Background The INBUILD trial investigated the efficacy and safety of nintedanib versus placebo in patients with progressive fibrosing interstitial lung diseases (ILDs) other than idiopathic pulmonary fibrosis (IPF). We aimed to establish the effects of nintedanib in subgroups based on ILD diagnosis. Methods The INBUILD trial was a randomised, double-blind, placebo-controlled, parallel group trial done at 153 sites in 15 countries. Participants had an investigator-diagnosed fibrosing ILD other than IPF, with chest imaging features of fibrosis of more than 10% extent on high resolution CT (HRCT), forced vital capacity (FVC) of 45% or more predicted, and diffusing capacity of the lung for carbon monoxide (DLco) of at least 30% and less than 80% predicted. Participants fulfilled protocol-defined criteria for ILD progression in the 24 months before screening, despite management considered appropriate in clinical practice for the individual ILD. Participants were randomly assigned 1:1 by means of a pseudorandom number generator to receive nintedanib 150 mg twice daily or placebo for at least 52 weeks. Participants, investigators, and other personnel involved in the trial and analysis were masked to treatment assignment until after database lock. In this subgroup analysis, we assessed the rate of decline in FVC (mL/year) over 52 weeks in patients who received at least one dose of nintedanib or placebo in five prespecified subgroups based on the ILD diagnoses documented by the investigators: hypersensitivity pneumonitis, autoimmune ILDs, idiopathic non-specific interstitial pneumonia, unclassifiable idiopathic interstitial pneumonia, and other ILDs. The trial has been completed and is registered with ClinicalTrials.gov, number NCT02999178.
We have investigated the influence of diabetes mellitus including the presence of late complications of the pulmonary system. To check this relationship 31 Type 1 (insulin-dependent) diabetic patients (mean age 30.6 +/- 5.32 years, mean duration of diabetes 12.9 +/- 5.05 years) were admitted into the trial and compared with 18 control subjects. Pulmonary function tests were measured including spirometric parameters, diffusing capacity, specific diffusing capacity and dynamic compliance measured at 20 and 60 breaths per min. No disturbance of the spirometric parameters was observed in the diabetic patients. Diffusing capacity in the diabetic patients with complications was significantly lower than in both the diabetic patients without complications and the control group (81.2 +/- 16.2%, 104 +/- 13.7%, 99.3 +/- 2.8%; p < 0.001, p < 0.005 respectively). Specific diffusing capacity was significantly lower in the diabetic patients than in the control subjects (80.3 +/- 13.1% vs 89.4 +/- 12.9%; p < 0.05). In the group with late complications specific diffusing capacity was lower than in the group without complications (69.7 +/- 9.17%; 87.2 +/- 10.7%, respectively; p < 0.001). Dynamic compliance at 20 breaths per min in diabetic patients was 84.06 +/- 17.08% vs 95.2 +/- 11.59% in the control subjects (p < 0.05). It was particularly low in the group with late complications 80.6 +/- 13.2% and patients with metabolic poor control, 80.3 +/- 12.02% (both p < 0.005 vs the control group). Dynamic compliance at 60 breaths per min was 60.1 +/- 15.0% as compared to 83.2 +/- 13.3% in the control group (p < 0.001).(ABSTRACT TRUNCATED AT 250 WORDS)
Very little is known about the role of adipokines in atopic dermatitis (AD) in children. This study aimed at analyzing the serum levels of resistin, apelin, and visfatin in children with AD in relation to body weight, AD severity, and gender. Serum concentration of adipokines was measured in 27 children with AD and in 46 healthy subjects. Selected biochemical parameters were evaluated and skin prick test was performed. Serum levels of resistin and apelin were significantly higher, whereas serum visfatin concentration was significantly lower in children with AD versus healthy controls, although an increase in resistin levels was exclusively demonstrated in boys. In AD group, a significant increase in apelin levels in girls was documented. There was no relationship between adipokines levels and the degree of allergic sensitization. Receiver operating characteristic curve analysis demonstrated that the serum apelin cutoff value differentiating children with AD from those without was >137.8 pg/mL. Resistin and visfatin cutoff values were >3.8 ng/mL and ≤ 2.13 ng/mL, respectively. Apelin and visfatin can serve as excellent indicators to distinguish children with AD from those without disease.
The problem of ventilation efficiency after total laser arytenoidectomy with posterior cordectomy due to bilateral vocal cord paralysis is discussed. There are a number of views on the usefulness and efficacy of different surgical procedures aimed at widening the glottis, but the studies concerning the long-term functional results are still lacking. The objective of the study is to evaluate the durability of ventilation results in patients after laser arytenoidectomy with posterior cordectomy based on the comparison between the early postoperative results and those assessed after a period of 5 years. Thirty patients (24 females, 6 males) aged between 30 and 80 (mean 58.5) with bilateral vocal cord paralysis after thyroid surgery, who underwent laser arytenoidectomy with posterior cordectomy, were analyzed. Ventilation tests were performed immediately after the operation and 5 years later with Body-Master Laab (Jaeger). The actual and predicted values of FVC, FEF(25), FEF(50), FEF(75), PEF, MMEF(75/25), AREA(Ex), sR(T0T), R(T0T) were compared and analyzed. Also, the values of the inspiratory parameters FIV(1), FIF(50), PIF and the coefficients FEF(50)/FIF(50) and FIV(1)/FEV(1) were assessed. Moreover, subjective evaluation was performed based on a questionnaire. The statistical analysis reveals a significant decrease in FIV(1), FIF(50), PIF and FIV(1)/FEV(1). FEF(50)/FIF(50) and sR(T0T) (actual and predicted values) increased significantly after 5 years from the operation. However, the patients did not complain nor was this tendency reflected in their answers to the questionnaire. The probable reasons for such ventilation results are discussed. The role of phoniatric rehabilitation and the time elapsed is emphasized. In general, it can be concluded that laser arytenoidectomy with posterior cordectomy is a durable and effective procedure, although the objective assessment does not fully match the patient's subjective impression.
It is believed that omentin is secreted by stromal cells of adipose tissue and modulates insulin sensitivity. Data from a few studies have shown lower serum omentin in obese children and higher in anorexia nervosa. However, to date, there is lack of research on serum omentin concentrations in adolescent patients in a wide range of body mass index (BMI) and insulin resistance. In this cross-sectional study omentin-1 serum concentrations were evaluated using commercially available ELISA kit in 47 Polish girls with restrictive anorexia nervosa (AN), 50 with simple obesity (OB) and 39 healthy controls (C). The mean serum omentin-1 concentration in girls with AN was statistically significantly higher than that of C and OB girls. Statistically significant (P<0.0001) negative correlations between the serum concentrations of omentin-1 and body weight (r=−0.73), BMI (r=−0.75), standard deviation score for body mass index (BMI-SDS) (r=−0.75), insulin (r=−0.81) and HOMA-IR index (r=−0.82) were seen in the entire examined population. We conclude, that omentin-1 is the nutritional marker reflecting body weight and insulin resistance. Our findings support the hypothesized role of omentin in maintenance of body weight and regulation of appetite and suggest the adaptation of its secretion to body weight and glucose metabolism.
Compared with healthy girls, serum VISF concentrations are decreased in girls with AN. Conversely, obese girls have elevated VISF levels. When calculated per BMI (VISF/BMI), the results in AN and OB groups were lower than in healthy participants.
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