Blum R A, Shi H, Karol M D, Greski-Rose P A, Hunt R H
Millard Fillmore Hospital, Buffalo, New York, USA.
Clin Ther. 1997 Sep-Oct;19(5):1013-23. doi: 10.1016/s0149-2918(97)80053-7.
The effects on 24-hour intragastric pH levels of once-daily doses of lansoprazole 15 mg and lansoprazole 30 mg were compared with the effects of omeprazole 20 mg QD and ranitidine 150 mg QID in a phase I, randomized, double-masked, four-way crossover study conducted in 29 healthy male volunteers. Subjects received each treatment regimen for 5 consecutive days with at least a 2-week washout between treatment periods. Ambulatory 24-hour intragastric pH values were monitored in each subject at baseline (2 days before crossover period 1) and again before dosing on day 5 of each of the four crossover treatment periods. Gastric pH values increased during all four regimens, with significantly higher mean 24-hour pH values noted in subjects receiving lansoprazole 30 mg QD (4.53 +/- 0.16) compared with those receiving lansoprazole 15 mg QD (3.97 +/- 0.16), omeprazole 20 mg QD (4.02 +/- 0.16), or ranitidine 150 mg QID (3.59 +/- 0.16). Lansoprazole 30 mg produced significantly greater mean percentages of time that the gastric pH was above 3.0 and 4.0 (75% and 63%, respectively) compared with the other treatment regimens. The mean percentages of time during which gastric pH was above 3.0 and 4.0, respectively, for the other treatments were lansoprazole 15 mg, 64% and 48%; omeprazole 20 mg, 63% and 51%; and ranitidine 150 mg, 52% and 38%. All treatment regimens were well tolerated, with no clinically significant differences between the regimens. Multiple-dose lansoprazole 30 mg QD produced a significantly increased intragastric pH level and significantly longer durations of increased intragastric pH level compared with lansoprazole 15 mg QD, omeprazole 20 mg QD, and ranitidine 150 mg QID.
在一项一期随机、双盲、四交叉研究中,将每日一次剂量的15毫克兰索拉唑和30毫克兰索拉唑对24小时胃内pH值的影响,与20毫克奥美拉唑每日一次及150毫克雷尼替丁每日四次的影响进行比较,该研究在29名健康男性志愿者中开展。受试者连续5天接受每种治疗方案,各治疗期之间至少有2周的洗脱期。在每个受试者的基线期(交叉期1前2天)以及四个交叉治疗期的每个第5天给药前,监测24小时动态胃内pH值。在所有四种治疗方案期间胃pH值均升高,与接受每日一次15毫克兰索拉唑(3.97±0.16)、20毫克奥美拉唑每日一次(4.02±0.16)或150毫克雷尼替丁每日四次(3.59±0.16)的受试者相比,接受每日一次30毫克兰索拉唑的受试者24小时平均pH值显著更高(4.53±0.16)。与其他治疗方案相比,30毫克兰索拉唑使胃pH值高于3.0和4.0的平均时间百分比显著更高(分别为75%和63%)。其他治疗方案使胃pH值高于3.0和4.0的平均时间百分比分别为:15毫克兰索拉唑,64%和48%;20毫克奥美拉唑,63%和51%;150毫克雷尼替丁,52%和38%。所有治疗方案耐受性良好,各方案之间无临床显著差异。与每日一次15毫克兰索拉唑、20毫克奥美拉唑每日一次及150毫克雷尼替丁每日四次相比,每日一次30毫克兰索拉唑多次给药可显著提高胃内pH值水平,并显著延长胃内pH值升高的持续时间。