Quartarone G
Medical Affairs Manager and Scientific Service Manager, Novartis CH, Italy -
Minerva Ginecol. 2013 Oct;65(5):541-9.
The prevalence of gastroesophageal reflux disease (GERD) symptoms in pregnancy is very high, up to 80%, with a maximum peak during the third trimester. Together with lifestyle modifications, antacids and antisecretive agents, such as proton pump inhibitors (PPIs) and histamine H2 receptor antagonists (H2RAs), are commonly prescribed in non-pregnant, adult population. In certain Countries these drugs are not allowed in or are allowed only during the late stages of pregnancy. Alginate-based formulations have been used for the symptomatic treatment of heartburn for decades, as they usually contain sodium or potassium bicarbonate. In the presence of gastric acid, a foamy raft is created above the gastric contents. The alginate raft moves into the esophagus in place or ahead of acidic gastric contents during reflux episodes physically preventing reflux of gastric contents into the esophagus. Alginate-based formulations are allowed with no restrictions also in pregnancy: their safety profile make them a very valid option taking into account the risk/benefit ratio for both parturient and unborn baby. This systematic review paper aims to explore the use of medications for treating GERD in pregnancy, including alginate raft-forming-agents, highlighting the benefits for both the mother and the fetus. Electronic search in databases was conducted on databases such as Medline, PubMed, Ovid retrieving data concerning the reflux treatments in pregnancy, with a special focus on alginate raft forming antireflux agents. From the literature on alginate use in pregnancy, no particular risks have been shown to date for both parturient and unborn baby when alginate had been administered during all the pregnancy trimesters. The physical mode of action ensures the maximum esophageal protection by the neutral foam floating in the stomach, maintaining physiological pH values at stomach level, without interfering with the digestive processes. The symptoms' healing has been markedly improved during the weeks of observation; the symptoms monitored in all studies were: heartburn, regurgitation, pain (chest). After four weeks of treatment little or no change was observed in maternal mean sodium or potassium concentrations. No sodium restriction diet has been adopted. No edema of lower limbs or weight gain occurred. No adverse reactions related to the testing drug had been reported and all the authors concluded that alginate was safe for the unborn baby. Nowadays pharmacological treatments for GER are available as OTC drugs, including antacids, antisecretive agents, PPIs and H2RAs, and as medical devices, such as alginate raft forming antireflux agents (i.e.: Reflubloc™, Novartis NCH Italy). On this last product, considering the specific indication in pregnancy and the safety profile, without restrictions of administration during the whole pregnancy period, furthermore the physical mode of action, it gives the gynecologists a very important option in treating GER in pregnancy, taking care of both pregnant and fetus. Raft-forming-antireflux agents are safe and effective in GER treatment during pregnancy.
妊娠期间胃食管反流病(GERD)症状的发生率非常高,可达80%,在妊娠晚期达到峰值。除了生活方式的改变外,抗酸剂和抗分泌药物,如质子泵抑制剂(PPI)和组胺H2受体拮抗剂(H2RA),在非妊娠成年人群中常用。在某些国家,这些药物在孕期禁用或仅在妊娠晚期允许使用。基于藻酸盐的制剂已经用于烧心症状的治疗数十年,因为它们通常含有碳酸氢钠或碳酸氢钾。在胃酸存在的情况下,会在胃内容物上方形成一个泡沫筏。在反流发作期间,藻酸盐筏会原位或在酸性胃内容物之前进入食管,从物理上防止胃内容物反流至食管。基于藻酸盐的制剂在孕期也可无限制使用:考虑到对产妇和未出生婴儿的风险/效益比,其安全性使其成为一个非常有效的选择。本系统评价论文旨在探讨孕期治疗GERD的药物使用情况,包括形成藻酸盐筏的药物,强调对母亲和胎儿的益处。对Medline、PubMed、Ovid等数据库进行了电子检索,获取有关孕期反流治疗的数据,特别关注形成藻酸盐筏的抗反流药物。从关于藻酸盐在孕期使用的文献来看,迄今为止,在整个孕期使用藻酸盐对产妇和未出生婴儿均未显示出特殊风险。其物理作用方式可通过漂浮在胃中的中性泡沫确保对食管的最大保护,维持胃内的生理pH值,而不干扰消化过程。在观察期间的几周内,症状的缓解有明显改善;所有研究中监测的症状包括:烧心、反流、疼痛(胸部)。治疗四周后,产妇的平均钠或钾浓度几乎没有变化。未采用限钠饮食。未出现下肢水肿或体重增加。未报告与受试药物相关的不良反应,所有作者均得出结论,藻酸盐对未出生婴儿是安全的。如今,GER的药物治疗可作为非处方药使用,包括抗酸剂、抗分泌药物、PPI和H2RA,也可作为医疗器械使用,如形成藻酸盐筏的抗反流药物(即:Reflubloc™,诺华意大利NCH公司)。对于最后这种产品,考虑到其在孕期的特定适应症和安全性,在整个孕期均可无限制给药,此外其物理作用方式,使其成为妇科医生治疗孕期GERD的一个非常重要的选择,同时兼顾孕妇和胎儿。形成筏的抗反流药物在孕期GER治疗中安全有效。