Çekin Ayhan Hilmi, Şahintürk Yasin, Akbay Harmandar Ferda, Uyar Seyit, Yolcular Başak Oğuz, Çekin Yeşim
Department of Gastroenterology, University of Health Sciences Antalya Training and Research Hospital, Antalya, Turkey.
Turk J Gastroenterol. 2017 Jan;28(1):3-11. doi: 10.5152/tjg.2016.0278. Epub 2016 Dec 23.
BACKGROUND/AIMS: To evaluate the effect of probiotics administered as an adjuvant to sequential Helicobacter pylori (H. pylori) eradication therapy on treatment outcome and patient compliance.
In total, 159 patients with H. pylori infection receiving sequential H. pylori eradication therapy were included in this randomized placebo-controlled study. Starting from day 0 of sequential eradication therapy (ERA), patients in the ERA+probiotic group [n=53, mean (SD) age: 47.7 (14.0) years, 54.7% were females] also received a probiotic supplement with Bifidobacterium animalis subsp. lactis B94 (1 capsule/day), patients in the ERA+placebo group [n=52, mean (SD) age: 46.4 (13.4) years, 51.9% were males] received placebo treatment (1 capsule/day), and patients in the ERA-only group [n=54, mean (SD) age: 46.3 (11.9) years, 55.6% were females] received no additional treatments. Eradication rates, patient compliance, and side effects of eradication therapy were recorded in each treatment group.
Significantly higher eradication rates were noted in the ERA+probiotic group (86.8% vs. 70.8%, p=0.025) than in the combined ERA (ERA-only and ERA-placebo) group. Non-compliance with anti-H. pylori treatment was noted in 24 (15.1%) of 159 patients. Lower rates of first week treatment non-compliance due to diarrhea (1.88% vs. 12.26%, p=0.036) were noted in the ERA+probiotic group than in the combined ERA (ERA-only and ERA-placebo) group. Treatment resistance (p: 0.389) was similar between the groups, indicating pure antibiotic resistance without any compliance problems. The number needed to treat for an additional beneficial outcome (NNTB) was 6.2 (CI 95%, 3.5 to 28.9) for probiotic use.
In conclusion, adjuvant administration of probiotic (B. animalis subsp. lactis) in 2-week sequential H. pylori eradication therapy is associated with a higher H. pylori eradication rate, lower first week diarrhea-related treatment discontinuation rates, less common self-reported side effects, and higher treatment compliance.
背景/目的:评估益生菌作为幽门螺杆菌(H. pylori)序贯根除治疗辅助药物对治疗效果和患者依从性的影响。
本随机安慰剂对照研究共纳入159例接受H. pylori序贯根除治疗的H. pylori感染患者。从序贯根除治疗(ERA)第0天开始,ERA+益生菌组[n = 53,平均(标准差)年龄:47.7(14.0)岁,54.7%为女性]患者还接受动物双歧杆菌乳亚种B94益生菌补充剂(1粒/天),ERA+安慰剂组[n = 52,平均(标准差)年龄:46.4(13.4)岁,51.9%为男性]患者接受安慰剂治疗(1粒/天),单纯ERA组[n = 54,平均(标准差)年龄:46.3(11.9)岁,55.6%为女性]患者不接受额外治疗。记录各治疗组的根除率、患者依从性和根除治疗的副作用。
ERA+益生菌组的根除率(86.8%对70.8%,p = 0.025)显著高于联合ERA组(单纯ERA组和ERA+安慰剂组)。159例患者中有24例(15.1%)未遵从不规则抗幽门螺杆菌治疗。ERA+益生菌组因腹泻导致的第一周治疗不依从率(1.88%对12.26%,p = 0.036)低于联合ERA组(单纯ERA组和ERA+安慰剂组)。各治疗组间的治疗耐药性(p:0.389)相似,表明为单纯抗生素耐药,不存在任何依从性问题。使用益生菌获得额外有益结果的治疗所需人数(NNTB)为6.2(95%CI,3.5至28.9)。
总之,在为期2周的H. pylori序贯根除治疗中辅助使用益生菌(动物双歧杆菌乳亚种)可提高H. pylori根除率,降低第一周因腹泻导致的治疗中断率,减少自我报告的副作用,提高治疗依从性。