Juvenile lupus, cytomegalovirus infection and cardiac tamponade: case report

ABSTRACT Objective: To describe a rare case of cardiac tamponade in a pediatric patient with systemic lupus erythematosus (SLE) and cytomegalovirus (CMV) infection, and to discuss the relationship between these morbidities, the diagnostic approach, and the possible treatments. Case description: A 9-year-old girl presented to the emergency department with severe dyspnea, muffled heart sounds, jugular vein distention, hemodynamic instability, and intense pallor. She had previously been followed up at the outpatient clinic for a six-month history of mild respiratory distress, polyarthritis, fever, and various cutaneous manifestations. Doppler echocardiogram revealed pericardial effusion. The patient was submitted to pericardiocentesis followed by water seal pleuropericardial drainage, with no complications. The investigation continued, with fulfillment of clinical and laboratory SLE criteria plus CMV antigenemia of 15/200,000 cells. Medications to control CMV infection and SLE were then initiated, with good clinical and laboratory response. Comments: Pediatric SLE commonly manifests in a more severe form, accounting for high morbimortality. Cardiac tamponade could be one of the first manifestations of SLE, which can also be precipitated by infectious agents, such as CMV, leading to diagnostic confusion and misleading the treatment. Changes in therapeutics must also be considered in the presence of both conditions. This study presents a juvenile SLE case aggravated by a CMV infection with the unusual manifestation of cardiac tamponade.%

Effects of Herbst Appliance Treatment on the Mandibular Incisor Segment: a Three-Dimensionally Analysis

Three-dimensionally evaluation of the treatment changes of a Herbst appliance using a lower anchorage unit not touching the lingual surface of the lower incisors. The sample consisted of 23 Class II:1 patients (12 males, 11 females) with a mean age of 15.7±1.7 years treated with a Flip-Lock Herbst® appliance (TP Orthodontics, Inc., La Porte, IN, USA). The lower anchorage unit for the Herbst appliance consisted of two anchor bands connected by a lingual arch with 3mm distance from the incisor’s lingual surface. Treatment changes in mandibular incisor inclination, overjet and overbite were evaluated by means of cone beam computed tomography images (i-CAT® Classic unit, Imaging Sciences International, Hatfield, PA, USA) obtained before and after treatment with the Herbst appliance. On average, there was a statistically significant increase in mandibular incisor inclination (2.6+1.8°) and a reduction in overjet (3.2+2.2mm) and overbite (1.3+0.9mm). Genders did not differ significantly. Incisor proclination was however only seen in 74% of the patients. The changes in mandibular incisor inclination were associated with the changes in overjet (/r/ = 0.1 to 0.5) and overbite (/r/ = 0.3 to 0.7). A Herbst appliance with a mandibular anchorage unit distant from the incisor’s lingual surface results in smaller amounts of mandibular incisor proclination compared to literature. However, as it induces canine anchorage loss, the decreased amount of proclination may not prevail after multibracket treatment. Keywords: Cone-Beam Computed Tomography. Mandibular Advancement. Tooth Movement Techniques. ResumoAvaliação tridimensional das alterações induzidas pelo aparelho Herbst utilizando a unidade de ancoragem inferior afastada da superfície lingual dos incisivos. A amostra incluiu 23 pacientes Classe II:1 (12 masculino, 11 feminino), média de idade 15,7 ± 1,7, tratados com aparelho Herbst Flip-Lock® (TP Orthodontics, Inc., La Porte, IN, EUA). A unidade de ancoragem inferior do aparelho Herbst consistiu-se de duas bandas conectadas por um arco lingual afastado 3mm da superfície lingual do incisivo. As alterações induzidas pelo tratamento na inclinação dos incisivos inferiores, trespasse horizontal e trespasse vertical foram avaliadas por meio de imagens de tomografias computadorizadas de feixe cônico (i-CAT® Classic unit, Imaging Sciences International, Hatfield, PA, USA) obtidas antes e após o tratamento com aparelho Herbst. Na média, houve diferença significativa com aumento da inclinação dos incisivos inferiores (2,6+1,8°) e diminuição do trespasse horizontal (3,2+2,2mm) e do trespasse vertical (1,3+0,9mm). Não houve diferença estatística entre os sexos. No entanto, a vestibularização do incisivo ocorreu em apenas 74% dos pacientes. As alterações na inclinação dos incisivos inferiores apresentam correlação estatisticamente significativa com as alterações no trepasse horizontal (/r/ = 0,1 a 0,5) e no trespasse vertical (/r/ = 0,3 a 0,7). O aparelho Herbst com uma unidade de ancoragem inferior afastada da superfície lingual dos incisivos resulta em menor quantidade de vestibularização do incisivo inferior em comparação com a literatura. Entretanto, como isto induz perda de ancoragem do canino, a diminuição da vestibularização pode não prevalecer ao final tratamento ortodôntico com braquetes. Palavras-chave: Tomografia Computadorizada de Feixe Cônico. Avanço Mandibular. Técnicas de Movimentação Dentária.

Outcomes Based on Plasma Biomarkers for the Phase 3 CELESTIAL Trial of Cabozantinib versus Placebo in Advanced Hepatocellular Carcinoma

<b><i>Introduction:</i></b> Cabozantinib, an inhibitor of MET, AXL, and VEGF receptors, significantly improved overall survival (OS) and progression-free survival (PFS) versus placebo in patients with previously treated advanced hepatocellular carcinoma (HCC). In this exploratory analysis, outcomes were evaluated according to plasma biomarker levels. <b><i>Methods:</i></b> Baseline plasma levels were evaluated for MET, AXL, VEGFR2, HGF, GAS6, VEGF-A, PlGF, IL-8, EPO, ANG2, IGF-1, VEGF-C, and c-KIT for 674/707 randomized patients; and Week 4 levels were evaluated for MET, AXL, VEGFR2, HGF, GAS6, VEGF-A, PlGF, IL-8, and EPO for 614 patients. OS and PFS were analyzed by baseline levels as dichotomized or continuous variables and by on-treatment changes at Week 4 as continuous variables; biomarkers were considered potentially prognostic if <i>p</i> &#x3c; 0.05 and predictive if <i>p</i> &#x3c; 0.05 for the interaction between treatment and the biomarker. Multivariable analyses adjusting for clinical covariates were also performed. <b><i>Results:</i></b> In the placebo group, high levels of MET, HGF, GAS6, IL-8, and ANG2 and low levels of IGF-1 were associated with shorter OS in univariate and multivariable analyses; these associations were also observed for MET, IL-8, and ANG2 in the cabozantinib group. Hazard ratios for OS and PFS favored cabozantinib over the placebo at low and high baseline levels for all biomarkers. No baseline biomarkers were predictive of a treatment benefit. Cabozantinib promoted pharmacodynamic changes in several biomarkers, including increases in VEGF-A, PlGF, AXL, and GAS6 levels and decreases in VEGFR2 and HGF levels; these changes were not associated with OS or PFS. <b><i>Conclusion:</i></b> Cabozantinib improved OS and PFS versus placebo at high and low baseline concentrations for all biomarkers analyzed. Low baseline levels of MET, HGF, GAS6, IL-8, and ANG2 and high levels of IGF-1 were identified as potential favorable prognostic biomarkers for survival in previously treated advanced HCC. Although cabozantinib promoted pharmacodynamic changes in several biomarkers, these changes were not associated with survival.

Clinical efficacy of Tailin formulation combined with continuous low-dose antimicrobial therapy for recurrent urinary tract infection: study protocol for a multicenter, double-blind, randomized, controlled clinical trial

Background Given the increasing rates of antimicrobial resistance (AMR), recurrent urinary tract infection (rUTI) is becoming refractory more and more. Antibiotic prophylaxis including continuous low-dose antibiotic therapy (CLAT), is the common treatment for rUTI of the world. However, the presumably adverse reactions caused by CLAT alone should be paid more attention. Studies indicated that Chinese herbal medicine (CHM) might be an available treatment method for rUTI. Tailin formulation (TLF) is a herbal prescription developed for the treatment of rUTI in the 2000s in Shanghai Municipal Hospital of Traditional Chinese Medicine. Our previous studies have shown TLF could prevent urinary tract infection both in pyelonephritis (PN) rat model and in PN patients. Additionally, our published data demonstrated TLF is helpful to reduce the recurrence of rUTI and protect renal tubular function in clinic. In order to find a novel treating project for rUTI to increase the clinical curative effect, we thus try to combine TLF with CLAT to treat rUTI and design an optimized, pragmatically clinical trial to evaluate the efficacy and safety of this project. Methods/design This is a multicenter, double-blind, randomized, controlled clinical trial. We will enroll 200 eligible patients diagnosed with uncomplicated rUTI and then divide them randomly into two groups with a 1:1 ratio: TLF + CLAT group and placebo + CLAT group. This trial consists of two stages, a 12-week period of treatment and a 12-week period of post-treatment follow-up, respectively. The primary outcome will be the recurrence rate at the 12th week of the follow-up period; the second outcomes will be the post-treatment changes in renal and liver function; furthermore, traditional Chinese medicine (TCM) symptoms, non-infection-related physical signs, and subjective symptoms will be scored, and the number of episodes of each subject will be also recorded; meanwhile, vital signs indicators and serious adverse events (SAEs) will be monitored throughout the trial. Discussion This study will provide convictive research-derived data to evaluate clinical efficacy and safety of TLF combined with CLAT for rUTI, and provide an evidence-based recommendation for clinicians. Moreover, post-treatment changes in non-infection-related physical signs and subjective symptoms were included in the efficacy evaluation, which is important and more significant for assessing the clinical benefits for those rUTI patients. Trial registration Chinese Clinical Trial Registry ChiCTR2100041914. Registered on 10 January 2021. Protocol date and version: September 12, 2020; version 1.

Implementation of the Treat-to-Target Concept in Evaluation of Psoriatic Arthritis Patients

Background: The treat-to-target approach was recently adopted for psoriatic arthritis (PsA) management. Objective: To assess the implementation of the “treat-to-target” (T2T) concept in daily management of PsA by use of composite scores of disease activity versus clinical judgement alone. Methods: A total of 117 PsA patients from a longitudinal PsA cohort were enrolled consecutively in the study during each patient’s first clinic visit during 2016–2017. Clinic notes from the treating rheumatologist were reviewed by an independent rheumatologist, noting clinical impression of disease activity, treatment changes based on clinical judgement, and rationale. Treatment changes were then compared to the use of formal disease activity parameters in Minimal Disease Activity (MDA) and Disease Activity Index for Psoriatic Arthritis (DAPSA) composite measures. All associations were assessed using the chi-square test or the Mann–Whitney test, as appropriate. Results: The 117 PsA patient cohort consisted of 65.5% women, mean age 58.4 ± 13.6 years. Clinical judgement of treating rheumatologist concorded with MDA and DAPSA in 76 (65.5%) and 74 (64.9%) patients, respectively. Agreement between clinical judgement and composite measure criteria did not correlate with patient age, sex, alcohol/tobacco use, or treatment regimens chosen. Disagreement between physician assessment and MDA occurred in 40 (34.5%) cases: in 30 cases, the MDA status was overestimated due to disregard of patient reported outcomes (PRO), while underestimation of MDA status occurred in 25% of cases with treatment changes made in patients with a single active joint or enthesis. Underestimation of disease activity using DAPSA occurred in 22 cases and could be attributed to disregarding tender joint count, patient pain visual analogue scale and C-reactive protein level. Conclusion: In our cohort, agreement between clinical impression and formal composite measure utilization for implementation of T2T strategy occurred in 65% of patients. Discordance resulted from physicians’ overlooking PRO and emphasizing objective findings when using clinical judgement alone.

Finding suitable candidates for vacuum bell therapy in pectus excavatum patients

Vacuum bell therapy has been acceptable substitute for pectus excavatum patients who want to improve their appearance but avoid surgical correction. The aim of this study was to assess the pre-treatment characteristics of patients with pectus excavatum and to establish characteristics that can potentially help identify ideal candidates for vacuum bell therapy. Expected improvements in thoracic indices were evaluated using pre-treatment chest computed tomography, which was performed before and after applying a vacuum bell device. Treatment results after 1-year of application were evaluated using changes in the Haller index before and after treatment. The patients were categorized into two groups according the post- treatment changes in Haller index calculated using chest radiographs: those with changes in Haller index less than 0.5 (Group 1) and those with greater than or equal to 0.5 (Group 2). Pre-treatment Haller index was significantly lower in Group 1 than in Group 2 (3.1 ± 0.46 vs. 4.2 ± 1.14, respectively, p < 0.001). The expected improvement in Haller index in Group 2 was significantly higher than that in Group 1 (3.3 ± 0.60 vs. 2.8 ± 0.54, respectively, p = 0.001). The cut-off value of the expected improvement in Haller index was 0.46 with a sensitivity of 75.8% and a specificity of 83.3%. Patients who demonstrated pliability with a vacuum bell were identified as suitable candidates.

Riding the COVID Waves: Clinical Trends, Outcomes, and Remaining Pitfalls of the SARS-CoV-2 Pandemic: An Analysis of Two High-Incidence Periods at a Hospital in Northern Italy

Background. Italy was the first western country to face an uncontrolled outbreak of SARS-CoV-2 infection. The epidemic began in March 2020 within a context characterised by a general lack of knowledge about the disease. The first scientific evidence emerged months later, leading to treatment changes. The aim of our study was to evaluate the effects of these changes. Methods. Data from a hospital in Genoa, Italy, were analysed. Patients deceased from SARS-CoV-2 infection were selected. Data were compared by dividing patients into two cohorts: “phase A” (March–May 2020) and “phase B” (October–December 2020). Results. A total of 5142 patients were admitted. There were 274 SARS-CoV-2-related deaths (162 phase A and 112 phase B). No differences were observed in terms of demographics, presentation, or comorbidities. A significant increase was recorded in corticosteroid use. Mortality was 33.36% during phase A, falling to 21.71% during phase B. When subdividing the trend during the two phases by age, we found a difference in people aged 65–74 years. Conclusions. There is scarce evidence regarding treatment for SARS-CoV-2 (especially for severe infection). However, treatment changes improved the prognosis for people under the age of 75. The prognosis for older people remains poor, despite the improvements achieved.