A randomized, double-blind, placebo-controlled study evaluating the efficacy of propolis and N-acetylcysteine in exacerbations of chronic obstructive pulmonary disease.

OBJECTIVE: Acute exacerbations of chronic obstructive pulmonary disease (AECOPDs) accelerate the progressive impairment of lung function and general health. Together with maintenance therapy for chronic obstructive pulmonary disease (COPD), N-acetylcysteine (NAC) and natural propolis have demonstrated pharmacological properties that address crucial pathophysiological processes underlying COPD and may prevent AECOPDs. This study aims at responding to dose-dependent efficacy and safety concerns regarding a propolis-NAC combination for the reduction of COPD exacerbation rates. PATIENTS AND METHODS: This was a single-center, randomized, double-blind, phase IV trial with three treatment arms: Placebo and two active substance groups, one (AS-600) received 600 mg of NAC + 80 mg of propolis while the other (AS-1,200) received 1,200 mg of NAC + 160 mg of propolis. Following an AECOPD, frequent-exacerbation phenotype patients (n=46) were assigned a once-daily three-month therapy with the study drug and one year follow-up. The primary endpoint was the COPD exacerbation incidence rate during the follow-up period as a measure of dose-dependent efficacy of NAC-propolis combination compared to placebo. RESULTS: There was a statistically significant difference in the AECOPD incidence rate: 52.6% in patients that received placebo, 15.4% that received AS-600 and only 7.1% that received AS-1,200 (Fisher's exact test, p = 0.013). Compared to placebo, AECOPD frequency was significantly lower only in AS-1,200 (p=0.009). Compared to placebo, the relative risk for exacerbation was 0.29 in AS-600 and 0.13 in AS-1,200. No adverse events related to the treatment were reported. CONCLUSIONS: Oral combination of natural propolis with NAC confirmed formulation efficiency with a favorable safety profile. Our results need to be confirmed by larger clinical trials.

Comparison of 18F-FDG PET/CT and MDCT for staging/restaging of non-small cell lung cancer.

UNLABELLED: Multi-detector computed tomography (MDCT) is most commonly used for staging of non-small cell lung cancer (NSCLC). In recent years, 18F- fluorodeoxyglucose positron emission tomography combined with computed tomography (18F-FDG PET/CT) has also been used for the same purpose. Since studies comparing these two methods are scarce, our aim was to determine how the TNM classification and thereby staging of NSCLC compare between 18F-FDG PET/CT and MDCT. 18F-FDG PET/CT and MDCT were collected in 83 patients with NSCLC 3 to 30 days apart (median 17 days). The investigators interpreting 18F-FDG PET/CT were unaware of MDCT results. The Cohen's kappa (κ) was calculated to determine the rate of agreement. The hypothesis was that the strength of agreement between the two methods will be at least moderate (κ>0.40) based on the adopted criteria (κ<0.20 poor; 0.21-0.40 fair; 0.41-0.60 moderate; 0.61-0.80 good; 0.81-1.00 very good agreement). The agreement was moderate for determining the T class (κ=0.45, overall agreement 58%), poor for the N class (κ=0.13, 42%) and fair for the M class (κ=0.22, 58%). The agreement for overall staging of NSCLC was poor (κ=0.20, 45%). The major source of disagreement was that metastases were present more frequently and/or in larger number on 18F-FDG PET/CT than MDCT in the contralateral mediastinal, supraclavicular, and distant lymph nodes, as well as in the bones and suprarenal glands. Since 18F-FDG PET/CT detected more regional and distant metastases than MDCT, we conclude that FDG PET/CT is useful for staging/restaging and planning treatment of patients with NSCLC. KEYWORDS: Non-small cell lung cancer, positron emission tomography, multidetector computed tomography, metastases detection.

Psychological well-being in advanced NSCLC patients in Serbia: impact of sociodemographic and clinical factors.

UNLABELLED: Patients with advanced non-small cell lung cancer (NSCLC) usually undergo toxic treatment (chemotherapy and/or radiotherapy). They can experience devastating effects of illness and therapies on their psychological and emotional well-being. On the other hand, untreated psychological distress is associated with reduced quality of life and inadequate palliation of physical symptoms.
In order to estimate frequency of anxiety and depressive symptoms and influence of demographic, socioeconomic and clinical factors on psychological well-being, we performed this cross-sectional study in group of 100 patients with advanced stage of disease. Symptoms of anxiety and depression were assessed using the Hamilton Anxiety Rating Scale (HARS) and Hamilton Depression Rating scale (HDRS). Health-related quality of life data are obtained by EORTC QLC C30 and SF 36.
Patients with poor performance status (PS) experienced significantly more anxiety and depressive symptoms (p=0.001) and worse emotional (p=0.001) and mental functioning (p=0.001). Treated patients had significantly better mental (p=0.011) and emotional (p=0.001) functioning in compared to newly diagnosed ones. Somewhat unusual, unemployed participants reported significantly less anxiety (p=0.029) and depressive (p=0.002) symptoms, better mental (p=0.030) and emotional functioning (p=0.007). Additionally, nausea and vomiting adversely affected mental health and emotional functioning and correlated significantly positively with HARS and HDRS scores.
Our findings suggest significant impact of some disease-related factors (PS, active treatment) and treatment-related factors (chemotherapy -induced nausea and vomiting) on psychological well-being of patients with advanced NSCLC. This should be taking an account when appropriate interventions are planned. KEYWORDS: lung cancer, anxiety, depression, quality of life, chemotherapy, chemotherapy-induced nausea and vomiting.

The risk of occupational tuberculosis in Serbian health care workers.

SETTING: Health care workers in the Clinical Center of Serbia. OBJECTIVE: To evaluate tuberculosis (TB) incidence by job category comparing the rates of TB in health care workers (HCWs) working in pulmonary departments, other (non-pulmonary) departments, and in the general population in Serbia. DESIGN: Prospective cohort study from 1992 to 2004. Assessment of the relationship between employment in different departments and TB incidence was expressed by relative risk (RR), which was calculated using the annual TB incidence in the population of Serbia as the baseline rate. RESULTS: A total of 24 HCWs developed active TB in the study period. The mean incidence rate was 413.2 per 100000 persons (RR = 12.2) for hospital staff in the pulmonary department and 20.3/100000 (RR = 0.6) for other departments. Nurses and technicians were at 7.8 times higher risk of developing TB than doctors. The mean working period before the onset of illness was 15.1 years (95%CI 5.1-25.1) for HCWs in pulmonary departments and 8.1 years (95%CI 4.6-11.6) in non-pulmonary departments (P = 0.006). CONCLUSION: This study indicates that HCWs were at an increased risk of TB, most likely from nosocomial transmission in high-risk departments.

Knowledge and misconceptions of tuberculosis in the general population in Serbia.

This study was conducted in Serbia, including Vojvodina and central Serbia, but excluding Kosovo. We aimed to assess the level of knowledge and misconceptions about tuberculosis (TB) in the general population in Serbia. A total of 1,129 inhabitants aged at least 15 years old were interviewed. A combination of telephone and field surveys was used. More than 20% of respondents correctly understood the modes of transmission of TB. However, more than a quarter (28.5%) of respondents had some misconceptions about the possible modes of transmission. Analysis showed that the only significant predictors of a correct understanding of the modes of transmission were the education level and a close personal relationship with a patient with TB. The strongest predictors of misconceptions were older age and an urban type of settlement (odds ratio [OR] 1.5, confidence interval [CI] 1.3-1.6; OR 0.4, CI 0.3-0.6, respectively). A total of 33.9% of respondents could not identify any sign of TB and 86.6% of respondents knew that TB could be treated effectively, but only 20.1% knew that the treatment was free of charge. Our study showed that knowledge about TB is not satisfactory in the general population in Serbia.

[Survival of patients with planocellular bronchial carcinoma who were treated conservatively and with surgery]. / Prezivljavanje bolesnika sa planocelularnim karcinomom bronha u kojih je primenjeno hirursko i konzervativno lecenje.

The paper presents the analysis of survival rate among 133 patients with squamous cell bronchial carcinoma during the five-year follow-up period, from 1985 to the end of 1989, treated at the Institute of Pulmonary Diseases and Tuberculosis in Belgrade. Duration of the survival was monitored in four therapeutical groups: B1 (surgically treated - 34 cases), B2 (conservatively treated using combined chemotherapy and irradiation therapy - 44 cases), B2-1 (treated with only chemotherapy - 32 cases) and B2-2 (treated with only irradiation therapy--23 cases). Maximal survival among the patients with squamous cell bronchial carcinoma was evidenced in surgically treated group of patients (8.8% survived for 5 years). Conservative therapy achieved three-year survival in 4.5% of group B2 patients and 9.4% of group B2-1 patients. Minimum survival was recorded in patients treated with a single irradiation therapy with maximal duration of 2 years achieved in 4.3% of cases. The mean duration of survival ranged from 28.1 +/- 15.2 months in group B1, being similar in groups B2 and B2-1 (15.3 +/- 8.0 and 15.1 +/- 8.2 months, respectively), while it was the least in the group B2-2: 8.8 +/- 6.4 months. Variance analysis revealed highly significant statistical difference in mean duration of survival among the patients with squamous cell bronchial carcinoma classified in different therapeutical groups (F = 107.783; p < 0.0001).

[Evaluation of the results of radiotherapy in planocellular bronchial carcinoma]. / Procena rezultata radioterapije planocelulnog karcinoma bronha.

The analysis comprised 23 patients with planocellular bronchial carcinoma in whom monoradiotherapy was used. Stage III dominated in the studied group (56.6%). Positive response to therapy was achieved in 60.9% of the patients. The effect was maintained for 9 months and after that the disease continued to progress. In 17.4% of the patients the findings remained unchanged, while in 21.7% uninterrupted progression of the disease was noted. Therapeutical doses of 45 Gy and 60 Gy were applied in 52.2% and 47.8% patients, respectively. Survival of one year was achieved in 26.1% while 4.3% survived for two years. Advanced stage of the disease dominating in the studied group could be the reason for the low survival rate. The results presented as well as the referential ones suggest the better response to therapy and longer survival of patients with planocellular bronchial carcinoma in whom higher therapeutical irradiation dose was applied (60 Gy).

[Planocellular bronchial carcinoma--patho-anatomic characteristics, tumor growth rate and possibilities of modern diagnosis]. / Planocelulni karcinom bronha--patoanatomske karakteristike, brzina rasta tumora i mogucnost savremene dijagnostike.

Basic features of squamous cell bronchial carcinoma are reviewed since this is one of the most common histologic forms of this malignoma. Referential data reveal pathoanatomic features of squamous cell bronchial carcinoma and classification according to degree of differentiation to well, moderately and poorly differentiated histologic type. Data on the growth rate of squamous cell bronchial carcinoma are presented and correlated to other histologic groups of bronchial carcinoma. The most commonly applied diagnostic measures and their efficacy have also been discussed.

[Evaluation of the results of chemotherapy in squamous cell bronchial carcinoma]. / Procena rezultata hemioterapije planocelularnog karcinoma bronha.

Chemotherapy according to the MACC protocol (Methotrexate, Adriamycin, Cyclophosphamide, CCNU) was applied in 32 patients with squamous cell bronchial carcinoma. The following criteria were used for the evaluation of the effect of therapy: response to therapy (evaluation of decrease in tumor mass), duration of response and survival time. A positive response to therapy was achieved in 3 (9.4%) cases. In 22 (68.7%) the condition remained unchanged, while in 7 (21.9%) cases there came to a progression of the disease. Mean duration of survival was 15.1 +/- 8.2 months. More than a half of the patients lived for a year (59.4%), while 12.5% and 9.4% survived two and three years, respectively. By comparison of the results with findings from literature it seems that the application of chemotherapy in the combination of Cisplatin and Vindesin is more effective in the case of poorly differentiated squamous cell bronchial carcinoma.