• Loomis Butt posted an update 6 months, 1 week ago

    A possible case of ulcerative colitis (UC) developed during treatment with ixekizumab is reported. Ixekizumab is a human monoclonal antibody approved for chronic plaque psoriasis that works by blocking interleukin-17 (IL-17). Cytoquines, such as IL-17, may be involved in the pathophysiology of psoriasis and inflammatory bowel diseases. We describe the case of a 76-year-old woman who presented with an episode of acute self-limited colitis after receiving ten doses of ixekizumab. It was resolved after treatment withdrawal. A re-challenge was done after 3 months and symptoms returned. Colonoscopy results confirmed the diagnosis of UC. Symptoms remitted after drug discontinuation and treatment with corticosteroids. Four months after stopping ixekizumab, she remains asymptomatic and she is being treated with guselkumab with adequate response. The Naranjo algorithm revealed a probable causal relationship.This adverse event should be taken into account by physicians and pharmacists before prescribing or reviewing therapies in order to improve patients’ safety.A possible case of bullous pemphigoid (BP) that developed during treatment with ustekinumab is reported. Ustekinumab is a human monoclonal antibody found in pathologies such as psoriasis, which works by inhibiting the activity of interleukin-12 and interleukin-23. We describe the case of a 75-year-old woman who presented with new onset of erythematous and bullous lesions 5 days after receiving a fifth dose of ustekinumab. The patient was treated with corticosteroids and dapsone, whereupon the lesions disappeared. Ustekinumab was withdrawn. Currently the patient remains asymptomatic. In addition, the histopathological and immunofluorescence findings confirmed the diagnosis of BP. Three causality algorithms were applied and revealed a probable causal relationship. There may be a causal relationship between the use of ustekinumab and BP. This association should be taken into account by physicians when prescribing and reviewing drug therapies.

    To develop methods for surface bioburden determination of ampoules and vials to be used in the validation of the disinfection procedures and in routine monitoring of ampoules and vials.

    The surface bioburdens of ampoules and vials are determined before and after disinfection by contact plates and total immersion.

    The mean surface bioburdens of non-disinfected ampoules and vials taken straight from the original boxes are 2.4 and 5.01 cfu (total immersion; n = 20), and 0.97 and 0.94 cfu (contact plates; n = 60). The mean surface bioburdens of ampules and vials after disinfection by wiping are 1.15 and 7.50 cfu (total immersion; n = 20), and 0.12 and 0.10 cfu (contact plates; n = 60). The high number of cfu on vials (total immersion) indicate hidden cfu around the neck not removable by wiping and not detected by contact plates. Total immersion needs special laboratory facilities and is expensive (about €50 a sample). Therefore, it is less appropriate for use in routine monitoring. However, because of the high recovery, it is the method of choice for the validation of the disinfection procedure. Surface bioburden determination by contact plates is relatively simple. Non-flat surfaces cannot be reached, but the recovery from the touched flat part of the surface is high (around 50%). The recovery from swabs is low (around 10%). Another disadvantage of swabs is the laboratory work after sampling. selleckchem We therefore advise contact plates for routine monitoring. To get a reliable value of the mean surface bioburden at least 30 samples need to be examined.

    Total immersion is the method of choice for the determination of the effectiveness of a disinfection procedure for ampoules and vials. Contact plate is the method of choice for routine monitoring of the surfaces of ampoules and vials.

    Total immersion is the method of choice for the determination of the effectiveness of a disinfection procedure for ampoules and vials. Contact plate is the method of choice for routine monitoring of the surfaces of ampoules and vials.

    Current retrospective cohort study analyses clinical database records of 4792 assisted reproduction procedures to assess the significance of target effectiveness endpoints from a safety perspective.

    Stimulation protocols with urinary, recombinant or combination of both types gonadotrophin preparations are compared according to the following primary endpoints incidence of ovarian hyperstimulation syndrome (OHSS), cycle cancellation, follicle count, induced estradiol values, clinical pregnancy achieved and cycles reached embryo transfer/freezing. We have investigated the incidence of cases evaluated as ‘risky for OHSS’ by secondary efficacy endpoints (exogenous gonadotrophin exposure, luteinising hormone and progesterone values, oocyte yield, eggs with normal maturation). The following statistical methods were applied descriptive statistics, Mann-Whitney

    test, Kruskal-Wallis test, Pearson chi-square test, Fisher’s exact test, binary logistic regression.

    Only 16 cases (0.42%) of moderate and delayed OHSeds the incidence of OHSS. Suboptimal effectiveness of stimulation protocols may also jeopardise the well-being of ART patients. Gonadotrophin exposure, induced values of sex hormones, and quantity and quality of extracted oocytes should be considered to minimise any unintended suffering of treated couples.

    Safety surveillance of ART exceeds the incidence of OHSS. Suboptimal effectiveness of stimulation protocols may also jeopardise the well-being of ART patients. Gonadotrophin exposure, induced values of sex hormones, and quantity and quality of extracted oocytes should be considered to minimise any unintended suffering of treated couples.

    To describe the association between exposure to different antidepressant drugs and hip fracture in an elderly Mediterranean population.

    Cases were all patients aged 50-95 years admitted to the emergency room of our hospital with hip fracture not related to a high intensity trauma during 2010. For each case, four controls were identified from primary care electronic medical records matched by age (±3 years), gender, date of consultation at the primary care centre (±1 month) and primary care centre. Pharmacological treatments received within the previous 5 years were retrieved from the prescription records. Crude and adjusted risks associated with exposures were calculated by conditional logistic regression. ORs were adjusted by matching variables and by significant risk factors identified in the bivariate analysis (prescription of ≥4 drugs, osteoporosis, diabetes mellitus and previous fracture).

    136 cases and 544 controls were analysed. Adjusted OR (95% CI) for hip fracture associated with exposure to any antidepressants was 2.

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