de Bortoli Nicola, Leonardi Giulia, Ciancia Eugenio, Merlo Andrea, Bellini Massimo, Costa Francesco, Mumolo Maria Gloria, Ricchiuti Angelo, Cristiani Fabrizio, Santi Stefano, Rossi Mauro, Marchi Santino
Department of Medical and Surgical Gastroenterology, University of Pisa, Pisa, Italy.
Am J Gastroenterol. 2007 May;102(5):951-6. doi: 10.1111/j.1572-0241.2007.01085.x. Epub 2007 Feb 21.
Helicobacter pylori is causally associated with gastritis and peptic ulcer diseases. Recent data (meta-analysis) have demonstrated that triple therapy with amoxicillin, clarithromycin, and a proton pump inhibitor has an eradication rate of only 74-76% and new therapeutic protocols may be necessary. The aim of this study was to examine whether adding bovine lactoferrin (bLf) and probiotics (Pbs) to the standard triple therapy for H. pylori infection could improve the eradication rate and reduce side effects.
H. pylori infection was diagnosed in 206 patients: in 107 based on an upper endoscopy exam and a rapid urease test, and in 99 by means of the H. pylori stool antigen-test and the C(13) urea breath test (C(13) UBT). The patients were randomized into two groups: 101 patients (group A) underwent standard triple eradication therapy (esomeprazole, clarithromycin, amoxicillin), while 105 patients (group B) underwent a modified eradication therapy (standard triple eradication therapy plus bLf and Pb). Successful eradication therapy was defined as a negative C(13) UBT 8 wk after completion of the treatment. Results were evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis. Data were evaluated and considered positive when P<0.05.
At the end of the study 175/206 patients showed negative C(13) UBT results. According to intention-to-treat analysis, the infection was eradicated in 73/101 patients from Group A and in 93/105 from Group B. PP analysis showed 73/96 patients from Group A and 93/101 from Group B to have been successfully treated. More patients from group A than from group B reported side effects from their treatment (P<0.05).
The results of our study suggest that the addition of bLf and Pbs could improve the standard eradication therapy for H. pylori infection--bLf serving to increase the eradication rate and Pbs to reduce the side effects of antibiotic therapy.
幽门螺杆菌与胃炎和消化性溃疡病存在因果关联。近期数据（荟萃分析）表明，阿莫西林、克拉霉素和质子泵抑制剂的三联疗法根除率仅为74 - 76%，可能需要新的治疗方案。本研究的目的是检验在幽门螺杆菌感染的标准三联疗法中添加牛乳铁蛋白（bLf）和益生菌（Pbs）是否能提高根除率并减少副作用。
206例患者被诊断为幽门螺杆菌感染：107例通过上消化道内镜检查和快速尿素酶试验确诊，99例通过幽门螺杆菌粪便抗原检测和C（13）尿素呼气试验（C（13）UBT）确诊。患者被随机分为两组：101例患者（A组）接受标准三联根除疗法（埃索美拉唑、克拉霉素、阿莫西林），而105例患者（B组）接受改良根除疗法（标准三联根除疗法加bLf和Pbs）。成功的根除疗法定义为治疗完成8周后C（13）UBT结果为阴性。结果通过意向性分析（ITT）和符合方案分析（PP）进行评估。当P<0.05时，数据被评估并视为阳性。
研究结束时，175/206例患者C（13）UBT结果为阴性。根据意向性分析，A组101例患者中有73例感染被根除，B组105例患者中有93例感染被根除。PP分析显示，A组96例患者中有73例、B组101例患者中有93例得到成功治疗。A组报告治疗副作用的患者比B组多（P<0.05）。
我们的研究结果表明，添加bLf和Pbs可改善幽门螺杆菌感染的标准根除疗法——bLf有助于提高根除率，Pbs有助于减少抗生素治疗的副作用。
