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.

Exposure to tobacco smoke among asthmatic children: parents' smoking habits and level of education.

SETTING: Children's Hospital for Respiratory Diseases and Tuberculosis, Belgrade, Serbia. OBJECTIVES: To compare parents' educational level and smoking habits with asthma in children exposed to environmental tobacco smoke (ETS) and in those not exposed. METHODS: In this cross-sectional study, 231 asthmatic children (average age 10.6 years, 49% boys) from smoking and non-smoking families were compared by birth weight, birth length, first episode of wheezing, number of respiratory infections and exacerbations per year, severity of asthma, number of hospitalisations, total serum immunoglobulin E (IgE), skin prick tests and allergic manifestations. RESULTS: In our study, 77% of the children were from smoking families: 45.9% had active smoking mothers and 51% active smoking fathers. Smoking was more common among parents with lower education level. The mother being the only smoker in the family had a greater impact on respiratory infections and asthma exacerbations in the first years of life; however, after the third year, the effect of having both smoking parents was important. Children exposed to ETS had more allergic manifestations. The percentage of children with both non-smoking parents decreased and that of children with both smoking parents increased with increasing asthma severity (χ(2) = 17.73, P < 0.05). CONCLUSION: ETS has a negative impact on illness among children with asthma.

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.

Clinical and epidemiological evaluation of tuberculosis in Serbia, 1990-2004.

SETTING: Republic of Serbia, excluding Kosovo. OBJECTIVE: To estimate the clinical and epidemiological pattern of tuberculosis (TB) in Serbia during the period 1990-2004. DESIGN: A retrospective analysis of clinical and epidemiological data on TB patients registered in annual TB reports. RESULTS: During the 15-year period, TB incidence levelled off in Serbia. The slightly decreasing trend occurred in both total pulmonary TB (PTB) and laboratory confirmed PTB (PTB+) incidence (P > 0.05), while the trend of extra-pulmonary TB (EPTB) incidence increased slightly (P > 0.05). During the same period, TB mortality showed a significantly decreasing trend (P < 0.05). The mean annual proportion of PTB+ cases among newly reported PTB cases was 62.7%. The mean proportion of EPTB cases among total TB cases was 6.1%. The mean percentage of cases with resistance to at least one anti-tuberculosis drug was 4.8%. CONCLUSION: Thanks to the good organisation and efficient work of anti-tuberculosis dispensaries in Serbia, as well as to the low incidence of AIDS and low frequency of Mycobacterium tuberculosis resistant strains, TB incidence did not increase during the period observed and TB mortality significantly decreased, despite markedly deteriorated socio-economic conditions during the 1990s.