Department of Internal Medicine, Kaohsiung Veterans General Hospital and National Yang-Ming University, Kaohsiung, Taiwan.
J Gastroenterol Hepatol. 2012 Mar;27(3):498-503. doi: 10.1111/j.1440-1746.2011.06885.x.
Most clinical trials concerning sequential therapy have been conducted in Italy. The efficacy of sequential therapy for Helicobacter pylori (H. pylori) eradication in Asia remains unclear. The aim of this study was to compare the efficacy of sequential therapy with standard triple therapy in Taiwan.
From January 2005 to December 2009, 233 H. pylori-infected patients receiving either a 10-day sequential therapy (40 mg pantoprazole and 1 g amoxicillin, twice daily, for the initial 5 days, followed by 40 mg pantoprazole, 500 mg clarithromycin, and 500 mg metronidazole, twice daily, for the subsequent 5 days, n = 118) or a 7-day standard triple therapy (40 mg pantoprazole, 500 mg clarithromycin, and 1 g amoxicillin twice daily for 7 days, n = 115) were included in the retrospective study. All the patients underwent a follow-up endoscopy with a rapid urease test and histological examination or a urea breath test at 8 weeks after the end of anti-H. pylori therapy to assess H. pylori status.
Intention-to-treat analysis demonstrated a significantly higher eradication rate for the sequential group than for the triple group (93% vs 80%, respectively, P = 0.003). Per-protocol analysis also showed similar results (93% vs 80%, P = 0.005). Both groups had similar frequencies of adverse events (29% vs 22%) and drug compliance (98% vs 97%).
Sequential therapy achieves a higher eradication rate than standard triple therapy in Taiwan. The novel treatment can be used as a first-line therapy for H. pylori infection for Taiwanese.
大多数关于序贯疗法的临床试验都是在意大利进行的。序贯疗法治疗亚洲幽门螺杆菌(H. pylori)感染的疗效尚不清楚。本研究的目的是比较序贯疗法与标准三联疗法在台湾的疗效。
从 2005 年 1 月至 2009 年 12 月,233 例 H. pylori 感染患者接受了 10 天序贯疗法(前 5 天每天给予 40mg 泮托拉唑和 1g 阿莫西林 2 次,随后 5 天给予 40mg 泮托拉唑、500mg 克拉霉素和 500mg 甲硝唑 2 次)或 7 天标准三联疗法(前 7 天每天给予 40mg 泮托拉唑、500mg 克拉霉素和 1g 阿莫西林 2 次)治疗。所有患者在抗 H. pylori 治疗结束后 8 周接受了随访内镜检查,包括快速尿素酶试验和组织学检查或尿素呼气试验,以评估 H. pylori 状态。
意向治疗分析显示,序贯组的根除率明显高于三联组(分别为 93%和 80%,P = 0.003)。按方案分析也显示出相似的结果(93%和 80%,P = 0.005)。两组的不良反应发生率(29%和 22%)和药物依从性(98%和 97%)相似。
序贯疗法在台湾的根除率高于标准三联疗法。这种新的治疗方法可以作为台湾 H. pylori 感染的一线治疗方法。