Delving into the Latest Updates on Bismuth Pectin with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Colloidal Bismuth Pectin, 胶体果胶铋

Target-

Mechanism-

Therapeutic Areas

Digestive System Disorders

Active Indication

GastritisPeptic Ulcer

Inactive Indication

Chronic superficial gastritisGastritis, AtrophicUlcer

Originator Organization

Shanxi Xinbaoyuan Pharmaceutical Co., Ltd.

Active Organization

Shanxi Xinbaoyuan Pharmaceutical Co., Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

CN (01 Jan 1992),

GastritisPeptic Ulcer

Regulation-

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This study aims to evaluate the efficacy and safety of 14-day quadruple therapy based on fecal molecular antimicrobial susceptibility tests for the first-line eradication of H. pylori infection, thus, providing more evidence to inform the value of fecal antimicrobial susceptibility tests in the first-line treatment of H. pylori infection.

Start Date01 Mar 2023

Sponsor / Collaborator

Second Affiliated Hospital Zhejiang University College of

CTR20221488 / CompletedNot Applicable

含胶体果胶铋胶囊四联疗法根除幽门螺杆菌（Hp）有效性和安全性的多中心、随机、双盲双模拟、阳性对照临床研究

[Translation] A multicenter, randomized, double-blind, double-dummy, positive-controlled clinical study on the efficacy and safety of quadruple therapy containing colloidal pectin bismuth capsules in eradicating Helicobacter pylori (Hp).

采用含枸橼酸铋钾片四联疗法作为对照，评价含胶体果胶铋胶囊四联疗法根除Hp的有效性及安全性。

[Translation]

The efficacy and safety of quadruple therapy containing colloidal bismuth pectin capsules in eradicating Hp were evaluated by using quadruple therapy containing potassium citrate bismuth tablets as a control.

Start Date14 Jul 2022

Sponsor / Collaborator

Shanxi Ante Bio-Pharmaceutical Co., Ltd.

NCT05431075 / CompletedPhase 4IIT

Bismuth-containing Quadruple Therapy for Helicobacter Pylori First-line Treatment: A Multicenter Randomized Clinical Trial of Different Tetracycline Doses and Frequencies.

The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. The subjects were randomized to receive a dose and frequency of tetracycline 500mg tid or qid of bismuth quadruple eradication therapy. 6-8 weeks after treatment, the subjects will re-take the 13C-urea breath test. Calculate the eradication rates, adverse reaction rates, patient compliance and cost-effectiveness index of each group.

Start Date01 Jul 2022

Sponsor / Collaborator

Shandong University

[+1]

100 Clinical Results associated with Bismuth Pectin

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100 Translational Medicine associated with Bismuth Pectin

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100 Patents (Medical) associated with Bismuth Pectin

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16

Literatures (Medical) associated with Bismuth Pectin

01 Jun 2023·Helicobacter

Colloidal bismuth pectin-containing quadruple therapy as the first-line treatment of Helicobacter pylori infection: A multicenter, randomized, double-blind, non-inferiority clinical trial.

Article

Author: Hu, Yi ; Zhu, Yin ; Lu, Nong-Hua ; Li, Yan-Qing ; Wang, Qi-Zhi ; Xie, Yong ; Zhang, Zhen-Yu ; Liu, Xiao-Wei ; Zhang, De-Kui ; Wang, Hong ; Wang, Jiang-Bin

BACKGROUNDBismuth-containing quadruple therapy is an effective regimen for Helicobacter pylori (H. pylori) treatment. No head-to-head comparison trials have been conducted to evaluate the efficacy of colloidal bismuth pectin (CBP) in quadruple therapy for eradicating H. pylori. We aimed to compare the efficacy and safety of CBP quadruple therapy and bismuth potassium citrate (BPC) quadruple therapy for 14 days in the first-line treatment of H. pylori.METHODSIn this multicenter, randomized, double-blind, non-inferiority clinical trial, H. pylori-infected subjects without eradication history were randomized to receive amoxicillin 1 g twice daily, tetracycline 500 mg three time daily, esomeprazole 20 mg twice daily in combination with CBP 200 mg three time daily or BPC 240 mg twice daily for 14 days. ¹³ C-urea breath tests were used to access the eradication rate at least 4 weeks after treatment.RESULTSBetween April 2021 and July 2022, 406 patients were assessed for eligibility and 339 subjects were randomized. The cure rates (primary outcome) of CBP and BPC quadruple therapy were 90.5% and 92.3% (p = 0.56) by intention-to-treat analysis, respectively, and 96.1% and 96.2% (p = 1.00) by per-protocol analysis, respectively. CBP quadruple therapy was non-inferior to BPC quadruple therapy in the intention-to-treat and per-protocol analysis (p < 0.025). The frequency of adverse events and compliance were not different among the two groups (p > 0.05).CONCLUSIONSBoth CBP and BPC quadruple therapy for 14 days provide high efficacy, good compliance, and safety in the first-line treatment of H. pylori in China.

11 Oct 2022·Computational and Mathematical Methods in Medicine

Effects of Quadruple Therapy Combined with Probiotics on Helicobacter Pylori-Related Peptic Ulcer

Article

Author: Li, Tingzan ; Zhou, Ye

The present study was designed to observe the effect of quadruple therapy combined with probiotics on Helicobacter pylori-related peptic ulcer. The patients in the control group (

n = 90

) were given regular quadruple therapy including proton pump inhibitor ilaprazole enteric-coated tablet + two antibiotics amoxicillin dispersible tablet and metronidazole tablet + colloidal bismuth pectin capsule for 2 weeks. Patients in the study group (

n = 90

) were given abovementioned quadruple therapy combined with probiotics live combined Bifidobacterium, Lactobacillus, and Enterococcus Capsules, oral for 2 weeks. Then Hp clearance rate, recurrence rate, levels of gastrointestinal hormone makers, and advance reactions between two groups were compared. At the 2nd week after the treatment, the Helicobacter pylori clearance rate in the study group (87.79%) was significantly higher than the control group (78.89%), and the total recurrence rate in the study group (6.67%) was significantly lower than the control group (13.33%) (

P < 0.05

). Serum gastrin and motilin expression were lower, and somatostatin expressions was significantly higher than those in the control group (

P < 0.05

). There was no significant difference in the total incidence of adverse reactions between the two groups (

P > 0.05

). In summary, quadruple therapy combined with probiotics in the treatment of Helicobacter pylori-related peptic ulcer can improve the Helicobacter pylori clearance rate, reduce the Helicobacter pylori recurrence rate, and is beneficial to improving the level of gastrointestinal hormones, with certain safety.

03 Oct 2022·Postgraduate Medicine

Impact of insufficient doses of medications on Helicobacter pylori eradication: a retrospective observational study

Article

Author: Shi, Xiaoye ; Ma, Shaoze ; Meng, Fanjun ; Liu, Tingwei ; Wang, Chunmei ; Xu, Guangqin ; Li, Hongyu ; Qi, Xingshun ; Guo, Xiaozhong

BACKGROUND AND AIMSThe doses of medications may influence the success of Helicobacter pylori (H. pylori) eradication. This real-world observational study aimed to explore the impact of insufficient doses of medications prescribed for the bismuth-containing quadruple therapy (BQT) regimen on successful H. pylori eradication.METHODSWe retrospectively screened the patients who were diagnosed with H. pylori infection and received BQT regimens for H. pylori eradication at our department between January 2017 and July 2020. The rate of successful H. pylori eradication was compared according to the doses of medications prescribed. Standard doses were defined according to the clinical guidelines.RESULTSOverall, 1054 patients were included. The rate of successful H. pylori eradication was 78.2% (824/1054). Among them, proton pump inhibitors (PPIs) and antibiotics were prescribed at insufficient doses in 37.0% (390/1054) and 6.7% (71/1054) of patients, respectively. Furthermore, pantoprazole (98.7% [385/390]) was the most common type of PPIs prescribed at insufficient doses, and nitroimidazoles (85.9% [61/71]) were the most common type of antibiotics prescribed at insufficient doses. Among the patients receiving colloidal bismuth pectin (CBP) (200 mg tid) and standard-dose antibiotics, the rate of successful H. pylori eradication was lower in insufficient-dose PPIs group than standard-dose PPIs group (78.1% [271/347] versus 82.6% [438/530], P = 0.095). Among the patients receiving CBP (200 mg tid) and standard-dose PPIs, the rate of successful H. pylori eradication was significantly lower in insufficient-dose antibiotics group than standard-dose antibiotics group (37.8% [14/37] versus 82.6% [438/530], P < 0.0001). Among the patients receiving CBP 200 mg tid, the rate of successful H. pylori eradication was significantly lower in patients receiving both PPIs and antibiotics at insufficient doses than those at standard doses (46.4% [13/28] versus 82.6% [438/530], P < 0.0001).CONCLUSIONAmong the BQT regimens, PPIs and/or antibiotics, especially pantoprazole and metronidazole, are often prescribed at insufficient doses, compromising the success of H. pylori eradication.ABBREVIATIONSH. pylori, Helicobacter pylori; UBT, urea breath test; DPM, disintegrations per minute; BQT, bismuth-containing quadruple therapy; PPI, proton pump inhibitor; CBP, colloidal bismuth pectin; qd, once daily; bid, twice daily; tid, three times daily; qid, four times daily.

100 Deals associated with Bismuth Pectin

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Gastritis	CN	Shanxi Xinbaoyuan Pharmaceutical Co., Ltd.	01 Jan 1992
Peptic Ulcer	CN	Shanxi Xinbaoyuan Pharmaceutical Co., Ltd.	01 Jan 1992

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic superficial gastritis	Phase 2	CN	Shanxi Xinbaoyuan Pharmaceutical Co., Ltd.	09 Jan 2020
Gastritis, Atrophic	Phase 2	CN	Shanxi Xinbaoyuan Pharmaceutical Co., Ltd.	09 Jan 2020
Ulcer	Phase 2	CN	Shanxi Xinbaoyuan Pharmaceutical Co., Ltd.	09 Jan 2020

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


UEGW	Not Applicable	Helicobacter pylori infection First line CYP2C19 polymorphisms	270	Esomeprazole+Bismuth Pectin+Clarithromycin+Amoxicillin	dxrfglkvam(azvuwdpgzw) = sorbqqviiz ypnnbxtffa (ltuityuxya )	Positive	01 Oct 2016
				Esomeprazole+Bismuth Pectin+Levofloxacin+Amoxicillin	dxrfglkvam(azvuwdpgzw) = uwyqitkmvv ypnnbxtffa (ltuityuxya )