Probiotic prophylaxis in predicted severe acute pancreatitis : a randomised, double-blind, placebo-controlled trial  

Oleh:

Besselink, Marc G.H. ; Santvoort, Hjalmar C. Van ; Buskens, Erik ; Boermeester, Marja A. ; Goor, Harry Van

Jenis: Article from Journal - ilmiah internasional
Dalam koleksi: The Lancet (keterangan: ada di Proquest) vol. 371 no. 9613 (Feb. 2008), page 651.

Ketersediaan

Perpustakaan FK Nomor Panggil: L01.K.2008.02 Non-tandon: 1 (dapat dipinjam: 0) Tandon: tidak ada

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Isi artikel

Background Infectious complications and associated mortality are a major concern in acute pancreatitis. Enteral administration of prebiotics could prevent infectious complications, but convincing evidence is scarce. Our aims was to assess the effects of probiotic prophylaxis in patients with predicted severe acute pancreatitis. Methods In this multicentre randomised, double blind, placebo controlled trial, 298 patients with predicted severe acute pancreatitis (Acute Physiology and Chronic Health Evaluation [APACHE II] score >8, Imrie score >3, or C-reactive protein >150mg/L) were randomly assigned within 72 h of onset of symptoms to receive a meltispecies probiotic preparation (n=153) or placebo (n=145), administered enterally twice daily for 28 days. The primary endpoint was the composite of infectious complications-ie, infected pancreatitis necrosis, becteraemia, pneumonia, urosepsis, or infected ascites- during admission and 90-day follow-up. Analyses were by intention to treat. this study is registered. Findings One person in each group was excluded from analyses because of incorrect diagnoses of pancreatitis; thus, 152 individuals in the probiotics group and 144 in the placebo group were analysed. Groups were much the same at baseline in terms of patients' characteristics and disease severity. Infectious complications occurred in 46 (30%) patients in the probiotics group and 41 (28%) of those in the placebo group (relative risk 1·06, 95% CI 0·75–1·51). 24 (16%) patients in the probiotics group died, compared with nine (6%) in the placebo group (relative risk 2·53, 95% CI 1·22–5·25). Nine patients in the probiotics group developed bowel ischaemia (eight with fatal outcome), compared with none in the placebo group (p=0·004). Interpretation In patients with predicted severe acute pancreatitis, probiotic prophylaxis with this combination of probiotic strains did not reduce the risk of infectious complications and was associated with an increased risk of mortality. Probiotic prophylaxis should therefore not be administered in this category of patients.

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