Safety Of Short Course Research Articles

The efficacy and safety of Short course therapy with Cefixime in URTI in Indian Scenario

Upper respiratory tract infections (URTI) are one of the commonest cause for a patient’s visit to outpatient department (OPD). Short course therapies with penicillin and cephalosporin class of antibiotics are commonly prescribed in URTI cases. This study was a retrospective, multicentre, observational cohort analysis, planned to evaluate the effectiveness and safety of Cefixime 400 mg per day in patients of URTI, using WURSS 21 score. We analysed the data of 200 patients who were prescribed Cefixime for URTI. Most of the patients (55%) were male. The baseline mean WURSS score of 41.09 ± 33.45 decreased to 25.74 ± 22.29 [(-37.3%), p value<0.05] at visit 2; moreover, it further decreased to 5.75 ± 6.75 [(-86.0%), p value<0.05] at visit 3. Similar trend was noted for WURSS symptom score and WURSS Quality of life score. At baseline, mean WURSS Symptom score was 25.34 ± 15.97 which was reduced to 16.32 ± 11.50 at visit 2 and 4.15 ± 4.50 at visit 3. Similarly, mean WURSS Quality of life score at baseline was 15.74 ± 18.41 which was reduced to 9.42 ± 11.66 and 1.59 ± 2.75 at visit 2 and visit 3 respectively. None of the patients reported adverse effects. The findings of the present survey confirm the effectiveness and safety of short course of Cefixime therapy in URTI.

Efficacy and Safety of short courses of antibiotic therapy for bacteremia caused by Enterobacteriaceae

Efficacy and Safety of short courses of antibiotic therapy for bacteremia caused by Enterobacteriaceae

Efficacy and safety of short course adjuvant trastuzumab combination chemotherapy in breast cancer

Background:The adjuvant short course 9-week trastuzumab combination therapy for human epidermal receptor 2 positive breast cancer patients may often be considered as a cost-effective and safe option and has important implications for the Indian subcontinent as well as other developing countries. However, such regimens of shorter duration trastuzumab therapy like FinHer, offered in view of economic constraints, may not be able to achieve globally comparable cure rates in early breast cancer especially with high-risk women with more than 3 lymph node positive.Methods and Material:Outcome of 21 patients with HER2 positive breast cancer was treated with short course trastuzumab combination chemotherapy in the adjuvant setting was studied.Results:Out of 21 patients 15 are alive and disease free with a follow up of up to 73 months (median follow up 42 months).

Androgen therapy for delayed male puberty

Delayed puberty in men is a commonly presenting problem to paediatricians and an understanding of the available evidence on cause, treatments and outcomes is important to guide practice. Understanding of the regulation of the onset of puberty is gradually unfolding, although the genetic factors that dictate the timing of puberty in individuals and families remain poorly elucidated. Mutations and polymorphisms in candidate genes are being actively studied and it is likely that there is significant overlap between traditional diagnostic categories. Also, environmental endocrine disruptors may interact with the genetic regulation of puberty. Delayed puberty may not always be a benign condition, with increased risks of failing to achieve target height, adverse psychological and educational consequences, delayed sexual and psychosocial integration into society and effects on skeletal proportions and bone mass reported. Appropriate evaluation and follow-up is needed to guide clinical practice, particularly to distinguish constitutional delay in growth and puberty from that associated with other medical disease or permanent disorders. In milder cases of delayed puberty, treatment is often not required; however, considerable evidence exists for the efficacy and safety of short courses of low-dose testosterone therapy for appropriately selected individuals. This treatment is associated with high levels of patient satisfaction. There is not yet sufficient evidence for the routine use of other therapies (e.g. growth hormone, aromatase inhibitors) for constitutional delay in growth and puberty and better characterization of cause may lead to more targeted individual therapy.

Rapid correction of low vitamin D status in nursing home residents

This prospective study finds that ergocalciferol 50,000 IU three times weekly for four weeks effectively and safely corrects vitamin D inadequacy in nursing home residents. Low vitamin D status is common among nursing home residents and contributes to bone loss, falls and fractures. The objective of this study was to evaluate the efficacy and safety of short course, high dose, oral vitamin D(2) (ergocalciferol) treatment. This prospective study included 63 nursing home residents. The 25 with low vitamin D status (serum 25(OH)D < or = 25 ng/ml) received oral ergocalciferol 50,000 IU three times weekly for four weeks; the others received no change to their routine care. Serum total 25(OH)D, 25(OH)D(2), 25(OH)D(3), calcium, parathyroid hormone (PTH), bone turnover markers and neuro-cognitive assessments were obtained at baseline and four weeks. Mean total 25(OH)D concentration increased (p < 0.0001) from 17.3 to 63.8 ng/ml in the treated group and remained unchanged in the comparison group. Serum 25(OH)D(3) remained stable in the comparison group, but declined (p < 0.0001) with D(2) treatment from 15.4 to 9.1 ng/ml. Serum PTH trended down in the treatment group (p = 0.06). No treatment-induced improvement in ambulation, cognition or behavior was observed. No hypercalcemia or other adverse effects were observed with ergocalciferol treatment. Four weeks of oral vitamin D(2) supplementation effectively and safely normalizes serum 25(OH)D in nursing home residents.

Efficacy and Safety of Short Course (5-day) Moxifloxacin vs 7-day Ceftriaxone in the Treatment of Acute Exacerbations of Chronic Bronchitis (AECB)

The aim of this multicenter, open, randomized study was to compare the efficacy and tolerability of a 5-day treatment course with oral moxifloxacin (MXF) vs a 7-day course with i.m. ceftriaxone (CRO) in 476 patients with acute exacerbations of chronic bronchitis (AECB), and to conduct a cost minimization analysis of the two treatments from the perspectives of both the Italian National Health Service (INHS) and society. The study was conducted in Italy. Clinical success rates at test-of-cure in the 423 patients of the PP (Per Protocol) population (primary efficacy parameter) were 90.6% and 89.0% for MXF and CRO, respectively. Statistical non-inferiority of MXF vs CRO was confirmed. Similar results were found between study drugs on the secondary efficacy parameters, including success at end-of-treatment (95.3% for MXF vs 92.9% for CRO), success at test-of-cure in bacteriologically-positive patients (94.1% vs 90.7%) and eradication/presumed eradication rates (91.7% vs 93.3%). ITT (Intention-to-Treat) analysis confirmed these data. There was a low incidence of adverse events (10.8% vs 9.1%). During a 6-month follow-up period, relapse rates were lower for MXF vs CRO (23.3% vs 28.3%; p>.05). Compared with CRO, MXF was associated with cost savings per patient ranging from €226.57 (INHS perspective) to €448.23 (societal perspective), with lower hospitalization rate the major variable contributing to reduced costs. MXF appears to be an ideal candidate for AECB treatment.