Potgieter Wilna, Samuels Caroline Selma, Snyman Jacques Renè
Department of Pharmacology, School of Medicine, Faculty of Health Sciences, University of Pretoria, Pretoria, Gauteng, South Africa.
Clin Exp Gastroenterol. 2014 Jul 1;7:215-20. doi: 10.2147/CEG.S51222. eCollection 2014.
The cation exchanger, a potentiated clinoptilolite (Absorbatox™ 2.4D), is a synthetically enhanced aluminosilicate. The aim of this study was to evaluate the possible benefits of a potentiated clinoptilolite as a gastroprotective agent in reducing the severity of clinical symptoms and signs associated with 1) endoscopically negative gastroesophageal reflux disease (ENGORD) and 2) nonsteroidal anti-inflammatory drug (NSAID) medication.
Two randomized, double-blind, placebo-controlled, pilot studies, the ENGORD and NSAID studies, were conducted. After initial negative gastroscopy, a total of 25 patients suffering from ENGORD were randomized to receive either placebo capsules or 750 mg Absorbatox twice daily for 14 days. The NSAID study recruited 23 healthy patients who received orally either 1,500 mg Absorbatox or placebo three times daily, plus 500 mg naproxen twice daily. Patients underwent gastroscopic evaluation of their stomach linings prior to and on day 14 of the study. Gastric biopsies were obtained and evaluated via the upgraded Sydney system, whereas visible gastric events and status of the gastric mucosa were evaluated via a 0-3 rating scale. During both studies, patients recorded gastric symptoms in a daily symptom diary.
In the ENGORD study, patients who received the potentiated clinoptilolite reported a significant reduction (P≤0.05) in severity of symptoms including reduction in heartburn (44%), discomfort (54%), and pain (56%). Symptom-free days improved by 41% compared to the group who received placebo (not significant). This was over and above the benefits seen with the proton pump inhibitor. In the NSAID study, the reduction in gastric symptom severity was echoed in the group who received the potentiated clinoptilolite. Treatment with the potentiated clinoptilolite resulted in significant prevention (P≤0.05) of mucosal erosion severity as graded by the gastroenterologist.
Absorbatox is a nonabsorbable aluminosilicate with potential gastroprotective benefits as it protected against ENGORD symptoms and NSAID-induced gastric events. The exact mechanism of action is not clear but may be due to its binding to hydrogen ions and biologically active amines and nitrates.
阳离子交换剂,一种强化斜发沸石(Absorbatox™ 2.4D),是一种合成增强的铝硅酸盐。本研究的目的是评估强化斜发沸石作为一种胃保护剂在减轻与1)内镜检查阴性的胃食管反流病(ENGORD)和2)非甾体抗炎药(NSAID)用药相关的临床症状和体征严重程度方面的潜在益处。
进行了两项随机、双盲、安慰剂对照的试点研究,即ENGORD研究和NSAID研究。在初次胃镜检查为阴性后,共有25名ENGORD患者被随机分为两组,分别接受安慰剂胶囊或每天两次、每次750毫克的Absorbatox,持续14天。NSAID研究招募了23名健康患者,他们每天口服1500毫克的Absorbatox或安慰剂三次,外加每天两次、每次500毫克的萘普生。在研究前和研究第14天,患者接受了胃黏膜的胃镜评估。获取胃活检组织并通过改良的悉尼系统进行评估,而可见的胃部事件和胃黏膜状态则通过0 - 3评分量表进行评估。在两项研究中,患者在每日症状日记中记录胃部症状。
在ENGORD研究中,接受强化斜发沸石的患者报告症状严重程度显著降低(P≤0.05),包括烧心(降低44%)、不适(降低54%)和疼痛(降低56%)。与接受安慰剂的组相比,无症状天数改善了41%(无统计学意义)。这超过了质子泵抑制剂所带来的益处。在NSAID研究中,接受强化斜发沸石的组胃部症状严重程度也有所降低。强化斜发沸石治疗导致胃肠病学家分级的黏膜糜烂严重程度得到显著预防(P≤0.05)。
Absorbatox是一种不可吸收的铝硅酸盐,具有潜在的胃保护益处,因为它能预防ENGORD症状和NSAID引起的胃部事件。确切的作用机制尚不清楚,但可能是由于它与氢离子、生物活性胺和硝酸盐结合。