【2017年整理】PPI-药物安全通讯.docVIP

FDA Drug Safety Communication: Low magnesium levels can be associated with long-term use of Proton Pump Inhibitor drugs(PPIs)美国食品药品监督管理局（FDA）药物安全通讯：长期使用质子泵抑制剂（PPIs）可能导致低镁血症Safety Announcement 安全通告[3-2-2011] The U.S. Food and Drug Administration (FDA) is informing the public that prescription proton pump inhibitor (PPI) drugs may cause low serum magnesium levels (hypomagnesemia) if taken for prolonged periods of time (in most cases, longer than one year). In approximately one-quarter of the cases reviewed, magnesium supplementation alone did not improve low serum magnesium levels and the PPI had to be discontinued.[2011年3月2日] 美国食品药品监督管理局告知公众，长期（大多数情况下，指超过1年）使用处方药类质子泵抑制剂（PPIs）可能导致血清镁水平降低(低镁血症)。其中约1/4的病例，单纯进行补充镁无法对血镁水平有明显改善，必须停止使用相关的质子泵抑制剂。PPIs work by reducing the amount of acid in the stomach and are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus. In 2009, approximately 21 million patients filled PPI prescriptions at outpatient retail pharmacies in the United States.2 Patients who take prescription PPIs usually stay on therapy for an average of about 180 days (6 months).3质子泵抑制剂可降低胃酸水平，用于胃食管反流症（GERD）、胃和小肠溃疡以及食管炎等疾病的治疗。2009年，美国大约有2100万患者通过门诊零售药房调配了质子泵抑制剂[2]。患者接受质子泵抑制剂治疗的平均治疗时间为180天（6个月）[3]。Prescription PPIs include Nexium (esomeprazole magnesium), Dexilant (dexlansoprazole), Prilosec (omeprazole), Zegerid (omeprazole and sodium bicarbonate), Prevacid (lansoprazole), Protonix (pantoprazole sodium), and AcipHex (rabeprazole sodium). Vimovo is a prescription combination drug product that contains a PPI (esomeprazole magnesium and naproxen). Over-the-counter (OTC) PPIs include Prilosec OTC (omeprazole), Zegerid OTC (omeprazole and sodium bicarbonate), and Prevacid 24HR (lansoprazole).处方药类质子泵抑制剂包括Nexium (埃索美拉唑镁)、Dexilant（右旋兰索拉唑）、Prilosec（奥美拉唑）、Zegerid（奥美拉唑+碳酸氢钠）、Prevacid（兰索拉唑）、Protonix（泮托拉唑钠）、以及AcipHex（雷贝拉唑钠）。Vimovo的成分为埃索美拉唑镁和萘普生，是含有一种质子泵抑制剂的复方处方药。非处方药类质子泵抑制剂包括Prilose