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影响胃食管反流病患者治疗结局的因素:一项针对亚洲患者的前瞻性实用试验的结果

Factors influencing treatment outcome in patients with gastroesophageal reflux disease: outcome of a prospective pragmatic trial in Asian patients.

作者信息

Goh Khean Lee, Choi Kee Don, Choi Myung-Gyu, Hsieh Tsai-Yuan, Jung Hwoon-Yong, Lien Han-Chung, Menon Jayaram, Mesenas Steven, Park Hyojin, Sheu Bor-Shyang, Wu Justin Cy

机构信息

The Chinese University of Hong Kong, Shatin, Hong Kong SAR, Republic of China.

出版信息

BMC Gastroenterol. 2014 Sep 9;14:156. doi: 10.1186/1471-230X-14-156.

Abstract

BACKGROUND

Predicting response to proton pump inhibitor (PPI) treatment can aid the effective management of gastroesophageal reflux disease (GERD). The aim was to investigate the predictors of symptomatic response to pantoprazole in Asian patients with GERD; the first study of its kind in Asian patients.

METHODS

Asian patients with GERD symptoms (N = 209) received pantoprazole 40 mg daily for 8 weeks in a multinational, prospective, open-label study. Response was assessed using ReQuest™. Baseline and demographic factors were examined using logistic regression to determine if they were related to treatment response.

RESULTS

Response rates were 44.3% (Week 4) and 63.6% (Week 8) in Asian patients versus 60.7% (P < 0.001) and 72.2% (P = 0.010) for the rest of the world. Higher response rates at 8 weeks occurred in patients with erosive reflux disease (ERD; 71.3%) versus those with non-erosive reflux disease (NERD) at baseline (48.5%). The presence of ERD (P = 0.0143) and lower ReQuest™-GI scores at baseline (P = 0.0222) were associated with response. Improvements in quality of life (QoL) and anxiety and depression at 4 and 8 weeks were associated with treatment response (both P < 0.0001). Patient satisfaction correlated with treatment response (P < 0.0001), and improvement in anxiety and depression (P < 0.0001) and QoL (P < 0.0001).

CONCLUSIONS

Asian patients with GERD, especially those with NERD, may have lower response rates to PPIs than Western populations. ERD and less severe gastrointestinal symptoms may help to predict symptomatic responses to PPIs in Asian patients.

TRIAL REGISTRATION

ClinicalTrial.gov identifier: NCT00312806.

摘要

背景

预测质子泵抑制剂(PPI)治疗的反应有助于有效管理胃食管反流病(GERD)。本研究旨在调查亚洲GERD患者对泮托拉唑症状反应的预测因素;这是亚洲患者中首例此类研究。

方法

在一项多国、前瞻性、开放标签研究中,209名有GERD症状的亚洲患者每天服用40毫克泮托拉唑,持续8周。使用ReQuest™评估反应。通过逻辑回归分析基线和人口统计学因素,以确定它们是否与治疗反应相关。

结果

亚洲患者的反应率在第4周为44.3%,第8周为63.6%,而世界其他地区分别为60.7%(P < 0.001)和72.2%(P = 0.010)。糜烂性反流病(ERD)患者在第8周的反应率更高(71.3%),而基线时非糜烂性反流病(NERD)患者的反应率为48.5%。ERD的存在(P = 0.0143)和基线时较低的ReQuest™-GI评分(P = 0.0222)与反应相关。第4周和第8周生活质量(QoL)以及焦虑和抑郁的改善与治疗反应相关(均P < 0.0001)。患者满意度与治疗反应相关(P < 0.0001),与焦虑和抑郁的改善(P < 0.0001)以及QoL的改善(P < 0.0001)相关。

结论

亚洲GERD患者,尤其是NERD患者,对PPI的反应率可能低于西方人群。ERD和较轻的胃肠道症状可能有助于预测亚洲患者对PPI的症状反应。

试验注册

ClinicalTrial.gov标识符:NCT00312806。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9155/4176852/9b7dd0cea410/12876_2013_1184_Fig1_HTML.jpg

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