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Biomedical subjects

L S Andersen

Publications and source records attributed to L S Andersen.

17 recordsLinked to original sources
PubMed2005

Routine database registration of biological therapy increases the reporting of adverse events twentyfold in clinical practice. First results from the Danish Database (DANBIO).

OBJECTIVE: To present from the Danish Database for Biological Therapies in Rheumatology (DANBIO) the frequencies and types of adverse events as well as risk factors during treatment with biological agents in clinical practice. METHODS: Adverse events during the first 2 years of clinical use of biological agents in Denmark were reported to the nationwide DANBIO and compared to the mandatory reports to the Danish Medicines Agency. RESULTS: Almost 90% of the patients treated with biological agents were registered in the DANBIO, and the database picked up 20 times as many adverse events as the Danish Medicines Agency. Infections and hypersensitivity reactions were the most prevalent adverse events. Age, disease duration, and previous number of disease-modifying anti-rheumatic drugs (DMARDS) were found to be risk factors for bacterial infections. CONCLUSION: A routine-based Danish database for biological therapies covers approximately 90% of patients and improves the reporting of adverse events.

Adult↗
PubMed2001

Medicare ambulance service.

Medicare coverage of ambulance services is a topic that receives little attention in educational materials but is a major source of confusion for people with Medicare, their families and professionals. In this brief we discuss and clarify coverage issues and payment policies for ambulance services, including the potential costs for consumers. We conclude with a look at situations where appeals of denial of payment for these services may be appropriate.

Ambulances↗
PubMed2000

Production of interleukin (IL)-1beta, IL-1 receptor antagonist and IL-10 by blood mononuclear cells in chronic arthritis.

Joint erosion is a prevalent feature of rheumatoid arthritis (RA) but not of many other chronic inflammatory arthritides (non-RA). Joint destruction is mediated by cytokines, primarily interleukin (IL)-1 and tumour necrosis factor. Less erosive activity in patients with non-RA compared to RA might be related to factors that inhibit production and/or function of IL-1. Release of IL-1beta, and the two antagonists, IL-1 receptor antagonist (IL-1ra) and IL-10 from blood mononuclear cells were therefore quantitated by ELISA in 22 patients with RA, 11 with non-RA and 15 healthy age-matched controls. Release of IL-1beta was comparable between the three groups but only detectable in cultures stimulated with lipopolysaccharide; it decreased in patients treated with prednisolone: 3.8 ng/10(6)monocytes (median) vs 11.7 (P=0.045). Release of IL-1ra was in all but IgG-stimulated cultures comparable between groups. The ratio of IL-1ra/IL-1beta was elevated in LPS-stimulated cells from RA patients only: 2.0 versus 1.3 (P=0.02). In contrast, IgG-induced IL-1ra release was significantly elevated only in non-RA patients: 95 ng/10(6)monocytes vs 40 (P=0.014), and the levels correlated positively to those of blood CRP (P=0.02). Though stimulated release of IL-10 was similar between the three groups, the levels were lower in non-erosive than erosive arthritis patients, and controls (P=0. 05). In conclusion, increased IgG-stimulated IL-1ra release and elevated IL-1ra/IL-1beta ratio may protect against actions of IL-1 in vivo, and decreased release of IL-10 might be related to features of non-erosive arthritis.

Adult↗
PubMed1999

[Fatal poisonings among drug addicts in the county of Funen in 1995 and 1996].

The aim of this investigation was to examine the deaths of drug addicts from poisoning in the county of Funen in 1995 and 1996. The cause of death was related to drugs on the illicit market. Social conditions (homelessness, involvement in crime, psychogenic disease, circumstance of death) are discussed. The study included 47 drug addicts. Median age was 34, age span: 20-43. The main cause of death was poisoning by heroin. In 28% of the drug addicts cocaine was detected and in 13% amphetamine. About half had used benzodiazepines. Few were employees, most were criminals and eight were homeless. Thirty-eight percent were found in public lavatories. Eight had a serious psychiatric diagnosis. We can conclude that the drug addicts are socially marginalized. They abused a mixture of drugs. The drugs detected in the drug addicts compared well with the drugs on the illicit market and cocaine had gained access to the market.

Adult↗
PubMed1999

Production of IL-1beta, IL-1 receptor antagonist and IL-10 by mononuclear cells from patients with SLE.

Depositions of immune-complexes are responsible for many of the pathological features of systemic lupus erythematosus (SLE). For example, immune-complex-induced tissue damage in glomerulonephritis has been shown to be mediated, at least in part, by interleukin (IL)-1. Inappropriate production or function of IL-1 may therefore contribute to disease manifestations in SLE. We investigated lipopolysaccharide (LPS)- and adherent IgG-stimulated release of IL-1beta, IL-1 receptor antagonist (IL-1ra) and IL-10, a potent modulator of IL-1, by blood mononuclear cells from patients with SLE. Mediator production was measured as ng cytokines/10(6) monocytes and compared with clinical parameters. Release of IL-1beta was only detectable in LPS-stimulated cultures and substantially reduced in patients with both active and inactive disease (P < 0.001). LPS-stimulated IL-1ra release was normal and the IL-1ra/IL-1beta ratio was therefore increased (P < 0.05) and correlated inversely to prednisolone dosage (P = 0.009). IgG-stimulated release of IL-1ra was reduced in patients with active disease compared to those with inactive disease and controls (P = 0.002). IL-10 release was similar in patients and controls. We conclude that monocytes from patients with active SLE are deficient in Fc gamma-R-mediated production of IL-1ra, whereas LPS-stimulated IL-1beta release by SLE monocytes is reduced regardless of disease activity. The former may contribute to immune-complex-mediated tissue damage in SLE.

Adult↗
PubMed1997

Limited effect of sulphasalazine treatment in reactive arthritis. A randomised double blind placebo controlled trial.

OBJECTIVE: To assess the efficacy and safety of sulphasalazine in reactive arthritis. METHODS: Double blind placebo controlled trial of six months duration comparing sulphasalazine 2-3 g per day (n = 37) with matching placebo (n = 42) in adults with active reactive arthritis (age 19-57 years, median 34). Treatment response was evaluated once a month by changes in erythrocyte sedimentation rate (ESR), pain, peripheral arthritis, tender iliosacral joints, entesopathy, extra-articular manifestations, and working ability. RESULTS: 15 patients in the sulphasalazine group and eight in the placebo group withdrew from the study prematurely. Adverse events, primarily gastrointestinal, were the main reason for withdrawal in the actively treated group. Intention-to-treat analyses showed significant improvements over time in both groups in ESR, pain, and number of swollen joints (P < 0.01). Number of days on sick leave decreased significantly in the sulphasalazine group only (P < 0.01). No significant differences between the two groups were present after six months. Among the patients completing the trial according to protocol, persistent complete remission had occurred within two months in five (23%) of the actively treated, but in no placebo treated patients (P = 0.013). CONCLUSIONS: Sulphasalazine seemed to improve only the very short term outcome of reactive arthritis. The possible beneficial effect of the drug should also be weighed against the risk of adverse events. Although these were mainly mild, almost 25% of the patients in the actively treated group gave up treatment for this reason.

Adult↗
PubMed1997

Prospectively measured red cell folate levels in methotrexate treated patients with rheumatoid arthritis: relation to withdrawal and side effects.

OBJECTIVE: To investigate whether red cell folate (RCF) levels relate to side effects, withdrawals, or disease activity during treatment with the folic acid antagonist methotrexate (MTX) for rheumatoid arthritis (RA). METHODS: Side effects were recorded monthly, RCF levels were measured by lactoglobulin binding radioassays, and 8 variables for disease activity were measured in a placebo controlled double blind trial of 28 weeks' duration comparing efficacy of MTX (n = 23) and D-penicillamine (n = 23). RESULTS: From Week 20 RCF levels decreased only in the MTX group (p < 0.02), and 5 MTX treated patients withdrew due to side effects. Withdrawals had lower RCF values at Weeks 0 and 9 compared to the remaining patients (p < 0.05). Folate deficiency evolved in 5 patients; 2 of these developed cytopenia. Aberrations in the scheduled dosage increase were related to lower pretreatment values of RCF (p = 0.007). Side effect scores were inversely correlated to RCF values at Weeks 0, 9, and 28 (p < 0.05). RCF levels measured concomitantly with liver enzyme elevation were lower than the remaining values (p < 0.001). When side effects were reported, 96% of concomitantly measured RCF values were below 800 nmol/l. RCF values at entry did not correlate to improvement in any variable for disease activity, or a graded overall improvement. CONCLUSION: RCF levels decrease during MTX treatment and relate to side effects, withdrawals, liver enzyme elevations and aberrant MTX dosage increase, but not to the therapeutic effect. RCF above 800 nmol/l protects against side effects.

Aged↗
PubMed1995

IgG for intravenous use, autologous serum and plasma induce comparable interleukin-1 receptor antagonist liberation from human mononuclear cells: an in vitro phenomenon depending upon plastic adherence.

Immunoglobulin G (IgG) for intravenous use (IVIg) selectively stimulates production of interleukin-1 receptor antagonist protein (IL-1ra) by mononuclear cells in vitro and has been proposed to stimulate IL-1ra production in vivo as part of the therapeutic effect. We tested if IVIg differed from human IgG-containing media (i.e., autologous serum (HS) and plasma (HP)) in stimulating IL-1ra release by MNC in vitro and whether IVIg induced a delayed increase in serum levels of IL-1ra. IVIg, 0.01-0.5 mg/ml, increased the IL-1ra liberation from MNC 10-15 times over that of untreated controls. HP and HS (5% v/v) had comparable effects. However, the stimulated IL-1ra liberation was reduced to less than twice the background liberation when fetal calf serum (FCS)-precoated tubes were used. Three days of high-dose IgG infusion had no significant effect on the serum levels of IL-1ra. It is concluded that therapeutic effects of IVIg cannot be ascribed to significant stimulation of IL-1ra production in vivo, as previously suggested, and that the observed stimulation of IL-1ra production in vitro is an epiphenomenon strictly dependent upon adherence of human serum and plasma constituents.

Adult↗
PubMed1994

The humoral immune response to Chlamydia trachomatis in patients with acute reactive arthritis.

Sera from 25 patients with clinical signs of reactive arthritis were analysed for antibodies against Chlamydia trachomatis by immunoblotting. Purified elementary bodies, purified Chlamydia outer membrane complexes, and purified recombinant subcomponents were used as antigens. Antibodies against C. trachomatis cysteine rich outer membrane protein 2 (Omp2) and lipopolysaccharide (LPS) were detected in 10 patients. Thus 40% of the patients presented antibodies specific for C. trachomatis. There was no correlation between acute reactive arthritis and antibodies to heat-shock proteins GroEL, GroES and DnaK.

Acute Disease↗
PubMed1994

Serum transferrin receptor levels in anaemic patients with rheumatoid arthritis.

The value of s-Transferrin Receptor (s-TfR) measurements in recognizing simultaneous iron deficiency in anaemia of chronic disease was examined in 35 anaemic patients with active rheumatoid arthritis. Based on a quantification of stainable bone marrow (marrow iron grade 0-4) and serum ferritin concentrations (levels < 60 micrograms l-1) compatible with iron deficiency) the anaemia was found to be aggravated by iron deficiency in 19/35 or 54% of the patients. There was no significant difference between the mean s-TfR concentrations in patients with adequate iron in comparison to patients with iron depletion [2.9 (1.6) mg l-1 v. 2.7 (1.4) mg l-1; t = 0.273; p = 0.786; Student's t-test]. Mean s-TfR levels in both patients with adequate iron and depleted iron stores were within the normal range, but tended to be higher than in normal individuals [mean (SD): 1.54 (0.43) mg l-1]. In patients with no stainable marrow iron (MIG 0; N = 15) a significant inverse correlation was found between s-TfR concentrations and s-ferritin levels (r = 0.57; p < 0.05). 5/15 patients with MIG = 0 exhibited significantly raised concentrations of s-TfR values > 3.05 mg l-1 (the highest normal value of the normal range). Increases of s-TfR levels were consistently moderate, and never exceeded a level of 7 mg l-1, which is markedly lower than concentrations measured in patients with iron deficiency anaemia.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1992

Renal handling of carboplatin.

The mechanism for renal handling of carboplatin was studied in 17 ovarian cancer patients treated with a combination of carboplatin and cyclophosphamide. Carboplatin and [51Cr]-ethylenediaminetetraacetic acid (EDTA) renal clearances were measured simultaneously during short intervals of from 45 to 120 min. A total of 131 clearance intervals were analyzed during 35 chemotherapy courses. The carboplatin/[51Cr]-EDTA clearance ratio (R) served as an indicator of the net tubular reabsorption (R less than 1) or secretion (R greater than 1). The R value was calculated for each sampling interval. No significant difference was found between interpatient and intertreatment variation. The intertreatment variation as tested against the variation in the short intervals by an F-test was highly significant. We calculated the average R value for each treatment and consequently based our results on a total of 35 observations. The mean R value was 0.77 (t-test for R = 1; P less than 0.001). We conclude that the renal elimination of carboplatin takes place by glomerular filtration followed by tubular reabsorption.

Adult↗
PubMed1992

The prevalence of hyperhidrosis in patients with spinal cord injuries and an evaluation of the effect of dextropropoxyphene hydrochloride in therapy.

The prevalence of annoying hyperhidrosis (HH) in patients with spinal cord traumatic lesions was investigated by a questionnaire. A total of 192 patients were sent the questionnaire, 154 patients answered, and 41 patients reported annoying sweating. Of these 41 patients, 13 had a somatic underlying cause and 28 indicated having annoying HH without a contributing somatic cause. Twenty-five patients with spinal cord injury (SCI) were included in a double-blind, randomized, placebo-controlled, crossover trial using dextropropoxyphene hydrochloride (DP) in a slow release form (Abalgin Retard 150 mg Benzon Pharma A/S, Copenhagen) twice a day, for the treatment of annoying HH. Nineteen patients with lesions between C4 and L4 completed the study. Eight found the active drug to be so effective that they wanted to continue the treatment while 3 preferred placebo. Six patients dropped out, 5 due to adverse effects. There was a trend towards an effect on sweating in daytime (p = 0.08-0.14). Given that the patients had a preference, which 15 of 19 had, the true frequency of patients preferring active treatment ranged from 32 to 84% (95% exact confidence limits). For those with SCI above T6 level the limits ranged from 40 to 97%. We conclude that in spite of the lack of statistically significant effect, it seems worthwhile to try DP for annoying HH, especially in patients with lesions above T6 level.

Adult↗
PubMed1992

Bioavailability and analgesic effect of sustained release cetobemidone capsules in cancer patients with chronic pain of malignant origin.

Ever since its introduction in 1952, Ketogan has consisted of a combination of the opioid cetobemidone and a spasmolytic drug, A29, in the ratio of 1:5. Its main limitations are the relatively short duration of action and an apparent ceiling effect due to A29. We therefore developed a cetobemidone formulation with sustained release properties (cetobem. s.r.). Forty-seven patients with advanced cancer with moderate/severe pain, treated with regular doses of Ketogan tablets took part in an open phase 1 type pharmacologic/toxicologic study comparing Ketogan tablets and cetobem. s.r. The patients spent at least 4 days in the department. After evaluation during 12 h with Ketogan tablets (3-4 dosing intervals), a loading phase lasting for 36 h with cetobem. s.r. given twice/24 h (total dose of Ketogan tablets per 24 h divided by 2), and synchronous reduction of the dose of Ketogan tablets, a similar evaluation period of 12 h was performed when on treatment with cetobem. s.r. alone. Comparison of data from the two observation periods showed the following: Average relative bioavailability 0.77 SD 0.28. Only 2 patients were remedicated before 12 h when on cetobem. s.r. Duration of action mean 11.9 h, SD 0.3 h. There was no significant difference between Ketogan tablets and cetobem. s.r. periods concerning 'time with no pain'. Side-effects were few. The only significant difference was dry mouth being more severe during the tablet period. Vital signs were unaffected by treatment. It is concluded that cetobem. s.r. can be given every 12 h to cancer patients with chronic pain with satisfactory analgesic effect, a very modest change in side-effect profile and no significant effects on vital signs when substituting cetobem. s.r. for Ketogan tablets in equal daily doses.

Adult↗
PubMed1990

Anaemia of rheumatoid arthritis: serum erythropoietin concentrations and red cell distribution width in relation to iron status.

Immunoreactive serum erythropoietin concentrations were measured in 35 patients with anaemia associated with active rheumatoid arthritis. Based on an evaluation of stainable iron in the bone marrow (marrow iron grade 0-4) and serum ferritin concentrations (concentrations less than or equal to 60 micrograms/l compatible with iron deficiency) the anaemia was found to be complicated by iron deficiency in 19/35 (54%) of the patients. The mean serum erythropoietin level (57.6 (SD) 27.3) U/l) was sufficiently raised for the degree of anaemia irrespective of the size of the marrow iron stores. Thus the data do not support the contention that suppressed secretion of erythropoietin is involved in the pathogenesis of anaemia of chronic disorders. There was a significant inverse correlation between the haemoglobin concentration and log serum erythropoietin in the patients with rheumatoid arthritis. In the patients with adequate iron stores, but not in the iron depleted patients, there was a tendency for serum erythropoietin concentrations to correlate positively both with C reactive protein and erythrocyte sedimentation rate. Red cell distribution width (mean (SD) 16.3 (1.8)%) was above normal (11.5-14.5%) both in the iron replete and the iron depleted patients, and the mean red cell distribution width values did not differ significantly among the two subpopulations. The plasma lactoferrin concentration (mean (SD) 137.6 (109.9) micrograms/l) was normal and did not differ significantly between the iron deficient patients and those with adequate iron.

Adult↗