Hauser Goran, Salkic Nermin, Vukelic Karina, JajacKnez Alenka, Stimac Davor
From the Department of Gastroenterology, Clinical Hospital Centre, Rijeka, Rijeka, Croatia (GH, DS); Department of Gastroenterology and Hepatology, University Clinical Centre, Tuzla, Tuzla, Bosnia and Herzegovina (NS); and JGL d.d. Rijeka, Croatia (KV, AJ).
Medicine (Baltimore). 2015 May;94(17):e685. doi: 10.1097/MD.0000000000000685.
The primary objective in the study is determination of efficacy of probiotic preparation as a supportive therapy in eradication of Helicobacter pylori.The study was multicenter, prospective, randomized, placebo controlled, and double-blind. The subjects first filled out a specially designed questionnaire to assess the severity of the 10 symptoms, which can be related to eradication therapy to be monitored during the trial. Each subject then received 28 capsules of probiotic preparation or matching placebo capsules, which they were supposed to take over the following 14 days, twice a day, at least 2 hours prior to or after the antibiotic therapy administration.A total of 804 patients were enrolled in the trial, of which 650 (80.85%) were included in the analysis. The results show a significantly larger share of cured subjects in the probiotic arm versus the placebo arm (87.38% vs 72.55%; P < 0.001). Additionally, presence and intensity of epigastric pain, bloating, flatulence, taste disturbance, loss of appetite, nausea, vomiting, heartburn, rash, and diarrhea were monitored over the study period. At 15 days postinclusion, probiotic treatment was found superior to placebo in 7 of 10 mentioned symptoms. Average intensity for symptoms potentially related to antibiotic therapy was significantly higher in the placebo group, 0.76 vs 0.55 (P < 0.001).Adding probiotics to the standard triple therapy for H pylori eradication significantly contributes to treatment efficacy and distinctly decreases the adverse effects of therapy and the symptoms of the underlying disease.
该研究的主要目的是确定益生菌制剂作为根除幽门螺杆菌辅助治疗的疗效。该研究为多中心、前瞻性、随机、安慰剂对照和双盲研究。受试者首先填写一份专门设计的问卷，以评估10种症状的严重程度，这些症状可能与试验期间要监测的根除治疗有关。然后，每位受试者接受28粒益生菌制剂胶囊或匹配的安慰剂胶囊，他们应在接下来的14天内每天服用两次，在抗生素治疗给药前或后至少2小时服用。共有804名患者参加了试验，其中650名（80.85%）纳入分析。结果显示，益生菌组治愈的受试者比例明显高于安慰剂组（87.38%对72.55%；P<0.001）。此外，在研究期间监测上腹部疼痛、腹胀、肠胃胀气、味觉障碍、食欲不振、恶心、呕吐、烧心、皮疹和腹泻的出现情况及强度。纳入后15天，在上述10种症状中的7种症状方面，发现益生菌治疗优于安慰剂。安慰剂组中与抗生素治疗潜在相关症状的平均强度明显更高，为0.76对0.55（P<0.001）。在标准三联疗法中添加益生菌进行幽门螺杆菌根除，可显著提高治疗效果，并明显降低治疗的不良反应和基础疾病的症状。
