Trevisani L, Sartori S, Caselli M, Ruina M, Verdianelli G, Abbasciano V
Department of Internal Medicine, S. Anna Hospital, Ferrara, Italy.
Am J Gastroenterol. 1998 Mar;93(3):390-3. doi: 10.1111/j.1572-0241.1998.00390.x.
The current guidelines recommend 1-wk triple therapy regimens for eradicating H. pylori infection. Until now, shorter regimens have scarcely been investigated. Azithromycin is a new generation macrolide antibiotic with unusual and favorable pharmacokinetics, and seems to be a very promising agent for innovative anti-H. pylori regimens. We assessed the efficacy and tolerability of a new 4-day low dose triple therapy in comparison with a well established 1-wk triple therapy in the treatment of Helicobacter pylori infection.
One hundred-sixty consecutive patients with biopsy-proven H. pylori infection were randomized to receive lansoprazole 30 mg b.i.d. on days 1-4, azithromycin 500 mg u.i.d. on days 2-4, and tinidazole 2000 mg u.i.d. on day 3 (LAT group), or 7 days of triple therapy of omeprazole 20 mg u.i.d., clarithromycin 250 mg b.i.d., and tinidazole 500 mg b.i.d. (OCT group). Patients with gastric or duodenal active ulcer received proton pump inhibitors for an additional 4 wk. H. pylori eradication was defined as negative of both rapid urease test and histology on biopsies taken from the gastric body and antrum at least 1 month after the end of treatment.
Seven patients in the LAT group and four in the OCT group were lost to follow-up. No significant difference in either efficacy or tolerability was observed between the two regimens. Active ulcers healed in 97.8% of cases with LAT and in 100% of cases with OCT. The eradication rate was 80.8% in the LAT group and 85.5% in the OCT group, considering the per-protocol results, and 73.3% and 81.2%, respectively, considering the intention-to-treat results. Side effects occurred in one LAzT patient and in two OCT patients; they were mild and did not interfere with compliance.
The new proposed ultrashort triple therapy, including lansoprazole, low dose azithromycin for 3 days, and a single dose of tinidazole, appears to be a very effective anti-H. pylori regimen, a simpler, cheaper, well-tolerated, and equally effective alternative to 1-wk triple therapy.
当前指南推荐采用1周的三联疗法根除幽门螺杆菌感染。到目前为止，较短疗程的疗法鲜有研究。阿奇霉素是新一代大环内酯类抗生素，具有独特且良好的药代动力学特性，似乎是创新抗幽门螺杆菌疗法中一种非常有前景的药物。我们评估了一种新的4天低剂量三联疗法与一种成熟的1周三联疗法在治疗幽门螺杆菌感染方面的疗效和耐受性。
160例经活检证实幽门螺杆菌感染的连续患者被随机分组，在第1 - 4天接受兰索拉唑30 mg每日2次，在第2 - 4天接受阿奇霉素500 mg每日1次，在第3天接受替硝唑2000 mg每日1次（LAT组），或接受7天的三联疗法，即奥美拉唑20 mg每日1次、克拉霉素250 mg每日2次、替硝唑500 mg每日2次（OCT组）。患有胃或十二指肠活动性溃疡的患者额外接受4周的质子泵抑制剂治疗。幽门螺杆菌根除定义为在治疗结束后至少1个月从胃体和胃窦取活检进行快速尿素酶试验和组织学检查均为阴性。
LAT组有7例患者、OCT组有4例患者失访。两种疗法在疗效和耐受性方面均未观察到显著差异。LAT组97.8%的活动性溃疡病例愈合，OCT组为100%。按符合方案分析结果，LAT组根除率为80.8%；OCT组为85.5%。按意向性分析结果，分别为73.3%和81.2%。LAT组有1例患者、OCT组有2例患者出现副作用；副作用轻微，未影响依从性。
新提出的超短程三联疗法，包括兰索拉唑、3天低剂量阿奇霉素和单剂量替硝唑，似乎是一种非常有效的抗幽门螺杆菌疗法，是1周三联疗法的一种更简单、更便宜、耐受性良好且同样有效的替代方案。
