross-sectional survey conducted in postmenopausal women aged 45–75 years. Data on demographic and clinical variables, as well as vaginal, vulvar and urinary symptoms were collected. The EuroQoL questionnaire (EQ5D3L), the Day-to-Day Impact of Vaginal Aging (DIVA), the Female Sexual Function Index (FSFI) and the Female Sexual Distress Scale - revised (FSDS-R) were filled out.
Association between treatments for VVA and symptom frequency.
Women on VVA treatment presented with more severe symptoms. The sexual function score was higher in the treated women (FSFI: 15.6 vs 16.7; p = 0.010), as was the score for sexual distress (FSDS-R: 9.2 vs 12.3, p < 0.0005). The systemic hormone group presented with fewer VVA symptoms, lower vaginal impact (DIVA), and better sexual function (FSFI and FSDS-R) and vaginal health. The rates of sexual distress and vulvar atrophy were higher in the non-hormonal treatment group. No significant differences were found according to treatment duration.
Postmenopausal women with VVA receiving treatment complained of more severe symptoms than those untreated. Women on systemic treatment had fewer and milder VVA symptoms and presented with better vaginal and vulvar health than women on other treatments. Many women request effective local treatment too late, when VVA symptoms are already severe. Our data suggest that VVA treatments should ideally be initiated when symptoms commence and cause distress, rather than later, when symptoms may have become more severe and even a cause of intolerable distress for the woman.
About 40% of invasive group B streptococcal (GBS) isolates are capsular polysaccharide (CPS) types Ia or Ib. Because infant and maternal GBS infections may be preventable by maternal vaccination, ...individual GBS CPS have been coupled to tetanus toxoid (TT) to prepare vaccines with enhanced immunogenicity. Immunogenicity in rabbits and protective capacity in mice of a series of type Ia- and Ib-TT conjugates increased with the degree of polysaccharide-to-protein cross-linking. In total, 190 healthy, nonpregnant women aged 18–40 years were randomized in four trials to receive Ia- or Ib-TT conjugate (dose range, 3.75–63 μg of CPS component), uncoupled Ia or Ib CPS, or saline. All vaccines were well-tolerated. CPS-specific IgG serum concentrations peaked 4–8 weeks after vaccination and were significantly higher in recipients of conjugated than of uncoupled CPS. Immune responses to the conjugates were dose-dependent and correlated in vitro with opsonophagocytosis. These results support inclusion of Ia- and Ib-TT conjugates when formulating a multivalent GBS vaccine.
Planck intermediate results Adam, R; Aghanim, N; Ashdown, M ...
Astronomy and astrophysics (Berlin),
12/2016, Volume:
596
Journal Article
Peer reviewed
Open access
We investigate constraints on cosmic reionization extracted from the Planck cosmic microwave background (CMB) data. We combine the Planck CMB anisotropy data in temperature with the low-multipole ...polarization data to fit LambdaCDM models with various parameterizations of the reionization history. We obtain a Thomson optical depth tau= 0.058 + or - 0.012 for the commonly adopted instantaneous reionization model. This confirms, with data solely from CMB anisotropies, the low value suggested by combining Planck 2015 results with other data sets, and also reduces the uncertainties. We reconstruct the history of the ionization fraction using either a symmetric or an asymmetric model for the transition between the neutral and ionized phases. To determine better constraints on the duration of the reionization process, we also make use of measurements of the amplitude of the kinetic Sunyaev-Zeldovich (kSZ) effect using additional information from the high-resolution Atacama Cosmology Telescope and South Pole Telescope experiments. The average redshift at which reionization occurs is found to lie between z= 7.8 and 8.8, depending on the model of reionization adopted. Using kSZ constraints and a redshift-symmetric reionization model, we find an upper limit to the width of the reionization period of Deltaz< 2.8. In all cases, we find that the Universe is ionized at less than the 10% level at redshifts above z = 10. This suggests that an early onset of reionization is strongly disfavoured by the Planck data. We show that this result also reduces the tension between CMB-based analyses and constraints from other astrophysical sources.
Background. Infections caused by group B streptococcal (GBS) type V are increasingly common. Capsular polysaccharide (CPS)-protein conjugate GBS vaccines are immunogenic in healthy adults, but type V ...vaccines have not previously been tested. Methods. Thirty-five healthy, nonpregnant women were randomized to receive an intramuscular dose of GBS type V CPS-tetanus toxoid (TT) vaccine (n=15), GBS type V CPS-cross-reactive material (CRM197) conjugate vaccine (n=15), or placebo (n=5) (double-masked design). Levels of serum antibodies to type V CPS were measured by ELISA, and functional activity was measured by opsonophagocytosis. Results. The vaccines were well tolerated. Significant increases in type V CPS-specific immunoglobulin G (IgG) were elicited by both vaccines, peaking at 4*8 weeks and persisting for 26 weeks. Four-fold or greater increases in type V CPS*specific IgG concentrations were noted in postimmunization serum samples obtained from 93% of subjects in each vaccine group. These concentrations persisted in ⩾85% of conjugate-vaccine recipients 104 weeks later. Type V CPS*specific immunoglobulin M was a dominant isotype of immune response to each conjugate. Postimmunization serum samples promoted opsonophagocytic killing of GBS type V in vitro, whereas those from placebo recipients did not. Conclusion. GBS type V conjugate vaccines are safe and immunogenic and would be appropriate for inclusion in a candidate multivalent GBS vaccine.
To determine whether 2 monovalent group B streptococcus (GBS) serotype II or III capsular polysaccharide (CPS)-tetanus toxoid (TT) conjugate vaccines combined in a single intramuscular dose would ...elicit immune responses comparable to those of monovalent vaccines, 75 healthy adults were randomized to receive GBS II-TT (3.6 µg of CPS), GBS III-TT (12.5 µg of CPS), or a bivalent mixture of GBS II-TT/III-TT vaccine (double-masked design). Vaccines were well tolerated. Four-fold or greater increases in GBS II or III CPS-specific IgG, respectively, were noted in postimmunization serum samples from 80%–90% of bivalent conjugate vaccine recipients, and these responses were similar to those of recipients of GBS II-TT or GBS III-TT monovalent vaccines. Immune serum samples promoted the opsonophagocytic killing of types II and III GBS in vitro. Unexpectedly, some recipients of these vaccines developed cross-reactive antibodies to the structurally similar heterologous polysaccharide. These results support the feasibility of a multivalent vaccine for the 5 prevalent invasive disease-causing GBS CPS serotypes.
The authors reply to the comment by R. P. Steer discussing the reasons for their incorrect assignment of the luminescence decay of the novel compound ...5,10,15-(triphenyl),20-ethynyl-(4-carboxy)phenyltetrabenzoporphyrinate Zn(ii) (PETBP). Further DFT and TDDFT calculations have been performed on the compound to investigate the possibility of a direct S
-S
decay instead of a S
-S
conversion with a subsequent emission to the ground state. In addition, the presence of traces of very luminescent contaminants of the ring-opened type has been considered on the grounds of calculated absorption and fluorescence spectra. The results of these investigations confirm that the S
-S
emission reported in the commented paper is not attributable to the target molecule but rather to a neglected luminescent impurity.
Introduction
Due to established teratogenicity of valproates, the EU risk minimisation measures (RMMs) with a pregnancy prevention programme (PPP) for valproate were updated in March 2018.
Objectives
...To investigate the effectiveness of the 2018 EU RMMs on valproate utilisation in five European countries/regions.
Methods
A multi-database, times series study of females of childbearing potential (12–55 years) was conducted using electronic medical records from five countries/regions (01.01.2010–31.12.2020): Denmark, Tuscany (Italy), Spain, the Netherlands, and the UK. Clinical and demographic information from each database was transformed to the ConcePTION Common Data Model, quality checks were conducted and a distributed analysis was performed using common scripts. Incident and prevalent use of valproate, proportion of discontinuers and switchers to alternative medicine, frequency of contraception coverage during valproate use, and occurrence of pregnancies during valproate exposure were estimated per month. Interrupted time series analyses were conducted to estimate the level or trend change in the outcome measures.
Results
We included 69,533 valproate users from 9,699,371 females of childbearing potential from the five participating centres. A significant decline in prevalent use of valproates was observed in Tuscany, Italy (mean difference post-intervention −7.7%), Spain (−11.3%), and UK (−5.9%) and a non-significant decline in the Netherlands (−3.3%), but no decline in incident use after the 2018 RMMs compared to the period before. The monthly proportion of compliant valproate prescriptions/dispensings with a contraceptive coverage was low (<25%), with an increase after the 2018 RMMs only in the Netherlands (mean difference post-intervention 12%). There was no significant increase in switching rates from valproates to alternative medicine after the 2018 intervention in any of the countries/regions. We observed a substantial number of concurrent pregnancies during valproate exposure, but with a declining rate after the 2018 RMMs in Tuscany, Italy (0.70 per 1000 valproate users pre- and 0.27 post-intervention), Spain (0.48 and 0.13), the Netherlands (0.34 and 0.00), and an increasing rate in UK (1.13 and 5.07).
Conclusion
There was a small impact of the 2018 RMMs on valproate use in the studied European countries/regions. The substantial number of concurrent pregnancies with valproate exposure warrants a careful monitoring of implementation of the existing PPP for valproate in clinical practice in Europe, to see if there is any need for additional measures in the future.
Estimates of the association between COVID-19 vaccines and myo-/pericarditis risk vary widely across studies due to scarcity of events, especially in age- and sex-stratified analyses.
...Population-based cohort study with nested self-controlled risk interval (SCRI) using healthcare data from five European databases. Individuals were followed from 01/01/2020 until end of data availability (31/12/2021 latest). Outcome was first myo-/pericarditis diagnosis. Exposures were first and second dose of Pfizer, AstraZeneca, Moderna, and Janssen COVID-19 vaccines. Baseline incidence rates (IRs), and vaccine- and dose-specific IRs and rate differences were calculated from the cohort The SCRI calculated calendar time-adjusted IR ratios (IRR), using a 60-day pre-vaccination control period and dose-specific 28-day risk windows. IRRs were pooled using random effects meta-analysis.
Over 35 million individuals (49·2% women, median age 39-49 years) were included, of which 57·4% received at least one COVID-19 vaccine dose. Baseline incidence of myocarditis was low. Myocarditis IRRs were elevated after vaccination in those aged < 30 years, after both Pfizer vaccine doses (IRR = 3·3, 95%CI 1·2-9.4; 7·8, 95%CI 2·6-23·5, respectively) and Moderna vaccine dose 2 (IRR = 6·1, 95%CI 1·1-33·5). An effect of AstraZeneca vaccine dose 2 could not be excluded (IRR = 2·42, 95%CI 0·96-6·07). Pericarditis was not associated with vaccination.
mRNA-based COVID-19 vaccines and potentially AstraZeneca are associated with increased myocarditis risk in younger individuals, although absolute incidence remains low. More data on children (≤ 11 years) are needed.
Planck intermediate results Adam, R; Ade, P A R; Alves, M I R ...
Astronomy and astrophysics (Berlin),
12/2016, Volume:
596
Journal Article
Peer reviewed
Open access
Recent models for the large-scale Galactic magnetic fields in the literature have been largely constrained by synchrotron emission and Faraday rotation measures. We use three different but ...representative models to compare their predicted polarized synchrotron and dust emission with that measured by the Planck satellite. We first update these models to match the Planck synchrotron products using a common model for the cosmic-ray leptons. We discuss the impact on this analysis of the ongoing problems of component separation in the Planck microwave bands and of the uncertain cosmic-ray spectrum. In particular, the inferred degree of ordering in the magnetic fields is sensitive to these systematic uncertainties, and we further show the importance of considering the expected variations in the observables in addition to their mean morphology. We then compare the resulting simulated emission to the observed dust polarization and find that the dust predictions do not match the morphology in the Planck data but underpredict the dust polarization away from the plane. We modify one of the models to roughly match both observables at high latitudes by increasing the field ordering in the thin disc near the observer. Though this specific analysis is dependent on the component separation issues, we present the improved model as a proof of concept for how these studies can be advanced in future using complementary information from ongoing and planned observational projects.
The aim of the present study was to evaluate the effectiveness of the ultramicronized-palmitoylethanolamide (um-PEA) and co-micronised palmitoylethanolamide/polydatin m(PEA/PLD) in the management of ...chronic pelvic pain related to endometriosis in patients desiring pregnancy.
Thirty symptomatic women with laparoscopic diagnosis of endometriosis and pregnancy desire were enrolled. Patients were treated with um-PEA twice daily for 10 days followed by m(PEA/PLD) twice daily for 80 days. Intensity of chronic pelvic pain, dyspareunia, dysmenorrhea, dyschezia, and dysuria were evaluated at baseline, after 10, 30, 60, 90 days and after 30 days from the end of treatment, by VAS. Quality of life and women's psychological well-being were evaluated at baseline and at the end of the treatment after 90 days with 36-Item Short Form Health Survey questionnaire and Symptom Check list-90 questionnaire, respectively. All collected data were analyzed with the non-parametric Wilcoxon test.
At the end of the treatment, all patients showed a significant improvement in chronic pelvic pain, deep dyspareunia, dysmenorrhea, dyschezia, as well as in quality of life and psychological well-being.
In spite of the study's limited sample size and the open-label design, this research suggests the efficacy of um-PEA and m(PEA/PLD) in reducing painful symptomatology and improving quality of life as well as psychological well-being in patients suffering from endometriosis. Additionally, this treatment did not show any serious side effect, proving particularly suitable for women with pregnancy desire and without other infertility factors.
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