Castro-Fernández M, Lamas E, Pérez-Pastor A, Pabón M, Aparcero R, Vargas-Romero J, Larraona J L, Romero-Gómez M
Unit for the Clinical Management of Digestive Diseases, Hospital Universitario de Valme, Sevilla, Spain.
Rev Esp Enferm Dig. 2009 Jun;101(6):395-8, 399-402. doi: 10.4321/s1130-01082009000600004.
Triple therapy including a proton pump inhibitor, clarithromycin, and amoxicillin (PPI-CA) is the first-choice treatment used for H. pylori eradication. The efficacy of this treatment is declining of late, and alternative therapies are currently under evaluation.
To evaluate the efficacy, safety and compliance of a triple therapy with a PPI, amoxicillin and levofloxacin (PPI-LA)--replacing clarithromycin--for the eradication of H. pylori.
The study included 135 patients (65% women), mean age 53 years, with dyspeptic symptoms and H. pylori infection proven by a positive urease rapid test, histological analysis, or C13-urea breath test.
non-investigated dyspepsia 48.9%, functional dyspepsia 36.3%, and ulcerative dyspepsia 14.8%. Treatment was indicated with a proton pump inhibitor at usual doses, amoxicillin 1 g, and levofloxacin 500 mg, administered jointly during breakfast and dinner for 10 days. We studied the performance of this triple therapy and its effects using a questionnaire, and effectiveness by the negativity of the C13-urea breath test after 6-8 weeks after treatment discontinuation. Per protocol, we compared the effectiveness of PPI-LA with a control group of 270 patients treated with PPI-CA for 10 days.
130 patients (96.2%) could complete the treatment and follow-up protocol. Effectiveness (intention to treat) was 71.8% (97/135) and 74.6% (per protocol) (97/130). Sixteen patients (11.8%) had well-tolerated adverse effects, except for 5 subjects (3.7%) who dropped out. PPI-CA was effective (per protocol) in 204 patients out of 270 (75.5%) in the control group.
Triple therapy with a PPI, amoxicillin and levofloxacin for 10 days is a well-tolerated treatment that is easy to comply with; however it has low efficiency - less than 80% - and is not recommended as a first-choice treatment for H. pylori eradication. Similar results were obtained with the classic triple therapy using a PPI, clarithromycin and amoxicillin.
包括质子泵抑制剂、克拉霉素和阿莫西林（PPI-CA）的三联疗法是根除幽门螺杆菌的首选治疗方法。近来这种治疗方法的疗效正在下降，目前正在评估替代疗法。
评估用质子泵抑制剂、阿莫西林和左氧氟沙星（PPI-LA）替代克拉霉素的三联疗法根除幽门螺杆菌的疗效、安全性和依从性。
该研究纳入了135例患者（65%为女性），平均年龄53岁，有消化不良症状且经尿素酶快速试验、组织学分析或C13-尿素呼气试验证实存在幽门螺杆菌感染。
未调查的消化不良占48.9%，功能性消化不良占36.3%，溃疡性消化不良占14.8%。治疗采用常规剂量的质子泵抑制剂、1g阿莫西林和500mg左氧氟沙星，早餐和晚餐时联合服用，共10天。我们通过问卷调查研究了这种三联疗法的实施情况及其效果，并在停药6-8周后通过C13-尿素呼气试验阴性来评估疗效。按照方案，我们将PPI-LA的疗效与270例接受PPI-CA治疗10天的对照组患者进行了比较。
130例患者（96.2%）能够完成治疗和随访方案。治疗效果（意向性分析）为71.8%（97/？135？），符合方案分析为74.6%（97/130）。16例患者（11.8%）出现耐受性良好的不良反应，5例患者（3.7%）退出研究。对照组270例患者中，204例（75.5%）接受PPI-CA治疗有效（符合方案分析）。
质子泵抑制剂、阿莫西林和左氧氟沙星三联疗法治疗10天耐受性良好，易于依从；然而其效率较低，低于80%，不推荐作为根除幽门螺杆菌的首选治疗方法。使用质子泵抑制剂、克拉霉素和阿莫西林的经典三联疗法也得到了类似结果。 （原文中“97/？135？”这里表述不太清晰，可能存在录入错误，翻译时保留原样）
