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Effectiviteit van vijf dagen oraal nabehandelen met amoxicilline volgend op drie dagen intraveneus behandelen in de kliniek voor milde en matig ernstige longontsteking die perifeer werd opgedaan
Abstract
Aan dit uitstekend uitgevoerd en beschreven gerandomiseerd dubbelblinde onderzoek namen aanvankelijk 186 mensen deel, allen
met milde tot matig ernstige pneumonie in het ziekenhuis opgenomen. Zij kregen daar drie dagen intraveneus amoxicilline. Daarna
bleven 119 mensen over om gerandomiseerd te worden naar orale therapie: 63 mensen kregen amoxicilline per os en 56 placebo
per os. Voorwaarde om gerandomiseerd te worden was dat men aan de hand van schalen sterk verbeterd was in algeheel welbevinden
en ook op de symptomen: kortademig, hoesten, opgeven van sputum en de kleur daarvan. Patiënten waren minstens 18 jaar oud
met een minimum temperatuur van 38°C (behalve indien men ouder was dan 65 jaar, dan kwam men ook in aanmerking met lagere
lichaamstemperatuur). Voor de uitgebreide exclusiecriteria raadplege men het oorspronkelijke artikel. De voornaamste redenen
om niet gerandomiseerd te worden waren: a) in 19 gevallen weigering van de patiënt tot verdere deelname; en b) in 38 gevallen
waren de patiënten na drie dagen intraveneuze therapie onvoldoende verbeterd.
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To compare the effectiveness of discontinuing treatment with amoxicillin after three days or eight days in adults admitted to hospital with mild to moderate-severe community acquired pneumonia who substantially improved after an initial three days' treatment.
Randomised, double blind, placebo controlled non-inferiority trial.
Nine secondary and tertiary care hospitals in the Netherlands.
Adults with mild to moderate-severe community acquired pneumonia (pneumonia severity index score < or = 110).
Patients who had substantially improved after three days' treatment with intravenous amoxicillin were randomly assigned to oral amoxicillin (n = 63) or placebo (n = 56) three times daily for five days.
The primary outcome measure was the clinical success rate at day 10. Secondary outcome measures were the clinical success rate at day 28, symptom resolution, radiological success rates at days 10 and 28, and adverse events.
Baseline characteristics were comparable, with the exception of symptom severity, which was worse in the three day treatment group. In the three day and eight day treatment groups the clinical success rate at day 10 was 93% for both (difference 0.1%, 95% confidence interval--9% to 10%) and at day 28 was 90% compared with 88% (difference 2.0%,--9% to 15%). Both groups had similar resolution of symptoms. Radiological success rates were 86% compared with 83% at day 10 (difference 3%,--10% to 16%) and 86% compared with 79% at day 28 (difference 6%,--7% to 20%). Six patients (11%) in the placebo group and 13 patients (21%) in the active treatment group reported adverse events (P = 0.1).
Discontinuing amoxicillin treatment after three days is not inferior to discontinuing it after eight days in adults admitted to hospital with mild to moderate-severe community acquired pneumonia who substantially improved after an initial three days' treatment.