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益生菌作为标准三联疗法辅助治疗幽门螺杆菌相关消化性溃疡病的疗效:一项随机对照试验。

Efficacy of Probiotics as Adjuvant to the Standard Triple Therapy for the Treatment of Helicobacter Pylori-Associated Peptic Ulcer Disease: A Randomized-Control Trial.

机构信息

Dr Birendra Nath Saha, Associate Professor, Department of Gastroenterology, Shaheed Tajuddin Ahmad Medical College, Gazipur, Bangladesh; E-mail:

出版信息

Mymensingh Med J. 2024 Oct;33(4):1166-1171.

PMID:39351739
Abstract

Helicobacter pylori (H. pylori) is a major cause of peptic ulcer disease (PUD), which needs effective eradication of the organism to heal ulcers and prevent a recurrence. In recent years, increasing resistance of H. pylori to clarithromycin and amoxicillin have decreased peptic ulcer cure rate following treatment with standard triple therapy worldwide. The addition of probiotics with standard triple therapy has shown excellent efficacy in H. pylori eradication and has appeared to be an alternative treatment strategy. This study aimed to assess the efficacy of standard triple therapy plus probiotics for H. pylori eradication and ulcer healing compared to standard triple therapy alone. This double-blind, randomized placebo-controlled clinical trial included 158 with endoscopically proven H. pylori-positive PUD who were randomly allocated equally into two groups; Group A was treated with standard triple therapy plus probiotics, and Group B was treated with standard triple therapy plus placebo for 14 days. The outcome was evaluated at the end of treatment (14th day) (symptoms plus adverse events) and after 60 days of treatment completion (H. pylori eradication and ulcer healing). One hundred forty four (144) study subjects (73 in Group A and 71 in Group B) completed the study. Significantly higher H. pylori eradication rate (82.2%vs. 67.6%, p=0.043) and ulcer healing rate (92.3% vs. 60.0%, p=0.049) were observed in the standard triple therapy plus probiotic group than the standard triple therapy plus placebo group. Early relief of epigastric pain was also seen among patients getting probiotics than the placebo in addition to standard triple therapy (42.3% vs. 15.1%, p<0.001).The addition of probiotics significantly improves the H. pylori eradication rate and ulcer healing rate among the patients getting standard triple therapy. Further large-scale, multi-center studies are needed to recommend routine use of probiotics with standard triple therapy for H. pylori eradication.

摘要

幽门螺杆菌(H. pylori)是消化性溃疡病(PUD)的主要病因,需要有效根除该病原体以治愈溃疡并预防复发。近年来,由于全球范围内 H. pylori 对克拉霉素和阿莫西林的耐药性不断增加,标准三联疗法治疗后的消化性溃疡治愈率有所下降。在标准三联疗法中添加益生菌已显示出在 H. pylori 根除方面的优异疗效,并且似乎是一种替代治疗策略。本研究旨在评估标准三联疗法加益生菌与单独使用标准三联疗法治疗 H. pylori 根除和溃疡愈合的疗效。这是一项双盲、随机安慰剂对照临床试验,纳入了 158 例经内镜证实的 H. pylori 阳性 PUD 患者,将他们平均随机分配到两组;A 组接受标准三联疗法加益生菌治疗,B 组接受标准三联疗法加安慰剂治疗 14 天。在治疗结束时(第 14 天)(症状加不良反应)和治疗完成后 60 天(H. pylori 根除和溃疡愈合)评估结果。144 例(73 例 A 组和 71 例 B 组)研究对象完成了研究。标准三联疗法加益生菌组的 H. pylori 根除率(82.2%vs. 67.6%,p=0.043)和溃疡愈合率(92.3%vs. 60.0%,p=0.049)明显高于标准三联疗法加安慰剂组。在标准三联疗法加益生菌组中,与加安慰剂相比,患者的上腹痛早期缓解也更多(42.3%vs. 15.1%,p<0.001)。在接受标准三联疗法的患者中添加益生菌可显著提高 H. pylori 的根除率和溃疡愈合率。需要进一步开展大规模、多中心研究,以推荐常规使用标准三联疗法加益生菌治疗 H. pylori 根除。

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