Treatment of helicobacter pylori infection using a novel antiadhesion compound (3′sialyllactose sodium salt).: A double blind, placebo-controlled clinical
Treatment of helicobacter pylori infection using a novel antiadhesion compound (3′sialyllactose sodium salt).: A double blind, placebo-controlled clinical
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DOI：
10.1046/j.1523-5378.2003.00152.x
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发表时间：
2003-08-01
期刊：
影响因子：
4.4
通讯作者：
Porro, GB
中科院分区：
文献类型：
--
作者：
Parente, F;Cucino, C;Porro, GB
背景和目标。3'唾液酸乳糖钠盐（3' SL）是人乳和牛乳中天然存在的低聚糖。能抑制H. pylori对人上皮细胞的作用。本研究的目的是测试这种寡糖是否可以抑制或治愈H。幽门螺杆菌定植在体内，并确定其在人类中的安全性。71例连续的消化不良患者H。幽门螺杆菌感染记录的组织学和C-13-尿素呼气试验（UBT）最初招募到这项研究。UBT值< 15的患者被排除在外，从而将入组人数减少至65名患者。根据一项随机双盲方案，他们在饭前或安慰剂中每天三次给予两种不同剂量的3 'SL（10 g或20 g /天），持续4周。在治疗期间（第1、2和4周结束时）和停药后4周，在所有患者中以固定间隔重复标准化C-13-UBT（使用100 mg C-13标记尿素）。每周随访一次，评价患者依从性和不良反应。5例患者因违反方案（不依从、失访）而从PP分析中排除，而61例患者正确完成了研究：17例接受3 'SL 10 g/天治疗，22例接受3' SL 20 g/天治疗，21例接受安慰剂治疗。三个治疗组在人口统计学或临床患者特征方面没有显著差异。三组治疗期间均未观察到严重不良事件。在治疗期间或治疗后没有患者变为UBT阴性（< 4），但在研究期间，治疗组和安慰剂组的UBT值均显著降低。抗粘连治疗安全且耐受性良好，但不能抑制或治愈H。幽门螺杆菌在人体内的定植。观察到的UBT值降低可以通过向平均效应回归来解释。
Background and Aim. 3' sialyllactose sodium salt (3'SL) is an oligosaccharide that occurs naturally in human and bovine milk. It can inhibit the adhesion of H. pylori to human epithelial cells in vitro. The aim of this study was to test whether this oligosaccharide can suppress or cure H. pylori colonization in vivo and to determine its safety in humans.Methods. Seventy-one consecutive dyspeptic patients with H. pylori infection documented by histology and C-13-Urea Breath Test (UBT) were initially recruited to this study. Patients with UBT values < 15 were excluded, thus reducing the enrolment to 65 patients. They were given two different dosages of 3'SL (10 g or 20 g /day) in three daily administrations before meals or placebo for 4 weeks, according to a randomised double-blind protocol. A standardized C-13-UBT (using 100 mg of C-13 labelled urea) was repeated in all patients at fixed intervals during treatment (at the end of weeks 1, 2 and 4) and 4 weeks after treatment withdrawal. Patients compliance and side-effects were evaluated at each weekly visit.Results. Five patients were excluded from the PP analysis due to violation of the protocol (noncompliance, lost to follow-up), whereas 61 patients completed correctly the study: 17 received 3'SL 10 g/day, 22 were treated with 3'SL 20 g/day and 21 were given placebo. The three treatment groups did not significantly differ in demographic or clinical patient characteristics. No serious adverse events were observed during therapy in any of the three groups. No patients became UBT negative (< 4) during or after treatment but UBT values decreased significantly during the study period in both treatment groups and placebo.Conclusions. Antiadhesive therapy was safe and well tolerated but did not suppress or cure H. pylori colonization in humans. The observed decrease in UBT values could be explained by a regression towards the mean effect.