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副干酪乳杆菌F19与安慰剂预防质子泵抑制剂引起的肠道症状的随机临床试验

Lactobacillus paracasei F19 versus placebo for the prevention of proton pump inhibitor-induced bowel symptoms: a randomized clinical trial.

作者信息

Compare Debora, Rocco Alba, Sgamato Costantino, Coccoli Pietro, Campo Salvatore Maria Antonio, Nazionale Immacolata, Larussa Tiziana, Luzza Francesco, Chiodini Paolo, Nardone Gerardo

机构信息

Department of Clinical Medicine and Surgery, Gastroenterology Unit, University Federico II, Naples, Italy.

Gastroenterology Unit, Nuovo Regina Margherita Hospital, Rome, Italy.

出版信息

Dig Liver Dis. 2015 Apr;47(4):273-9. doi: 10.1016/j.dld.2015.01.004. Epub 2015 Jan 19.

DOI:10.1016/j.dld.2015.01.004
PMID:25660822
Abstract

BACKGROUND

Proton pump inhibitors may foster intestinal dysbiosis and related bowel symptoms.

AIM

To evaluate the effect of Lactobacillus paracasei F19 on bowel symptom onset in patients on long-term proton pump inhibitors.

METHODS

In this randomized, double-blind, placebo-controlled study, patients with typical gastroesophageal reflux disease symptoms receiving pantoprazole 40 mg/d for six months were randomly assigned to receive: (A) Lactobacillus paracasei F19 bid for three days/week for six months; (B) placebo bid for three days/week for six months; (C) Lactobacillus paracasei F19 bid for three days/week for three months and placebo bid for three days/week for the following three months; (D) placebo bid for three days/week for three months and Lactobacillus paracasei F19 bid for three days/week for the following three months. Bloating, flatulence, abdominal pain and bowel habit were assessed monthly.

RESULTS

100/312 patients were enrolled. In the parallel groups, the treatment-by-time interaction affected bloating (p = 0.015), while Lactobacillus paracasei F19 treatment alone affected flatulence (p = 0.011). Moreover, the treatment-by-time interaction significantly affected the mean score of bloating (p = 0.01) and flatulence (p < 0.0001), the mean stool form (p = 0.03) and mean stool frequency/week (p = 0.016). Analysis of the cross-over groups, limited to the first three months because of carry-over effect, confirmed these results.

CONCLUSION

Lactobacillus paracasei F19 supplementation prevents bowel symptom onset in patients on long-term proton pump inhibitors.

摘要

背景

质子泵抑制剂可能会促进肠道菌群失调及相关肠道症状。

目的

评估副干酪乳杆菌F19对长期服用质子泵抑制剂患者肠道症状发生的影响。

方法

在这项随机、双盲、安慰剂对照研究中,将接受泮托拉唑40mg/d治疗6个月的典型胃食管反流病症状患者随机分配接受:(A)副干酪乳杆菌F19,每周3天,每天2次,共6个月;(B)安慰剂,每周3天,每天2次,共6个月;(C)副干酪乳杆菌F19,每周3天,每天2次,共3个月,接下来3个月接受安慰剂,每周3天,每天2次;(D)安慰剂,每周3天,每天2次,共3个月,接下来3个月接受副干酪乳杆菌F19,每周3天,每天2次。每月评估腹胀、肠胃气胀、腹痛和排便习惯。

结果

纳入312例患者中的100例。在平行组中,治疗与时间的交互作用影响腹胀(p = 0.015),而单独使用副干酪乳杆菌F19治疗影响肠胃气胀(p = 0.011)。此外,治疗与时间的交互作用显著影响腹胀平均分(p = 0.01)和肠胃气胀平均分(p < 0.0001)、平均大便形态(p = 0.03)和每周平均排便频率(p = 0.016)。由于存在残留效应,仅对前三个月的交叉组进行分析,证实了这些结果。

结论

补充副干酪乳杆菌F19可预防长期服用质子泵抑制剂患者肠道症状的发生。

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