二硝酸铋三钾(Tripotassium bismuth dicitrate)

概要

基本信息

药物类型

小分子化药

别名-

靶点-

作用机制-

治疗领域-

在研适应症-

非在研适应症-

原研机构

Takeda Pharmaceutical Co., Ltd.

在研机构-

非在研机构

Takeda Pharmaceutical Co., Ltd.

最高研发阶段无进展临床1期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

3

项与二硝酸铋三钾相关的临床试验

NCT06349486 / RecruitingN/AIIT

Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy, Vonoprazan-amoxicillin Dual Therapy and Proton Pump Inhibitor-based Standard Triple Therapy in the First-line Anti-H. Pylori Treatment

Compare the efficacies and safety of 14-day bismuth-amoxicillin-vonoprazan tiple therapy, 14-day vonoprazan dual therapy and 14-day rabeprazole triple therapy in the first-line treatment of H. pylori infection.
To investigate the impacts of antibiotic resistance of H. pylori as well as CYP3A4, CYP2C19 and IL-1B -511 genotypes of host on the eradication efficacies of anti-H. pylori treatments.

开始日期2023-11-28

申办/合作机构

高雄医学大学

NCT05850117 / RecruitingN/AIIT

Efficacies of Tetracycline-levofloxacin Quadruple Therapy, Standard Bismuth Quadruple Therapy and Amoxicillin-levofloxacin Quadruple Therapy in the Second-line Treatment of H Pylori Infection

Compare the efficacy of "Tetracycline combined with levofloxacin quadruple therapy", "standard tincture quadruple therapy" and "amoxicillin combined with levofloxacin quadruple therapy" on the second line of Helicobacter pylori sterilization.
To investigate the drug resistance of Helicobacter pylori and the host genotypes of CYP2C19 and IL-1B-511 on the sterilizing effect of three second-line Helicobacter pylori.

开始日期2020-02-10

申办/合作机构

高雄医学大学

NCT02892409 / Completed临床1期

A Phase 1, Double-Blind, Parallel Group Study to Evaluate the Safety and Pharmacokinetics of Quadruple Therapy (Bismuth, Clarithromycin, and Amoxicillin) With TAK-438 Versus Quadruple Therapy With Lansoprazole

To evaluate the safety, tolerability, and pharmacokinetics (PK) of quadruple therapy with bismuth, clarithromycin, amoxicillin, and TAK-438 versus quadruple therapy with bismuth, clarithromycin, amoxicillin, and lansoprazole.

开始日期2016-09-05

申办/合作机构

Takeda Pharmaceutical Co., Ltd.

100 项与二硝酸铋三钾相关的临床结果

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100 项与二硝酸铋三钾相关的转化医学

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100 项与二硝酸铋三钾相关的专利（医药）

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26

项与二硝酸铋三钾相关的文献（医药）

2016-03-03·Scandinavian Journal of Gastroenterology4区 · 医学

Comparison of the efficacy of culture-based tailored therapy forHelicobacter pylorieradication with that of the traditional second-line rescue therapy in Korean patients: a prospective single tertiary center study

4区 · 医学

Article

作者: Kwon, Yong Hwan ; Choi, Yoon Jin ; Suh, Ji Hyung ; Lee, Ju Yup ; Lee, Dong Ho ; Nam, Ryung Hee ; Lee, Jung Won ; Kim, Nayoung ; Yoon, Kichul

OBJECTIVEThe effectiveness of Helicobacter pylori therapies has declined with an increase in antibiotic resistance. To overcome this problem, the efficacy of tailored H. pylori eradication therapy based on antimicrobial susceptibility testing was compared with that of empirical second-line rescue regimens.MATERIAL AND METHODSPatients who had persistent H. pylori infection after the first eradication were recommended to undergo culture for determining the minimal inhibitory concentration (MIC) via gastroscopy, which increased the cost by 300%. Fourteen-day esomeprazole, tripotassium dicitrate bismuthate, metronidazole and tetracycline (EBMT) therapy or esomeprazole, moxifloxacin and amoxicillin (MEA) therapy was performed according to the results of antibiotic susceptibility testing. In case of refusal to undergo culture, the participants were treated with either 14-day empirical EBMT or MEA regimen for second eradication after explaining the complexity, side effects and costs associated with each regimen. This trial was registered at ClinicalTrials.Gov (NCT 02349685).RESULTSIn the 219 patients included, the intention to treat (ITT) and per protocol (PP) eradication rates was 75.3% and 79.8% in the 14-day EBMT group (n = 89), 70.8% and 72.4% in the 14-day MEA group (n = 89) and 87.8% and 100.0% in the 14-day tailored therapy group (n = 41), respectively. Based on the PP analysis, the 14-day tailored therapy group showed a significantly higher eradication rate than the 14-day EBMT or MEA group (both p ≤ 0.001).CONCLUSIONSTailored therapy based on H. pylori culture and MIC test could be an option as a second-line eradication regimen in the presence of high level of antimicrobial resistance.

2014-11-23·Gut and Liver3区 · 医学

The Efficacy of Moxifloxacin-Containing Triple Therapy after Standard Triple, Sequential, or Concomitant Therapy Failure for Helicobacter pylori Eradication in Korea

3区 · 医学

Article

作者: Kim, Nayoung ; Shin, Cheol Min ; Kim, Jin Wook ; Lee, Dong Ho ; Chung, Kwang Hyun ; Jin, Eunhyo ; Hwang, Jin-Hyeok ; Seo, Ji Yeon ; Cho, Yuri ; Jeong, Sook Hyang

BACKGROUND/AIMSRetreatment after initial treatment failure for Helicobacter pylori is very challenging. The purpose of this study was to evaluate the efficacies of moxifloxacin-containing triple and bismuth-containing quadruple therapy.METHODSA total of 151 patients, who failed initial H. pylori treatment, were included in this retrospective cohort study. The initial regimens were standard triple, sequential, or concomitant therapy, and the efficacies of the two following second-line treatments were evaluated: 7-day moxifloxacin-containing triple therapy (rabeprazole 20 mg twice a day, amoxicillin 1,000 mg twice a day, and moxifloxacin 400 mg once daily) and 7-day bismuth-containing quadruple therapy (rabeprazole 20 mg twice a day, tetracycline 500 mg 4 times a day, metronidazole 500 mg 3 times a day, and tripotassium dicitrate bismuthate 300 mg 4 times a day).RESULTSThe overall eradication rates after moxifloxacin-containing triple therapy and bismuth-containing quadruple therapy were 69/110 (62.7%) and 32/41 (78%), respectively. Comparison of the two regimens was performed in the patients who failed standard triple therapy, and the results revealed eradication rates of 14/28 (50%) and 32/41 (78%), respectively (p=0.015). The frequency of noncompliance was not different between the two groups, and there were fewer adverse effects in the moxifloxacin-containing triple therapy group (2.8% vs 7.3%, p=0.204 and 25.7% vs 43.9%, p=0.031, respectively).CONCLUSIONSMoxifloxacin-containing triple therapy, a recommended second-line treatment for initial concomitant or sequential therapy failure, had insufficient efficacy.

2013-12-01·BMC Gastroenterology3区 · 医学

Long-term follow up Helicobacter Pylori reinfection rate after second-line treatment: bismuth-containing quadruple therapy versus moxifloxacin-based triple therapy

3区 · 医学

ArticleOA

作者: Sung Eun Kim ; Young Soo Park ; Dong Hee Lee ; Hyun Jin Jo ; Min Soo Kim ; Cheol Min Shin ; Nayoung Kim

BACKGROUNDThe increasing trend of antibiotic resistance requires effective second-line Helicobacter pylori (H. pylori) treatment in high prevalence area of H. pylori. The aim of our study was to evaluate the reinfection rate of H. pylori after second-line treatment that would determine the long-term follow up effect of the rescue therapy.METHODSA total of 648 patients who had failed previous H. pylori eradication on standard triple therapy were randomized into two regimens: 1, esomeprazole (20 mg b.i.d), tripotassium dicitrate bismuthate (300 mg q.i.d), metronidazole (500 mg t.i.d), and tetracycline (500 mg q.i.d) (EBMT) or 2, moxifloxacin (400 mg q.d.), esomeprazole (20 mg b.i.d), and amoxicillin (1000 mg b.i.d.) (MEA). At four weeks after completion of eradication therapy, H. pylori tests were performed with 13C urea breath test or invasive tests. In patients who maintained continuous H. pylori negativity for the first year after eradication therapy, H. pylori status was assessed every year. For the evaluation of risk factors of reinfection, gender, age, clinical diagnosis, histological atrophic gastritis or intestinal metaplasia were analyzed.RESULTSThe recrudescence rate of the EBMT was 1.7% and of the MEA group 3.3% (p = 0.67). The annual reinfection rate of H. pylori of EBMT was found to be 4.45% and the MEA group 6.46%. Univariate analysis (Log-rank test) showed no association with any clinical risk factor for reinfection.CONCLUSIONSThe long-term reinfection rate of H. pylori stayed low in both of bismuth-containing quadruple therapy and moxifloxacin-based triple therapy; thus reinfection cannot affect the choice of second-line treatment.TRIAL REGISTRATIONClinical Trial Registration Number NCT01792700.

100 项与二硝酸铋三钾相关的药物交易

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临床结果

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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


NCT02892409 (CTgov)	临床1期	幽门螺杆菌感染	30	Tripotassium bismuth dicitrate+TAK-438+Clarithromycin+Amoxicillin (Clarithromycin + Amoxicillin + Bismuth + TAK-438)	衊艱鹹齋鹽淵構艱獵憲(觸餘淵顧窪顧願鑰衊憲) = 築積壓淵鏇選築鏇鏇獵憲糧鬱範齋網夢鹹艱鑰 (範憲鬱鹹鹽膚壓鏇窪醖, 夢廠夢夢繭範鹹醖鹽襯 ~ 鹹鏇艱積選廠觸襯鏇夢) 更多	-	2019-01-03
				Tripotassium bismuth dicitrate+Lansoprazole+Clarithromycin+Amoxicillin (Clarithromycin + Amoxicillin + Bismuth + Lansoprazole)	衊艱鹹齋鹽淵構艱獵憲(觸餘淵顧窪顧願鑰衊憲) = 範憲觸遞築範憲襯廠鏇憲糧鬱範齋網夢鹹艱鑰 (範憲鬱鹹鹽膚壓鏇窪醖, 艱觸範築艱襯艱鹹獵壓 ~ 壓鏇襯簾廠選餘築範鹹) 更多