Department of Pediatrics, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan.
Department of Clinical Pathology, Taipei Medical University Hospital, Taipei, Taiwan.
J Clin Pharm Ther. 2021 Jun;46(3):786-793. doi: 10.1111/jcpt.13353. Epub 2021 Jan 6.
Proton-pump inhibitors (PPIs) and histamine-2-receptor antagonists (H2RAs) are two of the most widely used acid-suppressive drugs (ASDs). Some studies have reported that prenatal ASD exposure may increase the risk of asthma and other allergic diseases. This study investigated the effects of ASDs on the risk of atopic dermatitis in patients with upper gastrointestinal diseases.
This population-based retrospective cohort study used data of 289,850 patients with at least two diagnoses of upper gastrointestinal diseases (UGIDs) between 1 January 2001 and 31 December 2005, from Taiwan's National Health Insurance Research Database. The AD risks among ASD users and nonusers were compared. Differences in sociodemographic characteristics and potential covariates were examined. AD hazard ratios were estimated, and groups were compared using Cox proportional hazards regression analysis after adjustment for age, sex and other covariates.
In total, 109,980 patients were included. The adjusted hazard ratio (HR) of AD risk in ASD users relative to that in nonusers was 1.52 (95% confidence interval [CI]: 1.40-1.64, p < 0.001). For a dose-effect sub-analysis, patients were divided into four groups based on their defined daily dose. ASDs dose-dependently affected the AD risk (p for trend <0.01). Furthermore, the adjusted HR of the AD risk among ASD nonusers was 2.30 (95% CI: 2.06-2.57) relative to that in the comparison group (ASD nonusers without UGIDs). Among patients with UGIDs, ASD users had a higher AD risk than ASD nonusers. A subgroup analysis revealed only H2RA use was associated with an increased AD risk (adjusted HR 1.70, 95% CI: 1.53-1.89, p < 0.001).
These results indicate that the use of H2RAs was associated with an increased risk of AD among patients with UGIDs, and the increase in risk appeared to be dose-dependent. ASDs should be used only in situations where clear clinical benefits can be obtained.
质子泵抑制剂（PPIs）和组胺 2 受体拮抗剂（H2RAs）是两种最广泛使用的酸抑制药物（ASD）。一些研究报告称，产前 ASD 暴露可能会增加哮喘和其他过敏性疾病的风险。本研究调查了 ASD 对上消化道疾病患者特应性皮炎风险的影响。
本基于人群的回顾性队列研究使用了台湾全民健康保险研究数据库中 2001 年 1 月 1 日至 2005 年 12 月 31 日期间至少有两次上消化道疾病（UGID）诊断的 289850 名患者的数据。比较 ASD 使用者和非使用者的 AD 风险。检查了社会人口统计学特征和潜在混杂因素的差异。在调整年龄、性别和其他混杂因素后，使用 Cox 比例风险回归分析估计 AD 危害比，并对各组进行比较。
共纳入 109980 名患者。与非使用者相比，ASD 使用者的 AD 风险调整后危害比（HR）为 1.52（95%置信区间[CI]：1.40-1.64，p<0.001）。对于剂量效应亚分析，根据患者的定义日剂量将患者分为四组。ASD 剂量依赖性地影响 AD 风险（p<0.01）。此外，与对照组（无 UGID 的 ASD 非使用者）相比，UGID 患者中 ASD 非使用者的 AD 风险的调整 HR 为 2.30（95%CI：2.06-2.57）。在 UGID 患者中，ASD 使用者的 AD 风险高于 ASD 非使用者。亚组分析显示，仅 H2RA 使用与 AD 风险增加相关（调整后 HR 1.70，95%CI：1.53-1.89，p<0.001）。
这些结果表明，H2RA 的使用与 UGID 患者的 AD 风险增加相关，并且风险增加似乎呈剂量依赖性。只有在明确的临床获益可以获得的情况下，才应使用 ASD。
