Improvement In Forced Vital Capacity Research Articles

Effects of a Progressive Stabilization Exercise Program Using Respiratory Resistance for Patients with Lumbar Instability: A Randomized Controlled Trial.

BackgroundThis study investigated the effects of progressive stabilization exercise program carried out with respiratory resistance in patients with lumbar instability.Material/MethodsForty-three patients with lumbar instability were randomly assigned to experimental (n=20) and control groups (n=23). The experimental group performed progressive lumbar stabilization exercises along with respiratory resistance, and the control group only performed progressive lumbar stabilization exercises, for 40 min per session, 3 sessions a week, for 4 weeks. Numeric rating scale (NRS), Korean-Oswestry disability index (K-ODI), static balance ability, Fear-Avoidance Beliefs Questionnaire (FABQ), and pulmonary function test (PFT) were performed before and after the intervention program for comparison.ResultsThe 2 groups showed significant differences in NRS, K-ODI, balance ability, and FABQ after the interventions (p<0.05), but greater improvements were shown by the experimental group in balance ability and FABQ values. PFT results in the experimental group showed a significant increase (p<0.05) in forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), and maximum voluntary ventilation (MVV). The experimental group showed a greater improvement (p<0.05) in FVC and MVV compared to the control group.ConclusionsProgressive stabilization exercise program with respiratory resistance is an effective method with clinical significance in pain reduction, psychosocial stability, and enhancement of motor and respiratory functions.

Secukinumab: A safe option to treat psoriasis and psoriatic arthritis in the presence of interstitial lung disease

Psoriasis is a commonly encountered skin condition with a significant percentage of patients developing arthritis. Psoriasis is associated with multiple comorbid conditions. However, the association of interstitial lung disease (ILD) with psoriasis is rarely reported in the literature. The therapeutic options for psoriasis and psoriatic arthritis are limited in the presence of ILD. We report a 63-year-old female with long-standing psoriasis and psoriatic arthritis with usual interstitial pneumonia pattern ILD. She developed severe arthritis and extensive psoriasis lesions which did not respond to conventional disease-modifying drugs as well as to oral phosphodiesterase inhibitor apremilast. She was planned for biological therapy. Antitumor necrosis factor therapy was not administered in view of coexistent ILD. She was treated with anti-interleukin-17 A monoclonal antibody, secukinumab 150 mg subcutaneous at 0, 1, 2, 3, and 4 weeks, followed by monthly once for 5 months for a total of ten doses. She had a resolution of skin lesions, and her arthritis went into remission. She had no clinical or radiological worsening of ILD. Spirometry showed improvement in forced vital capacity. This case report suggests that secukinumab can be safely used in psoriasis and psoriatic arthritis without worsening of underlying ILD.

Influence of Evjenth-Hamberg Stretching on the Lung Function of Adults with Forward Head Posture

This study was conducted to examine the effects of Evjenth-Hamberg stretching of the sternocleidomastoid, upper trapezius, and pectoralis major on the lung function of adults with forward neck posture. The subjects were 20 adult students in P university located in Pohang, Korea, whose degree of head forward displacement measured according to NEW YORK state posture test was mild. The subjects were randomly and equally assigned to the Evjenth- Hamberg Stretching group (EHSG, n=10) and the control group (CG, n=10). Their forced vital capacity (FVC), slow vital capacity (SVC), and maximal voluntary ventilation (MVV) were measured before and after the experiment. In within-group comparison, only the EHSG experienced statistically significant improvement in FVC, forced expiratory volume in the first second (FEV1), and peak expiratory flow (PEE) after the experiment, compared to before the experiment (.05<p). In between-group comparison, the PEE of EHSG was statistically significantly higher than CG (.05<p). Regarding SVC, only the EHSG experienced statistically significant improvement in inspiratory vital capacity after the experiment, compared to before the experiment. With regard to MVV, only the EHSG experienced statistically significant improvement in their tidal volume during maximal voluntary ventilation after the experiment compared to before the experiment. Our results indicated that Evjenth- Hamberg stretching was an effective physical therapy intervention to improve the lung function of adults with FHP by correcting their head forward displacement.

A prospective 5-year study of exercise performance following Melody valve implant

The long-term benefits of Melody valve implant for right ventricular outflow tract conduit obstruction or insufficiency on exercise capacity are undefined. As part of the Melody valve clinical trial, 136 patients with congenital heart disease underwent serial cardiopulmonary exercise testing prior to, 6 months after, and annually for up to 5 years postimplant. Mean age at Melody valve implantation was 22.4 ± 0.9 years (range 7-53 years). The 95 patients who completed the study protocol provide the basis of this report. An initial improvement in % predicted workload was present at 6 months postimplant; however, at the final (5 year) follow-up, sustained or further improvements in workload were not demonstrated for the entire cohort compared to baseline. By subgroup analysis, age <17 years at implant and pulmonary regurgitation as the primary lesion were variables associated with sustained improvement in exercise performance. There were sustained improvements in the ventilatory equivalents for O2 (minute ventilation/O2 intake, P = .01) and CO2 (minute ventilation/CO2 output, P < .01) at the ventilatory anaerobic threshold at the study conclusion. Improvements in forced vital capacity were also observed during the study but not sustained at the final follow-up. A cautious appraisal of the cardiovascular benefits of Melody valve implant on sustained improvements in exercise performance appears warranted. Although the observed changes in pulmonary function suggest improved restrictive lung physiology and more efficient gas exchange, after an initial increase in % predicted performance, neither sustained nor further improvements in exercise performance were observed, except in specific patient subgroups.

Improving Treatment Related Mortality over Time - Data from the Non-Observational Trial on Autologous Stem Cell Transplantation in Systemic Sclerosis By the EBMT Autoimmune Diseases Working Party (ADWP)

Introduction: Systemic sclerosis (SSc) is a chronic autoimmune disease with ongoing high disease related mortality. Three randomized controlled trials proofed efficacy of autologous stem cell transplantation (aHSCT) in patients with severe SSc and superiority over the standard cyclophosphamide pulse therapy. Treatment related mortality is a major point of criticism and different treatment regimen are used in different centers.Methods: This prospective, open, multi-center, non-interventional study of the European Group for Blood and Marrow Transplantation (EBMT) analyzed data for consecutive aHSCT performed in SSc. Every center followed its own local protocol which usually refers to the recent update of the EBMT Guidelines. In order to be eligible for inclusion, patients had to be transplanted for the diagnosis of progressive SSc and aged between 18 and 65 years. Major exclusion criteria were an ejection fraction <40% by cardiac echo, pulmonary arterial hypertension with systolic pulmonary arterial pressure (sPAP) >50mmHg, creatinine clearance <30ml/min, reduced lung function with either FVC <50% or DLCO <30% of predicted values. Concurrent neoplasms, myelodysplasia, severe psychiatric illnesses as well as previously damaged bone marrow had to be ruled out.Progression free survival (PFS) was chosen as primary endpoint. Response to treatment, defined as the number of patients who achieve >25% improvement of the skin thickness, measured by the modified Rodnan Skin score (mRSS; range 0-51) and/or ≥10% improvement in forced vital capacity (FVC) or hemoglobin-adjusted diffusion lung capacity for carbon monoxide (DLCO) and relapse rate as well as safety considerations were secondary endpoints.Results: Between 2013 and 2015, 80 patients from 12 centers were followed for a median of 24.1 (5.97 - 59.8) months. Patients had a median age of 43 years at aHSCT and 70% were female. All patients were mobilized with cyclophosphamide (CYC) with a median of 2g/m2 and granulocyte-colony stimulating factor (GCSF) in 98%. In 45% of transplants stem cells were purified using CD34-positive selection. For conditioning, centers used CYC at 200 mg/kg (50 - 240) in 76 patients (95%) or CYC at 100 mg/kg and thiotepa 10 mg/kg in 4 patients. All patients received additional anti-thymocyte globulin (ATG; different brands were used) over 4-5 days.Progression free survival at 1 year was reached by 83.6% of our patients. Response to treatment at 1 year was achieved by 75% (63.7 - 83.2) and 10.1% relapsed or had further progression despite aHSCT. Figure 1 demonstrates the improvement of skin fibrosis over time. Median mRSS decreased from 24 (2 - 49) at baseline to 13 (0 - 40) at month 12, and 10.5 (0 - 32) at month 24. On multivariate analysis, creatine kinase (CK) levels < 250 U/ml, mRSS <24 and lung crepitation at baseline were significantly associated with response to treatment, but especially CD34-positive selection is a strong positive predictor for response to treatment with a hazard ratio of 2.19 as compared to patients treated with non-selected stem-cell.The 100-day treatment-related mortality for this population was 6.2% (n=5) (CI 2.3 - 13). Three of these 5 patients had a cardiac or cyclophosphamide related event that led to death. During the 24 months of follow up another 3 patients died due to progressive disease, which leads to an overall survival of 91.2% (CI: 85.1 - 97.4) at 2 years.Discussion: Although aHSCT has been proven effective in SSc, we still do not know which regimen is the best. With data from this non-interventional trial we could demonstrate the effectiveness of aHCST in a daily practice setting. Treatment seems to become safer over time with reduction of TRM from 10% in the European phase III Autologous stem cell transplantation international scleroderma trial (ASTIS; JAMA. 2014; 311(24): 2490-8) to 6.2% in our actual study; mainly due to increasing experience of the centers and exclusion of patients with advanced organ damage. Nevertheless indication for aHSCT should also be driven by negative predictive parameters for disease related mortality and it is fairly unlikely to further reduce TRM in these sick patients.We also found a potential value of CD34-selection in these patients. As a retrospective approach demonstrated no benefit to the outcome of SSc patient treated with AHSCT (Bone Marrow Transplant.2016; 51(4): 501-5), these findings have to be confirmed by prospective randomized trials. [Display omitted] DisclosuresNo relevant conflicts of interest to declare.

Haematopoietic stem cell transplantation in systemic sclerosis

Three randomised controlled trials of haematopoietic stem cell transplantation (HSCT) in systemic sclerosis (SSc) demonstrated long-term survival benefits, induction of clinically meaningful, sustained improvement of forced vital capacity with improvements...

The immediate effects of a single autogenic drainage session on ventilatory mechanics in adult subjects with cystic fibrosis.

IntroductionThe aim of this study was to gain insight into the physiological changes occurring in subjects with cystic fibrosis (CF) after autogenic drainage (AD). Changes in respiratory system resistance (Rrs), reactance (Xrs), and spirometry were analyzed in adult CF subjects after a single AD physiotherapy session.MethodsThis prospective observational study was conducted during the annual check-up of adult CF subjects in stable condition. Spirometry and Rrs and Xrs measurements using the forced oscillations technique at 5, 11, and 19 hertz (Hz) were performed before and 30 min after a 20-min AD session. Control CF subjects were tested at baseline and 50 min without AD. Results are expressed as mean ± standard deviation or median [interquartile range].ResultsThirty subjects were included in the physiotherapy group (age 29 [25–34] years, forced expiratory volume in 1 s (FEV1) 40.3 [30.1–57.9]% predicted) and 11 in the control group (age 31 [28.5–36.5] years, FEV1 43.6 [31.1–51.9] % predicted). No significant changes in any parameter were observed in the control group. AD modestly but significantly increased the forced vital capacity (FVC) and FEV1 (p<0.001). Inspiratory resistance was also significantly improved by AD: Rrs5 from 5.74±2.39 to 5.24±2.17 cmH2O/L/s, p<0.05; Rrs11 from 4.83±1.98 to 4.32±1.7 cmH2O/L/s, p = 0.003; and Rrs19 from 4.18 [3.46–5.07] to 3.86 [2.76–4.98] cmH2O/L/s, p<0.001. In contrast, AD had no significant effects on frequency dependence of resistance (Rrs5–Rrs19) or expiratory resistance. Inspiratory Xrs5, but not ΔXrs5 (expiratory—inspiratory Xrs), was improved by AD (p<0.05). Moderate correlations were detected between the improvement in FEV1 and FVC and inspiratory resistance (r = 0.53, p = 0.005 and r = 0.44, p = 0.02, respectively).ConclusionA single session of AD improved inspiratory airway resistance, except in the distal airways. The forced oscillations technique provides a new tool for understanding the pathophysiological effects of airway clearance physiotherapy in CF.

Efficacy and safety of autologous haematopoietic stem cell transplantation in systemic sclerosis: a systematic review of the literature.

We aimed to assess the efficacy of autologous haematopoietic stem cell transplantation (HSCT) for skin sclerosis (SSc) and lung function in SSc. We performed a systematic literature review in the PubMed and Scopus databases from the earliest records to March 2016. We assessed study quality using the Cochrane tool for randomized studies, the Newcastle-Ottawa Scale for controlled cohort studies and an 18-item quality-appraisal checklist for case series. The primary outcome was the improvement of skin thickening using the modified Rodnan Skin Score (mRSS). The secondary outcome was efficacy on lung function, using diffusing capacity of the lungs for carbon monoxide and forced vital capacity (FVC). The safety of the procedure was evaluated. The literature search identified 431 citations. There were 38 studies involving a total of 344 patients who fulfilled our inclusion criteria. No meta-analysis was performed due to a high heterogeneity. There was a significant improvement in mRSS in the majority of the reports (P < 0·05), and the results were sustained for up to 8 years after autologous HSCT. The randomized studies and the four cohort studies each showed a slight but statistically significant improvement in FVC at 1 or 2 years. The treatment-related mortality calculated by pooling patients of 35 studies (336 patients with a follow-up up to 146 months) was 8·3% after autologous HSCT and 1% in cyclophosphamide-treated groups. Despite heterogeneity among the studies, we determined that autologous HSCT significantly improved cutaneous fibrosis and slightly improved FVC. Safety of autologous HSCT is acceptable given the severity of the disease. This systematic review was registered on PROSPERO, number CRD42016027951.

Effect of Adjuvant Yoga Therapy on Pulmonary Function and Quality of Life Among Patients with Chronic Obstructive Pulmonary Disease: A Randomized Control Trial

Introduction: Previous studies have suggested that yoga may have a positive impact on lung function and quality of life (QoL) and hence the present prospective two-arm single-blinded controlled study evaluated effect of adjuvant yoga therapy on pulmonary function and QoL of patients with Chronic Obstructive Pulmonary Disease (COPD). Material and methods:In this interdisciplinary collaborative work, 72 COPD patients were recruited after obtaining informed consent and randomized to yoga group (22 M and 14 F) who received adjuvant yoga therapyin addition to standard medical management and control group (20 M and 16 F) who received only medical management. Yoga therapy protocol validated by CYTER was used and this included loosening exercises, postures (asanas), vitalising breathing techniques (pranayama) and relaxation. Forced vital capacity (FVC), forced expiratory volume in first second (FEV1) and FEV1/FVCwere measured using standard computerized pulmonary function test ‘Trueflow (ndd)’ before and after study period of 4 weeks. Saint George Respiratory Questionnaire (SGRQ) was used to asses QoL. Changes in pulmonary function parameters were correlated with QoL (symptoms, activity, impacts and quality) scores. Intra-group comparisons were done using Student’s paired ‘t’ test and intergroup comparisons using unpaired ‘t’ test. Results:There was significant improvement (p < 0.01) in body weight, BMI, FVC and FEV1 after four weeks of adjuvant yoga therapy while controls showedsignificant decline in all parameters. There were improvements in all QoL scores, namely symptoms score (p<0.001) and activity score (p<0.05), impacts score (p<0.01) and quality score (p<0.001)in yoga group while no significant changes in controls.Significant correlation was found between pulmonary function and QoL in Yoga group. Discussion:Significant improvements of lung function with adjuvant yoga therapy can be attributed to comprehensive yoga therapy package administered to participants. This may be due to with decreased airway resistance and better lung compliance attributed to nonspecific broncho-protective or broncho-relaxing effect. Significant improvement in QoL scores implies patients were able to participate in more activities than earlier, and this can be attributed to improved vital capacity as well as enhanced self-confidence /self-reliance. Our results are consistent with previous such studies and we conclude that yoga has a positive and additive role as an adjuvant therapy along with standard medical management of COPD.

Validation of a 52-gene risk profile for outcome prediction in patients with idiopathic pulmonary fibrosis: an international, multicentre, cohort study

BackgroundThe clinical course of Idiopathic Pulmonary Fibrosis (IPF) is unpredictable. Clinical prediction tools are not accurate enough to predict disease outcomes.MethodsAll-comers with Idiopathic Pulmonary Fibrosis diagnosis were enrolled in a six-cohort study. Peripheral blood mononuclear cells or whole blood was collected at baseline from 425 participants and during follow up from 98 patients. The 52-gene signature was measured by the nCounter® analysis system in four cohorts and extracted from microarray data in two others. The Scoring Algorithm for Molecular Subphenotypes (SAMS) was used to classify patients into low or high risk groups based on a 52-gene signature. Mortality and transplant-free survival were studied using Competing risk and Cox proportional-hazard models, respectively. Time course data and response to anti-fibrotic drugs were analyzed using linear mixed-effect models.FindingsThe application of SAMS to the 52-gene signature identified two groups of IPF patients (low and high risk) with significant differences in mortality or transplant-free survival in each of the six cohorts (HR 2·03–4·37). Pooled data revealed similar results for mortality (HR:2·18, 95%CI:1·53–3·09, P<0·0001) or transplant-free survival (HR:2·04, 95%CI: 1·52–2·74, P<0·0001). Adding 52-gene risk profiles to the Gender, Age and Physiology (GAP) index significantly improved its mortality predictive accuracy. Temporal changes in SAMS scores were associated with changes in forced vital capacity (FVC) in two cohorts. Untreated patients did not shift their risk profile over time. A simultaneous increase in up score and decrease in down score was predictive of transplant-free survival (HR:3·18· 95%CI 1·16, 8·76, P=0·025) in the Pittsburgh cohort. A simultaneous decrease in up score and increase in down score after initiation of anti-fibrotic drugs was associated with a significant (P=0·005) improvement in FVC in the Yale cohort.InterpretationThe peripheral blood 52-gene expression signature is predictive of outcome in patients with IPF. The potential value of the 52-gene signature in predicting response to therapy should be determined in prospective studies.

Feasibility of combined treatment for type III spinal muscular atrophy: a pilot study

Feasibility of combined treatment for type III spinal muscular atrophy: a pilot study Nataliia Sych, 1 Mariya Klunnyk,1 Iryna Matiyashchuk,1 Mariya Demchuk,1 Olena Ivankova,1 Andriy Sinelnyk,1 Khrystyna Sorochynska,2 Marina Skalozub3 1Clinical Department, 2Stem Cells Bank, 3Laboratory and Biotechnology Department, Cell Therapy Center EmCell, Kyiv, Ukraine Objective: To find solutions and improve methods of therapy for patients suffering from type III spinal muscular atrophy (SMA-III) by way of a combination of conventional treatment (medicines, physiotherapy) and fetal stem cells (FSCs) transplantation using suspensions extracted from stem cells of fetal liver and brain of human embryos.Materials and methods: Our study included 7 children suffering from SMA-III, including 5 boys and 2 girls, aged from 3 to 12 years who were allocated into the main group (MG). SMA children in the MG were administered fetal stem cell preparations, mainly suspensions which contained fetal cells of human liver and fetal brain along with standard treatment (treatment by use of medicines if required and physiotherapy). The control group (CG) included 6 children – 3 boys and 3 girls aged from 3.5 to 13 years.Results: The authors proved effectiveness and safety of treatment using FSCs for patients with SMA-III. Improvement of forced vital capacity of lungs and forced expiratory volume per 1 second was characteristic for the patients of the MG, starting from the period of observation at 6 months after FSCs transplantation. In patients from the CG, such values revealed characteristic improvement at 12 months after FSCs treatment. Significant reductions of alanina aminotransferase, aspartate aminotransferase, creatine phosphokinase, and lactate dehydrogenase ranges have been recorded in the patients of the MG at 6 months after treatment with FSCs. Such values show a significant reduction at 12 months after treatment.Conclusion: FSCs use in complex treatment of patients with SMA results in stable disease compensation, improvement of laboratory results, and improved ranges of forced vital capacity and forced expiratory volume in 1 second. Keywords: fetal stem cells, forced expiratory volume per 1 second, forced vital capacity of the lungs, type III spinal muscular atrophy

Long-term Pulmonary Function After Open Anterior Thoracolumbar Surgery in Thoracolumbar/Lumbar Idiopathic Adolescent Scoliosis

A prospectively updated, long-term case series analysis. The aim of this study was to report the effect of thoracolumbar anterior open surgery performed during adolescence on adult pulmonary function. There seems to be subclinical impairment of pulmonary function in the mid-term (2-5 years) in patients who underwent thoracotomy or thoraco-phreno-laparotomy after adolescent idiopathic scoliosis (AIS) surgery. However, long-term results when patients reach adulthood are lacking. Prospective data of pulmonary function tests (PFTs) on adult patients who underwent anterior open surgery during adolescence due to main thoracolumbar/lumbar curves were collected. Forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), and the Tiffeneau index (TI: FEV1/FVC) with a 12-year minimum follow-up were recorded. These figures were compared with reference (predicted) values and preoperative data. Twenty-four patients were included. All patients had undergone a thoraco-phreno-laparotomy. None of the patients had pulmonary disease. Mean age was 15.83 years at the time of surgery and the mean follow-up was 18.26 years (12-29 years).Long-term results of the 24 operated patients (mean ± SD: FVC = 3.3 ± 0.39; FEV1 = 2.6 ± 0.38; TI = 80.3 ± 5.7) showed a similar FVC and slightly worse FEV1 than reference values (FVC = 3.4 ± 0.48; FEV1 = 3.03 ± 0.42; TI = 82.4 ± 1.3), (P = 0.21; P = 0.02; P = 0.3, respectively). Nevertheless, the values were within the normal percent-predicted range for FVC (93.5% ± 11.2) and FEV1 (91.4% ± 12.8). In 14 patients, long-term figures (median ± IQR): FVC = 3.2 ± 0.6; FEV1 = 2.54 ± 0.42; TI = 81.5 ± 11.2) were compared with preoperative values (median ± IQR: FVC = 2.9 ± 0.8; FEV1 = 2.47 ± 0.93; TI = 84.8 ± 34.2), (P = 0.08, P = 0.92, P = 0.026, respectively). Only the TI showed significant differences due to disproportionate improvement of FVC and FEV1 during the follow-up years. Thoracolumbar/lumbar AIS patients who underwent a thoraco-phreno-laparotomy during adolescence showed, in the long-term (18 years follow-up), a similar FVC compared with the reference values that was slightly superior than the values before surgery. Despite the lower FEV1 than the reference values and taking into consideration our limitations, the percent-predicted values were within the normal range, indicating no major pulmonary impairment in the long run. 4.

Effect of allergic phenotype on treatment response to inhaled bronchodilators with or without inhaled corticosteroids in patients with COPD.

BackgroundChronic obstructive pulmonary disease (COPD) is a heterogeneous disorder encompassing different phenotypes with different responses to treatment. The present 1-year, two-center hospital-based study investigated whether the plasma immunoglobulin E (IgE) level and/or eosinophil cell count could be used as biomarkers to stratify patients with COPD according to predicted responses to inhaled corticosteroids (ICS)-based therapy.MethodsA hospital-data based cohort study of COPD patients treated at two territory hospital centers was conducted for 1 year. Allergic biomarkers, including blood eosinophil counts and IgE levels, were assessed at baseline. Lung function parameters, including forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), and the COPD Assessment Test (CAT), were also evaluated. The frequencies of acute exacerbation (AE) and pneumonia were also measured. Eosinophilia and a high IgE level were defined as >3% and 173 IU/mL, respectively.ResultsA total of 304 patients were included. Among patients with eosinophilia and high IgE levels, ICS-based therapy was associated with significant improvements in FEV1, FVC, and CAT scores, compared with bronchodilator (BD) therapy (P≤0.042). ICS-based therapy was also associated with a significantly lower incidence of AE vs BD-based therapy (11.7% vs 24.1%; P<0.008). Among patients with only eosinophilia, ICS-based therapy yielded significantly better CAT score results vs BD-based treatment (7 vs 13; P=0.032). A receiver operating characteristic curve analysis found that the combination of a high plasma IgE level and eosinophilia most sensitively and specifically identified patients who would benefit from the addition of ICS to BD therapy.ConclusionOur findings support the use of blood eosinophil cell counts plus IgE levels as predictive biomarkers of the ICS response in certain patients with COPD. Both biomarkers could potentially be used to stratify COPD patients regarding ICS-based therapy.

Value of forced expiratory volume in 6 seconds (FEV(6)) in the evaluation of pulmonary function in Chinese elderly males

Objective: To evaluate the value of forced expiratory volume in 6 seconds (FEV(6)) in the evaluation of pulmonary function in Chinese elderly males. Methods: Pulmonary function tests of elderly who had received regular physical examination in Beijing Hospital from July 2003 to April 2015 were analyzed on subjects with the following characteristics: aged 60 years or older, completion of bronchial dilation test and able to exhale for at least six seconds. The included subjects were divided into 2 groups: 60-<80 years group and ≥80 years group. The association of FEV(6) with forced vital capacity (FVC), FEV(1)/FEV(6) with FEV(1)/FVC, the diagnostic efficiency and influencing factor of FEV(6) and FEV(1)/FEV(6) were analyzed; the value of FEV(6) in the evaluation of pulmonary function in the study population was evaluated. Results: A total of 475 elderly men aged 60 years or older were enrolled, with a mean age of (77.13±9.53) years. Totally there were 269 subjects in 60-<80 years group, which accounted for 56.6%; 206 subjects were in ≥80 years group, which accounted for 43.4%. There were 292 subjects with irreversible airflow obstruction, accounting for 61.5%. In all the included subjects, FEV(6) was significantly correlated with FVC and post-bronchodilator FEV(1)/FEV(6) was significantly correlated with post-bronchodilator FEV(1)/FVC(r=0.971, 0.978; both P<0.001), which were similar in 60-<80 years group and ≥80 years group (r=0.967, 0.974 and r=0.955, 0.967; all P<0.001). FEV(1)/FEV(6) showed excellent accuracy in diagnosing airflow obstruction[area under curve (AUC)=0.990(95%CI: 0.983-0.996); P<0.001]. Using FEV(1)/FVC<0.70 as a reference, FEV(1)/FEV(6)<0.73 had the best sensitivity (0.952) and specificity (0.945), and there was excellent agreement between the two diagnostic cutoffs (κ=0.891; P<0.001). When difference between before and after bronchial dilation test was analyzed, no correlation was observed between FEV(6) improvement and the improvement of forced expiratory time (r=0.089; P=0.053), but FVC improvement was significantly correlated with the improvement of forced expiratory time (r=0.460; P<0.001). Similar results were also found in subjects with irreversible airflow obstruction. Subjects with FEV(1)/FEV(6)≥0.70 and FEV(1)/FVC<0.70 were categorized as pulmonary function middle group, a total of 73 cases, which included 20 cases ≥80 years old. The proportion of middle group among ≥80 years group was significantly less than that of the 60-<80 years group (χ(2)=8.958; P=0.003). In pulmonary function middle group, FEV(1)/FEV(6) or FEV(1)/FVC had no correlation with inspiratory capacity or residual volume/total lung capacity (all P>0.05). Conclusions: FEV(6) and FEV(1)/FEV(6) are strongly correlated with FVC and FEV(1)/FVC, and there is excellent agreement between FEV(1)/FEV(6) and FEV(1)/FVC. FEV(6) is simple, easy to operate and with less influencing factors, which can be used as a valid alternative for FVC in diagnosing airflow obstruction in elderly males.

Surgical Outcomes of Pneumatic Compression Using Carbon Dioxide Gas in Thoracoscopic Diaphragmatic Plication.

BackgroundSurgical correction needs to be considered when diaphragm eventration leads to impaired ventilation and respiratory muscle fatigue. Plication to sufficiently tense the diaphragm by VATS is not as easy to achieve as plication by open surgery. We used pneumatic compression with carbon dioxide (CO2) gas in thoracoscopic diaphragmatic plication and evaluated feasibility and efficacy.MethodsEleven patients underwent thoracoscopic diaphragmatic plication between January 2008 and December 2013 in Pusan National University Hospital. Medical records were retrospectively reviewed, and compared between the group using CO2 gas and group without using CO2 gas, for operative time, plication technique, duration of hospital stay, postoperative chest tube drainage, pulmonary spirometry, dyspnea score pre- and postoperation, and postoperative recurrence.ResultsThe improvement of forced expiratory volume at 1 second in the group using CO2 gas and the group not using CO2 gas was 22.46±11.27 and 21.08±5.39 (p=0.84). The improvement of forced vital capacity 3 months after surgery was 16.74±10.18 (with CO2) and 15.6±0.89 (without CO2) (p=0.03). During follow-up (17±17 months), there was no dehiscence in plication site and relapse. No complications or hospital mortalities occurred.ConclusionThoracoscopic plication under single lung ventilation using CO2 insufflation could be an effective, safe option to flatten the diaphragm.

Topical cystic fibrosis transmembrane conductance regulator gene replacement for cystic fibrosis-related lung disease.

Cystic fibrosis is caused by a defective gene encoding a protein called the cystic fibrosis transmembrane conductance regulator (CFTR), and is characterised by chronic lung infection resulting in inflammation and progressive lung damage that results in a reduced life expectancy. To determine whether topical CFTR gene replacement therapy to the lungs in people with cystic fibrosis is associated with improvements in clinical outcomes, and to assess any adverse effects. We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register comprising references identified from comprehensive electronic database searches, handsearching relevant journals and abstract books of conference proceedings.Date of most recent search: 05 May 2016.An additional search of the National Institutes for Health (NIH) Genetic Modification Clinical Research Information System (GeMCRIS) was also performed for the years 1992 to 2015.Date of most recent search: 20 April 2016. Randomised controlled studies comparing topical CFTR gene delivery to the lung, using either viral or non-viral delivery systems, with placebo or an alternative delivery system in people with confirmed cystic fibrosis. The authors independently extracted data and assessed study quality. Authors of included studies were contacted and asked for any available additional data. Meta-analysis was limited due to differing study designs. Four randomised controlled studies met the inclusion criteria for this review, involving a total of 302 participants lasting from 29 days to 13 months; 14 studies were excluded. The included studies differed in terms of CFTR gene replacement agent and study design, which limited the meta-analysis. One study only enrolled adult males, the remaining studies included both males and females aged 12 years and over.Risk of bias in the studies was moderate. Random sequence generation and allocation concealment was only described in the more recent study; the remaining three studies were judged to have an unclear risk of bias. All four studies documented double-blinding to the intervention, but there is some uncertainty with regards to participant blinding in one study. Some outcome data were missing from all four studies.There were no differences in either the number of respiratory exacerbations or the number of participants with an exacerbation between replacement therapy or placebo groups at any time point. Meta-analysis of most respiratory function tests showed no difference between treatment and placebo groups, but the smallest study (n = 16) reported forced vital capacity (litres) increased more in the placebo group at up to 24 hours. A further study reported a significant improvement in forced expiratory volume at one second (litres) at 30 days after participants had received their first dose of favouring the gene therapy agent, but this finding was not confirmed when combined with at second study in the meta-analysis. The more recent study (n = 140) demonstrated a small improvement in forced vital capacity (per cent predicted) at two and three months and again at 11 and 12 months for participants receiving CFTR gene replacement therapy compared to those receiving placebo. The same study reported a significant difference in the relative change in forced expiratory volume at one second (per cent predicted) at two months, three months and 12 months.One small study reported significant concerns with "influenza-like" symptoms in participants treated with CFTR gene replacement therapy; this was not reported on repeated use of the same agent in a larger recent study.There was no other evidence of positive impact on outcomes, in particular improved quality of life or reduced treatment burden.Two studies measured ion transport in the lower airways; one (n = 16) demonstrated significant changes toward normal values in the participants who received gene transfer agents (P < 0.0001), mean difference 6.86 (95% confidence interval 3.77 to 9.95). The second study (n = 140) also reported significant changes toward normal values (P = 0.032); however, aggregate data were not available for analysis. In the most recent study, there was also evidence of increased salt transport in cells obtained by brushing the lower airway. These outcomes, whilst important, are not of direct clinical relevance. One study of liposome-based CFTR gene transfer therapy demonstrated some improvements in respiratory function in people with CF, but this limited evidence of efficacy does not support this treatment as a routine therapy at present. There was no evidence of efficacy for viral-mediated gene delivery.Future studies need to investigate clinically important outcome measures.

Rituximab in autoimmune connective tissue disease-associated interstitial lung disease.

CTD-associated interstitial lung disease (ILD) often fails to respond to conventional immunomodulatory agents. There is now considerable interest in the use of rituximab in systemic autoimmune CTD in patients refractory to standard treatments. The aim of this study was to review the experience of North Bristol NHS Trust managing patients with CTD-associated ILD with rituximab and explore possible associations with treatment response. We conducted a retrospective analysis of all patients who received rituximab under the Bristol CTD-ILD service, having failed to respond to other immunomodulatory treatments. Results were collated for pulmonary function and radiological outcomes before and after treatment. Twenty-four patients were treated with rituximab. Their physiological parameters had failed to improve despite other immunomodulatory agents, with a mean change in forced vital capacity (FVC) prior to therapy of - 3.3% (95% CI - 5.6, -1.1) and mean change in diffusing capacity of carbon monoxide of - 4.3% (95% CI - 7.7, -0.9). After rituximab, radiology remained stable or improved for 11 patients, while worsening was observed in 9 patients. The decline in FVC was halted following treatment, with a mean change of + 4.1% (95% CI 0.9, 7.2), while diffusing capacity of carbon monoxide was stable [mean change +2.1% (95% CI - 1.0, 5.2)]. Patients with myositis overlap or antisynthetase syndrome appeared to respond well to treatment, with four patients showing clinically significant improvement in FVC >10%. Rituximab is a therapeutic option in treatment-refractory CTD-associated ILD. Some disease subgroups may respond better than others, however, more work is needed to define its role in managing these patients.

Long-term safety of glycopyrrolate: A randomized study in patients with moderate-to-severe COPD (GEM3)

BackgroundChronic obstructive pulmonary disease (COPD) is one of the leading causes of death in the United States. Long-acting muscarinic antagonists (LAMAs) are a class of medications used as maintenance therapy for COPD. The GEM3 (Glycopyrrolate Effect on syMptoms and lung function) study assessed the long-term safety and efficacy of a LAMA, glycopyrrolate (GLY) 15.6 μg twice daily (b.i.d.), compared with an approved long-acting β2-agonist (LABA), indacaterol (IND) 75 μg once daily (q.d.) in patients with stable, symptomatic COPD with moderate-to-severe airflow limitation. MethodsThis 52-week, multicenter, double-blind, parallel-group study randomized patients (1:1) of the United States to receive GLY 15.6 μg b.i.d. or IND 75 μg q.d. both delivered via the Neohaler® device. The primary objective was to assess the safety and tolerability in terms of adverse event (AE) reporting rates over 52 weeks. Safety was also determined by evaluating multiple secondary endpoints, including vital signs, electrocardiograms (ECGs), and time to first moderate or severe exacerbation. Efficacy-related secondary endpoints included pre-dose forced expiratory volume in one second (FEV1) and forced vital capacity (FVC). ResultsOf the 511 randomized patients (GLY, n = 254; IND, n = 257), 81.6% completed the study. The overall incidences of AEs (GLY, 77.3%; IND, 77.0%) and serious AEs (GLY, 13.1%; IND, 13.3%) were comparable between the groups. The incidence of major adverse cardiovascular events was low and comparable between the groups. No clinically relevant differences for vital signs or ECG parameters were observed between the treatment groups. The three sudden deaths reported within 30 days of the treatment (GLY, n = 2; IND, n = 1) were adjudicated as unrelated to the study medication. In terms of efficacy, GLY 15.6 μg b.i.d. showed improvements in pre-dose FEV1 and FVC from baseline, which was comparable to those with IND 75 μg q.d., with no statistically significant differences. No significant differences were observed between the treatment groups in the time to first moderate or severe COPD exacerbation. ConclusionGLY 15.6 μg b.i.d. showed a long-term safety profile comparable to that of IND 75 μg q.d. and provided rapid and sustained bronchodilation over 52 weeks in patients with COPD with moderate-to-severe airflow limitation. Clinical trial registration numberNCT01697696.

Change in Pulmonary Function after Incentive Spirometer Exercise in Children with Spastic Cerebral Palsy: A Randomized Controlled Study.

PurposeThe aim of this study was to investigate the effect of incentive spirometer exercise (ISE) on pulmonary function and maximal phonation time (MPT) in children with spastic cerebral palsy (CP).Materials and MethodsFifty children with CP were randomly assigned to two groups: the experimental group and the control group. Both groups underwent comprehensive rehabilitation therapy. The experimental group underwent additional ISE. The forced vital capacity (FVC), forced expiratory volume at one second (FEV1), FEV1/FVC ratio, peak expiratory flow (PEF), and MPT were assessed as outcome measures before and after 4 weeks of training.ResultsThere were significant improvements in FVC, FEV1, PEF, and MPT in the experimental group, but not in the control group. In addition, the improvements in FVC, FEV1, and MPT were significantly greater in the experimental group than in the control group.ConclusionThe results of this randomized controlled study support the use of ISE for enhancing pulmonary function and breath control for speech production in children with CP.

Evaluation effects of nebulized gentamicin in exacerbation of chronic obstructive lung disease.

Background:Chronic obstructive pulmonary disease (COPD) is a major cause of chronic morbidity and mortality throughout the world. Exacerbation of COPD has negative effect on quality of life. Therapeutic effect of nebulized antibiotics in pulmonary infections has been reported previously. Hence, we evaluated the effect of nebulized gentamicin in acute exacerbation of COPD (AECOPD).Materials and Methods:In this clinical trial study, 86 hospitalized patients with AECOPD were divided into two groups for using nebulized gentamicin twice daily (case group) and placebo (control group) for 5 days in addition to standard treatment. On admission and on the 6th day, respiratory rate (RR), white blood cell (WBC), spirometry, and SPO2 (arterial O2 saturation by pulse oxymetry) were measured in groups. The severity of dyspnea was evaluated by the Medical Research Council scale.Results:In both groups, changes of SpO2, RR, forced an expiratory volume of first second (FEV1), and forced vital capacity (FVC) were significant during the times of intervention (P < 0.05). However, changes of FEV1 and FVC were significantly different between two groups (P < 0.05). So that increments of FEV1 and FVC were higher in the case group than control group. WBC decreased significantly in the case group (P < 0.05) compared to control group. There was no significant difference between groups in severity of dyspnea after intervention (P > 0.05).Conclusion:Treatment with Nebulized Gentamicin in AECOPD exacerbation resulted in further improvement of FVC and FEV1 on the 6th day.