Intravaginal nonablative radiofrequency in the treatment of genitourinary syndrome of menopause symptoms: a single-arm pilot study.

BACKGROUND: Genitourinary syndrome of menopause (GSM) involves vaginal dryness (VD), pain during sexual activity (SAPain), vaginal itching (VI), burning, pain, and symptoms in the urinary organs. Non-ablative radiofrequency (RF) is a type of current with electromagnetic waves with a thermal effect that generates an acute inflammatory process with consequent neocolagenesis and neoelastogenesis. We aimed to describe the clinical response to VD, SAPain, vaginal laxity (VL), VI, burning sensation, pain in the vaginal opening, urinary incontinence, sexual dysfunction, cytological changes, and adverse effects of non-ablative RF in patients with GSM. METHODS: This single-arm pilot study included 11 women diagnosed with GSM with established menopause. Patients with hormone replacement initiation for six months, who used a pacemaker, or had metals in the pelvic region, were excluded. Subjective measures (numeric rating scale of symptoms, Vaginal Health Index-VHI) and objective measures (vaginal maturation index-VMI, vaginal pH, sexual function by the FSFI, and urinary function by the ICIQ-SF) were used. A Likert scale measures the degree of satisfaction with the treatment. Five sessions of monopolar non-ablative RF (41°C) were performed with an interval of one week between each application. The entire evaluation was performed before treatment (T0), one month (T1), and three months (T2) after treatment. Adverse effects were assessed during treatment and at T1 and T2. RESULTS: The symptoms and/or signs were reduced after treatment in most patients (T1/T2, respectively): VD 90.9%/81.8%, SAPain 83.3%/66.7, VL 100%/100%, VI 100%/100%, burning 75%/87.5%, pain 75%/75%, and VHI 90.9%/81.9%. Most patients did not show changes in VMI (54.5%) and pH (63.6%) at T1, but there was an improvement in VMI in most patients (54.5%) at T2. Nine patients were satisfied, and two were very satisfied at T1. The treatment was well tolerated, and no adverse effects were observed. There was an improvement in sexual function (72.7%) and urinary function (66.7% in T1 and 83.3% in T2). CONCLUSION: Intravaginal RF reduced the clinical symptoms of GSM in most patients, especially during T1, and women reported satisfaction with treatment. The technique showed no adverse effects, and there were positive effects on sexual and urinary function. Trial registration This research was registered at clinicaltrial.gov (NCT03506594) and complete registration date was posted on April 24, 2018.

Comparison of oral amoxicillin given thrice or twice daily to children between 2 and 59 months old with non-severe pneumonia: a randomized controlled trial.

OBJECTIVES: Oral amoxicillin (50 mg/kg/day) thrice daily is the first-line therapy for non-severe childhood pneumonia. Compliance could be enhanced if two daily doses are employed. We assessed the equivalence of oral amoxicillin (50 mg/kg/day) thrice or twice daily in those patients. PATIENTS AND METHODS: This randomized (1 : 1), controlled, triple-blinded investigation conducted at one centre in Brazil included children aged 2-59 months with non-severe pneumonia diagnosed by trained paediatricians based on respiratory complaints and radiographic pulmonary infiltrate/consolidation. Participants were randomly assigned to receive one bottle (Amoxicillin 1) at 6 am, 2 pm and 10 pm and the other bottle (Amoxicillin 2) at 8 am and 8 pm: one bottle contained amoxicillin and the other placebo and vice versa. Only the pharmacist knew patients' allocation. Follow-up assessments were done at 2, 5 and 14 days after enrolment. Chest radiographs were read by three independent radiologists. Primary outcome was treatment failure (development of danger signs, persistence of fever, tachypnoea, development of serious adverse reactions, death and withdrawal from the trial) at 48 h. ClinicalTrials.gov: identifier NCT01200706. RESULTS: Four hundred and twelve and 408 participants received amoxicillin thrice or twice daily, respectively. Treatment failure was detected in 94 (22.8%) and 94 (23.0%) patients in intention-to-treat analysis (risk difference 0.2%; 95% CI: -5.5%-6.0%) and in 80 (20.1%) and 85 (21.3%) patients in per-protocol analysis (risk difference 1.2%; 95% CI: -4.4%-6.8%). Pneumonia was radiologically confirmed by concordant reading in 277 (33.8%) cases, among whom treatment failure was registered in 25/133 (18.8%) and 27/144 (18.8%) participants from the thrice and twice daily doses subgroups, respectively (risk difference -0.05%; 95% CI: -9.3%-9.2%). CONCLUSIONS: Oral amoxicillin (50 mg/kg/day) twice daily is as efficacious as thrice daily.

Incidence, aetiology and serotype coverage for pneumococcal vaccines of community-acquired pneumonia in adults: a population-based prospective active surveillance study in Brazil.

OBJECTIVES: To determine the incidence, aetiology and pneumococcal serotype distribution of community-acquired pneumonia (CAP) in Brazilian adults during a 2-year period. DESIGN: Prospective population-based surveillance study. SETTING: Patients from two emergency hospitals in Brazil were consecutively included in this study. PARTICIPANTS: A total of 111 adults aged 50 years and older with radiographically-confirmed CAP requiring an emergency department visit were prospectively enrolled between January 2018 and January 2020. MAIN OUTCOME MEASURES: Incidence rates of CAP were calculated according to age and pathogen. Pathogens were identified by conventional microbiological methods. Additionally, a novel, Luminex-based serotype specific urinary antigen detection assay was used to detect serotypes included in pneumococcal vaccines. RESULTS: Mean age of participants was 64 years and 31% were aged ≥70 years. Aetiology was established in 61 (57%) patients; among identified cases, the most common pathogens were Streptococcus pneumoniae (42/61, 69%) and influenza (4/61, 7%). Among serotypes identified from the 42 cases of pneumococcal CAP, estimated coverage ranged by pneumococcal vaccine formulations from 47.6% (13-valent), 59.5% (20-valent, licenced in the USA only) and 71.4% (23-valent). In patients with CAP, 20-valent pneumococcal vaccine serotypes were identified 2.5 times more frequently than 10-valent pneumococcal vaccine serotypes (22.5% vs 9.0%). The incidence rate for CAP in adults aged ≥50 years was 20.1 per 10 000 person-years. In general, the incidence of CAP increased consistently with age, reaching 54.4 (95% CI 36.8 to -76.6) per 10 000 in adults 80 years or older. CONCLUSIONS: We observed a high burden of pneumococcal CAP among adults in Brazil. Despite the routine immunisation of children and high-risk adults against pneumococcal disease in the Brazilian national vaccination programme, a persistent burden of pneumococcal CAP caused by vaccine serotypes remains in this population.

Infection by Streptococcus pneumoniae in children with or without radiologically confirmed pneumonia.

OBJECTIVE: Community-acquired pneumonia is an important cause of morbidity in childhood, but the detection of its causative agent remains a diagnostic challenge. The authors aimed to evaluate the role of the chest radiograph to identify cases of community-aquired pneumonia caused by typical bacteria. METHODS: The frequency of infection by Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis was compared in non-hospitalized children with clinical diagnosis of community acquired pneumonia aged 2-59 months with or without radiological confirmation (n=249 and 366, respectively). Infection by S. pneumoniae was diagnosed by the detection of a serological response against at least one of eight pneumococcal proteins (defined as an increase ≥2-fold in the IgG levels against Ply, CbpA, PspA1 and PspA2, PhtD, StkP-C, and PcsB-N, or an increase ≥1.5-fold against PcpA). Infection by H. influenzae and M. catarrhalis was defined as an increase ≥2-fold on the levels of microbe-specific IgG. RESULTS: Children with radiologically confirmed pneumonia had higher rates of infection by S. pneumoniae. The presence of pneumococcal infection increased the odds of having radiologically confirmed pneumonia by 2.8 times (95% CI: 1.8-4.3). The negative predictive value of the normal chest radiograph for infection by S. pneumoniae was 86.3% (95% CI: 82.4-89.7%). There was no difference on the rates of infection by H. influenzae and M. catarrhalis between children with community-acquired pneumonia with and without radiological confirmation. CONCLUSIONS: Among children with clinical diagnosis of community-acquired pneumonia submitted to chest radiograph, those with radiologically confirmed pneumonia present a higher rate of infection by S. pneumoniae when compared with those with a normal chest radiograph.

Infection by Streptococcus pneumoniae in children with or without radiologically confirmed pneumonia / Infecção por Streptococcus pneumoniae em crianças com ou sem pneumonia radiologicamente confirmada

Abstract Objective: Community-acquired pneumonia is an important cause of morbidity in childhood, but the detection of its causative agent remains a diagnostic challenge. The authors aimed to evaluate the role of the chest radiograph to identify cases of community-aquired pneumonia caused by typical bacteria. Methods: The frequency of infection by Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis was compared in non-hospitalized children with clinical diagnosis of community acquired pneumonia aged 2-59 months with or without radiological confirmation (n = 249 and 366, respectively). Infection by S. pneumoniae was diagnosed by the detection of a serological response against at least one of eight pneumococcal proteins (defined as an increase ≥2-fold in the IgG levels against Ply, CbpA, PspA1 and PspA2, PhtD, StkP-C, and PcsB-N, or an increase ≥1.5-fold against PcpA). Infection by H. influenzae and M. catarrhalis was defined as an increase ≥2-fold on the levels of microbe-specific IgG. Results: Children with radiologically confirmed pneumonia had higher rates of infection by S. pneumoniae. The presence of pneumococcal infection increased the odds of having radiologically confirmed pneumonia by 2.8 times (95% CI: 1.8-4.3). The negative predictive value of the normal chest radiograph for infection by S. pneumoniae was 86.3% (95% CI: 82.4-89.7%). There was no difference on the rates of infection by H. influenzae and M. catarrhalis between children with community-acquired pneumonia with and without radiological confirmation. Conclusions: Among children with clinical diagnosis of community-acquired pneumonia submitted to chest radiograph, those with radiologically confirmed pneumonia present a higher rate of infection by S. pneumoniae when compared with those with a normal chest radiograph.

Resumo Objetivo: Avaliar o papel do raios X de tórax na identificação de casos de pneumonia adquirida na comunidade (PAC) causada por agentes bacterianos. Métodos: A frequência de infecção por Streptococcus pneumoniae, Haemophilus influenzae e Moraxella catarrhalis em crianças com PAC não hospitalizadas foi comparada com a presença de confirmação radiológica da pneumonia (n = 249 crianças com pneumonia radiologicamente confirmada e 366 crianças com raios X de tórax normal). Infecção por S. pneumoniae foi diagnosticada com base na resposta sorológica a pelo menos uma dentre oito proteínas pneumocócicas investigadas (aumento ≥ 2 vezes nos níveis de IgG em relação a Ply, CbpA, PspA1 e 2, PhtD, StkP-C e PcsB-N ou aumento≥ 1,5 vez em relação aPcpA). Infecção por H. influenzae e M. catarrhalis foi definida por aumento ≥ 2 vezes nos níveis de IgG específica a antígenos de cada agente. Resultados: Crianças com pneumonia radiologicamente confirmada apresentaram maior taxa de infecção pelo pneumococo. Além disso, a presença de infecção pneumocócica foi um fator preditor de pneumonia radiologicamente confirmada, o que aumenta sua chance de detecção em 2,8 vezes (IC 95%: 1,8-4,3). O valor preditivo negativo do raios X normal para a infecção por S. pneumoniae foi 86,3% (IC95%: 82,4%-89,7%). Não houve diferença nas frequências de infecção por H. influenzae e M. catarrhalis entre crianças com PAC com ou sem confirmação radiológica. Conclusão: Crianças com diagnóstico clínico de PAC submetidas a um raios X de tórax que apresentam confirmação radiológica têm maior taxa de infecção por S. pneumoniae comparadas com as crianças com raios X normal.

Infection by Streptococcus pneumoniae in children with or without radiologically confirmed pneumonia

O objetivo deste estudo foi avaliar o papel do raio-X de tórax na identificação de casos de pneumonia adquirida na comunidade (PAC) causada por agentes bacterianos.Métodos: A frequência de infecção por Streptococcus pneumoniae, Haemophilus influenzae e Moraxella catarrhalis em crianças com PAC não hospitalizadas foi comparada com a presença de confirmação radiológica da pneumonia (n = 249 crianas com pneumonia radiologicamente confirmada e 366 crianças com raio X de tórax normal). Infecção por S. pneumoniae foi diagnos-ticada com base na resposta sorológica a pelo menos uma dentre oito proteínas pneumocócicas investigadas (aumento ≥2 vezes nos níveis de IgG em relação a Ply, CbpA, PspA1 e 2, PhtD, StkP-C e PcsB-N ou aumento≥1,5 vezes em relação aPcpA). Infecção por H. influenzae e M.catarrhalis foi definida por aumento≥2 vezes nos níveis de IgG específica a antígenos de cada agente. Resultados: Crianças com pneumonia radiologicamente confirmada apresentaram maior taxa de infecção pelo pneumococo. Além disso, a presença de infecção pneumocócica foi um fatorpreditor de pneumonia radiologicamente confirmada, aumentando sua chance de detecção em 2,8 vezes (IC 95%: 1,8-4,3). O valor preditivo negative do raio X normal para a infecção por S. pneumoniae foi 86,3% (IC95%: 82,4%-89,7%). Não houve diferença nas frequências de infecção por H. influenzae e M. catarrhalis entre crianças com PAC com ou sem confirmação radiológica.Conclusões: Crianç¸as com diagnóstico clínico de PAC submetidas a um raio X de tórax que apresentam confirmação radiológica tem maior taxa de infecção por S. pneumoniae, comparado às crianças com raio X normal.

Clinical failure among children with nonsevere community-acquired pneumonia treated with amoxicillin.

OBJECTIVE: To estimate the clinical failure and adverse events in children with nonsevere pneumonia receiving amoxicillin, identifying risk factors. RESEARCH DESIGN/METHODS: 192 patients aged 2 - 59 months were prospectively followed up. Pneumonia diagnosis was based on respiratory complaints and radiographic pulmonary infiltrate or pleural effusion. Amoxicillin (50 mg/kg/day) was given. Demographic data and clinical findings on admission, daily evolution up to the 5th day of treatment and 2 - 4 weeks after enrollment were collected. MAIN OUTCOME MEASURES: Clinical failure included persistence of fever, difficulty breathing or tachypnea beyond the first 48 h of treatment or of cough beyond the first 96 h of treatment or sign of severe/very severe disease up to the 5th day of treatment. RESULTS: Amoxicillin failed in 6 (3.1%) cases. By excluding one child diagnosed with cystic fibrosis after continued follow-up, the final clinical failure rate was 2.6%. The total adverse effect frequency was 14 (7.3%), but amoxicillin was discontinued only in 1 (0.5%) case. No relapse was identified at the 2 - 4-week interval evaluation. By multivariate analysis, age (OR = 1.1; 95% CI 1.01 - 1.19) was an independent risk factor for clinical failure which occurred in older children (47 +/- 9 vs 31 +/- 16 months; p = 0.01). CONCLUSIONS: Clinical failures were few, especially among those aged < 2 years. Amoxicillin discontinuation due to adverse reaction was rare.