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Background
A visual analogue scale (VAS) is a psychometric instrument widely used in the Rhinology field to subjectively quantify patient’s symptoms severity. In allergic rhinitis, VAS has been found to correlate well with the allergic rhinitis and its impact on asthma severity classification, as well as with rhinoconjunctivitis quality of life questionnaire. In chronic rhinosinusitis (CRS), total VAS score are often used to classify disease burden into mild, moderate, and severe, with few studies correlating VAS scores with more complex and validated instruments assessing disease-specific burden like Sino-Nasal Outcome Test (SNOT)-22.Methods
We correlated VAS scores for total and individual sino-nasal symptom with SNOT-22 scores in a randomly selected group of 180 CRS patients. Pearson’s rho was selected as a correlation coefficient for analysis.Results
VAS scores for total nasal symptom score and individual symptoms correlated significantly with SNOT-22, irrespective of VAS based subclasses for sino-nasal, ocular, and bronchial symptoms.Conclusions
VAS for total sino-nasal symptom severity might be used for assessing disease severity, monitoring the course of the disease, and can be used for treatment decisions and disease burden.3.
Kija Shah-Hosseini Eva-Maria Krudewig Meike Hadler Efstrathios Karagiannis Ralph Mösges 《Advances in therapy》2017,34(6):1382-1397
Introduction
Allergen immunotherapy is the only treatment option for allergic rhinitis with disease-altering potential. It was the objective of this study to assess the effectiveness and tolerability of a 5-grass pollen tablet in a large population of non-selected grass pollen allergic patients, i.e. patients with different clinical profiles in daily clinical practice.Methods
In a 2-year, prospective, open-label, multicenter, non-controlled, observational study patients were included from 327 centers across Germany. Rhinoconjunctivitis symptoms, symptomatic medication intake and adverse events were recorded.Results
A total of 1482 patients aged 4–75 years were included. During the 2-year period of 5-grass pollen tablet therapy, mean rhinoconjunctivitis score decreased significantly in the overall study population by 65.5% (P < 0.001). The percentage of patients taking symptomatic medication decreased from 83.8% to 42.7%. Mean 2-year improvements in rhinoconjunctivitis scores and decreases in the percentage of patients taking symptomatic medication were broadly similar in adults, adolescents and children, in patients with polyallergy versus monoallergy, and in patients with/without asthma. Among polyallergic patients, concomitant application of another specific immunotherapy did not impair treatment outcomes. Adverse drug reactions, predominantly affecting the local application area, occurred in 15.4% of the overall patient population (n = 229). No cases of anaphylaxis or epinephrine use were documented.Conclusion
This study indicates that sublingual immunotherapy with the 5-grass pollen tablet is well tolerated and provides sustained effectiveness over 2 years in patients with different clinical profiles, producing a significant decrease in allergic symptoms and a reduction in the use of symptomatic medication.Funding
Stallergenes GmbH.4.
Objective
To compare the safety and estimate the response profile of olanzapine, a second-generation antipsychotic, to haloperidol in the treatment of delirium in the critical care setting.Design
Prospective randomized trialSetting
Tertiary care university affiliated critical care unit.Patients
All admissions to a medical and surgical intensive care unit with a diagnosis of delirium.Interventions
Patients were randomized to receive either enteral olanzapine or haloperidol.Measurements
Patient’s delirium severity and benzodiazepine use were monitored over 5 days after the diagnosis of delirium.Main results
Delirium Index decreased over time in both groups, as did the administered dose of benzodiazepines. Clinical improvement was similar in both treatment arms. No side effects were noted in the olanzapine group, whereas the use of haloperidol was associated with extrapyramidal side effects.Conclusions
Olanzapine is a safe alternative to haloperidol in delirious critical care patients, and may be of particular interest in patients in whom haloperidol is contraindicated.5.
Aims
Create an educational program in chronic pain (EPCP).Material and methods
We used a four-step process to create the EPCP tailored to patient’s needs.Results
Five groups of patients can benefit from the program annually. Based on their own assessment, patients stated that their knowledge of chronic pain improved between 2.8 to 24%. The satisfaction with the EPCP was 8.67/10.Conclusion
Our EPCP helps patients gain and maintain the skills they need to best manage their lives with a chronic pain.6.
Introduction
Most asthma patients have mild disease, although the burden of mild asthma is not well understood nor studied. Some evidence suggests that many patients with mild asthma experience suboptimal symptom control and exacerbations. This study characterizes the burden of illness and treatment patterns among patients with a confirmed diagnosis of mild asthma, defined as GINA Step 1 or Step 2, and residing in China, France, Germany, Italy, Japan, Spain, the United Kingdom, or the United States.Methods
The Respiratory Disease-Specific Programme prospective cross-sectional survey was conducted with primary care and specialty physicians in each of the eight countries. Physician and patient surveys assessed demographic and clinical characteristics, frequency and timing of asthma symptoms, exacerbations, and rescue inhaler usage, the most recent FEV1% predicted, and healthcare utilization. GINA Step was determined by prescribed treatment regimen. GINA Step 1 patients were prescribed as-needed reliever medication and Step 2 required treatment with a low-dose inhaled corticosteroid, leukotriene receptor antagonist, or theophylline. Treatment adherence was assessed with the Morisky Medication Adherence scale, disease control with the Asthma Control Test, and work and activity impairments with the Work Productivity and Activity Impairment scale.Results
The sample included 1115 GINA Step 1 and 2 patients, with 53% classified as Step 2. Overall asthma control was suboptimal, with reports of nocturnal symptoms (40.6%), symptom worsening (10.5%), and rescue inhaler usage in the last 4 weeks (33.6%). 25% of patients were uncontrolled. The overall mean number of exacerbations in the last 12 months was 0.4, with a higher frequency of exacerbations in Step 2 patients who also experienced more exacerbations requiring treatment intensification, an emergency department visit, or hospitalization.Conclusion
Mild asthma imposes a substantial burden on patients, establishing the need for comprehensive management plans and ongoing support for treatment adherence.Funding
AstraZeneca.7.
Henrik Svedsater Helen A. Doll Jake Macey Gail Miles Lisa Bradshaw Magdalena Vanya 《Advances in therapy》2018,35(9):1378-1399
Introduction
This study evaluated patients’ experiences with fluticasone furoate/vilanterol (FF/VI) combination therapy in UK patients with asthma or chronic obstructive pulmonary disease (COPD).Methods
Participants aged ≥?18 years, with self-reported, physician-diagnosed asthma or COPD (≥?1 year) who had been receiving FF/VI (≥?3 months) were recruited from UK primary care. This two-phase, mixed-methods study consisted of a semi-structured, telephone-interview phase (qualitative) and a self-completed online/paper-survey phase (quantitative).Results
The telephone-interview phase included 50 individuals [asthma, n?=?25; COPD, n?=?25; mean age (SD) 56.7 years (13.3); 50% female]. Of these, 21 with asthma reported that their condition was stable/well controlled and 13 with COPD felt their condition was manageable. Most participants found FF/VI easy to use (asthma, 25; COPD, 23), easy to integrate into their daily routine (asthma, 25; COPD, 24), and able to control symptoms for ≥?24 h (asthma, 14; COPD, 16). During the survey phase, 199 individuals were recruited [asthma, n?=?100; COPD, n?=?99; mean age (SD) 63.6 years (15.1); 59.3% female]. Most participants were satisfied/very satisfied with the efficacy of FF/VI in terms of all-day symptom relief (asthma, 84%; COPD, 75%) and found FF/VI easy/very easy to fit into their daily routine (asthma, 99%; COPD, 96%), easy/very easy to use (asthma, 97%; COPD, 92%), and convenient/very convenient to take as instructed (asthma, 95%; COPD, 93%). Significantly more individuals with asthma (87% versus 46%, P?<?0.001) and numerically more individuals with COPD (84% versus 76%, P?=?0.055) were satisfied/very satisfied with FF/VI compared with their most recent previous maintenance medication.Conclusion
The majority of individuals in this study had confidence in FF/VI and were satisfied or very satisfied with various key attributes of the treatment.Trial Registration
GSK study HO-15-15503/204888.Funding
GSK.8.
William W. Busse Jorge F. Maspero Klaus F. Rabe Alberto Papi Sally E. Wenzel Linda B. Ford Ian D. Pavord Bingzhi Zhang Heribert Staudinger Gianluca Pirozzi Nikhil Amin Bolanle Akinlade Laurent Eckert Jingdong Chao Neil M. H. Graham Ariel Teper 《Advances in therapy》2018,35(5):737-748
Introduction
Dupilumab, a fully human anti-IL-4Rα monoclonal antibody, inhibits signaling of both interleukin (IL)-4 and IL-13, which are key drivers of type 2-mediated inflammation. Dupilumab is approved in the EU, USA, and other countries for the treatment of adults with inadequately controlled moderate-to-severe atopic dermatitis. Following positive phase 2 results in asthma, the phase 3 Liberty Asthma QUEST trial was initiated to provide further evidence for dupilumab efficacy and safety in patients with uncontrolled, moderate-to-severe asthma.Methods
Liberty Asthma QUEST is a phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial (NCT02414854) in patients with persistent asthma who are receiving continuous treatment with inhaled corticosteroids (ICS) plus one or two other asthma controller medicines. A total of 1902 patients (aged?≥?12 years) were randomized in a 2:2:1:1 ratio to receive 52 weeks of add-on therapy with subcutaneously administered dupilumab 200 or 300 mg every 2 weeks or matched placebo. The study consisted of a 4?±?1-week screening period, 52-week randomized treatment period, and 12-week post-treatment follow-up period. All patients continued to receive their prescribed ICS plus up to two additional controller medications. The primary efficacy endpoints were annualized rate of severe exacerbation events during the 52-week treatment period and absolute change from baseline in pre-bronchodilator FEV1 at week 12.Conclusion
Uncontrolled asthma patients with persistent symptoms represent a population of significant unmet need, for whom new treatments are required. Patients with severe asthma are at high risk of asthma exacerbations, and face an accelerated decline in lung function and impaired quality of life. QUEST examines the efficacy of dupilumab in this at-risk patient population; it is the largest placebo-controlled study in uncontrolled, moderate-to-severe asthma with a biologic agent to date, and the only phase 3 study of a biologic therapy of asthma that enrolled patients irrespective of baseline type 2 inflammatory biomarker levels.Funding
Sanofi and Regeneron Pharmaceuticals, Inc.Clinical Trials.gov Identifier
NCT02414854.9.
V. Vion-Genovese C. Maindet D. Gillet C. Boscapomi S. Heritier A. Gauchet C. Rigolet L. Benitez J.-P. Petrod J. Amiel M. Baudrant 《Douleur et Analgésie》2017,30(3):123-127
Introduction
Patients and care providers came up with the idea of an educational tool for patients with chronic painMethodology
The educational sessions were developed over a five-year period, with four meetings per year.Results
“Kit KAD” answers the problems faced by patients in pain in everyday life. The “Kit KAD” offers tools and session leaders and can be used by any team trained in PTE (patient therapeutic education).Conclusion
The “Kit KAD” group, assisted on methodology by the Eastern region UTEP (Transversal Patient therapeutic Education Unit), created an innovative educational tool for patients in chronic pain.10.
Eiji Ryo Rina Sakurai Hideo Kamata Michiharu Seto Masayoshi Morita Takuya Ayabe 《Journal of Medical Ultrasonics》2016,43(2):237-242
Purpose
To investigate changes in uterine flexion after cesarean delivery in comparison with vaginal delivery, and their relationship with the presence of deficient cesarean section scars.Methods
In 147 women who had a vaginal delivery and 101 women who had a cesarean delivery, transvaginal ultrasonographic photographs of the uterus were obtained at the first trimester of pregnancy and at 1 month postpartum, and they were reviewed to determine changes in uterine flexion. The presence of a deficient cesarean section scar was also reviewed in women with a cesarean section.Results
Changes in uterine flexion were observed more frequently among the woman with a cesarean delivery than in those with a vaginal delivery. The incidence of post-flexed uterus during puerperium tended to increase depending on the number of cesarean sections the woman had undergone. In the women with a cesarean section, changes in uterine flexion were more frequently observed in the women with a deficient cesarean section scar than in those without one.Conclusion
Changes in uterine flexion after birth occurred more frequently in the women who had a cesarean delivery than in those who had a vaginal delivery, especially in the presence of a deficient cesarean section scar.11.
Maneesh Gupta 《Clin Pract Epidemiol Ment Health》2007,3(1):12
Background
Quetiapine causes less prolactin elevation and/or galactorrhoea than other atypical antipsychotics.Case Presentation
Ms AB had galactorrhoea and raised prolactin levels at only 100 mg of quetiapine daily.Conclusion
Low dose quetiapine can also cause galactorrhoea.12.
Arie Barlev Vincent W. Lin Aaron Katz Kuolung Hu Ze Cong Beth Barber 《Advances in therapy》2017,34(1):148-155
Introduction
Blinatumomab is a bispecific T cell-engaging antibody construct indicated for adult patients with relapsed/refractory (R/R) Ph(?) B-precursor acute lymphoblastic leukemia (ALL), an aggressive disease with poor prognosis. A phase 2 single-arm clinical study showed that 43% of patients achieved CR/CRh within two cycles and approximately 20% of patients receiving blinatumomab were still alive after 2 years.Methods
The objective of the current analysis was to estimate long-term survival of patients receiving blinatumomab beyond the observed time period in the clinical study using a large historical observational dataset. Conditional survival probabilities of blinatumomab-treated patients beyond month 60 were assumed to be the same as the US general population.Results
At month 60, the estimated proportion of blinatumomab-treated patients alive was more than double that of historical patients (12.6% vs 5.4%). The mean overall survival was 76.1 months for blinatumomab patients and 39.8 months for historical patients. Sensitivity analyses including additional follow-up data from the clinical study showed consistent results.Conclusions
These findings suggest that blinatumomab provides substantial overall survival benefit to patients with (R/R) Ph(?) B-precursor ALL compared with salvage chemotherapy.Funding
Amgen.Trial Registration
ClinicalTrials.gov identifier NCT01466179 and NCT02003612.13.
Background
The study was performed to reveal the effect of an individualized personal outpatient therapy program, based on a multidisciplinary assessment, on pain and health-related quality of life in patients with chronic pain.Methods
Fifty patients were prospectively evaluated before and 3 months after establishment of an individualized outpatient therapy program. Health-related quality of life, pain and pain-related disability, depression and motivation to adopt self-management of chronic pain were assessed. Therapy adherence was tested with a structured interview.Results
Only marginal improvements were observed in terms of pain and health-related quality of life. Therapy adherence varied between the different therapies.Conclusions
An individualized personal outpatient therapy program has only marginal effects on pain and health-related quality of life in patients with chronic pain.14.
Background
The subjective state of health with respect to pain and psyche was surveyed utilizing validated pain questionnaires in patients undergoing special pain therapy and represents the basis for targeted treatment measures.Objective
The purpose of this study was to investigate the possible distortion of answers due to social desirability of responses in chronic pain patients.Material and methods
During two survey periods assessing patient satisfaction using both anonymized and personalized questionnaires, the effects arising from socially desirable response patterns were analyzed. The sample consisted of chronic pain patients being treated in an inpatient therapy setting.Results
In both periods of observation no significant impact on the response behavior of chronic pain patients was found in personalized or anonymized questionnaires.Conclusion
The results of the study suggest that the responses of chronic pain patients with respect to their subjective state of health are not influenced by social desirability. Thus, scoring systems such as the German pain questionnaire will not be influenced by social desirability in chronic pain patients and can therefore be used as a part of diagnostics and therapy planning.15.
Objective
To study the clinical effect of body mass index (BMI) in the optimal time of weaning from sequential invasive-noninvasive mechanical ventilation (MV) by treating severity chronic obstructive pulmonary disease (COPD) patients.Methods
94 patients with severity COPD were divided into the control group (BMI<21) and the study group (BMI>21). These two groups were treated by similar symptomatic therapies such as mechanical ventilation, antibacterial, antispasmodic, relieving asthma, antitussive, expectorant, correction of electrolyte imbalance and acid-base balance disorders, strengthen nutritional support, etc.Results
Compared with the control group, the study group had shorter duration of invasive mechanical ventilation, non-invasive mechanical ventilation time, total mechanical ventilation time, total hospital stay (P<0.01). There are significant differences between these two groups in re-intubation rate, VAP occurred in the number of case, hospital mortality rate in 28 days (P<0.05).Conclusions
It is difficult to wean successfully from sequential mechanical ventilation for severity COPD patients (BMI<21), so BMI as one of important reference index can be used to estimate the optimal time for weaning from sequential mechanical ventilation for severity COPD patients.16.
Background
In addition to idiopathic shoulder stiffness, secondary shoulder stiffness in particular is often associated with extra-articular subacromial adhesions between the rotator cuff and the surrounding anatomical structures.Objective
The aim of this article is to present clinical results and complications as well as the surgical technique of extra-articular release in the context of secondary shoulder stiffness.Material and Methods
Selective review of the literature and presentation of own clinical experience.Results
Intra-articular and extra-articular release are related to a high patient satisfaction and an improved range of motion. Exact knowledge of the extra-articular anatomy is necessary to prevent iatrogenic lesions of vessels, nerves and the rotator cuff. Compared to patients with a primary stiff shoulder, patients suffering from posttraumatic stiff shoulder benefit more from arthroscopic interventions with intracapsular and extracapsular release.Conclusion
Restrictions in range of motion of the shoulder can be related to extra-articular adhesions. These adhesions need to be specifically addressed during arthroscopic treatment of stiff shoulders.17.
Objectives
1) to assess the prevalence of hepatitis C virus (HCV) infection in a population of acute psychiatric in-patients; 2) to find out relationships between HCV comorbidity and clinical features of psychiatric patients.Methods
Prospective observational study in a 6-year period.Results
2396 cases (1492 patients) were admitted in the considered period. Forty-two patients (2.8%) were affected by HCV infection. HCV infection was more frequent in patients with less years of education, lower social class, lower last year best Global Assessment of Functioning score, more hostile or violent behavior in hospital, with a lifetime history of previous suicide attempt, and with substance-related disorders.Conclusion
HCV infection in psychiatric patients constitutes a major threat to the health of psychiatric patients and is related with unfavorable social background, worse global functioning, hostile or violent behavior, substance-related disorders. It appears also to be a significant risk of suicidal behavior.18.
Michał Pirożyński Piotr Hantulik Agnieszka Almgren-Rachtan Jerzy Chudek 《Advances in therapy》2017,34(12):2648-2660
Introduction
The effectiveness of single-inhaler budesonide/formoterol fumarate combination therapy for asthma has been previously shown for the original product. The aim of this nonrandomized, open-label, postauthorization efficacy study (PAES) real-life clinical assessment was to evaluate the clinical effectiveness of a second product (Bufomix Easyhaler®) in the daily clinical practice of asthma therapy.Methods
This multicenter PAES was conducted by 220 unselected allergologists and pulmonologists who enrolled 2200 adult outpatients (age 49.8 ± 17.9 years) with asthma treated with Bufomix Easyhaler® for at least 14 days before enrolment. Asthma control was assessed during three subsequent visits with 8–12-week intervals on the basis of the Asthma Control Test (ACT). Adherence was assessed with the Medication Adherence Questionnaire. In addition, patient satisfaction with Bufomix Easyhaler® was scored, and adverse drug reactions were recorded.Results
The percentage of patients with well-controlled asthma or total control of asthma (ACT score 20-25 points) increased from 46.6% at the first visit to 90.8% at the third visit (p < 0.001). In addition, the percentage of patients with poor control of asthma (ACT score less than 15 points) decreased from 14.9% to 1.2% (p < 0.001). The adherence rate increased from 88% at the first visit to 95.3% at the third visit. Patient satisfaction with the use of this dry powder inhaler increased with the duration of its use. Only one adverse drug reaction was reported.Conclusion
The results obtained confirm the effectiveness of Bufomix Easyhaler® in the treatment of asthma in outpatient adults in daily clinical practice.Funding
Orion Corporation19.
Yoshiko Sagara Shunro Matsumoto Masatoshi Oga Norio Hongo Norimasa Kaneko Hiromu Mori 《Abdominal imaging》2016,41(9):1722-1727
Purpose
The aim of this study was to investigate the multidetector computed tomography (MDCT) features of strangulated ileus caused by epiploic appendix of the sigmoid colon.Methods
We retrospectively evaluated MDCT images of four patients who underwent surgery in our hospital between 2011 and 2014. Patients were aged from 66 to 79 years, and two were female.Results
Closed loop obstruction of the small bowel was confirmed in all patients. A fatty peritoneal band around the orifice of the ileus was detected in two patients, but was equivocal in the other two patients. Traction of the sigmoid colon toward the hilum of the closed loop of the small bowel was obvious in three patients.Conclusion
When traction of the sigmoid colon is detected in MDCT in a case of closed loop obstruction of the small bowel, strangulated ileus caused by an epiploic appendix should be considered in the differential diagnosis.20.
Shichuan Zhang Chengping Hu Rongli Lu Ruichao Niu Xinyue Hu Ling Qin Ruoxi He Juntao Feng 《Advances in therapy》2018,35(10):1578-1584