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H Michalsen

Publications and source records attributed to H Michalsen.

At least 19 recordsLinked to original sources
PubMed1998

Multicenter, open-label study of recombinant human DNase in cystic fibrosis patients with moderate lung disease. DNase International Study Group.

Cystic fibrosis is characterized by the accumulation of thick viscous purulent secretions. Recombinant human deoxyribonuclease I (rhDNase) breaks down extracellular DNA, which contributes to the increased viscosity of sputum. A multinational, open-label study was conducted in 974 cystic fibrosis patients with moderate lung disease [forced vital capacity (FVC) 40-70% of predicted values] to examine the safety and efficacy of aerosolized rhDNase, 2.5 mg, once daily over a period of at least 12 weeks. Patients were assessed under conditions reflecting routine clinical practice. During rhDNase therapy, at least one respiratory tract infection (RTI) requiring intravenous antibiotics was experienced by 29.5% of patients. Forced expiratory volume in 1 second (FEV1) and FVC were significantly improved from baseline by a mean of 10.5% and 7.2%, respectively. Voice alteration and pharyngitis were the most frequent rhDNase-related adverse events, but only 2% of all patients discontinued treatment due to adverse events. The results obtained were similar to a subanalysis of data from the first 3 months of a placebo-controlled U.S. study. The patients in the present study had a similar frequency of RTIs and improvement in pulmonary function, and reported fewer rhDNase-related and cystic fibrosis-related adverse events than patients in the U.S. study. We conclude that administration of rhDNase is safe, well tolerated, and effective under conditions reflecting routine clinical practice in patients with cystic fibrosis and moderate lung disease.

Administration, Inhalation↗
PubMed1993

Frequency of the delta F508 and exon 11 mutations in Norwegian cystic fibrosis patients.

We have searched for the delta F508 mutation in 77 Norwegian cystic fibrosis patients. Of the 154 chromosomes tested, 93 (60%) carried the delta F508 mutation. Haplotypes at the D7S23 locus (KM19 and XV2C markers) were determined. Of 81 chromosomes with the F508 mutation, the B haplotype was found on 77. We found three patients with the G551D and one patient with the R553X mutation in exon 11 of the CFTR locus.

Cystic Fibrosis↗
PubMed1990

Serum antibodies to dietary antigens: a prospective study of the diagnostic usefulness in celiac disease of children.

We examined 1,541 consecutive serum samples from 707 children with suspected food intolerance and 32 with treated celiac disease (CD) for IgG and IgA antibody reactivities to antigens from gluten, egg, and cow's milk by an enzyme-linked immunosorbent assay (ELISA). Samples from 72 patients showed increased IgA and/or IgG reactivity to gluten antigens; four were known CD patients not complying with a gluten-free diet, 13 were suspected CD patients challenged with gluten, and 30 most likely had CD as suggested by small intestinal villous atrophy and histological and/or clinical improvement on a gluten-free diet. The remainder with increased antigluten activity had other disorders that might have affected mucosal permeability. Nevertheless, the median IgA reactivity to gluten was significantly higher in the CD group, and the probability for CD increased from 25 to 100% when this reactivity was above 2.4 optical density (OD) units in our ELISA. Sixteen CD patients (but none of those without CD) had IgA reactivity to gluten higher than 2.4 OD units. We conclude that ELISA determinations of levels of serum antibodies reacting to dietary antigens is a valuable adjunct in the diagnosis of CD in children.

Adolescent↗
PubMed1988

Five-year follow-up of pulmonary function and peak oxygen uptake in 16-year-old boys with cystic fibrosis, with special regard to the influence of regular physical exercise.

Eight Norwegian boys with cystic fibrosis (CF) 16 years of age were included in a 5-year follow-up study. They underwent pulmonary function and bicycle exercise tests 2-16 times each. The individual's habitudinal level of physical exercise was registered by interviews and training diaries to study whether it could be correlated to the developments in lung function, peak oxygen uptake (peak VO2), and Shwachman score. The boys were characterized by a large interindividual variation in both lung function, peak VO2, and Shwachman score at the first test in the study. Four boys trained regularly 3-9 h weekly, while the four others had no regular exercise. Two of the latter, who also had the lowest Shwachman scores, died during the study. The other two in the non-training group deteriorated significantly in clinical scores, lung function variables, and peak VO2 during the study period of 5 years. The four boys in the training group improved in lung function and peak VO2 in accordance with or even better than expected in healthy adolescent boys during the same growth period. Even though the material is small, and several factors might influence the results, the study indicates that regular physical exercise has beneficial long-term effects on lung function, physical fitness, and Shwachman score in adolescent CF boys.

Adolescent↗
PubMed1988

Effect of daily short bouts of trampoline exercise during 8 weeks on the pulmonary function and the maximal oxygen uptake of children with cystic fibrosis.

Six girls and two boys with cystic fibrosis (CF) 10-13.5 years of age (mean 11.5 years) participated in a prescribed exercise program on a mini-trampoline, maximum 109 min/week, during 8 weeks. The training consisted of three short bouts of trampoline exercise. The CF children were divided into two groups. The first group was a control as the other group exercised on the trampoline and vice versa. Three patients in each group completed the study. Pulmonary and exercise tests were performed before and after the exercise/control periods. The pulmonary tests (FVC, FEV1, and PEFR) showed minor changes during the exercise period, but a slight increase in FVC (P less than 0.05) during the total time of the study was found. The two patients with more advanced lung disease improved their spirometric results during the training period. The maximal oxygen uptake (VO2 max) improved from 45 to 49 ml/kg/min (P less than 0.025) during the exercise period. Trampoline exercise programs are suggested to supply other types of training to avoid monotony in the training for CF patients.

Adolescent↗
PubMed1988

Imipenem/cilastatin, an alternative treatment of pseudomonas infection in cystic fibrosis.

Imipenem, a new N-formimidoyl thienamycin was given together with cilastatin to 20 patients with cystic fibrosis and pulmonary infection due to Pseudomonas aeruginosa. The antibiotic was given in short-term infusions for 9-14 days (mean 11.5) in a dose of 45-60 mg/kg body weight/day. Good clinical results were obtained in all patients with significant improvement of clinical score, pulse rate, vital capacity and FEV1.0 (P less than 0.001). Blood PO2 increased and WBC decreased significantly. A slight increase in the minimum inhibitory concentration was noted during treatment but all strains examined were fully susceptible at follow-up one month later. The peak serum concentration was significantly increased in patients receiving the high dose of imipenem, but the sputum concentration was low in all patients and there was no difference in clinical or bacteriological outcome. The plasma and urinary clearance increased with body weight and was inversely correlated to clinical score. Imipenem/cilastatin appears a good alternative for the treatment of pulmonary infections caused by P. aeruginosa in cystic fibrosis.

Adolescent↗
PubMed1988

Screening for cystic fibrosis among newborns in Norway by measurement of serum/plasma trypsin-like immunoreactivity. Results of a 2 1/2-year pilot project.

A pilot project for neonatal screening for cystic fibrosis (CF) by measuring trypsin-like immunoreactivity (TLI) in liquid serum or plasma samples was carried out in Norway from May 1982 to December 1984. A total of 72,320 newborns was screened. Twelve infants were recalled for sweat testing; 11 were confirmed to have CF. One infant had normal sweat sodium and chloride levels and no clinical symptoms. The incidence of CF in this study was 1:6574, and the recall rate for second blood samples was 0.6%. No false-negative cases have yet been reported. The level of TLI was affected by the use of heparin in plasma preparation, being reduced by about 20% as compared to serum levels.

Cystic Fibrosis↗
PubMed1988

Cystic fibrosis in Norway.

A material of 165 Norwegian patients with cystic fibrosis (CF) is presented. 149 patients are still alive. The material is based on a central registry for CF with information gathered from yearly distribution of questionnaires. The mean age at diagnosis is high in Norway, even when screened infants are included. A further characteristic of the material is the striking male preponderance in the younger age groups, whereas there is no sex difference in the group of adult CF patients. Very striking is the low incidence and prevalence of chronic respiratory tract infections caused by Pseudomonas aeruginosa; the reason for this is unexplained.

Cystic Fibrosis↗
PubMed1988

Social-medical aspects of cystic fibrosis in Norway. I. Characterization of the material.

The families of 90 children with cystic fibrosis and the families of 1977 control children have answered extensive questionnaires, which are the basis for this study. In the first part of the study the two groups are compared for some important factors, to detect differences that would make further analysis of the material questionable. The two groups were commensurable concerning their economic situation, standard of housing, ages of children, and the family situation in general. The educational level of the parents in the two groups did differ, the parents of children with cystic fibrosis having less education. The parents of children with cystic fibrosis were more dissatisfied with their situation than those in the control group. These differences are probably a result of having cystic fibrosis in the family; consequently, it is concluded that the two groups can well be compared.

Adolescent↗
PubMed1988

Social-medical aspects of cystic fibrosis in Norway. II. Economy and housing situation.

The economic status of families with a child cystic fibrosis is compared with the situation for control families. The housing situation for the two groups is also evaluated. The study is based on questionnaires. The families with children with cystic fibrosis have a higher income than the controls, but they also have greater expenses. The increase is not only in expenses related to the treatment of cystic fibrosis but also in the general expenses related to having children, in the group of families with cystic fibrosis. The housing expenses are also greater in the families with children with cystic fibrosis; this is probably due to the fact that home treatment of cystic fibrosis adds certain demands to the quality of the housing conditions for these families.

Adolescent↗
PubMed1988

Social-medical aspects of cystic fibrosis in Norway. III. The education and occupation of mothers.

On the basis of questionnaires answered by the parents of 90 children with cystic fibrosis (CF) an analysis has been made of the education situation and the professional activity of the mothers of children with CF. The findings are compared with those obtained from mothers without CF children and with those of the fathers of CF children. There are striking differences between the CF mothers and the controls with regard to their possibility of having a career. Even greater differences are evident when the mothers in families with CF children are compared with the fathers in the same families. The education and professional career of the fathers of CF children are generally not influenced by having a chronically disabled child to care for, whereas the mothers to a large extent have felt compelled to give up their education or their professional career.

Adolescent↗
PubMed1988

Social-medical aspects of cystic fibrosis in Norway. IV. A comparison of the parents' and the professionals' judgement of the severity of the handicap.

To obtain information about their knowledge and their degree of acceptance of their child's condition, the parents of children with cystic fibrosis were asked to give a general judgement of their child's handicap. The study was based on questionnaires answered by the parents of 90 children with cystic fibrosis. One pediatrician and one social worker independently gave their judgement on the same issues. The parents judged 61% of the children as lightly handicapped, 33% as moderately, and 6% as seriously affected, while the professional judgement was 43%, 37% and 19%, respectively. The study indicates that the parents tend to judge their child's condition as less severe than the professionals. The difference of opinion is greatest in the group of seriously affected children.

Adolescent↗