Noorbakhsh Nafeh, Nikpour Shahriar, Salehi Mohammad
Department of Internal Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Gastroenterol Hepatol Bed Bench. 2022 Spring;15(2):146-152.
In this clinical trial we use furazolidone-bismuth quadruple therapy with or without probiotics for eradication.
Increasing rates of eradication failure in infection mainly due to antibiotic resistance has led to search for alternative regimens such as using novel antibiotics and/or using probiotic supplementation as conjunctive to the standard eradication regimens.
This double blind clinical trial was performed in gastrointestinal clinic of Loghman Hakim University Hospital, Tehran, Iran. Patients with a positive pathology test for were enrolled to the study and received a 14 day course of furazolidone 100 mg q.i.d, bismuth 240 mg b.i.d, amoxicillin 1000 mg b.i.d, pantoprazole 40 mg b.i.d plus either probiotic (Familact) b.i.d or placebo b.i.d. Adverse effects and adherence to therapy were evaluated at the end of the treatment course. Eradication was established by fecal antigen test.
A total of 200 patients entered the study and were randomly assigned to two groups of placebo and probiotic. There was no significant difference regarding age or gender between placebo and probiotic groups. Adherence to therapy was higher than 90% in total and not significantly different between placebo and probiotic groups. Total eradication rate was 80.5% (n=161). Eradication rate was 84% in probiotic group vs 77% in placebo group (P=0.2). Total rate of adverse effects was 30% in probiotic group vs 62% in placebo group. The most common adverse effects were abdominal pain (15% in probiotic group vs 28% in placebo group, P=0.03) followed by diarrhea (5% in probiotic group vs 12% in placebo group, P=0.1).
According to our results, adding probiotic to furazolidone-bismuth quadruple therapy did no increase the eradication rate significantly. However, adverse effects particularly abdominal pain was lower in the probiotic group when compared with placebo.
在本临床试验中，我们使用含或不含益生菌的呋喃唑酮 - 铋四联疗法进行根除治疗。
主要由于抗生素耐药性导致的感染根除失败率不断上升，促使人们寻找替代方案，如使用新型抗生素和/或在标准根除方案中联合使用益生菌补充剂。
本双盲临床试验在伊朗德黑兰洛格曼·哈基姆大学医院胃肠科进行。病理检查确诊为[某种疾病]阳性的患者纳入研究，接受为期14天的治疗，服用呋喃唑酮100毫克每日4次、铋240毫克每日2次、阿莫西林1000毫克每日2次、泮托拉唑40毫克每日2次，外加益生菌（法米拉克）每日2次或安慰剂每日2次。在治疗疗程结束时评估不良反应和治疗依从性。通过粪便抗原检测确定根除情况。
共有200名患者进入研究并被随机分为安慰剂组和益生菌组。安慰剂组和益生菌组在年龄或性别方面无显著差异。总体治疗依从性高于90%，安慰剂组和益生菌组之间无显著差异。总根除率为80.5%（n = 161）。益生菌组的根除率为84%，安慰剂组为77%（P = 0.2）。益生菌组的不良反应总发生率为30%，安慰剂组为62%。最常见的不良反应是腹痛（益生菌组为15%，安慰剂组为28%，P = 0.03），其次是腹泻（益生菌组为5%，安慰剂组为12%，P = 0.1）。
根据我们的结果，在呋喃唑酮 - 铋四联疗法中添加益生菌并未显著提高根除率。然而，与安慰剂组相比，益生菌组的不良反应尤其是腹痛较少。
