更新于：2024-12-31
Itopride Hydrochloride
盐酸伊托必利
更新于：2024-12-31
概要
基本信息
药物类型 小分子化药 |
别名 Itax、Itopride、Itopride Hydrochloridc + [19] |
作用机制 AChE抑制剂(乙酰胆碱酯酶抑制剂)、D2 receptor拮抗剂(多巴胺D2受体拮抗剂) |
非在研适应症 |
最高研发阶段批准上市 |
首次获批日期 日本 (1995-06-30), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构
分子式C20H27ClN2O4 |
InChIKeyZTOUXLLIPWWHSR-UHFFFAOYSA-N |
CAS号122892-31-3 |
关联
39
项与 盐酸伊托必利 相关的临床试验A Bioequivalence Study of Open-label, Randomized, Single Oral Dose, Two-way Crossover Design of Generic Itopride Hydrochloride 50 mg Film Coated Tablets and Reference Product (Ganaton) in Healthy Thai Subjects under Fasting Conditions
盐酸伊托必利片在健康受试者中单剂量、随机、开放、空腹两周期/餐后四周期、两序列、交叉设计的生物等效性试验
Randomized Multicentre Open-label Study to Investigate the Non-inferiority of Itopride Hydrochloride 150mg Once Daily Versus Itopride Hydrochloride 50 mg Thrice Daily in Subjects With Functional (Non-ulcer) Dyspepsia or Chronic Gastritis
100 项与 盐酸伊托必利 相关的临床结果
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100 项与 盐酸伊托必利 相关的转化医学
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100 项与 盐酸伊托必利 相关的专利（医药）
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169
项与 盐酸伊托必利 相关的文献（医药）2025-01-01ALIMENTARY PHARMACOLOGY & THERAPEUTICS
Clinical Trial: Treatment of Functional Dyspepsia According to Subtype Compared With Empirical Proton Pump Inhibitor
Article
作者: Hian, Wen Xuan ; Mahadeva, Sanjiv ; Chuah, Kee Huat ; Khoo, Stanley ; Khoo, Xin Hui ; Natarajan, Vicraman ; Jubri, Nurhidayah Binti Mohammad ; Panirsheeluam, Sarala ; Loo, Qing Yuan
ABSTRACT:
Background:
International guidelines recommend contrasting initial treatment strategies for functional dyspepsia (FD).
Aims:
To evaluate the efficacy and safety of treatment according to subtypes, compared with empirical proton pump inhibitor (PPI), in the initial treatment of FD.
Methods:
We performed a single‐blinded, randomised controlled trial of adults with FD. In the intervention group (treatment according to subtype), patients were categorised into epigastric pain syndrome (treatment esomeprazole); postprandial distress syndrome (PDS; treatment itopride) and overlap (treatment itopride, maintain, add/or switch to esomeprazole at week 4). The control group received esomeprazole only. The primary efficacy outcome was the assessment of global symptom improvement (primary end point: best two points from the 7‐point Likert scale) over 8 weeks. Secondary outcomes included assessment of the change in nine individual upper gastrointestinal symptoms, quality of life (Short‐Form Nepean Dyspepsia Index) and adverse events.
Results:
We randomised 180 patients (median age: 50; 68.7% female 56.7% PDS) 1:1 into intervention and control arms. The percentage of patients achieving the primary efficacy outcome were 74.4% and 72.2%, respectively (p = 0.74). The improvement of individual symptoms in both groups were similar. The SF‐NDI improved after treatment in both groups (p < 0.001) but there was no significant difference in the degree of change between groups. Rates of adverse events between groups were similar at week 8.
Conclusion:
Initial treatment of FD according to subtype was not more effective than empirical PPI alone for up to 8 weeks. Further multicentre studies, with a larger sample size, are recommended to validate these findings.Trial Registration: ClinicalTrials.gov identifier: NCT04918017
2024-12-01The Journal of the Association of Physicians of India
Proposed Algorithm for the Diagnosis and Management of Functional Dyspepsia in India.
Article
作者: Mohan, V G ; Rai, Ramesh R ; Goyal, Omesh ; Zargar, Showkat A ; Pratap, Nitesh ; Shankar, Ravi B
Disorders of gut-brain interaction (DGBI), formerly known as functional bowel disorders, encompass a diverse array of conditions and symptoms that may manifest in different parts of the gastrointestinal tract. Some of the most prevalent DGBIs include functional dyspepsia, irritable bowel syndrome, functional constipation, functional diarrhea, and functional bloating and distension. Around 80% of patients with dyspepsia have no identifiable organic cause and are labeled as functional dyspepsia. Globally, functional dyspepsia prevalence ranges from 11 to 30%. In India, physicians encounter 20-40% of patients with functional dyspepsia, with variations attributed to diagnostic criteria and regions. However, Indian clinical guidelines for functional dyspepsia are currently lacking. Fifty gastroenterologists participated in focus group discussions to create an India-specific algorithm for the diagnosis and management of functional dyspepsia. After several national and regional discussions among groups of gastroenterologists across India, an algorithm was finalized for careful and thorough clinical evaluation of patients presenting with chronic dyspeptic symptoms. This guidance document highlights the role of endoscopic evaluation and Helicobacter pylori infection in the diagnosis of functional dyspepsia, along with the role of proton pump inhibitors (PPIs) and prokinetics in its treatment. The experts also reviewed the use of several prokinetics and provided their views on the choice of drugs for varied clinical presentations of functional dyspepsia. Among prokinetics, the experts believed that itopride was the preferred and relatively safer option for the treatment of functional dyspepsia.
2024-09-01Respiratory Investigation
Gastroesophageal reflux disease in chronic obstructive pulmonary disease
Review
作者: Tanimura, Kazuya ; Muro, Shigeo
Gastroesophageal reflux disease (GERD) is one of the most common comorbidities of chronic obstructive pulmonary disease (COPD). Decreased lower and upper esophageal sphincter pressures, esophageal dysmotility, high transdiaphragmatic pressure, and decreased saliva secretion have been implicated as mechanisms leading to the development of GERD in COPD. Clinically, comorbid GERD in COPD is reportedly associated with worse symptoms, quality of life, and lung function, as well as a high risk of exacerbations. Aspiration of regurgitation and the cholinergic-mediated esophagobronchial reflex play a significant role in the pathophysiology. Abnormal swallowing reflexes and discoordination of swallowing can worsen aspiration. The diagnosis of GERD is not based on a single criterion; however, various approaches, including questionnaires and endoscopic evaluations, can be widely applied in clinical settings. Due to the increased risk of esophageal and gastric cancers in patients with COPD, the threshold for endoscopic examination should be low. Acid inhibitory agents, such as proton pump inhibitors and histamine H2 receptor antagonists, and prokinetic agents, including mosapride and itopride, are clinically used to treat GERD. Endoscopic fundoplication can be performed in patients with GERD refractory to medical treatment. There is still insufficient evidence, but an increasing number of studies have suggested the clinical efficacy of treatment in patients with COPD and GERD. As GERD is an evaluative and treatable common disease, and access to evaluation and treatment is relatively easy, clinicians should provide adequate care for GERD in the management of COPD.
100 项与 盐酸伊托必利 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 胃肠道疾病 | 印度 | 2003-01-20 | |
| 慢性胃炎 | 日本 | 1995-06-30 | |
| 心脏衰竭 | 中国 | - | - |
| 高血压 | 中国 | - | - |
| 恶心 | - | - | - |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 胃灼热 | 临床3期 | 美国 | 2006-10-01 | |
| 肠道疾病 | 临床3期 | 美国 | 2005-11-01 | |
| 腹部膨胀 | 临床3期 | 加拿大 | 2004-07-01 | |
| 消化不良 | 临床3期 | 德国 | 2000-12-01 | |
| 便秘型肠易激综合征 | 临床2期 | 巴基斯坦 | 2008-06-01 | |
| 呕吐 | 临床2期 | 美国 | 2005-08-01 | |
| 胰岛素依赖型糖尿病2 | 临床2期 | 澳大利亚 | 2005-03-01 | |
| 胃轻瘫 | 临床2期 | 澳大利亚 | 2005-03-01 |
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临床结果
临床结果
适应症
分期
评价
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N/A | - | - | 膚遞獵齋蓋醖廠顧膚窪(廠製遞蓋鹽簾簾夢顧憲) = 憲鑰鹹齋積製積積積餘 製選鑰衊蓋蓋鹹鹹簾積 (窪鹽淵鏇簾觸夢廠廠齋, 25) | - | 2018-10-01 | ||
膚遞獵齋蓋醖廠顧膚窪(廠製遞蓋鹽簾簾夢顧憲) = 糧鹽觸膚廠壓獵淵齋鑰 製選鑰衊蓋蓋鹹鹹簾積 (窪鹽淵鏇簾觸夢廠廠齋, 32) | |||||||
N/A | - | 獵獵繭鏇願夢齋鑰齋製(壓築蓋餘鏇憲糧壓鹽衊) = 艱廠鹹觸築築簾簾獵廠 鹹鹹艱構窪鹽繭積憲獵 (蓋獵簾簾網壓窪繭鹹蓋 ) 更多 | - | 2005-06-01 | |||
Placebo | 獵獵繭鏇願夢齋鑰齋製(壓築蓋餘鏇憲糧壓鹽衊) = 餘膚簾餘遞顧鏇選獵醖 鹹鹹艱構窪鹽繭積憲獵 (蓋獵簾簾網壓窪繭鹹蓋 ) 更多 |
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