Incidence and risk factors for striae gravidarum Picard, Damien, MD, PhD; Sellier, Séverine, MD; Houivet, Estelle, PhD ...
Journal of the American Academy of Dermatology,
10/2015, Volume:
73, Issue:
4
Journal Article
Background Occupational exposure is reported as playing a substantial causative role in systemic sclerosis (SSc). Objective We sought to compare the characteristics of SSc in patients with and ...without occupational exposure to crystalline silica/solvents. Methods In all, 142 patients with SSc were enrolled in this prospective study. An expert committee performed blind evaluation of occupational exposure to crystalline silica/solvents. Results Patients exposed to crystalline silica more often exhibited: diffuse cutaneous SSc ( P = .02), digital ulcers ( P = .05), interstitial lung disease ( P = .0004), myocardial dysfunction ( P = .006), and cancer ( P = .06). Patients exposed to solvents more frequently developed: diffuse cutaneous SSc ( P = .001), digital ulcers ( P = .01), interstitial lung disease ( P = .02), myocardial dysfunction ( P = .04), and cancer ( P = .003); in addition, these patients were more frequently anti-Scl 70 positive and anticentromere negative. Under multivariate analysis, significant factors for SSc associated with exposure to silica/solvents were: male gender (odds ratio 19.31, 95% confidence interval 15.34-69.86), cancer (odds ratio 5.97, 95% confidence interval 1.55-23.01), and digital ulcers (odds ratio 2.42, 95% confidence interval 1.05-5.56). Limitations The cohort originated from a single geographic region. Conclusion Occupational exposure to crystalline silica/solvents is correlated with more severe forms of SSc characterized by: diffuse cutaneous involvement, interstitial lung disease, general microangiopathy (digital ulcers and myocardial dysfunction), and association with cancer. Occupational exposure should be systematically checked in all patients with SSc, as exposed patients seem to develop more severe forms of SSc.
Older age and the use of bilateral internal thoracic artery (ITA) grafting are both considered risk factors for surgical wound infection (SWI) after coronary artery bypass grafting (CABG). The 2014 ...European Guidelines recommend that bilateral ITA grafting should be considered in patients aged younger than 70 years. Our aim was to investigate interaction between age and the number of ITA grafts.
All patients aged 18 years and older who had undergone CABG with at least 1 ITA at Rouen University Hospital between 2001 and 2012 were selected. Data regarding surgical procedure (single/bilateral ITA grafting) were extracted from the medical information system. SWI was identified from prospective surveillance of patients according to Centers for Disease Control and Prevention criteria. Independent factors associated with SWI were assessed by logistic regression, and an interaction test between age (≤69 or ≥70 years) and the number of ITA grafts was performed.
SWI occurred in 71 of 2,726 patients (2.6%). Bilateral ITA grafting was associated with SWI (adjusted odds ratio aOR, 2.55; 95% confidence interval, 1.51 to 4.30). After fitting an interaction term between age and number of ITA grafts, the aORs for SWI after bilateral ITA grafting substantially differed between patients aged 69 years and younger (aOR, 1.88; 95% confidence interval, 0.94 to 3.75) and 70 years and older (aOR, 3.52; 95% confidence interval, 1.69 to 7.33). However, this interaction failed to reach statistical significance (p = 0.2213), possibly because of insufficient statistical power (23.5%) despite the large sample size.
Age 70 years and older compared with age 69 years and younger was associated with higher occurrence of SWI after bilateral ITA grafting, but this interaction was not statistically significant. Larger studies are needed to test this interaction.
In a French randomized trial, children at school-age demonstrated no evidence of harm from fetal exposure to MgSO4 before very preterm birth. Motor dysfunction/death, qualitative behavioral ...disorders, cognitive difficulties, school grade repetition, and education services were decreased in the children exposed to MgSO4 , although the differences were not significant.
Objective To compare components of the fibrinolytic cascade in newborns of gestational age ranging from extreme prematurity to full term, at birth and for the next 10 days, and in their mothers at ...delivery. Study design We studied 10 extremely preterm neonates, 10 very preterm neonates, 10 moderately preterm neonates, 10 full-term neonates, and their mothers (n = 40). We measured the antigen levels of tissue-type plasminogen activator (t-PA), plasminogen activator inhibitors 1 (PAI-1) and 2 (PAI-2), and thrombin-activatable fibrinolysis inhibitor, as well as PAI-1 activity, in neonates at birth and on postnatal days 3 and 10 and in mothers at delivery. Results On day 10, both PAI-1 antigen and activity were higher in extremely preterm neonates than in full-term neonates ( P = .004 and <.0006, respectively), and the t-PA/PAI-1 activity ratio was lower in the extremely preterm and very preterm neonates compared with the full-term neonates ( P = .002 and .017, respectively). No significant differences in the fibrinolytic system components were seen among the 4 groups of mothers. Conclusions The development of fibrinolysis suppression in extremely preterm infants within 10 days after birth may contribute to the increased risk of periventricular hemorrhagic infarction in these infants.
Study objective Patients with acute cardiogenic pulmonary edema may develop respiratory failure. Noninvasive respiratory support should be initiated rapidly to avoid tracheal intubation. The aim of ...this study is to compare the efficacy of continuous positive airway pressure (CPAP) delivered by the Boussignac CPAP device and bilevel positive airway pressure (bilevel PAP) in patients with acute respiratory failure caused by acute cardiogenic pulmonary edema. Methods This prospective multicenter randomized study was conducted in 3 emergency departments. Patients were assigned to Boussignac CPAP through a facemask or to bilevel PAP, in addition to standard therapy. The main outcome was a combined criterion (tracheal intubation, death, or acute myocardial infarction). Complications, durations of ventilation, and hospitalization were also assessed. Results After 1 hour of ventilation and at the end of the ventilation period, clinical parameters of respiratory distress and blood gas exchange significantly improved in each treatment arm. No significant differences were observed between the Boussignac CPAP and bilevel PAP arms for the combined criterion (5% versus 12%, respectively; odds ratio OR 0.4; 95% confidence interval CI 0.0 to 1.9) and also for severe complications (9% versus 6%; OR 1.5; 95% CI 0.3 to 9.9), duration of ventilation (median for both groups 2 hours; interquartile range IQR 1.2 to 3.0 hours), duration of hospitalization (CPAP 8.5 IQR 6 to 14 days; bilevel PAP 10 IQR 7 to 16 days), or intrahospital mortality (8% versus 14%; OR 1.8 IQR 0.4 to 8.8). Similar results were obtained among hypercapnic patients (PaCO2 >45 mm Hg). Whatever the ventilation support used, the combined criterion and severe complications were more frequently observed among hypercapnic patients. Conclusion Both Boussignac CPAP and bilevel PAP appeared effective in rapidly improving respiratory distress even in hypercapnic patients, but they were not different in terms of patient outcome.
Background Omalizumab has been shown to decrease the risk of hospitalization or ED visits in patients with uncontrolled severe allergic asthma compared with placebo. This longitudinal study observed ...the conditions under which omalizumab is prescribed in real-life settings and assessed whether its use as an add-on therapy alongside standard treatments decreases the risk of severe asthmatic exacerbations. Methods A cohort of adult patients with uncontrolled severe asthma despite optimal treatment with inhaled and oral corticosteroids and a long-acting β2 -agonist but no treatment with omalizumab upon entry was assembled. Risk of hospitalization or ED visits for asthma exacerbation was assessed using the Andersen-Gill extension of the Cox model for repeated events, controlling for age, sex, smoking history, BMI, gastroesophageal reflux, allergic status, allergic rhinitis, treatment, and hospitalization or ED visits for asthma in the 2 months prior to omalizumab treatment. Results Overall, 163 physicians recruited 767 patients, of whom 374 took omalizumab at least once (mean observation period, 20.4 months). Omalizumab use was associated with an adjusted relative risk of 0.57 (95% CI, 0.43-0.78) for hospitalization or ED visits for asthma. In users of omalizumab, the adjusted relative risk of hospitalization or ED visits for asthma during omalizumab treatment vs nontreatment periods was 0.40 (95% CI, 0.28-0.58). Conclusions Add-on omalizumab is associated with a significantly decreased risk of hospitalization or ED visits in patients with uncontrolled severe asthma in real-life practice.
Background To evaluate the real-life impact of ezetimibe on cardiovascular (CV) morbidity and mortality in France. Objective To estimate the number of non-fatal and fatal CV events that could be ...prevented and corresponding number of patients needed to treat (NNT) with ezetimibe to prevent one CV event over 5 years. Methods Non-interventional 48-month follow-up cohort conducted in hypercholesterolemic patients starting on ezetimibe <3 months at study entry, either as monotherapy or combined with statins. Prediction modeling using discrete event simulation with calibrated Framingham CV risk equations was applied to data from pivotal clinical trials on ezetimibe and real-life data derived from the cohort. Results A total of 3215 patients in the cohort accumulated 9314 person-years of follow-up for an average of 2.9 years. Mean age was 61.5 (standard deviation SD = 10.7), 54.6% were males, and 27.0% had a history of CV disease. Baseline LDL-cholesterol averaged 4.1 mmol/L (159 mg/dL; SD = 1.0) and HDL-C 1.6 mmol/L (62 mg/dL; SD = 0.5). LDL-C decreased in the first 12 months in ezetimibe-LLT (lipid-lowering therapy) initiators, switchers (monotherapy), and combination therapy with a statin by respectively 21.3%, 6.4%, and 29.1%. The corresponding predicted rate reductions of CV events (non-fatal and fatal) compared to no treatment or to a statin (combination therapy) were respectively 8, 2, and 12 per 1000 patients treated over 5 years, with a global NNT of 143 patients over 5 years. Conclusion These results, accounting for observed CV event rates, risk factors evolution over time and adherence to treatment in real life, were consistent with those from clinical trials.
Summary Background Outer-membrane-vesicle vaccines for meningococcal B outbreaks are complex and time consuming to develop. We studied the use of already available vaccine to control an outbreak ...caused by a genetically close strain. Methods From 2006 to 2009, all individuals younger than 20 years living in the region of Normandy, France, in which an outbreak caused by a B:14:P1.7,16 strain occurred, were eligible to receive MenBvac, a Norwegian vaccine designed 20 years earlier against a strain sharing the same serosubtype (B:15:P1.7,16). The immunogenicity (in a randomly selected cohort of 400 children aged 1–5 years), safety, and epidemiological effect of the vaccination were assessed. Findings 26 014 individuals were eligible to receive the vaccine. Shortage of vaccine production prompted start of the campaign in the highest incidence groups (1–5 years). 16 709 (64%) received a complete vaccination schedule of whom 13 589 (81%) received a 2+1 dose schedule (week 0, week 6, and month 8). At 6 weeks after the third dose, of 235 vaccinees for whom samples were available, 206 (88%) had a seroresponse, and 108 (56 %) of 193 had a seroresponse at 15 months. These results were similar to those described for tailor-made vaccines and their homologous strain. Only previously described adverse effects occurred. The incidence of B:14:P1.7,16 cases decreased significantly in the vaccine targeted population after the primary vaccination period (from 31·6 per 100 000 to 5·9 per 100 000; p=0·001). Interpretation The ready-to-wear approach is reliable if epidemic and vaccine strains are genetically close. Other meningococcal B clonal outbreaks might benefit from this strategy; and previously described outer-membrane-vesicle vaccines can be effective against various strains. Funding French Ministry of Health.
Summary Background High doses of corticosteroids are considered the standard treatment for pemphigus. Because long-term corticosteroid treatment can cause severe and even life-threatening ...side-effects in patients with this disease, we assessed whether first-line use of rituximab as adjuvant therapy could improve the proportion of patients achieving complete remission off-therapy, compared with corticosteroid treatment alone, while decreasing treatment side-effects of corticosteroids. Methods We did a prospective, multicentre, parallel-group, open-label, randomised trial in 25 dermatology hospital departments in France (Ritux 3). Eligible participants were patients with newly diagnosed pemphigus aged 18–80 years being treated for the first time (not at the time of a relapse). We randomly assigned participants (1:1) to receive either oral prednisone alone, 1·0 or 1·5 mg/kg per day tapered over 12 or 18 months (prednisone alone group), or 1000 mg of intravenous rituximab on days 0 and 14, and 500 mg at months 12 and 18, combined with a short-term prednisone regimen, 0·5 or 1·0 mg/kg per day tapered over 3 or 6 months (rituximab plus short-term prednisone group). Follow-up was for 3 years (study visits were scheduled weekly during the first month of the study, then monthly until month 24, then an additional visit at month 36). Treatment was assigned through central computer-generated randomisation, with stratification according to disease-severity (severe or moderate, based on Harman's criteria). The primary endpoint was the proportion of patients who achieved complete remission off-therapy at month 24 (intention-to-treat analysis). This study is registered with ClinicalTrials.gov , number NCT00784589. Findings Between May 10, 2010, and Dec 7, 2012, we enrolled 91 patients and randomly assigned 90 to treatment (90 were analysed; 1 patient withdrew consent before the random assignment). At month 24, 41 (89%) of 46 patients assigned to rituximab plus short-term prednisone were in complete remission off-therapy versus 15 (34%) of 44 assigned to prednisone alone (absolute difference 55 percentage points, 95% CI 38·4–71·7; p<0·0001. This difference corresponded to a relative risk of success of 2·61 (95% CI 1·71–3·99, p<0·0001), corresponding to 1·82 patients (95% CI 1·39–2·60) who would need to be treated with rituximab plus prednisone (rather than prednisone alone) for one additional success. No patient died during the study. More severe adverse events of grade 3–4 were reported in the prednisone-alone group (53 events in 29 patients; mean 1·20 SD 1·25) than in the rituximab plus prednisone group (27 events in 16 patients; mean 0·59 1·15; p=0·0021). The most common of these events in both groups were diabetes and endocrine disorder (11 21% with prednisone alone vs six 22% with rituximab plus prednisone), myopathy (ten 19% vs three 11%), and bone disorders (five 9% vs five 19%). Interpretation Data from our trial suggest that first-line use of rituximab plus short-term prednisone for patients with pemphigus is more effective than using prednisone alone, with fewer adverse events. Funding French Ministry of Health, French Society of Dermatology, Roche.
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