辅助益生菌可提高三联疗法根除幽门螺杆菌感染的效果。
Adjuvant probiotics improve the eradication effect of triple therapy for Helicobacter pylori infection.
机构信息
Department of Gastroenterology, Changhai Hospital, Second Military Medical University, Shanghai 200433, China.
出版信息
World J Gastroenterol. 2012 Nov 21;18(43):6302-7. doi: 10.3748/wjg.v18.i43.6302.
AIM
To investigate whether the addition of probiotics can improve the eradication effect of triple therapy for Helicobacter pylori (H. pylori) infection.
METHODS
This open randomized trial recruited 234 H. pylori positive gastritis patients from seven local centers. The patients were randomized to one-week standard triple therapy (omeprazole 20 mg bid, clarithromycin 500 mg bid, and amoxicillin 1000 mg bid; OCA group, n = 79); two weeks of pre-treatment with probiotics, containing 3 × 10(7)Lactobacillus acidophilus per day, prior to one week of triple therapy (POCA group, n = 78); or one week of triple therapy followed by two weeks of the same probiotics (OCAP group, n = 77). Successful eradication was defined as a negative C13 or C14 urease breath test four weeks after triple therapy. Patients were asked to report associated symptoms at baseline and during follow-up, and side effects related to therapy were recorded. Data were analyzed by both intention-to-treat (ITT) and per-protocol (PP) methods.
RESULTS
PP analysis involved 228 patients, 78 in the OCA, 76 in the POCA and 74 in the OCAP group. Successful eradication was observed in 171 patients; by PP analysis, the eradication rates were significantly higher (P = 0.007 each) in the POCA (62/76; 81.6%, 95% CI 72.8%-90.4%) and OCAP (61/74; 82.4%, 95% CI 73.6%-91.2%) groups than in the OCA group (48/78; 61.5%, 95% CI 50.6%-72.4%). ITT analysis also showed that eradication rates were significantly higher in the POCA (62/78; 79.5%, 95% CI 70.4%-88.6%) and OCAP (61/77; 79.2%, 95% CI 70%-88.4%) groups than in the OCA group (48/79; 60.8%, 95% CI 49.9%-71.7%), (P = 0.014 and P = 0.015). The symptom relieving rates in the POCA, OCAP and OCA groups were 85.5%, 89.2% and 87.2%, respectively. Only one of the 228 patients experienced an adverse reaction.
CONCLUSION
Administration of probiotics before or after standard triple therapy may improve H. pylori eradication rates.
目的
研究益生菌的添加是否能提高三联疗法根除幽门螺杆菌（H. pylori）感染的效果。
方法
这是一项开放、随机临床试验，共纳入来自 7 个当地中心的 234 例 H. pylori 阳性胃炎患者。患者被随机分为标准三联疗法（奥美拉唑 20mg，bid；克拉霉素 500mg，bid；阿莫西林 1000mg，bid；OCA 组，n=79）；在三联疗法前 2 周接受益生菌预处理，每天含 3×10（7）嗜酸乳杆菌（POCA 组，n=78）；或三联疗法后 2 周接受相同的益生菌治疗（OCAP 组，n=77）。成功根除定义为三联疗法后 4 周 C13 或 C14 尿素呼气试验阴性。患者在基线和随访时报告相关症状，并记录与治疗相关的副作用。采用意向治疗（ITT）和方案（PP）分析数据。
结果
PP 分析共纳入 228 例患者，OCA 组 78 例，POCA 组 76 例，OCAP 组 74 例。7 例患者失访。PP 分析显示，POCA 组（62/76；81.6%，95%CI72.8%-90.4%）和 OCAP 组（61/74；82.4%，95%CI73.6%-91.2%）的根除率显著高于 OCA 组（48/78；61.5%，95%CI50.6%-72.4%）（P=0.007 各）。ITT 分析也显示，POCA 组（62/78；79.5%，95%CI70.4%-88.6%）和 OCAP 组（61/77；79.2%，95%CI70%-88.4%）的根除率显著高于 OCA 组（48/79；60.8%，95%CI49.9%-71.7%）（P=0.014 和 P=0.015）。POCA、OCAP 和 OCA 组的症状缓解率分别为 85.5%、89.2%和 87.2%。228 例患者中仅有 1 例出现不良反应。
结论
在标准三联疗法前或后使用益生菌可能会提高 H. pylori 的根除率。
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