Effect of carbocisteine on acute exacerbation of chronic obstructive pulmonary disease (PEACE Study): a randomised placebo-controlled study.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is characterised by airflow limitation, and has many components including mucus hypersecretion, oxidative stress, and airway inflammation. We aimed to assess whether carbocisteine, a mucolytic agent with anti-inflammatory and antioxidation activities, could reduce the yearly exacerbation rate in patients with COPD. METHODS: We did a randomised, double-blind, placebo-controlled study of 709 patients from 22 centres in China. Participants were eligible if they were diagnosed as having COPD with a postbronchodilator forced expiratory volume in 1 s (FEV(1)) to forced vital capacity (FVC) ratio (FEV(1)/FVC) of less than 0.7 and an FEV(1) between 25% and 79% of the predicted value, were aged between 40 and 80 years, had a history of at least two COPD exacerbations within the previous 2 years, and had remained clinically stable for over 4 weeks before the study. Patients were randomly assigned to receive 1500 mg carbocisteine or placebo per day for a year. The primary endpoint was exacerbation rate over 1 year, and analysis was by intention to treat. This trial is registered with the Japan Clinical Trials Registry (http://umin.ac.jp/ctr/index/htm) number UMIN-CRT C000000233. FINDINGS: 354 patients were assigned to the carbocisteine group and 355 to the placebo group. Numbers of exacerbations per patient per year declined significantly in the carbocisteine group compared with the placebo group (1.01 [SE 0.06] vs 1.35 [SE 0.06]), risk ratio 0.75 (95% CI 0.62-0.92, p=0.004). Non-significant interactions were found between the preventive effects and COPD severity, smoking, as well as concomitant use of inhaled corticosteroids. Carbocisteine was well tolerated. INTERPRETATION: Mucolytics, such as carbocisteine, should be recognised as a worthwhile treatment for prevention of exacerbations in Chinese patients with COPD.

[Feasibility and predicted equations of spirometry in Shenzhen preschool children].

UNLABELLED: Morbidity of chronic lung disease in young children is relatively high, and could increase in the future. Pulmonary function testing is used for clinical assessment of patients with suspected or obvious pulmonary disease to assess the severity of dysfunction and to evaluate therapeutic effectiveness. In the recent few years, forced expiratory parameters assessing lung function have been measured in older children. In order to assess abnormalities of lung function in preschool patients with respiratory disorders based on changes of forced expiratory parameters, adequate reference values are needed. However, such data in healthy preschool children remain scant in the literature. OBJECTIVE: The aim of this study was to characterize the spirometry of preschool children and establish the normal lung function prediction equations for Chinese preschool children. METHODS: A survey in 343 healthy preschool children (184 boys and 159 girls) aged 3 to 6 years (73 children aged 3 years, 96 children aged 4 years, 91 children aged 5 years and 83 children aged 6 years) was carried out in Shenzhen in 2004. Eleven flow volume tests parameters, i.e., forced vital capacity (FVC), forced expiratory volume at 0.5 second (FEV(0.5)), forced expiratory volume at 0.75 second (FEV(0.75)), forced expiratory volume at one second (FEV(1)), maximal mid expiratory flow rate (FEF(25%-75%)), peak expiratory flow (PEF), forced expiratory time (FET100%) were measured by using COSMED spirometry produced in Italy. Stepwise multiple regressions and non-linear regressions were carried out with the statistical software SPSS10.0 for Windows to identify the best predictors of lung function parameters using standing height, weight, age and gender as potential determinants. RESULTS: Spirometric tests could be successfully carried out by using imagery methods in the following percentages of children: 69.9% of 3 to 4 years old, 70.8% of 4 to 5 years old, 92.3% of 5 to 6 years old and 91.6% of 6 to 7 years old children, 77.7% of the selected population (217/279) of children performed at least two acceptable tests respectively. The average forced expiratory time (FET) was 1.61 +/- 0.52 sec (x +/- s), the 5th percentile value was 0.9 sec, 18 of 279 (6.5%) children produced a FET less than 1 second. Forced expiratory volume in 0.50 and 0.75 sec (FEV(0.5), FEV(0.75)) were thus measured necessary in preschool children. All lung volumes and flow rates increased with age, height as well as weight growth in both gender groups. The correlation among most lung function parameters was higher in height than in age and weight in boys. Whereas the correlation among most lung function parameters was higher in age than in height and weight in girls. The regression equations of lung function were established. By comparison with the equations derived from this study and from studies by Nystad, it was found that there was a difference between the predicted values. CONCLUSION: Spirometric testing is feasible in preschool children by using imagery methods and may be useful for both clinical practice and research. The correlation among most lung function parameters was higher in height than in age and weight in boys. Whereas the correlation among most lung function parameters was higher in age than in height and weight in girls.

[Clinical and chest X-ray characteristics of 5 cases with severe acute respiratory syndrome in children in Shenzhen area].

OBJECTIVE: To explore clinical and chest X-ray features of SARS in children to facilitate correct diagnosis. METHODS: Clinical manifestations and chest X-ray findings in five children suffering from SARS admitted for treatment in the hospital between February and May, 2003 in Shenzhen area were analyzed. The diagnosis was confirmed by epidemiological, clinical, laboratory and radiological examinations. Among the 5 cases, 1 was a boy and the others were girls at the age of 4 to 13 years. RESULTS: Of the 5 SARS children, 3 presented a history of close contact with SARS patients. Fever was the initiative symptom, 4 had a body temperature of over 38 degrees C with the highest being 40 degrees C; fever sustained from 4 to 7 days with an average of 5.6 days. All the 5 cases developed nonproductive cough; on auscultation, both moist and dry rales could be heard in 3 out of the 5 cases. Mean total white count of peripheral blood was (2.96 - 6.9) x 10(9)/L, and was < 5.0 x 10(9)/L in 4 cases. SARS associated coronavirus specific RNA fragment was found positive by RT-PCR in 1 case; 1 case was positive for both IgM and IgG antibodies to the virus; 1 case was positive for only IgM antibody and another 2 cases were positive for only IgG antibody. IgG and IgM antibodies to Mycoplasma pneumoniae and Chlamydia pneumoniae as well as blood culture for bacteria were all negative. Findings on chest X-ray examination: 4 cases showed presence of patchy or macular opacities with cord-like shadows in unilateral lung plates while 1 case each showed ground-glass-like opacity and migratory changes; 1 case showed interstitial changes in the lungs in the form of irregular reticular lattice and cord-like shadows. Two cases received CT scanning and macular-patchy or spotty shadows were seen all over the lung. The shortest time for absorption of foci in the lungs was 7 days while the longest was 33 days with a mean of 15 +/- 6 days. None of the cases had any signs of fibrosis in the lungs. All the 5 cases were completely cured and discharged 7 to 40 days (mean 18 +/- 11 days) after admission. CONCLUSION: Compared with adult cases with SARS, children with SARS had milder symptoms and signs. Presence of unilateral patchy shadow in lungs represented the main chest X-ray findings.