国产24h食管pH监测导管数据采集可靠性临床初步研究

A clinical study on data acquisition reliability of 24-hour pH monitoring of a domestic esophagus catheter

[目的]研究国产24h食管pH监测导管与国外同类产品的数据一致性。[方法]对15例胃食管反流病患者同时采用国产24h食管pH监测导管与进口同类产品进行食管pH监测,比较2种导管的总反流时间、直立反流时间、平躺反流时间、反流次数、长反流次数、最长反流时间和DeMeester评分。[结果]国产、进口2种导管均能顺利采集数据,并下载分析。2种导管在总反流时间、直立反流时间、平躺反流时间、反流次数、长反流次数、最长反流次数和DeMeester评分等数据的比较差异无统计学意义(P>0.05),数据一致性良好。试验中无不良反应发生。[结论]2种导管采集的数据具有一致性,国产导管有代替进口产品的可能。

[Objective]To investigate the data acquisition reliability of 24-hour pH monitoring of a domestic esophagus catheter by comparison with an similar imported one.[Methods]Fifteen patients diagnosed as GERD were enrolled.After signing the informed consent,24-hour pH monitoring of esophagus was carried out with the two catheters simultaneously.The total percent time of pH<4,The time with pH<4 over 24-hours in the upright and recumbent position,number of reflux episodes,number of reflux episodes with pH<4 for more 5 minutes,the longest single acid-exposure episode,DeMeester score were collected.Statistical analysis was carried out.[Results]In this clinical study,no adverse reactions were observed about 24-hour pH monitoring of esophagus catheters.The domestic cather can recorded data successfully.Compared with the similar imported catheter,the drawings recorded by the domestic products were almost the same.Through statistical analysis,the indexes of the two cathers showed no significant difference(P>0.05).[Conclusion]The domestic 24-hour pH monitoring of esophagus catheter may have consistency by comparison with imported one.It may be a useful tool for diagnosing GERD in the future.