Johnson David A, Katz Philip O, Armstrong David, Cohen Henry, Delaney Brendan C, Howden Colin W, Katelaris Peter, Tutuian Radu I, Castell Donald O
Department of Gastroenterology, Eastern Virginia Medical School, 885 Kempsville Rd, Suite 114, Norfolk, VA, 23505, USA.
Division of Gastroenterology, Einstein Medical Center, 5401 Old York Rd, Suite 363 Klein Building, Philadelphia, PA, 19141, USA.
Drugs. 2017 Apr;77(5):547-561. doi: 10.1007/s40265-017-0712-6.
The availability of over-the-counter (OTC) proton pump inhibitors (PPIs) for the short-term (2 weeks) management of frequent heartburn (≥2 days/week) has increased markedly, yet evidence-based recommendations have not been developed. A panel of nine international experts in gastroesophageal reflux disease developed consensus statements regarding the risks and benefits of OTC PPIs using a modified Delphi process. Consensus (based on ≥80% approval) was reached through multiple rounds of remote voting and a final round of live voting. To identify relevant data, the available literature was searched and summarized. Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system terminology was used to rate the quality of evidence and strength of recommendations; consensus was based on ≥2/3 agreement. After 4 rounds of review, consensus was achieved for 18 statements. Notably, the available data did not directly reflect OTC use, but instead, prescription use; therefore, extrapolations to the OTC setting were often necessary. This limitation is regrettable, but it justifies performing this exercise to provide evidence-based expert opinion on a widely used class of drugs. The panel determined that using OTC PPIs according to label instructions is unlikely to mask the symptoms of esophageal or gastric cancer or adversely impact the natural history of related precursor conditions. OTC PPIs are not expected to substantially affect micronutrient absorption or bone mineral density or cause community-acquired pneumonia, Clostridium difficile infection, or cardiovascular adverse events. However, OTC PPI use may be associated with slightly increased risks for infectious diarrhea, certain idiosyncratic reactions, and cirrhosis-related spontaneous bacterial peritonitis. The available evidence does not suggest that OTC PPI use consistent with label instructions is associated with substantial health risks. To minimize potential risks, healthcare professionals and consumers must actively participate in decision making when managing reflux-related symptoms in the self-care setting.
用于短期（2周）治疗频繁烧心（≥每周2天）的非处方质子泵抑制剂（PPI）的可及性显著增加，但尚未制定基于证据的推荐意见。一个由9名国际胃食管反流病专家组成的小组采用改良德尔菲法就非处方PPI的风险和益处制定了共识声明。通过多轮远程投票和最后一轮现场投票达成了共识（基于≥80%的批准率）。为了识别相关数据，对现有文献进行了检索和总结。使用推荐分级、评估、制定与评价（GRADE）系统术语对证据质量和推荐强度进行评级；共识基于≥2/3的同意率。经过4轮审查，就18项声明达成了共识。值得注意的是，现有数据并未直接反映非处方使用情况，而是处方使用情况；因此，通常有必要外推至非处方用药场景。这一局限性令人遗憾，但它证明了开展此项工作以就一类广泛使用的药物提供基于证据的专家意见是合理的。该小组确定，按照标签说明使用非处方PPI不太可能掩盖食管癌或胃癌的症状，也不太可能对相关前驱疾病的自然病程产生不利影响。预计非处方PPI不会对微量营养素吸收或骨密度产生实质性影响，也不会导致社区获得性肺炎、艰难梭菌感染或心血管不良事件。然而，使用非处方PPI可能会使感染性腹泻、某些特异反应以及肝硬化相关自发性细菌性腹膜炎的风险略有增加。现有证据并不表明按照标签说明使用非处方PPI会带来重大健康风险。为了将潜在风险降至最低，医疗保健专业人员和消费者在自我护理环境中管理反流相关症状时必须积极参与决策。
