Digestive Physiology and Motility Lab, Instituto de Investigaciones Médico Biológicas, Universidad Veracruzana, Iturbide SN. Col Centro, Veracruz, VER, 91400, Mexico,
Clin Drug Investig. 2014 Feb;34(2):83-93. doi: 10.1007/s40261-013-0135-4.
To improve proton pump inhibitor effects, pharmacological modifications have been developed such as the use of enantiomer molecules (e.g., S-omeprazole, S-pantoprazole, or dexlansoprazole), or addition of NaHCO3 (for an immediate release) or magnesium (with a lower absorption for a more sustained effect).
The objective of this study was to assess the efficacy, safety, and tolerability of pantoprazole magnesium 40 mg once daily for 4 weeks, on the relief of reflux symptoms in gastroesophageal reflux disease (GERD) patients.
A phase IV, open-label, prospective, multicenter study was designed. Patients included were prescribed pantoprazole magnesium 40 mg orally once daily for 28±2 days. All patients had a history of persistent or recurrent heartburn and/or acid regurgitation for at least 3 months. Effectiveness and tolerability data obtained from patients who completed a minimum of 4 weeks of pantoprazole magnesium treatment were considered for analysis.
The account of baseline characteristics and demographics of GERD symptom intensity was made by analyzing the group of 4,343 patients that fulfilled all inclusion criteria; 54% were females (n=2,345) and 46% (n=1,998) males, with a mean age of 36.2±7.5 years. Severity of symptoms, assessed by the physician using the 4-point Likert scale, reduced by at least 80% from baseline intensity after treatment in the per protocol population. In the case of the intention-to-treat population, the improvement in symptom intensity was 73%. The number of patients that experienced any adverse events was 175/5,027 (3.48%).
Pantoprazole magnesium is a safe, effective, and well-tolerated drug that significantly improves GERD symptoms.
为了提高质子泵抑制剂的效果，已经开发了一些药理学修饰方法，例如使用对映体分子（例如 S-奥美拉唑、S-泮托拉唑或右旋兰索拉唑），或添加 NaHCO3（用于快速释放）或镁（吸收较低，作用更持久）。
本研究旨在评估泮托拉唑镁 40mg 每日一次，持续 4 周，治疗胃食管反流病（GERD）患者反流症状的疗效、安全性和耐受性。
设计了一项四期、开放标签、前瞻性、多中心研究。患者被规定口服泮托拉唑镁 40mg，每日一次，持续 28±2 天。所有患者均有持续或复发的烧心和/或胃酸反流至少 3 个月的病史。仅对完成至少 4 周泮托拉唑镁治疗的患者进行有效性和耐受性数据的分析。
对符合所有纳入标准的 4343 例 GERD 症状严重程度的基线特征和人口统计学数据进行了分析；54%为女性（n=2345），46%为男性（n=1998），平均年龄为 36.2±7.5 岁。在方案人群中，医生使用 4 分 Likert 量表评估的症状严重程度在治疗后至少从基线强度降低 80%。在意向治疗人群中，症状严重程度的改善为 73%。有任何不良事件的患者人数为 175/5027（3.48%）。
泮托拉唑镁是一种安全、有效、耐受性良好的药物，可显著改善 GERD 症状。
