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Of a total of 22,455 adverse medicine reaction (AMR) reports there were 943 reports of liver injury (4.2%). Two hundred and five drugs were associated with hepatic reactions. The top 20 drugs accounted for 57% of all liver reactions. Fifty-seven percent were reported in females. Hepatotoxicity was most commonly reported among patients 50-80 years old. Liver reactions were associated with a 3.3% mortality, but were responsible for 7.4% of all fatal occurrences. There was a steady increase in the number of reports over the 21 years. Although the largest number of reports of liver injury were received between 1988 and 1994, mortality was lowest during this period. There were substantial differences in the medicines associated with hepatic reactions during each of the three periods, although erythromycin was the commonest cause throughout. Erythromycin was associated with two deaths. Halothane and perhexilene were the most frequent cause of death and were two of the most important causes of liver injury during the first and second periods. Diclofenac, Augmentin and flucloxacillin were important causes of hepatotoxicity during period 3 but were not associated with a fatal outcome.
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To determine outcomes in acute otitis media (AOM) according to severity of disease and to assess different initial treatment regimens, 308 with AOM were enrolled and divided into severe (n = 277; 89.9%) and non-severe (n = 31; 10.1%) groups based on symptoms and tympanic membrane changes. Children in the severe group were initially managed with amoxicillin (AMPC) whereas children in the non-severe group were initially managed without antibiotics. Children were monitored on days 1, 5, 10, 14 and 28. Five outcome measures were assessed: disappearance of symptoms at day 5, resolution of tympanic membrane changes by day 28, disappearance of middle ear effusions by day 28, recurrence of acute symptoms prior to day 28, and need to change treatment regimens. Children with severe disease were more often male (57% versus 36%, P < 0.05) and more often colonized with pathogens (77% versus 55%, P < 0.05 than children with non-severe disease. The two groups were similar with respect to age and day care attendance. Despite differences in initial treatment regimens between the two groups, symptoms improved at the same rate for severe and non-severe disease, 94% by day 5. In contrast, tympanic membranes returned to normal in 69% of the severe and 81% of the non-severe groups by day 28; however, as early as day 5, 10% of the severe and 55% of the non-severe groups demonstrated normal tympanic membranes. Middle ear effusions similarly disappeared more slowly in the severe group, 52% versus 74% by day 14 and 76% versus 84% by day 28. Recurrence rates of acute symptoms occurred with equal frequency in the severe, 15%, and non-severe groups, 10%. Failure of the symptoms or the tympanic membranes to improve led to antibiotic changes in 59.9% of the severe group and to the addition of antibiotics in 51.6% of the non-severe group. Children in the severe group who failed to improve with an initial course of amoxicillin were younger (40.2 months versus 45.8 months, P < 0.05), had higher tympanic membrane scores (4.5 versus 4.1, P < 0.05), and were more often colonized with penicillin-resistant Streptococcus pneumoniae (33.8% versus 6.5%, P < 0.01) than children who responded to AMPC. In a similar manner, children with non-severe disease who failed to improve without antibiotics were younger (40.7 months versus 54.8 months, P < 0.05) and more often colonized with pathogens (75.0% versus 33.4%, P < 0.05).
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We studied 220 patients (138 men and 82 women) with uncomplicated gonorrhoea who were entered into a randomised double blind trial and treated with either Augmentin (amoxycillin 3 g and potassium clavulanate 125 mg) or amoxycillin 3 g, with probenecid 1 g by mouth in all cases. Seven (6.5%) of 108 patients treated with Augmentin were still culture positive after treatment, compared with 15 (13.4%) of 112 of those treated with amoxycillin. Penicillinase (beta lactamase) producing strains of Neisseria gonorrhoeae (PPNG) were found in 23 (10.5%) patients, of whom 10 were treated with Augmentin and 13 with amoxycillin. Treatment failed in all 13 patients who received amoxycillin. Augmentin was shown to be an effective treatment for gonorrhoea caused by PPNG strains.
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Both amoxicillin- and clavulanic acid-specific T cells participate in the liver injury that develops in certain patients exposed to amoxicillin-clavulanate.
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The pattern of CP in both the PROM and the SPL groups was similar, but functional outcomes were milder, compared with children with CP in the general population. However, in these groups the risk of CP was increased independently of gestational age. This is consistent with findings that ongoing inflammatory damage can cause CP.
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Of the 263 children enrolled in the study, 233 were evaluable at the primary evaluation 45 days after the start of treatment. Satisfactory clinical response rates (cure, delayed cure and improvement) were 60.5% in patients treated with azithromycin and 64.9% in patients treated with amoxicillin/clavulanate. Satisfactory clinical response rates at secondary evaluations were also comparable: 92.2% vs. 90.0% at Day 14 and 66.7% vs. 72.7% at Day 30 in patients treated with azithromycin and amoxicillin/clavulanate, respectively. No significant differences in treatment failures, relapses or recurrences were noted with either medication. Azithromycin was significantly better tolerated and caused fewer treatment-related adverse events (7.2%) than amoxicillin/clavulanate (17.1%) (P < 0.001). In response to the interview and questionnaire, parents of children treated with azithromycin noted less need for special arrangements to give medication (2.0% vs. 14.9%). Children liked the taste of azithromycin (89.2%) and did not have to be forced to take the medication (2.4%). Parents of children receiving amoxicillin/clavulanate noted that 61.8% liked the medication and 19.4% of children had to be forced to take it.
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Undifferentiated acute respiratory infections (ARIs) are a large and heterogeneous group of infections not clearly restricted to one specific part of the upper respiratory tract, which last for up to seven days. They are more common in pre-school children in low-income countries and are responsible for 75% of the total amount of prescribed antibiotics in high-income countries. One possible rationale for prescribing antibiotics is the wish to prevent bacterial complications.