Department of Gastroenterology II, Mohammed V Teaching Military Hospital, Rabat, Morocco.
Eur J Clin Pharmacol. 2013 Sep;69(9):1709-15. doi: 10.1007/s00228-013-1524-6. Epub 2013 May 22.
Eradication rates following standard triple therapy for Helicobacter pylori infection are declining. Recent studies, conducted in a number of countries, have shown that sequential therapy for H. pylori infection yields high cure rates.
To compare the efficacy and tolerability of a sequential regimen as a first-line treatment of H. pylori infection with a standard triple treatment regime in Morocco.
A total of 281 naive H. pylori-infected patients, confirmed by histological examination, were assigned randomly to one of two treatment groups: standard triple therapy [omeprazole (20 mg bid) + amoxicillin (1 g bid) + clarithromycin (500 mg bid) for 7 days] or sequential therapy [omeprazole (20 mg bid) + amoxicillin (1 g bid) for 5 days, followed by omeprazole (20 mg bid) + tinidazole (500 mg bid) + clarithromycin (500 mg bid) for an additional 5 days]. H. pylori eradication was checked 4-6 weeks after treatment initiation by using a ¹³C-urea breath test. Compliance and adverse events were assessed.
The two groups did not differ significantly in gender, age, previous disease history, endoscopic and histological features and smoking. The intention-to-treat and per-protocol eradication rates were 65.9 and 71 % in the standard triple therapy group, and 82.8 and 89.9 % in the sequential therapy group, respectively. The eradication rate was significantly higher in the sequential therapy group than in the standard triple therapy group (p < 0.001), There was no statistically significant difference in compliance (97.5 vs. 96.3 %) and incidence of side-effects (27.5 vs. 27.9 %) between the two groups.
Based on our results, we conclude that for eradication of H. pylori infection, the 10-day sequential therapy is more effective than the standard triple therapy and is equally tolerated. These results confirm those of other studies in other countries.
幽门螺杆菌感染的标准三联疗法根除率正在下降。最近在多个国家进行的研究表明，序贯疗法治疗幽门螺杆菌感染可获得较高的治愈率。
在摩洛哥，比较序贯疗法与标准三联疗法作为幽门螺杆菌感染一线治疗的疗效和耐受性。
共 281 例经组织学检查证实的初治幽门螺杆菌感染患者被随机分为两组：标准三联疗法[奥美拉唑（20mg，bid）+阿莫西林（1g，bid）+克拉霉素（500mg，bid），连用 7 天]或序贯疗法[奥美拉唑（20mg，bid）+阿莫西林（1g，bid）连用 5 天，然后奥美拉唑（20mg，bid）+替硝唑（500mg，bid）+克拉霉素（500mg，bid）连用 5 天]。治疗开始后 4-6 周，通过¹³C-尿素呼气试验检查幽门螺杆菌的清除情况。评估依从性和不良反应。
两组患者的性别、年龄、既往病史、内镜和组织学特征及吸烟状况无显著差异。标准三联疗法组的意向治疗和符合方案的根除率分别为 65.9%和 71%，序贯疗法组分别为 82.8%和 89.9%。序贯疗法组的根除率明显高于标准三联疗法组（p<0.001）。两组的依从性（97.5%比 96.3%）和不良反应发生率（27.5%比 27.9%）无统计学差异。
根据我们的结果，我们得出结论，对于幽门螺杆菌感染的根除，10 天序贯疗法比标准三联疗法更有效，且耐受性相当。这些结果证实了其他国家的研究结果。
