诺普拉赞在胃食道逆流症的不同剂量:实用性,交叉集群,随机对照试验的研究方案,患者偏好臂
Dongke Wang1, Dan Zhou1, Xinghuang Liu1
1Division of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Trials
|December 2, 2023
概括
这项研究调查了中国胃食道逆流症 (GERD) 的最佳普拉赞剂量. 探索不同的治疗方案旨在改善对标准治疗无反应的患者的症状缓解.
科学领域:
- 胃肠病学 胃肠病学
- 药理学 药理学是指药理学的学科.
背景情况:
- 与质子抑制剂相比,Vonoprazan在GERD中提供了优越的酸性抑制.
- 目前在中国使用vonoprazan仅限于侵蚀性食道炎,30-40%的GERD患者无法达到每天20毫克的治疗目标.
- 这项研究解决了对中国GERD患者优化诺普拉赞治疗的需求.
研究的目的:
- 评估vonoprazan在缓解中国患者非侵蚀性反流性疾病 (NERD) 症状方面的疗效.
- 为了确定是否增加诺普拉桑的剂量或改变服用时间可以提高GERD患者的治疗反应率.
主要方法:
- 一个务实的,开放的,交叉集群随机对照试验,涉及48家中国医院的2880名GERD患者.
- 患者被分配到强制随机化或患者偏好组,每天接受vonoprazan 20 mg一次 (早餐或晚餐) 或每天两次.
- 主要结局是治疗4周后的症状缓解率;次要结局包括愈合率,症状严重程度和长期复发.
主要成果:
- 这项研究旨在探索各种vonoprazan疗法在中国GERD患者中的有效性.
- 在6个月的随访期间,将收集有关症状缓解,愈合率和长期结果的数据.
结论:
- 这项试验将提供关于不同诺普拉赞剂量策略在中国GERD管理中的有效性的见解.
- 试验的设计包括患者的偏好和交叉集群随机化,以提高研究结果的概括性.
相关概念视频
Acid Suppressive Drugs for Peptic Ulcer Disease: Proton Pump Inhibitors
435
Peptic ulcers, often induced by H. pylori infections or NSAID usage, arise from disruptions in the delicate balance of gastric acid production. Peptic ulcers stem from heightened gastric acid levels due to H. pylori infections or NSAID use. The protective mucus layer diminishes in the presence of these factors, allowing gastric acid to erode the stomach lining and form ulcers.
Gastric acid, a potent cocktail of hydrogen and chloride ions, is produced in specialized parietal cells within the...
Gastric acid, a potent cocktail of hydrogen and chloride ions, is produced in specialized parietal cells within the...
435
Gastroesophageal Reflux Disease II: Clinical Features and Management
88
Gastroesophageal reflux disease, or GERD, is a persistent medical condition that affects many individuals worldwide. Its clinical manifestations can vary greatly, making diagnosis and management challenging for healthcare professionals. The following is a comprehensive overview of the clinical manifestations, assessment, and management strategies for GERD.
Clinical Manifestations
GERD presents itself in a multitude of ways, with symptoms varying from person to person. The hallmark symptoms are...
Clinical Manifestations
GERD presents itself in a multitude of ways, with symptoms varying from person to person. The hallmark symptoms are...
88
Dosage Regimen: Fixed Dose
1.9K
Fixed-dose regimens are a common approach to administer drugs to achieve and maintain desired levels of the drug in the body. In this dosing strategy, a specific amount of medication is given at regular intervals, often multiple times a day, to ensure a consistent drug concentration in the bloodstream.
Fixed-dose regimens can be used for various routes of administration, including intravenous (IV) injections and oral medications. For IV administration, a predetermined amount of the drug is...
Fixed-dose regimens can be used for various routes of administration, including intravenous (IV) injections and oral medications. For IV administration, a predetermined amount of the drug is...
1.9K
Acid Suppressive Drugs for Peptic Ulcer Disease: Histamine H2-Receptor Antagonists
487
Histamine H2 receptors, which are intricately located on the basolateral membrane of parietal cells, play a crucial role in modulating gastric acid secretion. When released from enterochromaffin-like cells, histamine engages H2 receptors, initiating the cyclic AMP (cAMP) pathway. In this pathway, adenylyl cyclase converts ATP into cAMP, elevating intracellular cAMP levels. The activation of protein kinase A follows, stimulating the proton pump. This stimulation prompts the secretion of hydrogen...
487
Drugs for Peptic Ulcer Disease: Sucralfate as Mucosal Protective Agents
499
In the intricate landscape of the gastric lumen, excessive acid secretion disrupts the natural defense mechanisms, weakening the mucus-bicarbonate barrier. This vulnerability allows pepsin to infiltrate epithelial cells, digesting mucosal proteins and triggering erosion, leading to ulcer formation.
In this scenario, mucosal protective agents like sucralfate play an essential role. Sucralfate, a complex of sulfated sucrose and aluminum hydroxide, demonstrates its usefulness in acidic conditions,...
In this scenario, mucosal protective agents like sucralfate play an essential role. Sucralfate, a complex of sulfated sucrose and aluminum hydroxide, demonstrates its usefulness in acidic conditions,...
499
Acid Suppressive Drugs for Peptic Ulcer Disease: Antacids
374
In the complex environment of the gastric lumen, excessive acid secretion can lead to the formation or worsening of ulcers within the delicate mucosal layer. Antacids, such as sodium bicarbonate and calcium carbonate, provide relief by neutralizing this acid, transforming it into harmless salt and water. This neutralization process raises the gastric pH from a highly acidic level of 1 to a more basic 3-4, reducing the acidity within the stomach.
However, this neutralization reaction between...
However, this neutralization reaction between...
374


