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十天序贯疗法与三联疗法治疗幽门螺杆菌根除:一项前瞻性、开放标签、随机试验。

Ten-day sequential versus triple therapy for Helicobacter pylori eradication: a prospective, open-label, randomized trial.

机构信息

Department of Internal Medicine, Gachon Graduate School of Medicine, Gil Medical Center, Incheon, Korea.

出版信息

J Gastroenterol Hepatol. 2012 Nov;27(11):1675-80. doi: 10.1111/j.1440-1746.2012.07249.x.

DOI:10.1111/j.1440-1746.2012.07249.x
PMID:22849546
Abstract

BACKGROUND AND AIM

Increased resistance of Helicobacter pylori to antibiotics has increased the need to develop new first-line treatments for H. pylori. We have prospectively evaluated 10-day sequential versus conventional triple therapy in peptic ulcer patients.

METHODS

One hundred and fifty-nine patients with peptic ulcer diseases were prospectively randomized to receive 10 days of lansoprazole, amoxicillin, and clarithromycin (conventional triple therapy) or 5 days of lansoprazole and amoxicillin followed by 5 days of lansoprazole, clarithromycin, and metronidazole (sequential therapy). Post-treatment H. pylori status was determined by the (13) C-urea breath test. Eradication rates, antibiotic resistance rates by agar dilution method, drug compliance, and side-effects were compared.

RESULTS

The intention-to-treat eradication rates were 75.9% (95% CI 66.5-85.3%, 60/79) in the sequential therapy group and 58.7% (95% CI 47.9-69.5%, 47/80) in the conventional triple therapy group (P = 0.01), while the per-protocol eradication rates were 86.8% (95% CI 78.7-94.8%, 59/68) and 67.6% (95% CI 56.5-78.7%, 46/68) (P = 0.01), respectively. Compliance and side-effects were similar in the two groups. Culture of H. pylori showed that 18.2% were resistant to clarithromycin, 41.9% to metronidazole. Dual resistance to both antibiotics was 9.6%.

CONCLUSIONS

Although 10-day sequential therapy yielded a higher H. pylori eradication rate than 10-day conventional triple therapy, the sequential therapy protocol did not result in a sufficiently satisfactory eradication rate. This might be related to the higher antibiotics resistance rate especially to dual resistance. More effective regimens are needed to overcome antibiotic resistance in Korea.

摘要

背景与目的

由于幽门螺杆菌对抗生素的耐药性增加,因此需要开发新的一线治疗方法。我们前瞻性地评估了 10 天序贯与传统三联疗法在消化性溃疡患者中的疗效。

方法

159 例消化性溃疡患者前瞻性随机分为 10 天兰索拉唑、阿莫西林和克拉霉素(传统三联疗法)或 5 天兰索拉唑和阿莫西林后序贯 5 天兰索拉唑、克拉霉素和甲硝唑(序贯疗法)。通过 (13)C-尿素呼气试验确定治疗后 H. pylori 状态。比较根除率、琼脂稀释法测定的抗生素耐药率、药物依从性和副作用。

结果

序贯治疗组的意向治疗根除率为 75.9%(95%CI 66.5-85.3%,60/79),传统三联疗法组为 58.7%(95%CI 47.9-69.5%,47/80)(P=0.01),而按方案治疗根除率分别为 86.8%(95%CI 78.7-94.8%,59/68)和 67.6%(95%CI 56.5-78.7%,46/68)(P=0.01)。两组的依从性和副作用相似。H. pylori 培养显示克拉霉素耐药率为 18.2%,甲硝唑耐药率为 41.9%,两种抗生素均耐药率为 9.6%。

结论

虽然 10 天序贯疗法的幽门螺杆菌根除率高于 10 天传统三联疗法,但序贯疗法方案并未达到令人满意的根除率。这可能与抗生素耐药率较高,特别是双重耐药有关。韩国需要更有效的方案来克服抗生素耐药性。

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