Department of Gastroenterology, Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, China; Institute of Gastroenterology, Zhejiang University, Hangzhou, Zhejiang Province, China.
Institute of Gastroenterology, Zhejiang University, Hangzhou, Zhejiang Province, China; Department of Gastroenterology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, China.
Clin Microbiol Infect. 2017 Jun;23(6):391-395. doi: 10.1016/j.cmi.2016.12.032. Epub 2017 Jan 7.
To investigate the effectiveness of 10-day bismuth-containing quadruple (B-quadruple) treatment as first-line therapy in patients with Helicobacter pylori-related chronic gastritis.
A randomized controlled trial was conducted from October 2011 to December 2013 in Zhejiang, China, including patients with H. pylori-related chronic gastritis who were randomly provided either 10-day omeprazole-based triple therapy (OM-triple; omeprazole 20 mg twice daily, clarithromycin 500 mg twice daily and amoxicillin 1 g twice daily) or 10-day B-quadruple therapy (OM-triple + bismuth subcitrate 120 mg four times daily). H. pylori status, pathologic findings and dyspeptic symptoms were assessed at baseline and after 3 months. The primary outcome was H. pylori eradication rates by intention-to-treat (ITT) and per-protocol (PP) analyses. The secondary outcomes were the histologic and symptomatic benefits from H. pylori eradication.
A total of 351 patients with H. pylori-related chronic gastritis were recruited. The eradication rates of the OM-triple and B-quadruple groups were 58.4% (108/185) and 86.1% (143/166) respectively according to ITT analysis (p <0.01). PP rates of H. pylori eradication were 63.2% (108/171) and 92.3% (143/155) respectively (p <0.01). According to the PP analysis, active and chronic inflammation in gastric mucosa was substantially improved in all treated patients (n=326). However, pathologic atrophic gastritis and intestinal metaplasia did not regress in both groups (n=326). The reduction of dyspeptic symptoms score was significantly higher in the B-quadruple group than in the OM-triple group (0.59±0.057 vs. 0.39±0.046) (p <0.01).
Ten-day B-quadruple therapy is more effective than OM-triple therapy as first-line therapy for patients with H. pylori-induced chronic gastritis in China.
研究 10 天铋剂四联疗法（B-四联）作为幽门螺杆菌相关慢性胃炎一线治疗的有效性。
2011 年 10 月至 2013 年 12 月在中国浙江进行了一项随机对照试验，纳入了幽门螺杆菌相关慢性胃炎患者，随机接受 10 天奥美拉唑为基础的三联疗法（OM-三联；奥美拉唑 20mg，每日 2 次，克拉霉素 500mg，每日 2 次，阿莫西林 1g，每日 2 次）或 10 天 B-四联疗法（OM-三联+枸橼酸铋钾 120mg，每日 4 次）。基线和 3 个月后评估幽门螺杆菌状态、病理发现和消化不良症状。主要结局为意向治疗（ITT）和方案分析（PP）的幽门螺杆菌根除率。次要结局为幽门螺杆菌根除后的组织学和症状获益。
共纳入 351 例幽门螺杆菌相关慢性胃炎患者。根据 ITT 分析，OM-三联和 B-四联组的根除率分别为 58.4%（108/185）和 86.1%（143/166）（p<0.01）。幽门螺杆菌根除的 PP 率分别为 63.2%（108/171）和 92.3%（143/155）（p<0.01）。根据 PP 分析，所有接受治疗的患者（n=326）的胃黏膜活动性和慢性炎症均得到显著改善。然而，两组的病理萎缩性胃炎和肠化生均未消退（n=326）。B-四联组消化不良症状评分的降低明显高于 OM-三联组（0.59±0.057 vs. 0.39±0.046）（p<0.01）。
10 天铋剂四联疗法作为中国幽门螺杆菌诱导的慢性胃炎一线治疗，比 OM-三联疗法更有效。
