Efficacy and safety of mixture of ivy leaf extract and coptidis rhizome in the treatment of acute bronchitis: multicenter, randomized, double-blinded, active-controlled, parallel, therapeutic confirmatory clinical trial.

BACKGROUND: Acute bronchitis is the most common respiratory disease. Mixture of Ivy Leaf Extract and Coptidis rhizome syrup has shown good treatment efficacy against chronic bronchitis and acute respiratory infections. This study aimed to evaluate the efficacy and safety of Mixture of Ivy Leaf Extract and Coptidis rhizome compared with those of Pelargonium sidoides extract, for the treatment of acute bronchitis. METHODS: We performed a multicenter, randomized, double-blind, active-controlled, parallel phase III study in 220 patients with acute bronchitis. The participants were offered either Mixture of Ivy Leaf Extract and Coptidis rhizome syrup (AGS) and placebo of P. sidoides tablet or placebo syrup and active tablet of P. sidoides (AGU) for 7 days. The primary endpoint was the change in the Bronchitis Severity Score (BSS) from the baseline visit (visit 2) to day 7 (visit 3). RESULTS: For the primary outcome, there was no significant difference in the change of total BSS between visits 2 and 3 (-4.10 ± 1.93 vs. -4.24 ± 1.85, p = 0.5125), and since the upper limit of the confidence interval (1.00) was smaller than the predetermined non-inferiority margin (1.17), it was confirmed that the AGS group was non-inferior to the AGU group. The changes in each symptom in the BSS between visits 2 and 3 also showed no significant differences. The overall improvement rate measured by the investigator (91.7 vs. 89.7%; p = 0.3506) and the satisfaction rate of the participants at visit 3 also showed no significant differences (97.2 vs. 94.4%; p = 0.4388). Regarding safety issues, adverse reactions were noted in both groups similarly, with no serious adverse events (4.55 vs. 3.64%, p > 0.999). CONCLUSION: Mixture of Ivy Leaf Extract and Coptidis rhizome syrup is as effective and safe as P. sidoides in controlling symptoms of acute bronchitis.

Durvalumab Consolidation After Chemoradiotherapy in Elderly Patients With Unresectable Stage III NSCLC: A Real-World Multicenter Study.

BACKGROUND: The PACIFIC trial demonstrated survival benefit of durvalumab after concurrent chemoradiotherapy (CCRT) in unresectable stage III non-small-cell lung cancer. Data on the effectiveness and safety of durvalumab in elderly patients is lacking. METHODS: This retrospective study was conducted between September 2017 and September 2022. Progression-free survival (PFS), overall survival (OS), recurrence patterns, first subsequent treatment after recurrence, factors associated with survival outcomes, and adverse events (AEs) were compared. RESULTS: Of the 286 patients, 120 (42.0%) were ≥ 70 years and 166 (58.0%) were < 70 years. The median PFS (17.7 vs. 19.4 months; P = .43) and median OS (35.7 months vs. not reached; P = .13) were similar between 2 groups. Proportion of patients who completed durvalumab was lower in elderly patients (27.5% vs. 39.2%; P = .040). In elderly patients, ECOG PS 0 or 1 was associated with better PFS, and being male and having received a cisplatin-based regimen during CCRT were factors associated with better and worse OS, respectively. In patients aged < 70 years, a PD-L1 ≥ 50% was associated with improved PFS and OS. Elderly patients experienced more treatment-related AEs, grade 3/4 AEs, permanent discontinuation of durvalumab, and treatment-related deaths. Among the AEs leading to permanent discontinuation or death, pulmonary AE was significantly more common in elderly patients. CONCLUSION: Durvalumab demonstrated similar outcomes in elderly compared to younger patients. However, AEs were more common in elderly patients. Thus, judicious selection of patients and chemotherapy regimens, coupled with careful AE monitoring, are important factors for ensuring optimal durvalumab treatment.

Acute Exacerbation According to GOLD 2017 Categories in Patients with Chronic Obstructive Pulmonary Disease / Exacerbación aguda en pacientes con enfermedad pulmonar obstructiva crónica según las categorías GOLD 2017

Introduction: The association between GOLD categorizations and future exacerbations has not been fully investigated. This study elucidates whether the GOLD 2017 classification is associated with different future exacerbation risk in patients with chronic obstructive pulmonary disease (COPD) compared with the previous GOLD categorization. Another objective was to investigate the impacts of the symptoms and FEV1 on the predicted future exacerbation independently of previous exacerbation history. Methods: We analyzed patients from three prospective COPD cohorts (SNUH, KOCOSS, and KOLD) and evaluated the risk of moderate to severe exacerbation among different models, including GOLD grade (FEV1), GOLD 2011, and GOLD 2017. Results: In total, 611 COPD patients were included (36 from SNUH, 257 from KOCOSS, and 318 from KOLD). GOLD 2017 classification, excluding FEV1% for categorization criteria, showed no differences in future exacerbation risk compared with GOLD grade and GOLD 2011 based on c-statistics. Among those with no frequent exacerbation history and FEV1 ≥ 50%, the group with more symptoms was significantly associated with future exacerbations than the group with less symptoms. A lower FEV1 (FEV1 < 50%) was not associated with a higher future exacerbation risk than a higher FEV1 (FEV1 ≥ 50%), regardless of prior exacerbation history and symptom group. Conclusion: The GOLD 2017 classification was not different from GOLD grade and GOLD 2011 regarding the association with future exacerbation risk, and there were no significant differences in exacerbation risk according to FEV1%. This suggests that FEV1 might not be an important factor in future exacerbation risk. These results partly support the GOLD 2017 assessment tool

Introducción: La asociación entre la categorización GOLD y la aparición de futuras exacerbaciones no se ha investigado a fondo. Este estudio analiza si la clasificación GOLD 2017 se asocia a un riesgo de padecer exacerbaciones futuras en pacientes con enfermedad pulmonar obstructiva crónica (EPOC) diferente al asociado a categorizaciones GOLD previas. Otro de los objetivos fue investigar el impacto de los síntomas y del volumen espiratorio forzado en el primer segundo (FEV1) en la exacerbación futura, independientemente de la historia previa de exacerbaciones. Métodos: Se analizaron prospectivamente 3 cohortes de pacientes con EPOC (SNUH, KOCOSS y KOLD) y se evaluó el riesgo de exacerbación moderada y grave entre los diferentes modelos, incluyendo el grado GOLD (FEV1), GOLD 2011 y GOLD 2017. Resultados: Se incluyeron un total de 611 pacientes con EPOC (36 de SNUH, 257 de KOCOSS y 318 de KOLD). La clasificación GOLD 2017 (excluyendo el porcentaje de FEV1 para el criterio de categorización) no mostró diferencias en el riesgo de exacerbación futura en comparación con el grado GOLD y GOLD 2011 según el estadístico C. Entre los pacientes sin historia previa de exacerbaciones y FEV1 ≥ 50%, aquellos con mayor número de síntomas presentaron una asociación significativamente mayor con la aparición de exacerbaciones futuras que el grupo con menor número de síntomas. Valores más bajos de FEV1 (FEV1 < 50%) no se asociaron con un mayor riesgo de exacerbación futura que valores más elevados de FEV1 (FEV1 ≥ 50%), independientemente de la historia previa de exacerbación y de los síntomas. Conclusión: La clasificación GOLD 2017 no resultó diferente al grado GOLD y a la clasificación GOLD 2011 respecto a la asociación con el riesgo de exacerbación futura. Tampoco se determinaron diferencias significativas en el riesgo de exacerbación de acuerdo con el porcentaje de FEV1. Esto sugiere que FEV1 podría no ser un factor importante para el riesgo de exacerbación futura. Estos resultados apoyan en parte el uso de la herramienta de evaluación GOLD 2017