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26:Lancet.2008Feb23;371(9613):651-9.Epub2008Feb14.RelatedArticles,LinksProbioticproph...
26: Lancet. 2008 Feb 23;371(9613):651-9. Epub 2008 Feb 14.
Related Articles, Links
Probiotic prophylaxis in predicted severe acute pancreatitis: a randomised, double-blind, placebo-controlled trial.
Besselink MG, van Santvoort HC, Buskens E, Boermeester MA, van Goor H, Timmerman HM, Nieuwenhuijs VB, Bollen TL, van Ramshorst B, Witteman BJ, Rosman C, Ploeg RJ, Brink MA, Schaapherder AF, Dejong CH, Wahab PJ, van Laarhoven CJ, van der Harst E, van Eijck CH, Cuesta MA, Akkermans LM, Gooszen HG; Dutch Acute Pancreatitis Study Group.
Department of Surgery, University Medical Center Utrecht, Utrecht, Netherlands.
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 > or =8, Imrie score > or =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.
Publication Types:
• Research Support, Non-U.S. Gov't
PMID: 18279948 [PubMed - in process] 展开
Related Articles, Links
Probiotic prophylaxis in predicted severe acute pancreatitis: a randomised, double-blind, placebo-controlled trial.
Besselink MG, van Santvoort HC, Buskens E, Boermeester MA, van Goor H, Timmerman HM, Nieuwenhuijs VB, Bollen TL, van Ramshorst B, Witteman BJ, Rosman C, Ploeg RJ, Brink MA, Schaapherder AF, Dejong CH, Wahab PJ, van Laarhoven CJ, van der Harst E, van Eijck CH, Cuesta MA, Akkermans LM, Gooszen HG; Dutch Acute Pancreatitis Study Group.
Department of Surgery, University Medical Center Utrecht, Utrecht, Netherlands.
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 > or =8, Imrie score > or =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.
Publication Types:
• Research Support, Non-U.S. Gov't
PMID: 18279948 [PubMed - in process] 展开
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26 ：柳叶刀。 2008年2月23日; 371 （ 9613 ） :651 - 9 。 Epub 2008年2月14日。
相关文章，链接
益生菌预防在预测重症急性胰腺炎：一项随机，双盲，安慰剂对照试验。
Besselink镁，范Santvoort慧聪， Buskens英， Boermeester马，范古尔小时， Timmerman陛下， Nieuwenhuijs VB中，博伦的TL ，范瓦Ramshorst乙， Witteman北京，罗斯曼ć ， Ploeg雷诺，布林克马， Schaapherder自动对焦， Dejong甲烷，瓦哈卜PJ ，范Laarhoven希杰范德尔Harst英，范Eijck甲烷，奎斯塔马， Akkermans长征， Gooszen汞;荷兰急性胰腺炎的研究小组。
部手术，乌得勒支大学医疗中心，乌得勒支，荷兰。
背景：感染性并发症和死亡率是一个主要关注的急性胰腺炎。肠道益生菌管理可以防止感染性并发症，但有说服力的证据很少。我们的目的是评估影响益生素预防患者的预测重症急性胰腺炎。方法：本多随机，双盲，安慰剂对照试验， 298例预测重症急性胰腺炎（急性生理和慢性健康评价[健康状况评分二]评分“或= 8 ， Imrie评分”或= 3或C -反应蛋白“ 150毫克/升） ，随机分配的72小时内出现症状，以获得多种群益生菌准备（ 153例）或安慰剂（ n = 145 ） ，管理enterally每天两次为28天。主要终点是复合感染并发症-即受感染的胰腺坏死，血症，肺炎， urosepsis ，或感染性腹水-住院期间和90天的后续行动。分析了意向治疗。这项研究是登记，编号ISRCTN38327949 。结论：人中就有一人被排除各组的分析，因为不正确的诊断胰腺炎;因此， 152个人在益生菌组和144安慰剂组进行了分析。集团同样在基准在病人的特点和疾病严重程度。感染性并发症发生在46 （ 30 ％ ）患者在益生菌组和41个（ 28 ％ ）的人，安慰剂组（相对危险度1.06 ， 95 ％ CI为0.75-1.51 ） 。 24 （ 16 ％ ）患者死亡益生菌组相比，有9个（ 6 ％ ）安慰剂组（相对危险度2.53 ， 95 ％ CI为1月22号至5月25号） 。 9例在肠道益生菌组制定缺血（ 8人死亡的结果） ，而没有在安慰剂组（ P = 0.004 ） 。解释：在患者的预测重症急性胰腺炎，益生菌预防与此相结合的益生菌菌株并不降低感染性并发症和与其有关的风险增加死亡率。益生菌预防，因此，不应加以管理这一类的病人。
出版物类型：
•研究支援，非美。官立
PMID ： 18279948 [ PubMed的-过程中]
相关文章，链接
益生菌预防在预测重症急性胰腺炎：一项随机，双盲，安慰剂对照试验。
Besselink镁，范Santvoort慧聪， Buskens英， Boermeester马，范古尔小时， Timmerman陛下， Nieuwenhuijs VB中，博伦的TL ，范瓦Ramshorst乙， Witteman北京，罗斯曼ć ， Ploeg雷诺，布林克马， Schaapherder自动对焦， Dejong甲烷，瓦哈卜PJ ，范Laarhoven希杰范德尔Harst英，范Eijck甲烷，奎斯塔马， Akkermans长征， Gooszen汞;荷兰急性胰腺炎的研究小组。
部手术，乌得勒支大学医疗中心，乌得勒支，荷兰。
背景：感染性并发症和死亡率是一个主要关注的急性胰腺炎。肠道益生菌管理可以防止感染性并发症，但有说服力的证据很少。我们的目的是评估影响益生素预防患者的预测重症急性胰腺炎。方法：本多随机，双盲，安慰剂对照试验， 298例预测重症急性胰腺炎（急性生理和慢性健康评价[健康状况评分二]评分“或= 8 ， Imrie评分”或= 3或C -反应蛋白“ 150毫克/升） ，随机分配的72小时内出现症状，以获得多种群益生菌准备（ 153例）或安慰剂（ n = 145 ） ，管理enterally每天两次为28天。主要终点是复合感染并发症-即受感染的胰腺坏死，血症，肺炎， urosepsis ，或感染性腹水-住院期间和90天的后续行动。分析了意向治疗。这项研究是登记，编号ISRCTN38327949 。结论：人中就有一人被排除各组的分析，因为不正确的诊断胰腺炎;因此， 152个人在益生菌组和144安慰剂组进行了分析。集团同样在基准在病人的特点和疾病严重程度。感染性并发症发生在46 （ 30 ％ ）患者在益生菌组和41个（ 28 ％ ）的人，安慰剂组（相对危险度1.06 ， 95 ％ CI为0.75-1.51 ） 。 24 （ 16 ％ ）患者死亡益生菌组相比，有9个（ 6 ％ ）安慰剂组（相对危险度2.53 ， 95 ％ CI为1月22号至5月25号） 。 9例在肠道益生菌组制定缺血（ 8人死亡的结果） ，而没有在安慰剂组（ P = 0.004 ） 。解释：在患者的预测重症急性胰腺炎，益生菌预防与此相结合的益生菌菌株并不降低感染性并发症和与其有关的风险增加死亡率。益生菌预防，因此，不应加以管理这一类的病人。
出版物类型：
•研究支援，非美。官立
PMID ： 18279948 [ PubMed的-过程中]
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