[利福昔明联合博氏酵母CNCM I-745治疗长期使用质子泵抑制剂相关小肠细菌过度生长的疗效研究]。

IF 0.3 4区医学 Q3 MEDICINE, GENERAL & INTERNAL

Terapevticheskii Arkhiv Pub Date : 2025-08-28 DOI:10.26442/00403660.2025.08.203301

I V Maev, D N Andreev, R I Shaburov, A V Zaborovsky, A K Fomenko, P S Sokolov, S V Tsaregorodtsev, M K Devkota, D T Dicheva, S V Cheremushkin, N V Cheremushkinа, A V Vychkin

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引用次数: 0

摘要

目的：评价利福昔明联合博氏酵母CNCM I-745与利福昔明单药治疗长期使用质子泵抑制剂（PPI）相关小肠细菌过度生长（SIBO）患者的疗效。材料与方法：前瞻性比较研究，两组平行。符合条件的患者是那些持续接受长期PPI治疗（bbb - 3个月）并确认SIBO的患者。所有患者均通过乳果糖氢/甲烷呼吸试验（HMBT）诊断SIBO。采用有效的“7 × 7”问卷评估症状严重程度，采用SF-36健康状况调查评估生活质量（QoL）。纳入的患者根据7天的治疗方案随机分为两组：1组接受利福昔明（400 mg，每日2次）；2组给予利福昔明（400 mg，每日2次）加益生菌博氏酵母菌CNCM I-745 （Enterol®药品，Biocodex，法国；500 mg，每日2次）。通过重复乳果糖HMBT确认SIBO根除，并在治疗结束后4周重新评估症状严重程度/生活质量。结果：108例患者入组，平均年龄38.7±8.9岁，女性65.7%。入组时PPI治疗的平均持续时间为4.81个月（95%可信区间4.15-5.46）。在4周的随访中，重复乳果糖HMBT显示41.5%的组1 （n = 22/53）和21.8%的组2 (n = 12/55; p = 0.038) SIBO持续性。只有第2组腹泻缓解有统计学意义（p = 0.033）。第2组最终“7 × 7”问卷得分中位数显著低于第2组（p = 0.0010）。两组在SF-36调查中均表现出明显的生活质量改善趋势。结论：这项前瞻性比较研究表明，在ppi相关SIBO患者中，利福昔明和博氏酵母CNCM I-745联合治疗在SIBO根除、症状消退和生活质量改善方面比利福昔明单药治疗更有效。

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[Study on the efficacy of combination therapy with rifaximin and Saccharomyces boulardii CNCM I-745 in patients with small intestinal bacterial overgrowth associated with long-term use of proton pump inhibitors].

Aim: To evaluate the efficacy of combination therapy with rifaximin and Saccharomyces boulardii CNCM I-745 versus rifaximin monotherapy in patients with small intestinal bacterial overgrowth (SIBO) associated with long-term proton pump inhibitor (PPI) use.

Materials and methods: A prospective comparative study with two parallel groups was conducted. Eligible patients were those on continuous long-term PPI therapy (> 3 months) with confirmed SIBO. SIBO was diagnosed in all patients using a lactulose Hydrogen/Methane Breath Test (HMBT). Symptom severity was assessed using the validated "7 × 7" Questionnaire, and Quality of Life (QoL) was evaluated using the SF-36 Health Status Survey. Enrolled patients were randomized into two groups based on a 7-day treatment regimen: Group 1 received rifaximin (400 mg twice daily); Group 2 received rifaximin (400 mg twice daily) plus the probiotic Saccharomyces boulardii CNCM I-745 (Enterol® drug product, Biocodex, France; 500 mg twice daily). SIBO eradication was confirmed via repeat lactulose HMBT, and symptom severity/QoL were reassessed 4 weeks after treatment completion.

Results: 108 patients were enrolled (mean age 38.7 ± 8.9 years; 65.7% female). Mean PPI treatment duration at enrollment was 4.81 months (95% confidence interval 4.15-5.46). At 4-week follow-up, repeat lactulose HMBT showed SIBO persistence in 41.5% of Group 1 (n = 22/53) versus 21.8% in Group 2 (n = 12/55; p = 0.038). Statistically significant resolution of diarrhea was observed only in Group 2 (p = 0.033). The final median "7 × 7" Questionnaire score was significantly lower in Group 2 (p = 0.0010). Both groups showed significant trends toward QoL improvement on the SF-36 survey.

Conclusion: This prospective comparative study demonstrates that combination therapy with rifaximin and Saccharomyces boulardii CNCM I-745 appears more effective than rifaximin monotherapy for SIBO eradication, symptom regression, and QoL improvement in patients with PPI-associated SIBO.

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来源期刊

Terapevticheskii Arkhiv 医学-医学：内科

CiteScore

1.40

自引率

33.30%

发文量

171

审稿时长

3-8 weeks

期刊介绍： Терапевтический архив The journal was founded by the prominent Russian therapists M.P. Konchalovsky and G.F. Lang in 1923. Then its editors-in-chief were Professors V.N. Vinogradov and A.G. Gukasyan. Since 1972, E.I. Chazov, Academician of the Russian Academy of Sciences, has been heading the editorial board of the journal. Over 90 years, there have been more than 1000 issues where the authors and editorial staff have done their best for readers to keep abreast of current advances in medical science and practice and for physicians to master the advanced principles of recognition and treatment of a wide spectrum of visceral diseases. The papers published in the journal (editorials, original articles, lectures, reviews, etc.) cover both current scientific achievements and practical experience in diagnosing, treating, and preventing visceral diseases. The authors of publications are not only Russian, but also foreign scientists and physicians. All papers are peer-reviewed by highly qualified Russian specialists. The journal is published monthly. Traditionally, each issue has predominantly certain thematic areas covering individual therapy specializations. Every year, one of the issues is devoted to related problems in practical medicine (allergology and immunology, neurology and psychiatry, obstetrics, oncology, etc.). This all draws the attention of the reading public to the journal. The journal is indexed in RSCI (Russian Science Citation Index), PubMed/Medline, Index Medicus, Scopus/EMBASE, Web of Science Core Collection (Science Citation Index Expanded), Web of Science (Russian Science Citation Index - RSCI, Current Contents Connect, BIOSIS Previews), Google Scholar, Ulrich''s Periodicals Directory. The journal is included in the list of periodicals recommended by the Higher Attestation Committee for publishing the papers containing the basic materials of doctoral and candidate dissertations. By the decision of the Presidium of the Russian Academy of Medical Sciences, the “Therapevticheskiy Arkhiv” was awarded the Botkin medal. It was admitted to the European Association of Sciences Editors (EASE). The journal was honored with the Golden Press Fund decoration at the 13th International Press Professional Exhibition.