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  • 1
    Electronic Resource
    Electronic Resource
    Springer
    European journal of clinical pharmacology 43 (1992), S. 215-218 
    ISSN: 1432-1041
    Keywords: Agranulocytosis ; Sulphasalazine ; adverse reactions ; survey methods
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary During the 18 year period 1972-1989 a total of 62 cases of agranulocytosis associated with the use of sulphasalazine were reported to the Swedish Adverse Drug Reactions Advisory Committee (SADRAC). The median age of the patients was 52 y and median duration of sulphasalazine treatment was 43 days. The fatality rate was 6.5 %, and among patients who recovered the median recovery time was 10 days. Twelve patients were treated concomitantly with other drugs generally suspected to induce agranulocytosis. From sales and prescription data the average incidence of agranulocytosis during sulphasalazine therapy was estimated to be 1/1750 patient years of exposure. From an ongoing Prescription Monitoring Project in a Swedish county it was possible to calculate the proportion of patients receiving sulphasalazine for different periods of time. The incidence of agranulocytosis during the first 30 days was estimated to be 1/2400 patients, while it was 1/700 between Days 31–90 and 1/11200 during Days 91–365. The risk of developing agranulocytosis during sulphasalazine treatment is considerable during the first three months of treatment, and the traditional way of expressing the risk (1/1750 patient years) underestimates the risk for the individual patient.
    Type of Medium: Electronic Resource
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  • 2
    Electronic Resource
    Electronic Resource
    Springer
    European journal of clinical pharmacology 43 (1992), S. 211-214 
    ISSN: 1432-1041
    Keywords: Agranulocytosis ; Sulphasalazine ; Trimethoprimsulphamethoxazole ; case-control study ; drug monitoring system ; risk estimates ; sales and prescription data
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary A comparison has been made of risk estimates for agranulocytosis connected with sulphasalazine and trimethoprim-sulphamethoxazole (T-SM) therapy calculated from data in the Swedish Drug Monitoring System (“spontaneous” reports, sales and prescription information) and a population based case-control study (the IAAAS). The relative risk for agranulocytosis during sulphasalazine treatment was calculated to be 107 and 123 by the spontaneous reporting system and the case-control study, respectively. The corresponding excess risk in both systems was 1.5. For T-SM the relative risk was 17 in the spontaneous reporting system and 12 in the case-control study, while the excess risk calculated for 3 days of treatment was 0.9 in the spontaneous reporting system, and 1.6 for 3 or more days of treatment in the case-control study. It is concluded that the Swedish Drug Monitoring System gives an appropriate estimate of the risk of developing agranulocytosis in association with the two drugs studied.
    Type of Medium: Electronic Resource
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  • 3
    Electronic Resource
    Electronic Resource
    Springer
    European journal of clinical pharmacology 55 (1999), S. 619-624 
    ISSN: 1432-1041
    Keywords: Key words Computerised electrocardiogram ; Heart rate changes ; Influence of food
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract Objective: To study the influence of food intake on electrocardiogram (ECG) variables (heart rate, QT-, QTc-, PR-intervals, QRS-time) and morphological alterations of the T-waves in 12 healthy male volunteers. Methods: The study was of open, three-period crossover design. On each occasion, all subjects fasted from midnight. During two of the study periods, the subjects were given a standardised meal at 1.5 h and 5.5 h after the baseline assessments, respectively, whereas, during the third period, they remained fasting for the entire study period of about 9 h. ECG and blood pressure were recorded at baseline and thereafter every hour for 8 h. Results: No ECG changes were observed following the fasting condition, whereas a clear change in ECG and an increased heart rate were recorded in response to the meal intake during the other two periods. The most prominent ECG effect was the change in the size and shape of the T-waves, which were described as flattened to biphasic and, occasionally, negative. These alterations were most pronounced in the precordial leads V4 to V6 in the ECG recording immediately following the meal intake, with a gradual return to baseline conditions over 4–5 h. Moreover, a transient increase of supine systolic blood pressure was also recorded in response to the meal intake. Conclusions: The intake of a meal can cause clear and consistent ECG changes in healthy male subjects, comprising increases in heart rate as well as alterations in the size and shape of the T-waves (flattened to biphasic and, occasionally, negative). Also, a post-meal increase in the supine systolic blood pressure was recorded.
    Type of Medium: Electronic Resource
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  • 4
    Electronic Resource
    Electronic Resource
    Springer
    Annals of hematology 61 (1990), S. 240-244 
    ISSN: 1432-0584
    Keywords: Aplastic anemia ; Pancytopenia ; Agranulocytosis ; Drug induced blood dyscrasia
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary From a population-based study on the incidence of potentially drug-associated blood dyscrasias 28 cases were identified with pancytopenia. Who recovered within 90 days after diagnosis. Early recovery occured more frequently in patients showing normal or increased cellularity of the bone marrow than in patients with bone marrow hypoplasia. Median recovery times of leukocytes were 14 and 10 days and of platelets 21 and 9 days in patients with and without bone marrow hypoplasia, respectively. Age and sex distribution were similar in both groups. Of 28 patients, 11 reported a period of fever before onset of pancytopenia. Sixteen patients in whom information on drug use was available had taken a median of 4 drugs before the onset of symptoms that were related to pancytopenia. From these results we present the hypothesis that transient pancytopenia with or without marrow hypoplasia can be the expression of the same type of bone marrow injury and that drugs or viral infections should be considered as etiological factors.
    Type of Medium: Electronic Resource
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