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Biomedical subjects

M Friis

Publications and source records attributed to M Friis.

18 recordsLinked to original sources

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↗

Iodixanol in paediatric gastrointestinal imaging: safety and efficacy comparison with iohexol.

Iodixanol (Visipaque) is a dimeric, non-ionic iodinated contrast medium that is isotonic with blood at all clinically relevant concentrations. Iodixanol was compared in a randomized, double blind, parallel group, phase III multicentre trial with a monomeric, non-ionic contrast medium, iohexol (Omnipaque), at two concentrations assessing safety, tolerability and radiographic efficacy during contrast enhanced gastrointestinal radiography examinations of children. 154 children entered the trial; 152 formed the safety population and 147 the efficacy population. All examinations were performed following standard departmental practice. Children were assigned into either a high or low concentration group (iodixanol, 150 mgI ml(-1) and 320 mgI ml(-1) vs iohexol, 140 mgI ml(-1) and 300 mgI ml(-1)). The primary outcome measure for efficacy was the overall quality of visualization, which was assessed using a 100 mm visual analogue scale (VAS). The secondary efficacy variables assessed were quality of contrast opacification, mucosal coating and overall quality of diagnostic information. Safety evaluation involved patient follow-up for at least 48 h. Taste acceptance was also assessed. There was no statistically significant difference between the two contrast media with regard to the primary and secondary efficacy variables assessed, although higher ratings were observed for iodixanol. The 100 mm VAS score overall was 86 mm for iodixanol and 82 mm for iohexol (95% confidence interval -2.56, 10.42). The frequency of adverse events was lower for patients receiving iodixanol. Adverse events, mainly diarrhoea, occurred in 12 patients (16.2%) in the iodixanol group and 28 patients (35.9%) in the iohexol group. This reached statistical significance (p=0.006). Overall, iodixanol is well suited for examinations of the gastrointestinal tract, giving good efficacy results and fewer adverse events than iohexol.

Adolescent↗

[Gallstones and pancreatic necrosis in acute pancreatitis].

The purpose of this study was to investigate the occurrence of gallstones and the severity of acute pancreatitis in a Danish population, and in severe cases, the relation between pancreatic necrosis and gallstones. We used Ranson's prognostic scoring system to measure the severity of acute pancreatitis, ultrasonography for detecting biliary stones, and computed tomography or laparotomy for detecting pancreatic necrosis. During a two year period, we registered 101 patients. Approximately 70% were mild cases, and we found 18 patients with and 53 patients without gallstones. Among patients with severe cases, we observed 14 with and 16 without gallstones. There was a significantly higher proportion of gallstones in severe cases. Eight of 30 patients with severe pancreatitis had pancreatic necrosis, but we found no relation between the occurrence of necrosis and gallstones. We conclude that patients with gallstone related pancreatitis have more severe disease than patients without stones, but the complication of pancreatic necrosis is not related to gallstones.

Acute Disease↗

Chest roentgenogram in the evaluation of heart defects in asymptomatic infants and children with a cardiac murmur: reproducibility and accuracy.

OBJECTIVES: To evaluate the reproducibility and the accuracy of pediatric radiologists' assessments of chest radiographs with respect to the presence or absence of heart defects in children with an asymptomatic heart murmur. DESIGN: Ninety-eight children, ages 1 month to 15 years (median, 30.1 months), referred for evaluation of a heart murmur were consecutively included. They all had a standard chest radiograph and a color Doppler echocardiograph (CDE) performed. Six specialists in pediatric radiology evaluated the chest radiographs independently on two occasions 6 months apart. The radiologists were asked to classify each set of films into one of two categories: heart disease or no heart disease. The outcome of the CDE was considered the definite diagnosis. kappa statistics were used to analyze the reproducibility of the radiologic assessments. Sensitivity, specificity, and the predictive value of a positive and a negative test were used for evaluation of the accuracy of the radiologic assessments. RESULTS: Mean intra- and interobserver kappa values were all <0.6, and the majority were <0.4. Mean sensitivity was 0.3 (range: 0.17-0.52), mean predictive value of a positive test was 0.4, implying that 60% of the positive assessments were falsely positive. Mean specificity was 0.86 (range: 0.75-0.93) and the mean predictive value of a negative test was 0.80 implying that 20% of the negative assessments were falsely negative. CONCLUSION: We found a low reproducibility, as well as a low accuracy, of the radiologic assessments of the chest radiographs of children with an asymptomatic heart murmur with respect to the presence or absence of heart disease. A false-positive radiologic assessment of the chest radiograph with respect to heart defects causes unnecessary anxiety and further examinations, whereas a false-negative assessment might result in omission of relevant investigations and proper identification of the heart defect. We cannot recommend the use of chest radiographs in the initial evaluation of the asymptomatic child with a heart murmur. If a heart defect cannot be excluded by clinical examination a CDE must be performed.

Adolescent↗

Progress of emphysema in severe alpha 1-antitrypsin deficiency as assessed by annual CT.

PURPOSE: To assess serial CT as a measure of the progress of emphysema in patients with severe alpha 1-antitrypsin deficiency (phenotype PiZ). MATERIAL AND METHODS: In a randomized placebo-controlled study of alpha 1-antitrypsin augmentation therapy, 22 patients with moderate emphysema were followed for 2-4 years with an annual lung CT. The images were analysed by means of semiautomatic lung detection, and the degree of emphysema was quantitated by the density-mask and the percentile methods. The influence of lung volume was standardised by a regression model. RESULTS: A highly significant decline in Hounsfield units (HU) was found in low-density areas, corresponding to a mean (SE) annual loss of lung tissue of 2.1 (0.4) g/l lung volume. Analysis of a single slice at 5 cm below the level of the carina gave comparable results: 2.4 (0.4) g/l. CONCLUSION: Serial CT is a sensitive measure of the progress of emphysema in patients with severe alpha 1-antitrypsin deficiency.

Acute Disease↗

[CT in the prognostic evaluation of apoplexy].

The purpose of our prospective study was to determine whether cranial computed tomography in connection with neurological assessment was useful in prognostic evaluation of survival after acute stroke. Two-hundred and forty-five consecutive stroke patients were included. Each underwent detailed neurological assessment and cranial computed tomography without intravenous contrast injection. The lesions were divided according to neuroanatomic regions. In the statistical analyses we used a multiple logistic regression model. Computed tomography showed that 76% of the patients had infarcts. 11% had haemorrhages, and 13% had no acute lesion. Forty-three patients had more than one acute lesion, and 57 had one or more old infarcts. The temporal, parietal and frontal regions and the basal ganglia were most often affected. We concluded that age, level of consciousness, and involvement of the temporal lobe on computed tomography were factors of prognostic significance regarding survival in the acute phase.

Acute Disease↗

Computed tomography in prognostic stroke evaluation.

BACKGROUND AND PURPOSE: Computed tomography is now routinely used in many hospitals to investigate cerebrovascular disease. The purpose of our prospective study was to determine whether cranial computed tomography in connection with neurological assessment was useful in prognostic evaluation of survival after acute stroke. METHODS: Two-hundred forty-five consecutive stroke patients were included in the project during a 1-year period. Each had a detailed neurological assessment 24-72 hours after stroke onset and underwent cranial computed tomography without intravenous contrast injection within the first week after admission. The lesions were divided according to neuroanatomic regions. In the statistical analyses we used a multiple logistic regression model with survival/death as the binary variable. RESULTS: Computed tomography showed 76% of the patients had infarcts, 11% had hemorrhages, and 13% had no acute lesion. Forty-three patients had more than one acute lesion, and 57 had one or more old infarctions. The temporal, parietal, and frontal regions and the basal ganglia were most often affected. CONCLUSIONS: We conclude that age, level of consciousness, and involvement of the temporal lobe on computed tomography were factors of prognostic significance regarding survival in the acute phase.

Adult↗

Ureteritis cystica.

Six cases of ureteritis cystica are reported. Pathogenesis and diagnosis are discussed emphasizing the papillary tumour as an important differential diagnosis. A conservative attitude is recommended with a follow-up until the intravenous urography has normalized.

Aged↗

[False negative mammography].

During the period 1.1.1984-31.12.1986, primary surgical treatment of 423 women with palpaple, invasively progressing cancer of the breast was performed. All of these had been examined mammographically prior to operation. The uncorrected nosographical sensitivity of the mammographic investigation was 0.93, decreasing to 0.83 prior to the age of 50 years. It is emphasized that patients in whom there is a disproportion between the mammographic and palpatory findings must be referred for surgical assessment without delay.

Adult↗

Computed tomography and the TNM classification of lung cancer.

Computed tomography (CT) of the thorax and upper abdomen was prospectively evaluated in 84 patients with potentially operable lung cancer. Invasion into the thoracic wall and the mediastinal structures was not accurately demonstrated by CT. For metastatic mediastinal lymph nodes, the sensitivity and specificity of CT were, respectively, 86% and 61% and the positive and negative predictive indices 49% and 91%. For T1, T2 and T3 tumours the negative indices were 100%, 96% and 71%. Positive predictive index did not differ between squamous cell carcinoma and adenocarcinoma. Adrenal metastases were CT-suspected in 17 cases and liver metastases in eight, but were verified by ultrasonography in only one and four cases. CT should be used in preoperative investigation of lung cancer, irrespective of stage. Demonstration of thoracic-wall or mediastinal invasion need not exclude tumour resection. Preoperative mediastinoscopy is indicated if CT shows nodal metastases or if there are signs of tumour invasion, but not in CT-negative T1 or T2 tumour. Abdominal metastases indicated by CT should be investigated with CT-guided needle biopsy.

Abdominal Neoplasms↗

[Non-palpable tumors of the breast demonstrated by mammography].

During the period 1.1.1985-28.2.1987, 114 mammographic markings with needles were undertaken on cancer-suspect, non-palpable tumours of the breast in 106 patients. In 27.2% of the cases, carcinomata were found and, in 16.7%, carcinoma in situ. Mammographic examination combined with needle marking is recommended as a diagnostic supplement to clinical examination.

Adult↗

Thoracic neuroblastoma of the neonate.

Five cases of neonatal thoracic neuroblastoma were either clinically asymptomatic or presented as uncharacteristic respiratory distress. Chest radiography demonstrated a spectrum of abnormalities varying from a lobulated, apical thoracic mass with or without evidence of expansion, to a spindle-shaped paraspinal soft tissue widening, or a homogeneously dense hemithorax. In the newborn a neoplasm in the posterior mediastinum most likely represents a neuroblastoma, either primary or metastatic. In a high percentage of cases the primary tumour as well as possible skeletal metastases have an increased uptake of radiopharmaceuticals. Therefore a bone scan should be the next step for evaluation of the neoplasm. Supplementary sonographic screening of the retroperitoneum and lesser pelvis is easily performed and may contribute significant information. Urography is hardly mandatory any longer. Metrizamide CT myelography, highly recommended in infants and children, may be omitted in the neonate with no neurologic deficit. Urinary excretion of catecholamine metabolites is usually elevated and must always be determined.

Catecholamines↗