Several physiological changes take place during hibernation, which are thought to allow animals to conserve energy and limit organ injury as might otherwise occur due to the physiological extremes of torpor and arousal. Significant changes occur in the immune system during torpor. The number of circulating leukocytes drops by *90% during entrance into torpor and seems to be driven by low body temperature. Normal cell counts restore upon arousal. Recently, we demonstrated that clearance of circulating lymphocytes is due to retention in lymphoid organs caused by a reduced plasma level of sphingosine-1-phosphate (S1P). Besides its effects on leukocyte migration, hibernation affects complement function, phagocytosis capacity, cytokine production, lymphocyte proliferation, and antibody production. The reduced immune function might play a major role in the etiology of White Nose Syndrome (WNS) in hibernating bats. Further, the ability to induce a fully reversible state of immune suppression in humans might aid the treatment of several inflammatory and immune-mediated diseases. Unraveling the
Background or Introduction: Amoxicillin alone and with clavulanic acid are among the most prescribing antibacterial agents in Italy. These drugs are generally well tolerated and usually prescribed by paediatrics, although published studies indicate that they are frequently associated with adverse drug reactions (ADRs), in particular cutaneous and gastrointestinal ones. We analyzed the Italian database of spontaneous reporting of suspected ADRs in order to compare the safety profile of amoxicillin and amoxicillin/clavulanic acid (amoxiclav) in pediatrics. Material and Methods: Reports of suspected ADRs due to amoxicillin and amoxi-clav in pediatric patients, until 1 September 2014, were extracted. ADRs were coded using MedDRA terminology. To evaluate the correlation between drug use and occurrence of ADRs a disproportionality analysis through Reporting Odds Ratio (ROR) was performed. Results: We collected 3.345 reports associated with amoxicillin and amoxicillin/clavulanic acid, 1.188 (35.5%) related to amoxicillin and 2.157 (64.5%) to amoxicillin with clavulanic acid. The percentages of serious ADRs were 12% for amoxicillin and 16% for amoxi-clav. The percentage of skin reactions was higher for amoxicillin (75%) than for amoxicillin/clavulanic acid (67%) and for gastrointestinal reactions was higher for amoxicillin/clavulanic acid (16%) than for amoxicillin (10%). For amoxicillin, significant disproportionality was observed only for cutaneous ADR like dermatitis (ROR, 2.31; 95% CI, 1.26-4.25), rash (1.30; 1.08-1.57), erythematous rash (1.70; 1.18-2.45). For amoxicillin/clavulanic acid was observed only for gastrointestinal ADR: diarrhoea (1.56; 1.15-2.12), abdominal pain (2.11; 1.14-3.93) and sickness (1.69; 1.20-2.38). Conclusions: Our analysis shows a different safety profile for amoxicillin and amoxi-clav in paediatrics: the first is associated with an higher risk of skin reactions while the amoxi-clav with gastrointestinal ones. Nevertheless, data did not reveal an increased risk of liver damage from clavulanic acid than amoxicillin alone, as widely reported in literature.
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