Department of Otorhinolaryngology Head and Neck Surgery, Deyang People's Hospital, Deyang Hospital Affiliated to Chengdu University of Traditional Chinese Medicine, Deyang, Sichuan, China.
Department of Otolaryngology Head and Neck Surgery, Longquanyi Hospital of West China Hospital of Sichuan University (The First People's Hospital of Longquanyi District of Chengdu), Chengdu, China.
PLoS One. 2024 May 2;19(5):e0302450. doi: 10.1371/journal.pone.0302450. eCollection 2024.
The incidence of gastroesophageal reflux disease (GERD) is increasing year by year, the clinical manifestations are complex and diverse, and the adverse effects of long-term use of proton pump inhibitors and gastrointestinal motility drugs have been of great concern in recent years. The effectiveness of tegoprazan in the treatment of GERD is still controversial. This protocol describes a systematic review and meta-analysis to evaluate the efficacy and safety of tegoprazan in the treatment of gastroesophageal reflux disease.
PubMed, Embase, Cochrane Library and Web of Science will be searched from the database inception to 1 March 2023. All randomized controlled trials related to tegoprazan for GERD will be included. Extracted data will include publication details, basic information, demographic data, intervention details and patient outcomes. The primary outcome will be complete resolution of major symptoms, complete resolution of heartburn, proportion of heartburn-free days, chronic cough, hoarseness, and adverse events. Risk of bias will be assessed using the Cochrane Collaboration's tool for assessing risk of bias. Article selection, data extraction and risk of bias assessment will be performed in duplicate by two independent reviewers. If the meta-analysis is precluded, we will conduct a descriptive synthesis using a best-evidence synthesis approach.
The results of this study will provide reliable evidence to evaluate the efficacy and safety of tegoprazan in the treatment of GERD and help patients, physicians and clinical investigators choose the most appropriate treatment.
胃食管反流病(GERD)的发病率逐年上升,临床表现复杂多样,质子泵抑制剂和胃肠动力药物长期使用的不良反应近年来备受关注。替戈拉赞治疗 GERD 的疗效仍存在争议。本方案描述了一项系统评价和荟萃分析,旨在评估替戈拉赞治疗胃食管反流病的疗效和安全性。
从数据库建立到 2023 年 3 月 1 日,我们将在 PubMed、Embase、Cochrane 图书馆和 Web of Science 上进行检索。所有与替戈拉赞治疗 GERD 相关的随机对照试验都将被纳入。提取的数据将包括出版物详细信息、基本信息、人口统计学数据、干预措施细节和患者结局。主要结局将是主要症状完全缓解、烧心完全缓解、无烧心天数比例、慢性咳嗽、声音嘶哑和不良事件。使用 Cochrane 协作组评估偏倚风险的工具来评估偏倚风险。文章选择、数据提取和偏倚风险评估将由两名独立的审查员进行重复。如果排除荟萃分析,我们将使用最佳证据综合方法进行描述性综合。
本研究的结果将提供可靠的证据来评估替戈拉赞治疗 GERD 的疗效和安全性,并帮助患者、医生和临床研究人员选择最合适的治疗方法。