Treiber G, Ammon S, Klotz U
Robert Bosch Hospital, Department of Gastroenterology, Stuttgart, Germany.
Aliment Pharmacol Ther. 1997 Aug;11(4):711-8. doi: 10.1046/j.1365-2036.1997.00210.x.
Combined treatment using an acid-inhibiting drug with antibiotics can cure Helicobacter pylori infection. However, eradication rates are highly variable, especially if a proton pump inhibitor is used with amoxycillin. Therefore it is important to define factors/predictors of the clinical outcome.
In a single-blind study, 60 H. pylori-positive patients prospectively matched for diagnosis (erosive gastritis, duodenal and gastric ulcer), age (above and below 50 years) and smoking habits were randomly treated (each group n = 20) for 2 weeks with amoxycillin (1 mg b.d.) and either omeprazole (20 mg b.d.), lansoprazole (30 mg b.d.) or ranitidine (300 mg b.d.). Intragastric pH and plasma levels of the administered drugs were monitored over a dosing interval of 12 h.
The overall eradication rates were 45% (intention-to-treat, ITT, 27/60) or 47% (per protocol 27/58); they did not differ (ITT) between omeprazole (50%), lansoprazole (40%) and ranitidine (45%). Median pH and time at which intragastric pH was above 4 was slightly lower for ranitidine (4.0 +/- 1.7; 51 +/- 25%) than for omeprazole (5.4 +/- 1.1: 77 +/- 25%; P < 0.05) or lansoprazole (4.4 +/- 1.6: 68 +/- 32%). Plasma concentrations of amoxycillin were comparable in all three treatment groups. Post-treatment H. pylori status was not dependent on those levels, or the drug-induced extent or duration of increased intragastric pH. However, H. pylori-eradicated patients were significantly (P < 0.05) older (56 +/- 13 years) than patients still H. pylori-positive (47 +/- 14 years). In addition, in patients older than 50 years (n = 33), eradication was higher (P < 0.01) than in patients (n = 25) below 50 years (65 vs. 24%). Eradication rate was highest (75-83%) in subgroups of patients (> 50 years and history of peptic ulcer or smokers). Neither activity/grade of peptic ulcer or erosive gastritis nor initial diagnosis were predictors for clinical outcome.
The age of patients must be regarded as a major determinant of H. pylori eradication rate and may represent an important factor contributing to the highly variable clinical results.
使用抑酸药物与抗生素联合治疗可治愈幽门螺杆菌感染。然而，根除率差异很大，尤其是当质子泵抑制剂与阿莫西林联用时。因此，确定临床结局的影响因素/预测指标很重要。
在一项单盲研究中，60例幽门螺杆菌阳性患者，根据诊断（糜烂性胃炎、十二指肠溃疡和胃溃疡）、年龄（50岁以上和50岁以下）和吸烟习惯进行前瞻性匹配，随机分为三组（每组n = 20），分别接受阿莫西林（每日2次，每次1 mg）联合奥美拉唑（每日2次，每次20 mg）、兰索拉唑（每日2次，每次30 mg）或雷尼替丁（每日2次，每次300 mg）治疗2周。在12小时的给药间隔内监测胃内pH值和所给药的血浆水平。
总体根除率为45%（意向性分析，ITT，27/60）或47%（符合方案分析，27/58）；奥美拉唑组（50%）、兰索拉唑组（40%）和雷尼替丁组（45%）之间的根除率（ITT）无差异。雷尼替丁组胃内pH值中位数及胃内pH值高于4的时间（4.0±1.7；51±25%）略低于奥美拉唑组（5.4±1.1：77±25%；P < 0.05）或兰索拉唑组（4.4±1.6：68±32%）。三个治疗组的阿莫西林血浆浓度相当。治疗后幽门螺杆菌状态不依赖于这些水平，也不依赖于药物诱导的胃内pH值升高的程度或持续时间。然而，幽门螺杆菌被根除的患者（56±13岁）明显比仍为幽门螺杆菌阳性的患者（47±14岁）年龄大（P < 0.05）。此外，50岁以上患者（n = 33）的根除率高于50岁以下患者（n = 25）（65%对24%，P < 0.01）。在患者亚组（> 50岁且有消化性溃疡病史或吸烟者）中根除率最高（75 - 83%）。消化性溃疡或糜烂性胃炎的活动度/分级以及初始诊断均不是临床结局的预测指标。
患者年龄必须被视为幽门螺杆菌根除率的主要决定因素，并且可能是导致临床结果差异很大的一个重要因素。
