预约演示
更新于：2025-03-21
Itopride Hydrochloride
盐酸伊托必利
更新于：2025-03-21
概要
基本信息
药物类型 小分子化药 |
别名 Itax、Itopride、Itopride Hydrochloridc + [19] |
作用方式 抑制剂、拮抗剂 |
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/序列
分子式C20H27ClN2O4 |
InChIKeyZTOUXLLIPWWHSR-UHFFFAOYSA-N |
CAS号122892-31-3 |
关联
38
项与 盐酸伊托必利 相关的临床试验TCTR20241012004
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
CTR20241978
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
NCT05966025
Evaluation of the Potential Benefits of Itopride in the Management of Patients With Metabolic Associated Fatty Liver Disease
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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424
项与 盐酸伊托必利 相关的文献（医药）2025-01-02Expert Opinion On Drug Safety
Risk of drug-induced delirium in older patients- a pharmacovigilance study of FDA adverse event reporting system database
Article
作者: Li, Jiayu ; Zhou, Ying ; Jia, Boying ; Zhou, Shuang ; Wan, Liyan ; Cui, Yimin
BACKGROUND:
Drug-induced delirium is known risk factors associated with increased morbidity and mortality in older patients. The objective was to evaluate the risk of drug-related delirium in older patients based on the FDA Adverse Event Reporting System (FAERS).
RESEARCH DESIGN AND METHODS:
Delirium reports in older patients (age ≥65) extracted from the FAERS database using Open Vigil 2.1. The reported odds ratio and the proportional reported ratio were calculated to detect the adverse reaction signal of delirium. Combined with published evidence, suspected drugs were categorized as known, possible, or new potential delirium-risk-increasing drugs.
RESULTS:
Of the 130,885 reports (including 28,850 delirium events and 1,857 drugs) analyzed for this study, 314 positive signal drugs were detected. Positive signal drugs are mainly concentrated on the drug of nervous system, cardiovascular system , alimentary tract and metabolism and anti-infectives for systemic use. Of the positive signal drugs, 26.11% (82/314) were known delirium-risk increasing drugs, 44.90% (141/314) were possible and 28.98% (91/314) were new potential.
CONCLUSION:
Drug-induced delirium risk is prevalent in older patients, according to the FAERS. The risk level of drug-induced delirium should be taken into account to optimize drug therapy in clinical practice.
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 ; Khoo, Stanley ; Chuah, Kee Huat ; Khoo, Xin Hui ; Natarajan, Vicraman ; Loo, Qing Yuan ; Jubri, Nurhidayah Binti Mohammad ; Panirsheeluam, Sarala
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.
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
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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 | - | - | 鑰繭範醖膚觸遞製蓋顧(構構衊鹽積廠夢窪鹽餘) = 窪齋糧淵壓鹹觸鹹範鏇 獵憲築願蓋網憲衊觸蓋 (簾艱鑰憲構壓醖餘淵鑰, 25) | - | 2018-10-01 | ||
鑰繭範醖膚觸遞製蓋顧(構構衊鹽積廠夢窪鹽餘) = 遞鹽廠膚獵窪襯蓋齋艱 獵憲築願蓋網憲衊觸蓋 (簾艱鑰憲構壓醖餘淵鑰, 32) | |||||||
N/A | - | 製積築鏇襯觸鬱餘遞鬱(鬱衊觸鏇範鬱網觸憲積) = 夢艱網範選鹹憲獵觸簾 網製顧糧網顧窪壓艱願 (醖憲糧遞壓積餘憲壓襯 ) 更多 | - | 2005-06-01 | |||
Placebo | 製積築鏇襯觸鬱餘遞鬱(鬱衊觸鏇範鬱網觸憲積) = 壓鏇觸網積構網築齋鑰 網製顧糧網顧窪壓艱願 (醖憲糧遞壓積餘憲壓襯 ) 更多 |
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