Xalyn-OR-Amoxicilina

Vnitr Lek. 2004 Nov;50(11):825-9.

Once or twice daily versus three times daily amoxicillin with or without clavulanate for the treatment of acute otitis media.

Thanaviratananich S, Laopaiboon M, Vatanasapt P.

Department of Otolaryngology, Faculty of Medicine, Khon Kaen University, 123 Friendship Road, Khon Kaen, Thailand, 40002.

Acute otitis media (AOM) is a common problem in children, for which the antibiotic amoxicillin, with or without clavulanate, is frequently prescribed. OBJECTIVES: To compare the effectiveness of one or two daily doses with three or four daily doses of amoxicillin, with or without clavulanate, for the treatment of AOM in children. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2008, issue 1), which contains the Acute Respiratory Infections (ARI) Group's Specialized Register; MEDLINE (January 1950 to March 2008); EMBASE (1974 to March 2008); the Science Citation Index (2001 to March 2008); and NLM Gateway (HSRProj) (March 2008). SELECTION CRITERIA: We included studies if they met the following criteria: randomized controlled trials (RCTs) of children aged 12 years or younger with AOM, diagnosed by the following explicit criteria: acute ear pain (otalgia) and inflamed ear drum (confirmed by positive tympanocentesis or tympanogram of type B or C). DATA COLLECTION AND ANALYSIS: We extracted data on treatment outcomes from individual trials. We assessed quality based on selection bias, performance bias, attrition bias and sample size calculation. The quality grading was defined as low risk of bias, moderate risk of bias or high risk of bias. The results were summarized as risk ratio (RR) and 95% confidence intervals (CI). MAIN RESULTS: We included six studies with 1601 children in the review. Although the clinical cure rates at the end of therapy and at the follow-up periods of each study were shown to be comparable between the two groups, we did not perform pooled data analysis because of moderate to high risk of biases in the included studies. Most of the children were aged 2 months to 12 years. None of the studies had any consistently significant results either for benefit or harm. The outcomes were assessed at the end of therapy (often 10 days) and this may have been too late to measure any differences. AUTHORS' CONCLUSIONS: This review showed insufficient evidence to judge whether once or twice daily doses of amoxicillin, with or without clavulanate, were comparable with three or four daily doses for the treatment of AOM. The evidence appears to be biased and therefore no firm conclusions can be drawn.

PLoS ONE. 2008 Apr 23;3(4):e1991

Does 3-day course of oral amoxycillin benefit children of non-severe pneumonia with wheeze: a multicentric randomised controlled trial.

Awasthi S, Agarwal G, Kabra SK, Singhi S, Kulkarni M, More V, Niswade A, Pillai RM, Luke R, Srivastava NM, Suresh S, Verghese VP, Raghupathy P, Lodha R, Walter SD.

King George's Medical University, Lucknow, India.

WHO-defined pneumonias, treated with antibiotics, are responsible for a significant proportion of childhood morbidity and mortality in the developing countries. Since substantial proportion pneumonias have a viral etiology, where children are more likely to present with wheeze, there is a concern that currently antibiotics are being over-prescribed for it. Hence the current trial was conducted with the objective to show the therapeutic equivalence of two treatments (placebo and amoxycillin) for children presenting with non-severe pneumonia with wheeze, who have persistent fast breathing after nebulisation with salbutamol, and have normal chest radiograph. METHODOLOGY: This multi-centric, randomised placebo controlled double blind clinical trial intended to investigate equivalent efficacy of placebo and amoxicillin and was conducted in ambulatory care settings in eight government hospitals in India. Participants were children aged 2-59 months of age, who received either oral amoxycillin (31-54 mg/Kg/day, in three divided doses for three days) or placebo, and standard bronchodilator therapy. Primary outcome was clinical failure on or before day- 4. PRINCIPAL FINDINGS: We randomized 836 cases in placebo and 835 in amoxycillin group. Clinical failures occurred in 201 (24.0%) on placebo and 166 (19.9%) on amoxycillin (risk difference 4.2% in favour of antibiotic, 95% CI: 0.2 to 8.1). Adherence for both placebo and amoxycillin was >96% and 98.9% subjects were followed up on day- 4. Clinical failure was associated with (i) placebo treatment (adjusted OR = 1.28, 95% CI: 1.01 to1.62), (ii) excess respiratory rate of >10 breaths per minute (adjusted OR = 1.51, 95% CI: 1.19, 1.92), (iii) vomiting at enrolment (adjusted OR = 1.49, 95% CI: 1.13, 1.96), (iv) history of use of broncho-dilators (adjusted OR = 1.71, 95% CI: 1.30, 2.24) and (v) non-adherence (adjusted OR = 8.06, 95% CI: 4.36, 14.92). CONCLUSIONS: Treating children with non-severe pneumonia and wheeze with a placebo is not equivalent to treatment with oral amoxycillin. TRIAL REGISTRATION: ClinicalTrials.gov NCT00407394.

Arch Dis Child. 2008 Jun;93(6):474-8. Epub 2008 Mar 12.  

Once-daily amoxicillin versus twice-daily penicillin V in group A beta-haemolytic streptococcal pharyngitis.

Lennon DR, Farrell E, Martin DR, Stewart JM.

Department of Paediatrics, University of Auckland, Private Bag 92019, Auckland, New Zealand.

Rheumatic fever is a preventable chronic disease preceded by group A beta-haemolytic streptococcal (GABHS) pharyngitis. OBJECTIVE: To test the non-inferiority of once-daily (QD) oral amoxicillin to the recommended twice-daily (BID) oral penicillin V in GABHS pharyngitis. METHODS: This was a randomised non-inferiority trial carried out in a school-based clinic in New Zealand. Children presenting with GABHS pharyngitis were randomised to oral amoxicillin 1500 mg QD (or 750 mg if bodyweight was <or=30 kg) or to oral penicillin V 500 mg BID (or 250 mg if bodyweight was <or=20 kg) for 10 days. Observed medication and weekend diary cards were used to monitor adherence. OUTCOME: Eradication of GABHS, determined with follow-up throat cultures on days 3-6, 12-16 and 26-36. GABHS isolates were serotyped to distinguish bacteriological treatment failures (and relapses) from new acquisitions. Non-inferiority was defined as an upper 95% confidence limit (CL) for the difference in success of eradication in the amoxicillin and penicillin V treatment groups of <or=10%. RESULTS: 353 children with positive throat swabs for GABHS were randomised to amoxicillin (n = 177) or penicillin V (n = 176). The upper 95% CL for the differences in positive cultures between the antibiotics was 4.9% at days 3-6, 6.5% at days 12-16 and 8.5% at days 26-36. Treatment failures (including relapses) occurred at each visit in 5.8%, 12.7% and 10.7% of amoxicillin recipients and 6.2%, 11.9% and 11.3% of penicillin V recipients, respectively. No significant differences in resolution of symptoms were noted between treatment groups. One case of unsubstantiated acute rheumatic fever occurred after 7 days of amoxicillin. CONCLUSION: In this adequately powered study, once-daily oral amoxicillin is not inferior to twice-daily penicillin V for the treatment and eradication of GABHS in children with pharyngitis.