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Purpose: Chronic obstructive pulmonary disease (COPD) is a disease characterized by frequent acute exacerbations (AEs), especially in severe and very severe cases. We aimed to evaluate the efficacy and safety of Bu-fei Yi-shen granules (BYGs) for COPD. Patients and Methods: We conducted a multicenter, randomized, double-blinded, placebo-controlled trial of 348 COPD patients with GOLD 3-4 COPD. The patients were randomly assigned into experimental or control groups in a 1:1 ratio. Patients in the experimental group were prescribed BYG, while those in the control group were administered a placebo, orally, twice daily, with 5 days on and 2 days off per week for 52 weeks. The outcomes included AEs, pulmonary function, clinical signs and symptoms, dyspnea scores (mMRC), quality of life scores, and a 6-minute walk test (6MWT). Results: A total of 280 patients completed the trial, including 135 patients in the experimental group and 145 in the control group. Compared to the control group, significant differences were observed in frequencies of AEs (mean difference: -0.35; 95% CI: -0.61, -0.10; P = 0.006) and AE-related hospitalizations (-0.18; 95% CI: -0.36, -0.01; P = 0.04), 6MWD (40.93 m; 95% CI: 32.03, 49.83; P < 0.001), mMRC (-0.57; 95% CI: -0.76, -0.37; P < 0.001), total symptoms (-2.18; 95% CI: -2.84, -1.53; P < 0.001), SF-36 (11.60; 95% CI: 8.23, 14.97; P < 0.001), and mCOPD-PRO (-0.45; 95% CI: -0.57, -0.33; P < 0.001) after treatment. However, there were no significant differences in mortality, pulmonary function, and mESQ-PRO scores (P > 0.05). No obvious adverse events were observed. Conclusion: BYG, as compared to a placebo, could significantly reduce the frequencies of AEs and AE-related hospitalizations for GOLD 3-4 COPD patients. Clinical symptoms, treatment satisfaction, quality of life, and exercise capacity improved. There was no significant improvement in mortality and pulmonary function.
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Enfermedad Pulmonar Obstructiva Crónica , Humanos , Enfermedad Pulmonar Obstructiva Crónica/diagnóstico , Enfermedad Pulmonar Obstructiva Crónica/tratamiento farmacológico , Calidad de Vida , Pulmón , Disnea , CaminataRESUMEN
Objective: Studies have confirmed that uric acid is involved in the regulation of cognitive function. This study aimed to investigate the expression of serum uric acid in alcohol-dependent patients and evaluate its clinical diagnostic value for cognitive impairment. Methods: Blood sample was collected for assessment of serum uric acid levels. Montreal Cognitive Assessment Scale scores were obtained to assess cognitive function. Anxiety and depression scores on the Symptom Check List 90 scale were used to assess mental health status. The alcohol-dependent patients were divided into non-cognitive impairment and cognitive impairment groups according to Montreal Cognitive Assessment Scale score, and the serum uric acid levels of these groups were analyzed. The receiver operating characteristic curve evaluated the diagnostic value of serum uric acid in cognitive impairment patients. Pearson correlation coefficient evaluated the correlation between uric acid and Montreal Cognitive Assessment Scale score, anxiety score, and depression score. Multivariate logistic regression analyzed the association between each index and cognitive impairment in patients. Results: Serum uric acid was higher in patients than in controls (P < .001). Uric acid was significantly increased in cognitive impairment patients than in non-cognitive impairment patients (P < .001). Serum uric acid has certain diagnostic value in patients with cognitive impairment. Anxiety score and depression score were positively correlated with uric acid level, while Montreal Cognitive Assessment Scale score was negatively correlated with uric acid. Additionally, serum uric acid, Montreal Cognitive Assessment Scale score, and anxiety and depression scores were the risk factors for cognitive impairment in patients (P < .05). Conclusion: The abnormal expression of uric acid has a high diagnostic accuracy for distinguishing cognitive impairment from non-cognitive impairment.
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AIM: To explore the expression of oxygenated hemoglobin (oxy-Hb) in the brain of patients with alcohol dependence. Further, to evaluate the diagnostic value of oxy-Hb in the cognitive impairment of patients with alcohol dependence. METHODS: Seventy-one alcohol-dependent adults and 70 healthy adults were recruited in the observation and control groups, respectively. The oxy-Hb level and scores of Wisconsin card sorting test, brief visuospatial memory test-revised, digital sequence test, digital span test, and continuous performance test were recorded and compared between the two groups. Further, the sensitivity and specificity of the oxy-Hb level for the diagnosis of cognitive impairment in patients with alcohol dependence were evaluated by drawing an ROC curve. Moreover, the correlation between the oxy-Hb level and cognitive function test scores was analyzed by Pearson's correlation analysis. RESULTS: During cognitive activities, the oxy-Hb levels in the observation group were lower than those in the control group (p<0.001). The area under the curve (AUC) of oxy-Hb was 0.930, and the sensitivity and specificity were 89.1% and 84.0%, respectively. The scores of responses administered, trials to compete first category, perseverative responses, and the perseverative response errors in executive function in the observation group were higher than those in the control group (p<0.001), whereas the correct responses score and categories completed score were lower than those in the control group (p<0.001). Similarly, the memory and attention scores of the observation group were lower than those of the control group (p<0.001). Moreover, the scores of correct responses, categories completed, brief visuospatial memory test-revised, digital sequence test, digital span test, and continuous performance test were positively correlated with the level of oxy-Hb (p<0.05). However, the scores of responses administered, trials to compete first category, and perseverative response errors were negatively correlated with the oxy-Hb level (p<0.001). CONCLUSIONS: The oxy-Hb levels are reduced in patients with alcohol dependence and have high diagnostic accuracy for cognitive impairment in such patients.
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Alcoholismo , Disfunción Cognitiva , Adulto , Humanos , Alcoholismo/complicaciones , Alcoholismo/diagnóstico , Disfunción Cognitiva/diagnóstico , Disfunción Cognitiva/etiología , Encéfalo/metabolismo , Oxihemoglobinas/metabolismo , Función EjecutivaRESUMEN
Studies using animal models have shown that depression affects the stability of the microbiota, but the actual structure and composition in patients with major depressive disorder (MDD) are not well understood. Here, we analyzed fecal samples from 46 patients with depression (29 active-MDD and 17 responded-MDD) and 30 healthy controls (HCs). High-throughput pyrosequencing showed that, according to the Shannon index, increased fecal bacterial α-diversity was found in the active-MDD (A-MDD) vs. the HC group but not in the responded-MDD (R-MDD) vs. the HC group. Bacteroidetes, Proteobacteria, and Actinobacteria strongly increased in level, whereas that of Firmicutes was significantly reduced in the A-MDD and R-MDD groups compared with the HC group. Despite profound interindividual variability, levels of several predominant genera were significantly different between the MDD and HC groups. Most notably, the MDD groups had increased levels of Enterobacteriaceae and Alistipes but reduced levels of Faecalibacterium. A negative correlation was observed between Faecalibacterium and the severity of depressive symptoms. These findings enable a better understanding of changes in the fecal microbiota composition in such patients, showing either a predominance of some potentially harmful bacterial groups or a reduction in beneficial bacterial genera. Further studies are warranted to elucidate the temporal and causal relationships between gut microbiota and depression and to evaluate the suitability of the microbiome as a biomarker.