对于有反流症状的胃食管反流病（GERD）患者，pH阻抗监测的反流发作次数与症状改善及治疗满意度相关。
Number of reflux episodes on pH-impedance monitoring associates with improved symptom outcome and treatment satisfaction in gastro-oesophageal reflux disease (GERD) patients with regurgitation.
作者信息
Rogers Benjamin D, Valdovinos Luis R, Crowell Michael D, Bell Reginald, Vela Marcelo F, Gyawali C Prakash
机构信息
Division of Gastroenterology, Washington University in Saint Louis, Saint Louis, Missouri, USA.
Division of Gastroenterology and Hepatology, Mayo Clinic Arizona, Scottsdale, Arizona, USA.
出版信息
Gut. 2021 Mar;70(3):450-455. doi: 10.1136/gutjnl-2020-321395. Epub 2020 May 28.
OBJECTIVE
Number of reflux episodes, an adjunctive metric on pH-impedance monitoring, is incompletely studied. We aimed to determine if number of reflux episodes associates with therapeutic outcome in regurgitation predominant gastro-oesophageal reflux disease (GERD).
DESIGN
We performed post hoc analysis of postintervention pH-impedance data from adult patients with moderate/severe regurgitation despite QD proton pump inhibitor (PPI), randomised to either two times a day PPI or magnetic sphincter augmentation (MSA) in 2:1 allocation. After 6 and 12 months, symptom response was defined by improvement in Foregut Symptom Questionnaire (FSQ) regurgitation score to none or minimal, ≥50% reduction in GERD health-related quality of life (HRQL) score and satisfaction with therapy. Univariate and multivariate analyses were performed to determine predictors of symptom improvement.
RESULTS
Of 152 randomised patients, 123 (age 46.9±1.2 year, 43% female) had complete data. Symptom and satisfaction scores significantly improved after MSA compared with two times a day PPI. Both acid exposure time (13.4%±0.7% to 1.3±0.2%, p<0.001) and reflux episodes (86±4 to 48±4, p<0.001) declined with therapy. Reduction to <40 reflux episodes was significantly more frequent in those with symptom response by FSQ regurgitation score, GERD HRQL score and satisfaction with therapy (p≤0.03 for each); <35 episodes performed better on receiver operating characteristic analysis. On multivariate analysis, improvement in regurgitation score remained independently predictive of satisfaction with therapy (p<0.001 for each). In patients crossing over to MSA, >80 episodes pretreatment predicted improvement.
CONCLUSIONS
Reduction of reflux episodes on pH-impedance to physiological levels associates with improved outcomes, while pathological levels predict improvement with MSA in regurgitation predominant GERD.
TRAIL REGISTRATION NUMBER
ClinicalTrials.gov: NCT02505945.
目的
反流发作次数作为pH阻抗监测的一项辅助指标，目前研究尚不充分。我们旨在确定反流发作次数是否与以反流为主的胃食管反流病（GERD）的治疗效果相关。
设计
我们对成年患者的干预后pH阻抗数据进行了事后分析，这些患者尽管每日服用质子泵抑制剂（PPI），仍有中度/重度反流，按2:1的比例随机分为每日两次PPI组或磁括约肌增强术（MSA）组。6个月和12个月后，症状缓解的定义为前肠症状问卷（FSQ）反流评分改善至无或轻微，GERD健康相关生活质量（HRQL）评分降低≥50%，以及对治疗满意。进行单因素和多因素分析以确定症状改善的预测因素。
结果
152例随机分组的患者中，123例（年龄46.9±1.2岁，43%为女性）有完整数据。与每日两次PPI相比，MSA治疗后症状和满意度评分显著改善。治疗后酸暴露时间（从13.4%±0.7%降至1.3±0.2%，p<0.001）和反流发作次数（从86±4次降至48±4次，p<0.001）均下降。FSQ反流评分、GERD HRQL评分及对治疗满意的患者中，反流发作次数减少至<40次的情况显著更常见（每项p≤0.03）；<35次在受试者工作特征分析中表现更佳。多因素分析显示，反流评分的改善仍然是治疗满意度的独立预测因素（每项p<0.001）。在转而接受MSA治疗的患者中，治疗前发作次数>80次可预测改善情况。
结论
pH阻抗监测中反流发作次数降至生理水平与治疗效果改善相关，而在以反流为主的GERD中，病理水平的发作次数可预测MSA治疗的改善情况。
试验注册号
ClinicalTrials.gov：NCT02505945。
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