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罗伊氏乳杆菌菌株组合治疗幽门螺杆菌感染:一项随机、双盲、安慰剂对照研究。

Lactobacillus reuteri strain combination in Helicobacter pylori infection: a randomized, double-blind, placebo-controlled study.

作者信息

Francavilla Ruggiero, Polimeno Lorenzo, Demichina Antonella, Maurogiovanni Giovanni, Principi Beatrice, Scaccianoce Giuseppe, Ierardi Enzo, Russo Francesco, Riezzo Giuseppe, Di Leo Alfredo, Cavallo Luciano, Francavilla Antonio, Versalovic James

机构信息

*Interdisciplinary Department of Medicine, Clinica Pediatrica "B. Trambusti" †Gastroenterology Unit, Department of Emergency and Organ Transplantation ¶Biomedical Sciences and Human Oncology (DIMO), University of Bari ‡Struttura Semplice Dipartimentale Endoscopia Digestiva Ospedale "Umberto I" Altamura ∥IRCCS "Saverio De Bellis Castellana Grotte, Bari §Gastroenterology Unit, Department Medical & Occupational Sciences, University of Foggia, Foggia, Italy #Human Genome Sequencing Center, Baylor College of Medicine, Houston, TX.

出版信息

J Clin Gastroenterol. 2014 May-Jun;48(5):407-13. doi: 10.1097/MCG.0000000000000007.

DOI:10.1097/MCG.0000000000000007
PMID:24296423
Abstract

GOALS

The goals of this study were to investigate the role of a new probiotic preparation (Lactobacillus reuteri DSM 17938 and L. reuteri ATCC PTA 6475) in Helicobacter pylori infection.

BACKGROUND

Specific probiotic strains play a role in H. pylori infection for their ability to decrease bacterial load and gastritis, prevent antibiotic-associated side effects, and increase the eradication rate.

STUDY

This is a prospective, double-blind, randomized, placebo-controlled study in a tertiary care setting. A total of 100 H. pylori-positive naive patients received either L. reuteri combination (2×10 Colony Forming Units) or placebo during a 3-phase study (pre-eradication, eradication, and follow-up). All underwent C urea breath test (C-UBT), blood assessments of gastrin-17 (G17), endoscopy, and the Gastrointestinal Symptom Rating Scale. Eradication was confirmed by C-UBT 8 weeks after the completion of therapy.

RESULTS

Fifty patients were allocated in each group. During pre-eradication period, C-UBT δ decreased by 13% in L. reuteri combination as compared with a 4% increase in placebo (-13.2±34% vs. 4.3±27%; P<0.03). During eradication, GSRS increased significantly in placebo as compared with L. reuteri combination (6.8±2.9 vs. 4±3.1; P<0.01). Significantly less patients in L. reuteri combination as compared with placebo-reported side effects (40.9% vs. 62.8%; P<0.04). An abnormal G17 value was found in patients receiving placebo as compared with L. reuteri combination (28% vs. 12%; P<0.02). Eradication rate was 75% in L. reuteri combination and 65.9% in placebo (P=NS). L. reuteri combination increased eradication rate by 9.1% (odds ratio: 1.5).

CONCLUSIONS

L. reuteri combination alone is able to exert an inhibitory effect on H. pylori growth, and when administered with eradication therapy, it determines a significant reduction in antibiotic-associated side effects. Moreover, L. reuteri combination was able to decrease serum G17 levels and to (not significantly) increase the H. pylori-eradication rate.

摘要

目的

本研究旨在探讨一种新型益生菌制剂(罗伊氏乳杆菌DSM 17938和罗伊氏乳杆菌ATCC PTA 6475)在幽门螺杆菌感染中的作用。

背景

特定的益生菌菌株因其降低细菌载量和胃炎的能力、预防抗生素相关副作用以及提高根除率的作用,在幽门螺杆菌感染中发挥作用。

研究

这是一项在三级医疗机构中进行的前瞻性、双盲、随机、安慰剂对照研究。在一项为期三个阶段(根除前、根除和随访)的研究中,共有100例幽门螺杆菌阳性初治患者接受了罗伊氏乳杆菌组合制剂(2×10菌落形成单位)或安慰剂治疗。所有患者均接受了碳-尿素呼气试验(C-UBT)、胃泌素-17(G17)血液评估、内镜检查以及胃肠道症状评分量表评估。治疗完成8周后通过C-UBT确认根除情况。

结果

每组分配50例患者。在根除前期,罗伊氏乳杆菌组合制剂组的C-UBT δ值下降了13%,而安慰剂组增加了4%(-13.2±34%对4.3±27%;P<0.03)。在根除期,与罗伊氏乳杆菌组合制剂组相比,安慰剂组的胃肠道症状评分量表得分显著增加(6.8±2.9对4±3.1;P<0.01)。与安慰剂组相比,罗伊氏乳杆菌组合制剂组报告有副作用的患者明显更少(40.9%对62.8%;P<0.04)。与罗伊氏乳杆菌组合制剂组相比,接受安慰剂治疗的患者中发现G17值异常的比例更高(28%对12%;P<0.02)。罗伊氏乳杆菌组合制剂组的根除率为75%,安慰剂组为65.9%(P=无统计学意义)。罗伊氏乳杆菌组合制剂使根除率提高了9.1%(优势比:1.5)。

结论

单独使用罗伊氏乳杆菌组合制剂能够对幽门螺杆菌生长产生抑制作用,并且与根除治疗联合使用时,它能显著降低抗生素相关副作用。此外,罗伊氏乳杆菌组合制剂能够降低血清G17水平,并(未显著)提高幽门螺杆菌根除率。

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