荷蘭Utrecht大學(xué)醫(yī)學(xué)中心Besselink等報(bào)告,,對(duì)于預(yù)測(cè)的重癥急性胰腺炎患者,,預(yù)防性使用復(fù)合菌株益生菌(probiotics)并不能降低患者感染性并發(fā)癥發(fā)生危險(xiǎn),相反會(huì)增加患者的死亡率,。因此,,對(duì)重癥急性胰腺炎患者,應(yīng)禁止使用益生菌治療。相關(guān)論文發(fā)表于《柳葉刀》(The Lancet)上,。
感染性并發(fā)癥及相關(guān)死亡是急性胰腺炎的重大研究課題,。腸內(nèi)給予益生菌可能能預(yù)防感染性并發(fā)癥發(fā)生,但一直缺少令人信服的證據(jù),。
Besselink等進(jìn)行了一項(xiàng)多中心隨機(jī)雙盲安慰劑對(duì)照研究,,納入295例預(yù)測(cè)的重癥急性胰腺炎患者(急性生理和慢性健康估測(cè)評(píng)分(APACHE Ⅱ)≥8、Imrie評(píng)分≥3或C反應(yīng)蛋白水平>150 mg/L),。納入者在出現(xiàn)癥狀后72小時(shí)內(nèi)被隨機(jī)分配接受復(fù)合菌株益生菌治療(益生菌組,,153例)或安慰劑治療(安慰劑組,145例),。兩組患者都接受腸內(nèi)給藥,,每天2次,共治療28天,。
主要觀察終點(diǎn)為治療期間和治療后90天隨訪期內(nèi)患者發(fā)生感染性并發(fā)癥的情況,,包括出現(xiàn)感染性胰腺壞死、菌血癥,、肺炎,、尿膿毒癥或腹水感染的情況。評(píng)估預(yù)防性使用益生菌治療預(yù)測(cè)的重癥急性胰腺炎的療效,。
結(jié)果兩組中各有1例患者因?yàn)檎`診為胰腺炎被排除,。最終,153例益生菌組患者和145例安慰劑組患者被納入分析,。兩者患者基線時(shí)的一般狀況和疾病的嚴(yán)重程度無(wú)顯著差異,。46例(30%)益生菌組患者出現(xiàn)感染性并發(fā)癥,對(duì)照組為41例(28%)(相對(duì)危險(xiǎn)為1.06),。24例(16%)益生菌組患者死亡,,對(duì)照組為9例(6%)(相對(duì)危險(xiǎn)為2.53)。9例益生菌組(16%)患者發(fā)生腸缺血,,其中8例患者死亡,,而對(duì)照組無(wú)患者發(fā)生(P=0.004)。
研究者指出,,目前并不十分清楚為什么益生菌對(duì)重癥急性胰腺炎患者有害,,但推測(cè)這與補(bǔ)充益生菌可能增加患者胃腸道氧需求和降低胃腸道血供有關(guān)。(來(lái)源:中國(guó)醫(yī)學(xué)論壇報(bào) 南樟)
生物谷推薦原始出處:
(The Lancet),,2008,; 371:651-659,Marc GH Besselink,,Hein G Gooszen
Probiotic prophylaxis in predicted severe acute pancreatitis: a randomised,, double-blind,, placebo-controlled trial
Marc GH Besselink MD , Hjalmar C van Santvoort MD ,, Erik Buskens MD ,, Marja A Boermeester MD , Harry van Goor MD ,, Harro M Timmerman PhD ,, Vincent B Nieuwenhuijs MD , Thomas L Bollen MD ,, Bert van Ramshorst MD ,, Ben JM Witteman MD , Camiel Rosman MD ,, Prof Rutger J Ploeg MD ,, Menno A Brink MD , Alexander FM Schaapherder MD ,, Cornelis HC Dejong MD ,, Peter J Wahab MD , Cees JHM van Laarhoven MD ,, Erwin van der Harst MD ,, Casper HJ van Eijck MD ,,
Summary
Background
Infectious complications and associated mortality are a major concern in acute pancreatitis. Enteral administration of probiotics could prevent infectious complications,, but convincing evidence is scarce. Our aim 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 >150 mg/L) were randomly assigned within 72 h of onset of symptoms to receive a multispecies 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 pancreatic necrosis,, bacteraemia,, pneumonia, urosepsis,, or infected ascites—during admission and 90-day follow-up. Analyses were by intention to treat. This study is registered,, number ISRCTN38327949.
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.