Pulmonary Therapy最新文献

Introduction: Cystic fibrosis (CF) is a life-limiting genetic disease caused by mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) is a CFTR modulator (CFTRm) that targets the underlying cause of CF. Based on safety and efficacy demonstrated in clinical trials, ELX/TEZ/IVA is approved in the US for the treatment of CF in people aged ≥ 2 years who have ≥ 1 F508del-CFTR mutation or a CFTR mutation that is responsive to ELX/TEZ/IVA based on in vitro data. While ELX/TEZ/IVA demonstrated unprecedented improvements in lung function and dramatic reductions in pulmonary exacerbations (PEx) and associated hospitalizations in clinical trials, a limited number of studies have examined the impact of ELX/TEZ/IVA on healthcare resource utilization (HCRU) and associated costs in a real-world setting. The aim of this retrospective study was to evaluate changes in PEx, HCRU, and associated non-CFTRm healthcare costs following initiation of ELX/TEZ/IVA among people with CF aged ≥ 12 years in the US.

Methods: We evaluated the rates of PEx, HCRU, and associated costs before and after initiation of ELX/TEZ/IVA in people with CF aged ≥ 12 years using data from the Merative MarketScan® Commercial Claims and Encounters Database and the Merative Multi-State Medicaid Database from April 21, 2019 to December 31, 2020. Because the study period included time following the onset of the COVID-19 pandemic, we limited our primary analysis to the period prior to the pandemic (October 21, 2019 to March 12, 2020). Outcomes following the onset of the pandemic (March 13 to December 31, 2020) were examined in an exploratory analysis.

Results: In both commercially insured and Medicaid-insured people with CF, ELX/TEZ/IVA was associated with reductions in PEx, hospitalizations, and associated costs prior to the COVID-19 pandemic, and these reductions were maintained following the onset of the pandemic.

Conclusions: These findings suggest that ELX/TEZ/IVA reduces the burden and costs associated with PEx and hospitalizations in people with CF.

Introduction: The fourth outbreak of COVID-19 with the delta variant in Vietnam was very fierce due to the limited availability of vaccines and the lack of healthcare resources. During that period, the high mortality of patients with severe and critical COVID-19 caused many concerns for the health system, especially the intensive care units. This study aimed to analyze the predictive factors of death and survival in patients with severe and critical COVID-19.

Methods: We conducted a cross-sectional and descriptive study on 151 patients with severe and critical COVID-19 hospitalized in the Intensive Care Unit of Binh Duong General Hospital.

Results: Common clinical symptoms of severe and critical COVID-19 included shortness of breath (97.4%), fatigue (89.4%), cough (76.8%), chest pain (47.7%), loss of smell (48.3%), loss of taste (39.1%), and headache (21.2%). The abnormal biochemical features were leukopenia (2.1%), anemia, thrombocytopenia (18%), hypoxia with low PaO₂ (34.6%), hypocapnia with reduced PaCO₂ (29.6%), and blood acidosis (18.4%). Common complications during hospitalization were septic shock (15.2%), cardiogenic shock (5.3%), and embolism (2.6%). The predictive factors of death were being female, age > 65 years, cardiovascular comorbidity, thrombocytopenia (< 137.10⁹/l), and hypoxia at inclusion or after the first week or blood acidosis (pH < 7.28). The use of a high dose of corticosteroids reduced the mortality during the first 3 weeks of hospitalization but significantly increased risk of death after 3 and 4 weeks.

Conclusions: Common clinical symptoms, laboratory features, and death-related complications of critical and severe COVID-19 patients were found in Vietnamese patients during the fourth wave of the COVID-19 pandemic. The results of this study provide new insight into the predictive factors of mortality for patients with severe and critical COVID-19.

Introduction: Understanding of the patient-perceived symptom burden of small cell lung cancer (SCLC) is limited. The objective of this study was to explore patients' experiences with SCLC, identify which treatment-/disease-related symptoms have the greatest impact on their well-being, and gain caregiver perspectives.

Methods: A noninterventional, cross-sectional, multimodal, mixed methods study was conducted from April-June 2021. Adult patients with SCLC and unpaid caregivers were eligible to participate. Patients' experiences, captured via 5-day video diaries and follow-up interviews, were scored 1-10 on how bothersome the patients perceived each symptom/symptomatic adverse event. Patients indicated if they believed a symptom was disease or treatment related. Caregivers participated in an online community board.

Results: The study included nine patients (five with extensive-stage [ES] disease, four with limited-stage [LS] disease) and nine caregivers. Except for one patient/caregiver pairing, patients and caregivers were unmatched. The most common impactful symptoms in patients with ES-SCLC were shortness of breath, fatigue, coughing, chest pain, and nausea/vomiting; in LS-SCLC, these were fatigue and shortness of breath. Among patients with ES disease, SCLC had a high impact on physical (leisure/hobbies, work, sleep, ability to do household chores and errands/responsibilities outside home), social (family dynamics, extrafamilial social interaction), and emotional (mental health) aspects. Patients with LS-SCLC faced the long-term physical effects of treatment, financial implications, and emotional toll of an uncertain prognosis. SCLC had a high personal and psychologic burden among caregivers, whose duties consumed much of their time. Caregivers observed similar symptoms and impacts of SCLC as those reported by patients.

Conclusions: This study provides valuable insight into patient- and caregiver-perceived burden of SCLC and can inform the design of prospective studies. Clinicians should seek to understand patients' opinions and priorities before making treatment decisions.

Introduction: The incidence of malignant pleural effusion (MPE) in patients with small cell lung cancer (SCLC) in an American population is approximately 11%, and overall survival in that group is 3 months (compared to 7 months without an effusion. To our knowledge, no study has been done in the United Kindgom and we thus sought to determine the characteristics of the local population.

Method: All patients coded as having small cell lung cancer from Somerset register from January 2012-September 2021 were reviewed. We excluded those with indeterminate pathology reports, carcinoid or large cell neuroendocrine cancers. Basic demographics, presence of an MPE and any interventions and outcomes were collected for descriptive analysis. Continuous variables are presented as mean (±) range, median (± IQR) when outliers were present and categorical variables as percentages where appropriate. Caldicott reference C3905.

Results: Four hundred one patients with SCLC were identified (11% of all patients, median time to death from presentation 208 days, IQR 304 [many outliers); 224 (55.9%) were female, 177 male [median age 75 years, IQR 13]. One hundred seven (27%) presented with an effusion: 23 were sampled, 10 had positive cytology, all were exudates, 8 required chest drainage, the mean performance status (PS) was 2 (range 1-4) and the median time to death 142 days, IQR 45. Of the 294 with no initial effusions, 70 (24%) developed a pleural effusion with progressive disease (mean PS 1, median age 71.5 years, IQR 14, median to death 327 days, IQR 395, 1 outlier); 224 patients never had a MPE with a median time to death of 212 days, IQR 305, multiple outliers and, when compared to those with a MPE at any point, median time to death was 211 days, IQR 295.5 (multiple outliers).

Conclusion: Meaningful analysis was difficult because of the presence of multiple outliers in values collected and not correcting for stage at presentation or treatment modalities and previous studies did not correct for those either. Those presenting with an MPE had a poorer prognosis, probably signifying advanced disease and the presence of MPE in our SCLC cohort seems higher. Large prospective databases for this are required.

Introduction: The objective of the present study was to evaluate the efficacy and safety of MP-AzeFlu nasal spray in comparison to commercially available azelastine hydrochloride and fluticasone propionate sprays in Chinese patients with moderate-to-severe allergic rhinitis (AR).

Methods: We conducted a 14-day multicenter, randomized, double-blind, active controlled prospective clinical study in adult and adolescent patients with AR, who had moderate-to-severe symptoms. The primary efficacy endpoint was the change from baseline in combined 12-h reflective total nasal symptom score (rTNSS) (morning [AM] + afternoon [PM]). The safety profile of the study medications was assessed through the recording, reporting, and analysis of baseline medical conditions, adverse events (AEs), vital signs, and focused nasal examination. Three hundred patients per treatment group were randomized, which led to a total sample size estimation of 900 patients.

Results: MP-AzeFlu group showed significantly higher symptom reduction for the entire 2-week treatment period in rTNSS when compared with the AZE group (LS mean difference: - 1.96; 95% CI: - 2.53, - 1.39; p < 0.0001), or the FLU group (LS mean difference: - 0.98; 95% CI: - 1.55, - 0.41; p = 0.0007). The results of adult RQLQ showed improvement in QoL in all treatment groups. Except for dysgeusia (bitter taste) that was reported by more patients (13 [4.3%]) in the MP-AzeFlu group, the incidence of all other TEAEs in the MP-AzeFlu group was comparable or even lower than in other treatment groups.

Conclusions: MP-AzeFlu, when administered as one spray per nostril twice daily for 14 days, alleviated AR symptoms in Chinese patients with moderate-to-severe AR.

Trial registration: Clinicaltrials.gov; NCT03599791, Registered June 29, 2018, retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03599791 .

Introduction: Previous studies in 2018 and 2022 have suggested increasing inpatient burden of pneumothorax and widespread variation in management. Local trends have never been elucidated. Northumbria Healthcare NHS Foundation Trust (NHCT) has a well-established pleural service, serving just over 600,000. Thus, we set up a local retrospective study to look at trends in pneumothorax presentation, management strategies, length of stay, and recurrence.

Methods: A coding search for 'pneumothorax' was performed for all patients attending NHCT between 2010 and 2020 was performed with local Caldicott approval. A total of 1840 notes were analysed to exclude iatrogenic, traumatic, and paediatric events. After excluding those cases, 580 remained for further analysis, consisting of 183 primary pneumothoraces (PSP) and 397 secondary pneumothoraces (SSP).

Results: Median age for PSP was 26.5 years (IQR 17) with 69% male, and for SSP 68 years (IQR 11.5), 62% male; 23.5% of PSP and 8.6% of SSP were never smokers. The proportion of smokers and ex-smokers has not really changed over time: > 65% every year have been smokers or ex-smokers. Yearly pneumothorax incidence shows a downward trend for PSP but upwards for SSP. Median length of stay (LoS) for PSP was 2 days (IQR 2), and SSP 5 days (IQR 8), with a clear downward trend. From 2010 to 2015 > 50% PSP were managed with drain, but in 2019-2020 at least 50% managed conservatively, with a significant reduction in aspiration. Trends of recurrence for PSP are increasing, whereas for SSP is decreasing. Seventy-six (20 PSP, 56 SSP) went for surgery at the index time with 5.3% recurrence (20% recurrence in those without surgery).

Conclusions: This is the first known analysis of pneumothorax trends in a large trust in the northeast of England. The data in this study have certain limitations, including the lack of information on the size of pneumothorax and frailty indicators that may influence the decision for conservative management. Additionally, there is a reliance on clinical coding, which can introduce potential inaccuracies, and not all patient notes were accessible for analysis. Updated larger datasets should help elucidate trends better.

Patients with coronavirus disease 2019 (COVID-19) usually suffer from post-acute sequelae of coronavirus disease 2019 (PASC). Pulmonary fibrosis (PF) has the most significant long-term impact on patients' respiratory health, called post-COVID-19 pulmonary fibrosis (PC19-PF). PC19- PF can be caused by acute respiratory distress syndrome (ARDS) or pneumonia due to COVID-19. The risk factors of PC19-PF, such as older age, chronic comorbidities, the use of mechanical ventilation during the acute phase, and female sex, should be considered. Individuals with COVID-19 pneumonia symptoms lasting at least 12 weeks following diagnosis, including cough, dyspnea, exertional dyspnea, and poor saturation, accounted for nearly all disease occurrences. PC19-PF is characterized by persistent fibrotic tomographic sequelae associated with functional impairment throughout follow-up. Thus, clinical examination, radiology, pulmonary function tests, and pathological findings should be done to diagnose PC19-PF patients. PFT indicated persistent limitations in diffusion capacity and restrictive physiology, despite the absence of previous testing and inconsistency in the timeliness of assessments following acute illness. It has been hypothesized that PC19-PF patients may benefit from idiopathic pulmonary fibrosis treatment to prevent continued infection-related disorders, enhance the healing phase, and manage fibroproliferative processes. Immunomodulatory agents might reduce inflammation and the length of mechanical ventilation during the acute phase of COVID-19 infection, and the risk of the PC19-PF stage. Pulmonary rehabilitation, incorporating exercise training, physical education, and behavioral modifications, can improve the physical and psychological conditions of patients with PC19-PF.

Systemic corticosteroids (CSs), a keystone in pulmonology, are drugs with strong antiinflammatory activity. They are cheap, easily available, and accessible, but with common and serious side effects. Moreover, the use of exogenous CSs may suppress the hypothalamic-pituitary-adrenal (HPA) axis, predisposing to adrenal insufficiency. Safe CS treatment is a challenge of pharmacological research. This narrative review examined the indications of CSs in some respiratory diseases, analyzing what types, dosages, and length of treatment are required as the dosage and duration of CS treatments need to be minimized. Chronic maintenance treatments with CSs are associated with poor prognosis, but they are still prescribed in patients with severe asthma, Chronic obstructive pulmonary disease (COPD), and interstitial lung diseases. When CS discontinuation is not possible, all efforts should be made to achieve clinically meaningful reductions. Guidelines suggest the use of methylprednisolone at a dose of 20-40 mg/day or equivalent for up to 10 days in subjects with COVID-19 pneumonia (but not other respiratory viral diseases) and respiratory failure, exacerbations of asthma, and COPD. Some guidelines suggest that CS treatment shorter than 10-14 days can be abruptly stopped, strictly monitoring subjects with unexplained symptoms after CS withdrawal, who should promptly be tested for adrenal insufficiency (AI) and eventually treated. CSs are often used in severe community-acquired pneumonia associated with markedly increased serum inflammation markers, in acute respiratory distress syndrome (ARDS), in septic shock unresponsive to hydro-saline replenishment and vasopressors, and acute exacerbations of interstitial lung diseases. As these cases often require higher doses and longer duration of CS treatment, CS tapering should be gradual and, when useful, supported by an evaluation of HPA axis function.

Over the past 22 years, annual GOLD Reports have documented important changes in guidance and recommendations for uniformly treating patients with chronic obstructive pulmonary disease (COPD) with the goal of improving outcomes in patients suffering from this condition. The most recent GOLD Report, released in 2023, shows continued refinement in several areas, including more precise definitions of COPD and exacerbations of COPD, a new set of parameters to assess exacerbation severity, an updated COPD assessment tool, updated guidelines for initial and follow-up treatment, new information regarding the association between pharmacological triple therapy and reduction in mortality, and new discussions of inhaler device choice and adherence to COPD medications. Whereas we do not address all of the new or updated material in GOLD's 2023 Report, we summarize key changes in GOLD's recommendations regarding inhalation therapy for stable COPD and frame these changes in the context of previous GOLD recommendations.