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首页> 外文期刊>European journal of gastroenterology and hepatology >Intra-oesophageal pH profiles and pharmacokinetics of pantoprazole and esomeprazole: a crossover study in patients with gastro-oesophageal reflux disease.
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Intra-oesophageal pH profiles and pharmacokinetics of pantoprazole and esomeprazole: a crossover study in patients with gastro-oesophageal reflux disease.

机译：top托拉唑和埃索美拉唑的食管内pH曲线和药代动力学：一项针对胃食管反流病患者的交叉研究。

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AIM To compare the effect of pantoprazole and esomeprazole on intra-oesophageal pH and investigate their pharmacokinetics in patients with symptomatic gastro-oesophageal reflux disease (GORD).METHODS Double-blind, randomized, two-period crossover study. Caucasian men with symptomatic GORD (n = 48) were selected on the basis of clinical records of typical GORD symptoms, confirmed by a pathological reflux time (oesophageal pH < 4 for >/= 6% of the time). They received oral pantoprazole 40 mg once daily (od) or esomeprazole 40 mg od for seven days. Continuous 24 h oesophageal pH-metry was performed at baseline and day 7. Evaluations included: pre- and post-treatment differences in the percentage of time with pH < 4.0 and < 3.0 between baseline and day 7; area under the curve (AUC), C(max), and T((1/2)); point estimates and 90% confidence intervals (CI) on days 1 and 7, calculated for ratios of the AUC and C(max).RESULTS Both drugs decreased the mean total number of reflux episodes and reduced the percentage of reflux time within 24 h to < 3%. No pathological reflux was detectable after repeated administration of either drug. The 90% CI were within the predefined range at all time points; thus, equivalence of pantoprazole and esomeprazole was concluded. For pantoprazole, C(max) and AUC were unchanged on day 7 vs day 1, confirming its high and constant bioavailability. For esomeprazole, C(max) and AUC were increased on day 7 vs day 1 by 80% and 50%, respectively, indicating low initial bioavailability. No clinically relevant side effects were seen for either drug.CONCLUSION Pantoprazole and esomeprazole have equivalent effect on oesophageal pH, since no pathological reflux was detected after treatment with either drug. For esomeprazole, the C(max) and AUC increased after multiple dosing; for pantoprazole the pharmacokinetics were predictable and independent of the number of administered doses.
机译：目的比较pan托拉唑和埃索美拉唑对有症状胃食管反流病（GORD）患者食管内pH的影响，并研究其药代动力学。方法双盲，随机，两期交叉研究根据典型的GORD症状的临床记录选择有症状的GORD的高加索男性（n = 48），并经病理性返流时间证实（食管pH <4≥6％）。他们每天口服一次odpanrazole 40 mg（od）或口服esomeprazole 40 mg od 7天。在基线和第7天连续进行24小时的食管pH测量。评估包括：基线至第7天，pH值<4.0和<3.0的治疗前后时间百分比差异;曲线下面积（AUC），C（max）和T（（1/2））;在第1天和第7天计算出的平均点数和90％的置信区间（CI），以AUC和C（max）的比值计算。结果两种药物均降低了平均反流发作总数，并减少了24 h至<3％。重复服用任何一种药物后均未检测到病理性反流。 90％CI在所有时间点都在预定义范围内;因此，得出了top托拉唑和埃索美拉唑的等效性。对于pan托拉唑，C（max）和AUC在第7天和第1天没有变化，证实了其高和恒定的生物利用度。对于埃索美拉唑，与第1天相比，第7天的C（max）和AUC分别增加了80％和50％，表明初始生物利用度较低。两种药物均未见临床相关副作用。结论top托拉唑和埃索美拉唑对食管pH值具有同等作用，因为在使用两种药物治疗后均未发现病理性反流。对于埃索美拉唑，多次给药后C（max）和AUC升高;对于pan托拉唑，其药代动力学是可预测的，并且与给药剂量的数量无关。

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