荷兰Utrecht大学医学中心Besselink等报告,对于预测的重症急性胰腺炎患者,预防性使用复合菌株益生菌(probiotics)并不能降低患者感染性并发症发生危险,相反会增加患者的死亡率。因此,对重症急性胰腺炎患者,应禁止使用益生菌治疗。相关论文发表于《柳叶刀》(The Lancet)上。
感染性并发症及相关死亡是急性胰腺炎的重大研究课题。肠内给予益生菌可能能预防感染性并发症发生,但一直缺少令人信服的证据。
Besselink等进行了一项多中心随机双盲安慰剂对照研究,纳入295例预测的重症急性胰腺炎患者(急性生理和慢性健康估测评分(APACHE Ⅱ)≥8、Imrie评分≥3或C反应蛋白水平>150 mg/L)。纳入者在出现症状后72小时内被随机分配接受复合菌株益生菌治疗(益生菌组,153例)或安慰剂治疗(安慰剂组,145例)。两组患者都接受肠内给药,每天2次,共治疗28天。
主要观察终点为治疗期间和治疗后90天随访期内患者发生感染性并发症的情况,包括出现感染性胰腺坏死、菌血症、肺炎、尿脓毒症或腹水感染的情况。评估预防性使用益生菌治疗预测的重症急性胰腺炎的疗效。
结果两组中各有1例患者因为误诊为胰腺炎被排除。最终,153例益生菌组患者和145例安慰剂组患者被纳入分析。两者患者基线时的一般状况和疾病的严重程度无显著差异。46例(30%)益生菌组患者出现感染性并发症,对照组为41例(28%)(相对危险为1.06)。24例(16%)益生菌组患者死亡,对照组为9例(6%)(相对危险为2.53)。9例益生菌组(16%)患者发生肠缺血,其中8例患者死亡,而对照组无患者发生(P=0.004)。
研究者指出,目前并不十分清楚为什么益生菌对重症急性胰腺炎患者有害,但推测这与补充益生菌可能增加患者胃肠道氧需求和降低胃肠道血供有关。(来源:中国医学论坛报 南樟)
生物谷推荐原始出处:
(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.