酒石酸铋(Bismuth Tartrate) - 在研适应症：溃疡性结肠炎，萎缩性胃炎，幽门螺杆菌感染_专利_临床

概要

基本信息

药物类型

小分子化药

别名

colloidal bismuth tartrate

靶点-

作用方式-

作用机制-

治疗领域

感染消化系统疾病

在研适应症

溃疡性结肠炎萎缩性胃炎幽门螺杆菌感染+ [1]

非在研适应症-

原研机构-

在研机构

盈信药业（汕头）有限公司

非在研机构-

权益机构-

最高研发阶段批准上市

首次获批日期-

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C12H18Bi2O18

InChIKeyYRPZNDFSTXWHOM-YDXPQRMKSA-N

CAS号6591-56-6

关联

20

项与酒石酸铋相关的临床试验

ChiCTR2500099092

/ SuspendedN/AIIT

A randomized, double-blind, controlled clinical study on the effect of Lactobacillus rhamnosus LR-G100 combined with bismuth quadruple therapy on Helicobacter pylori eradication

开始日期2025-03-08

申办/合作机构-

ChiCTR2400079593

/ Suspended临床4期IIT

Evaluation of the Efficacy and Safety of the Quadruple Therapy with Brachyspira Yeast and Bismuth in Eradicating Helicobacter pylori: A Prospective, Randomized, Open-Label Controlled Study.

开始日期2024-01-11

申办/合作机构

厦门大学附属第一医院（厦门市第一医院、厦门市红十字会医院、厦门市糖尿病研究所）

ChiCTR2300075609

/ Recruiting临床4期IIT

Vonoprazan-based Bismuth Quadruple therapy containing doxycycline and metronidazole as first-line Helicobacter pylori treatment in patients allergic to penicillin

开始日期2023-09-11

申办/合作机构

浙江大学医学院附属第二医院（浙江省第二医院）

100 项与酒石酸铋相关的临床结果

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100 项与酒石酸铋相关的转化医学

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100 项与酒石酸铋相关的专利（医药）

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1,923

项与酒石酸铋相关的文献（医药）

2025-07-01·Journal of Infection and Public Health

The efficacy and safety of vonoprazan-based high-dose dual therapy for eradication of Helicobacter pylori: A systematic review and meta-analysis

Review

作者: Wei, Yuan-Kui ; Wang, Mei-Ding ; Zhang, Ming-Ming ; Long, En-Wu ; Hu, Jia-Qiang ; Yang, Shi-Yu ; Zhang, Chang-Lan ; Zhu, Bao-Qiang

In order to evaluate the effectiveness and safety of high-dose dual therapy with vonoprazan for eradicating Helicobacter pylori, we searched seven electronic databases from the establishment of the database to March 2025, collecting randomized controlled clinical trials (RCTs) comparing high-dose dual therapy with vonoprazan to high-dose dual therapy with PPI and quadruple therapy with bismuth, including 13 RCTs with 4023 patients. The primary outcome is the eradication rate determined based on intention to treat analysis and protocol analysis, while secondary outcomes include incidence of adverse events and compliance. According to ITT analysis and PP treatment analysis, the eradication rates of VA therapy were 88.81 % and 93.56 %, respectively. The incidence of adverse reactions was significantly lower (14.56 % vs 26.00 %, RR=0.57, 95 % CI: 0.48-0.67, p < 0.0001), and compliance was better (96.29 % vs 93.56 %, RR=1.03, 95 % CI: 1.01-1.05, p = 0.003), making it a reliable alternative therapy.

2025-05-01·Reviews on Recent Clinical Trials

The Efficacy of Two Triple Therapy Regimens and One Quadruple Regimen [Omeprazole, Amoxicillin, Metronidazole with Bismuth] in Eradicating Helicobacter pylori in Patients with Peptic Ulcer: A Randomized Clinical Trial

Article

作者: Bahrami, Anvar ; Salehi, Amir Mohammad ; Ebrahimi, Alireza ; Hasanzarrini, Maryam ; Khanlarzadeh, Elham

Background:Helicobacter pylori (H. pylori) infection is the main cause of most PUD; therefore, the eradication of H. pylori is extremely important in the treatment of PUD. There are several recommended treatment regimens suggested to eradicate this organismAim:This study compared the efficacy of three anti-Helicobacter pylori regimens in patients with dyspepsia or peptic ulcer disease (PUD).Objective:The objective of this study was to assess the efficacy of three anti-H pylori treatments in patients based on C14 urease breath test (C-UBT) results, drug compliance, and adverse effects.Methods:This randomized, open-label clinical trial included 136 H. pylori-infected patients without prior treatment. Patients were randomly divided into three groups. The OAC group received 20 mg Omeprazole capsules twice a day, two 500 mg Amoxicillin capsules twice a day, and 500 mg Clarithromycin capsules twice a day for 14 days. The OAL group received 20 mg Omeprazole capsules twice a day, two 500 mg Amoxicillin capsules twice a day, and Levofloxacin 500 mg capsules twice a day for 14 days. The OAMB group received 20 mg Omeprazole capsules twice a day, two 500 mg Amoxicillin capsules twice a day, Metronidazole 500 mg three times a day, and Bismuth 240 mg twice a day for 14 days. Evaluation for compliance and drug-related adverse effects were assessed at the end of two weeks. H. pylori eradication was evaluated eight weeks after treatment using the C-UBT.Results:A total of 136 patients participated in this study, and their groups were matched based on age and sex. The results of the C-UBT test showed that the eradication rate of H. Pylori was 82.2%, 91.3%, and 97.3% for the three-drug OAC, OAMB, and OAL treatment regimens, respectively. Moreover, all the regimens showed high compliance among the patients. Only OAC and OAL showed a significant difference in the H. Pylori eradication rate, and no superiority was found between OAMB and OAL or OAC therapies.Conclusion:The regime of OAL achieved a satisfactory rate of H. pylori infection eradication with good tolerance in patients with PUD, without any acute side effects.

2025-04-02·Journal of Antimicrobial Chemotherapy

Vonoprazan improves the efficacy of bismuth quadruple therapy containing doxycycline and metronidazole as first-line Helicobacter pylori treatment in penicillin-allergic patients: a randomized controlled trial

Article

作者: Zhu, Renke ; Sun, Kefang ; Gu, Qing ; Wang, Jinghua ; Yan, Tianlian ; Chen, Ye ; Gao, Jianguo ; Ma, Dan ; Li, Lan ; Wang, Jiewei

AbstractBackgroundHelicobacter pylori eradication in penicillin-allergic patients presents challenges. Options of effective regimens are lacking in areas where tetracycline is unavailable.ObjectivesTo evaluate the efficacy of replacing the proton pump inhibitor (PPI) with a potassium-competitive acid blocker (P-CAB, vonoprazan) in standard bismuth quadruple therapy containing doxycycline and metronidazole as a first-line treatment for H. pylori.MethodsThis prospective randomized clinical trial enrolled 332 naive patients with H. pylori infection and penicillin allergy. Participants were randomly assigned in a 1:1 ratio to either the 14 day P-CAB/BDM group (vonoprazan 20 mg twice daily, colloidal bismuth 200 mg twice daily, doxycycline 100 mg twice daily and metronidazole 400 mg three times daily) or the 14 day PPI/BDM group (rabeprazole 10 mg twice daily, and the same dose of the three other drugs as in the 14 day P-CAB/BDM group).ResultsEradication rates in the P-CAB/BDM and PPI/BDM groups were 90.4% and 71.1% (P value for superiority was 0.013), respectively, by ITT analysis. The efficacy of P-CAB/BDM remained non-inferior and even superior to PPI/BDM therapy in all ITT, modified ITT and PP analyses. The overall frequency of adverse events (39.8% and 40.4%; P = 0.911) and compliance (88.0% and 91.0%; P = 0.372) were similar between P-CAB and PPI regimens. Patients with higher body surface area were significantly associated with eradication failure in both groups (P < 0.05).ConclusionsThe 14 day P-CAB/BDM therapy provided a satisfactory eradication rate of >90% (ITT analysis) and had a good safety profile as first-line H. pylori therapy, providing an alternative option for penicillin-allergic patients.

100 项与酒石酸铋相关的药物交易

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研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
溃疡性结肠炎	中国	盈信药业（汕头）有限公司	-
萎缩性胃炎	中国	盈信药业（汕头）有限公司	-
幽门螺杆菌感染	中国	盈信药业（汕头）有限公司	-
消化性溃疡	中国	盈信药业（汕头）有限公司	-

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


UEGW2022	N/A	幽门螺杆菌感染一线	126	VAS group (vonoprazan 20 mg twice/day, amoxicillin 750 mg three times/day and S. boulardii250 mg twice/day)	(遞鹹鹹醖淵廠簾製製夢) = 遞繭壓觸製齋鬱築壓襯鹹淵廠遞鏇襯遞構遞繭 (觸壓鬱鬱鏇膚襯範獵醖 ) 更多	积极	2022-10-09
				PCAB group (Esomeprazole 20 mg, amoxicillin 1000 mg, clarithromycin 500 mg and bismuth 220 mg twice/day)	(遞鹹鹹醖淵廠簾製製夢) = 簾網觸獵醖範築餘鏇鏇鹹淵廠遞鏇襯遞構遞繭 (觸壓鬱鬱鏇膚襯範獵醖 ) 更多
HP-EUREG (UEGW2016)	N/A	一线	-	Bismuth, Amoxicillin, Clarithromycin (BCA)	簾獵淵構憲憲鏇網範憲(憲鬱鑰網窪遞鏇鏇憲醖) = Adverse events were reported in 28% of cases and caused treatment discontinuation in 1 patient 鑰窪顧廠願遞觸齋憲艱 (積餘鏇積簾範壓鬱製艱 )	积极	2016-10-01
				Esomeprazole