Ayazi Shahin, Lipham John C, Portale Giuseppe, Peyre Christian G, Streets Christopher G, Leers Jessica M, Demeester Steven R, Banki Farzaneh, Chan Linda S, Hagen Jeffrey A, Demeester Tom R
Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles, California 90033, USA.
Clin Gastroenterol Hepatol. 2009 Jan;7(1):60-7. doi: 10.1016/j.cgh.2008.08.020. Epub 2008 Aug 16.
BACKGROUND & AIMS: The Bravo pH capsule is a catheter-free intraesophageal pH monitoring system that avoids the discomfort of an indwelling catheter. The objectives of this study were as follows: (1) to obtain normal values for the first and second 24-hour recording periods using a Bravo capsule placed transnasally 5 cm above the upper border of the lower esophageal sphincter determined by manometry and to assess concordance between the 2 periods, (2) to determine the optimal discriminating threshold for identifying patients with gastroesophageal reflux disease (GERD), and (3) to validate this threshold and to identify the recording period with the greatest accuracy.
Normal values for a manometrically positioned, transnasally inserted Bravo capsule were determined in 50 asymptomatic subjects. A test population of 50 subjects (25 asymptomatic, 25 with GERD) then was monitored to determine the best discriminating thresholds. The thresholds for the first, second, and combined (48-hour) recording periods then were validated in a separate group of 115 patients.
In asymptomatic subjects, the values measured using a manometrically positioned Bravo pH capsule were similar between the first and second 24-hour periods of recording. The highest level of accuracy with Bravo was observed when an abnormal composite pH score was obtained in the first or second 24-hour period of monitoring.
Normal values for esophageal acid exposure were defined for a manometrically positioned, transnasally inserted, Bravo pH capsule. An abnormal composite pH score, obtained in either the first or second 24-hour recording period, was the most accurate method of identifying patients with GERD.
Bravo pH胶囊是一种无需导管的食管内pH监测系统，可避免留置导管带来的不适。本研究的目的如下：（1）使用经鼻腔放置在通过测压确定的食管下括约肌上缘上方5 cm处的Bravo胶囊，获取第一个和第二个24小时记录期的正常值，并评估两个时期之间的一致性；（2）确定识别胃食管反流病（GERD）患者的最佳鉴别阈值；（3）验证该阈值并确定准确性最高的记录期。
在50名无症状受试者中确定经测压定位、经鼻腔插入的Bravo胶囊的正常值。然后对50名受试者（25名无症状，25名患有GERD）的测试人群进行监测，以确定最佳鉴别阈值。然后在另一组115名患者中验证第一个、第二个和联合（48小时）记录期的阈值。
在无症状受试者中，使用经测压定位的Bravo pH胶囊测量的值在第一个和第二个24小时记录期之间相似。当在监测的第一个或第二个24小时期间获得异常的综合pH评分时，观察到Bravo的最高准确度。
为经测压定位、经鼻腔插入的Bravo pH胶囊定义了食管酸暴露的正常值。在第一个或第二个24小时记录期获得的异常综合pH评分是识别GERD患者的最准确方法。
