A prospective study of the effects of carbocysteine lysine salt on frequency of exacerbations in COPD patients treated with or without inhaled steroids.

OBJECTIVE: COPD is one of the major causes of morbidity and mortality worldwide and represents one of the most important issues for public health. Frequent exacerbations induce a faster decline in lung function and poorer quality of life, increase mortality, and have a socio-economic impact with a high burden in terms of resources and healthcare costs. The clinical trials evaluated the effect of mucolytics in COPD and showed that the long-term carbocysteine, associated with bronchodilators, anticholinergics, and steroids, reduces the frequency of exacerbations and improves the quality of life. PATIENTS AND METHODS: The aim of this prospective real-life study was to evaluate the long-term impact on exacerbations (at 1 year) in COPD patients treated with carbocysteine lysine salt (single dose of 2.7 g once a day) in addition to background therapy with or without inhaled steroids. RESULTS: In a total of 155 evaluable patients, our study showed that the addition of a single dose of carbocysteine lysine salt to background therapy determines a statistically significant reduction of the average number of exacerbations vs. the number observed in the previous year (from 1.97±0.10 to 1.03±0.11; p<0.01), irrespective of treatment with or without inhaled steroids. In particular, in patients with ≥2 exacerbations in the previous year, the addition of carbocysteine lysine salt resulted in a statistically significant reduction in the exacerbations rate from 69% to 33% and from 58% to 25%, respectively (p<0.01) in patients with or without inhaled steroids. CONCLUSIONS: In summary, our data highlighted the efficacy of long-term administration of a single daily dose of carbocysteine lysine salt (2.7 g/day) in reducing the number and rate of exacerbations in COPD patients, independently from the use of inhaled steroids.

Is vitamin D supplementation necessary in healthy full-term breastfed infants? A follow-up study of bone mineralization in healthy full-term infants with and without supplemental vitamin D.

AIM: The aim of the study is to establish whether healthy full-term breastfed infants require supplemental vitamin D for proper bone mineralization. METHODS: Bone mineralization was studied by performing ultrasound scans of 73 healthy full-term subjects at the age of 3 months. The infants were divided into three groups. Group A: breastfed without supplemental vitamin D (BF); group B: breastfed with supplement of 400 IU/day of vitamin D (BFD); group C: fed with formula (with and without supplemental vitamin D 400 IU/day) (FF). The values of mcSOS (m/sec) and mcBTT (µsec) were assessed in all subjects. RESULTS: A statistically significant difference has been found between group A vs group B both in mcSOS (P=0.03) and in mcBTT (P=0.01) values and also between group A vs group C both in mcSOS (P=0.012) and in mcBTT (P=0.003) values. Significant differences between group B vs group C were not found. In 75% of subjects of group A mcSOS and mcBTT values were ≤ the 10th percentile, while in group B they were between the 10th and 50th percentile. In FF infants given supplemental vitamin D mcSOS and mcBTT values were between the 25th and 75th percentile. CONCLUSION: Human breast milk is an appropriate source of nutrition for the growth of healthy full-term newborns, but is poor in vitamin D as demonstrated by the impaired bone mineralization in the breastfed infants without supplemental vitamin D. The results presented demonstrate that exclusively breastfed infants require at least 400 IU/day of supplemental vitamin D.

Occupational exposure to n-hexane in Italy--analysis of a registry of biological monitoring.

OBJECTIVE: This study assesses 2,5-hexanedione (2,5-HD) in the urine of subjects exposed to n-hexane solvent between 1991 and 1998, from details obtained from the Registry of Biological Monitoring (BM) at the Florence Local Health Unit, and its development over time. METHODS: The Registry contains 15,925 samples from 6,650 subjects occupationally exposed to n-hexane, especially in leather (9,099 samples; 3,607 subjects) and shoe (3,865 samples; 1,938 subjects) production. RESULTS: Over the time span studied there was a total reduction of 31.9% in urinary 2,5-HD level. The yearly decrease over the entire period was 5.4%. Dividing the 8 years into three periods: before the introduction of the new legislation for health protection in the workplace (1991-1993), during its transition (1994-1996) and after its complete enforcement (1997-1998), respectively, we observed a marked decrease in the last period. Women and young people (under 30 years) experienced significantly higher absorption levels (respectively, 7.1% and 24.4%). CONCLUSION: The data suggest that monitoring was more frequent in subjects with higher starting values, and the greatest decrease was reported in this group. Reduction may be due to less n-hexane in the products used, better structural conditions in the factories, and the effectiveness of inspections carried out by the authority for hygiene and safety in the workplace. The results confirm the usefulness of the reporting of risk levels of exposure to industrial toxicants by routine biological monitoring.