Martínek Jan, Pantoflícková Drahoslava, Hucl Tomás, Benes Marek, Dorta Gian, Lukás Milan, Spicák Julius
Department of Hepatology and Gastroenterology, IKEM, Prague, Czech Republic.
Eur J Gastroenterol Hepatol. 2004 May;16(5):445-50. doi: 10.1097/00042737-200405000-00002.
Proton pump inhibitors (PPIs) taken twice daily do not effectively control night-time intragastric pH; nocturnal acid breakthrough (NAB) (arbitrarily defined as intragastric pH < 4 lasting longer than 1 h) occurs in more than 75% of patients. The effectiveness of PPIs depends rather on the Helicobacter pylori status.
To investigate the effectiveness of two regimens of omeprazole in H. pylori-positive subjects as well as the occurrence of NAB.
Fifteen otherwise healthy H. pylori-positive subjects participated in this randomized, crossover, double-blind study.
Night-time intragastric pH-metry was performed before (baseline) and on day 7 of two treatment courses with omeprazole (1 x 20 mg and 2 x 20 mg). A 14-day (minimum) wash-out period was respected between the two treatment courses.
Group medians (10-90% confidence intervals) for night-time intragastric pH (22:30-06:30 h) were as follows: baseline, 2 (1-6.1); 1 x 20 mg, 5 (3.3-6.9; P < 0.001 versus baseline); instead of, 2 x 20 mg, 6.3 (4.9-7.1; P < 0.001 versus baseline, P = 0.02 versus omeprazole 1 x 20 mg). The percentage of time with intragastric pH < 3 was 65.4% during baseline (P < 0.05 versus both omeprazole regimens), 27% with once-daily omeprazole (P = 0.001 versus omeprazole 2 x 20 mg) and 0% with twice-daily omeprazole. NAB occurred in eight (53.3%) subjects with once-daily omeprazole and in no subject taking twice-daily omeprazole.
In H. pylori-positive subjects, twice-daily omeprazole is highly effective in controlling nocturnal intragastric acidity. NAB does not occur in those subjects and there is no need to add bedtime H2-receptor antagonists to this regimen.
每日服用两次的质子泵抑制剂（PPI）不能有效控制夜间胃内pH值；超过75%的患者会出现夜间酸突破（NAB，定义为胃内pH值<4持续超过1小时）。PPI的有效性更多地取决于幽门螺杆菌状态。
研究两种奥美拉唑治疗方案对幽门螺杆菌阳性受试者的有效性以及NAB的发生情况。
15名其他方面健康的幽门螺杆菌阳性受试者参与了这项随机、交叉、双盲研究。
在使用奥美拉唑（1×20mg和2×20mg）的两个治疗疗程之前（基线）和第7天进行夜间胃内pH值测定。两个治疗疗程之间有14天（至少）的洗脱期。
夜间胃内pH值（22:30 - 06:30时）的组中位数（10 - 90%置信区间）如下：基线时为2（1 - 6.1）；1×20mg时为5（3.3 - 6.9；与基线相比P<0.001）；而2×20mg时为6.3（4.9 - 7.1；与基线相比P<0.001，与奥美拉唑1×20mg相比P = 0.02）。胃内pH值<3的时间百分比在基线时为65.4%（与两种奥美拉唑治疗方案相比P<0.05），每日一次服用奥美拉唑时为27%（与奥美拉唑2×20mg相比P = 0.001），每日两次服用奥美拉唑时为0%。NAB在每日一次服用奥美拉唑的8名（53.3%）受试者中出现，而在每日两次服用奥美拉唑的受试者中未出现。
在幽门螺杆菌阳性受试者中，每日两次服用奥美拉唑在控制夜间胃内酸度方面非常有效。这些受试者不会出现NAB，且该治疗方案无需添加睡前H2受体拮抗剂。
