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质子泵抑制剂使用者中无反应的相关因素:一项关于兰索拉唑治疗的研究。

Factors associated with non-response in proton pump inhibitor users: a study of lansoprazole therapy.

作者信息

Claessens A A, Heerdink E R, Lamers C B, van Eijk J T, Leufkens H G

机构信息

Department of Pharmacoepidemiology and Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht, The Netherlands.

出版信息

Pharm World Sci. 2001 Jun;23(3):107-10. doi: 10.1023/a:1011279426224.

Abstract

BACKGROUND

Proton pump inhibitors (PPI) demonstrate high healing rates of 85-98% in clinical trials. Due to the limited knowledge regarding response and non-response to lansoprazole in daily practice and for the reason that resistance to PPIs is scarce, we investigated factors possibly associated with non-response.

METHODS

Data were used from a prospective, open label, observational follow-up study in which 10,008 lansoprazole users were followed over time. The study was designed according to the SAMM guidelines. A matched nested case-control design was used to compare non-responding (cases) and responding (controls) lansoprazole users. Non-response was defined as worsening or non-improvement of symptoms at the first evaluation after at least 8 weeks of use, response as disappearance or improvement of symptoms within 8 weeks of use. Controls were matched for the evaluating physician.

RESULTS

A total of 186 non-responders and 372 responders to PPI treatment were identified as cases and controls. Age of over 60 years, heavy smoking and previous use of PPIs were significantly more common in non-responding patients compared with responding patients. There were no differences found between the reported diagnosis regarding response.

CONCLUSION

In daily clinical practice, previous use of PPIs, heavy smoking and an age > 60 years were significantly associated with non-response to treatment with lansoprazole. Previous use of PPIs in non-responding patients might suggest resistance to PPIs. The knowledge that non-response drives non-response may encourage physicians to follow PPI users with previous PPI use more closely.

摘要

背景

质子泵抑制剂(PPI)在临床试验中显示出85%-98%的高治愈率。由于在日常实践中对兰索拉唑反应和无反应的了解有限,且对PPI耐药的情况很少见,我们调查了可能与无反应相关的因素。

方法

数据来自一项前瞻性、开放标签、观察性随访研究,对10008名使用兰索拉唑的患者进行了长期随访。该研究是根据SAMM指南设计的。采用匹配巢式病例对照设计,比较兰索拉唑无反应(病例)和有反应(对照)的使用者。无反应定义为使用至少8周后首次评估时症状恶化或无改善,有反应定义为使用8周内症状消失或改善。对照与评估医生进行匹配。

结果

共确定186名PPI治疗无反应者和372名有反应者作为病例和对照。与有反应的患者相比,60岁以上、大量吸烟和既往使用过PPI在无反应患者中更为常见。在报告的诊断方面,有反应和无反应之间没有差异。

结论

在日常临床实践中,既往使用过PPI、大量吸烟和年龄>6岁与兰索拉唑治疗无反应显著相关。无反应患者既往使用过PPI可能提示对PPI耐药。了解无反应会导致无反应这一情况,可能会鼓励医生更密切地随访既往使用过PPI的PPI使用者。

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