The efficacy of bismuth-containing quadruple therapy with minocycline and metronidazole was not inferior to classical bismuth quadruple therapy for refractory H. pylori infection, though also accompanied with high occurrence of adverse events (55.4%). Optimization of minocycline-based regimen to achieve high eradication rate with fewer adverse events is imperative. This study aimed to compare the efficacy and tolerability of a 14-day bismuth-containing quadruple rescue therapy with different dosage of minocycline and metronidazole compared to classical bismuth quadruple therapy.

Start Date21 Aug 2024

Sponsor / Collaborator

Shanghai Jiao Tong University School of Medicine

NCT06561698 / RecruitingPhase 4IIT

High-dose Dual Therapy and Minocycline-cotaining Quadruple Therapy for Helicobacter Pylori Infection

This study is a multicentra, prospective study. The enrolled patients are HP positive. They are diagnosed as HP positive by rapid urease test and/or 13C urea breath test. According to the declaration of Helsinki, 200 patients will be included in this study. After obtaining the written informed consent of the patients, HP culture and drug sensitivity test will be conducted on all the selected patients with the success rate, adverse reactions, compliance, antibiotic resistance of HP and its impact on HP eradication.

Start Date21 Aug 2024

Sponsor / Collaborator

Shanghai Jiao Tong University School of Medicine

NCT06509139 / Enrolling by invitationPhase 4IIT

Optimal Treatment Duration of Bismuth Quadruple Therapy for Helicobacter Pylori Eradication in Female Patients and Comparison of the Efficacy with That of Male Patients

Helicobacter pylori eradication can reduce the risk of gastric cancer and decrease the recurrence of ulcers. However, in recent years, the increasing antibiotic resistance of Helicobacter pylori has reduced the efficacy of clarithromycin-based triple therapy to below 80%. The recent studies, including real-world data and a clinical trial, have consistently found that females have poorer eradication rate of Helicobacter pylori as compared with males. In previous clinical trial, investigators discovered that the efficacy of a 10-day bismuth quadruple therapy was not inferior to a 14-day bismuth quadruple therapy. However, it remains to be investigated whether the 10-day bismuth quadruple therapy is still non-inferior to the 14-day regimen in females.
This project continues the clinical trial to investigate whether the efficacy of the 10-day bismuth quadruple therapy in females is inferior to that in males and whether the 14-day bismuth quadruple therapy is superior to the 10-day regimen in females. The ultimate goal is to establish that male patients can use the 10-day bismuth quadruple therapy with fewer side effects and without compromising efficacy as compared with the 14-day regimen; while female patients are recommended to use the 14-day bismuth quadruple therapy as it would be more effective than the 10-day regimen.
Considering sex in research is becoming increasingly important, as females have more antibiotic-resistant Helicobacter pylori infection than males. The bismuth quadruple therapy can overcome most resistance issues. Researching and comparing the difference in the efficacy of bismuth quadruple therapy for Helicobacter pylori eradication between females and males are of significant clinical importance and align with current research trends.

Start Date09 Jul 2024

Sponsor / Collaborator

National Cheng Kung University Hospital

100 Clinical Results associated with Bismuth Potassium Citrate

100 Translational Medicine associated with Bismuth Potassium Citrate

100 Patents (Medical) associated with Bismuth Potassium Citrate

635

Literatures (Medical) associated with Bismuth Potassium Citrate

01 Dec 2024·British Journal of Anaesthesia

Machine learning-augmented interventions in perioperative care: a systematic review and meta-analysis

Review

Author: Gonzalez, Xiomara T ; Huang, Grace ; Mehta, Divya ; Abraham, Joanna ; Gonzalez, Xiomara T.

BACKGROUNDWe lack evidence on the cumulative effectiveness of machine learning (ML)-driven interventions in perioperative settings. Therefore, we conducted a systematic review to appraise the evidence on the impact of ML-driven interventions on perioperative outcomes.METHODSOvid MEDLINE, CINAHL, Embase, Scopus, PubMed, and ClinicalTrials.gov were searched to identify randomised controlled trials (RCTs) evaluating the effectiveness of ML-driven interventions in surgical inpatient populations. The review was registered with PROSPERO (CRD42023433163) and conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Meta-analysis was conducted for outcomes with two or more studies using a random-effects model, and vote counting was conducted for other outcomes.RESULTSAmong 13 included RCTs, three types of ML-driven interventions were evaluated: Hypotension Prediction Index (HPI) (n=5), Nociception Level Index (NoL) (n=7), and a scheduling system (n=1). Compared with the standard care, HPI led to a significant decrease in absolute hypotension (n=421, P=0.003, I²=75%) and relative hypotension (n=208, P<0.0001, I²=0%); NoL led to significantly lower mean pain scores in the post-anaesthesia care unit (PACU) (n=191, P=0.004, I²=19%). NoL showed no significant impact on intraoperative opioid consumption (n=339, P=0.31, I²=92%) or PACU opioid consumption (n=339, P=0.11, I²=0%). No significant difference in hospital length of stay (n=361, P=0.81, I²=0%) and PACU stay (n=267, P=0.44, I²=0) was found between HPI and NoL.CONCLUSIONSHPI decreased the duration of intraoperative hypotension, and NoL decreased postoperative pain scores, but no significant impact on other clinical outcomes was found. We highlight the need to address both methodological and clinical practice gaps to ensure the successful future implementation of ML-driven interventions.SYSTEMATIC REVIEW PROTOCOLCRD42023433163 (PROSPERO).

01 Nov 2024·Anesthesia & Analgesia

Does Nociception Level Index-Guided Opioid Administration Reduce Intraoperative Opioid Consumption? A Systematic Review and Meta-Analysis

Review

Author: Darçin, Kamil ; Kalyoncu, Ilayda ; Karakaya, Muhammet Ahmet ; Sogut, Muhammet Selman ; Manici, Mete

BACKGROUND:The nociception level (NOL) index is a quantitative parameter derived from physiological signals to measure intraoperative nociception. The aim of this systematic review and meta-analysis was to evaluate if NOL monitoring reduces intraoperative opioid use compared to conventional therapy (opioid administered at clinician discretion).METHODS:This meta-analysis comprises randomized clinical trials comparing NOL-guided opioid administration to conventional therapy in adult patients undergoing any type of surgery. A systematic search of PubMed, Scopus, and CENTRAL databases was conducted. The primary outcome was intraoperative opioid consumption and the effect estimate of the NOL index was measured using the standardized mean difference (SMD) where 0.20 is considered a small and 0.80 a large effect size. A random-effects model with Hartung-Knapp-Sidik-Jonkman adjustment was applied to estimate the treatment effect. Heterogeneity was explored clinically and statistically (using the inconsistency I² statistic, prediction intervals, and influence analysis). The quality (certainty) of evidence was evaluated using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) guidelines methodology.RESULTS:This review comprised 9 trials (519 patients). The intraoperative opioid SMD (NOL monitoring versus conventional therapy) was −0.26 (95% confidence interval [CI], −0.82 to 0.30; P = .31; low certainty of evidence). We observed substantial clinical (intraoperative opioid regimens) and statistical heterogeneity with the I² statistic being 86% (95% CI, 75%–92%). The prediction interval was between −1.95 and 1.42 indicating where the SMD between NOL and conventional therapy would lie if a similar study were conducted in the future.CONCLUSIONS:This meta-analysis does not provide evidence supporting the role of NOL monitoring in reducing intraoperative opioid consumption.

01 Nov 2024·Cellular Immunology

Gastrodenol suppresses NLRP3/GSDMD mediated pyroptosis and ameliorates inflammatory diseases

Article

Author: Chen, Peipei ; Wang, Tingting ; Tang, Huaiping ; Wang, Jing ; Wang, Yunshu ; Xu, Yun ; Liu, Zhuo ; Ji, Sen-Lin

Pyroptosis, a form of inflammatory programmed cell death, plays a pivotal role in the pathogenesis of various diseases. This process is primarily mediated by the nucleotide-binding oligomerization domain-like receptor family pyrin domain-containing protein 3 (NLRP3). Gastrodenol (Bismuth tripotassium dicitrate, GAS) is a mineral compound which is used to treat duodenal and gastric ulcers associated with Helicobacter pylori. In this study, GAS was found to exhibit protective effects against classical pyroptosis in macrophages. Specifically, GAS effectively inhibits the activation of the NLRP3 inflammasome, Gasdermin D (GSDMD)-mediated pyroptosis, and the secretion of pro-inflammatory cytokines. Mechanistically, GAS inhibited NLRP3 oligomerization and reduced the oligomerization of adaptor protein apoptosis-associated speck like protein containing a caspase activation and recruitment domain (ASC) by directly binding to NLRP3. The interaction between GAS and NLRP3 is primarily mediated through hydrogen bonding and hydrophobic forces. Hydrogen bonds are formed with PHE-727, LEU-723, and ASP-700. Remarkably, GAS treatment attenuated pyroptosis-mediated inflammatory diseases, including experimental autoimmune encephalomyelitis (EAE), lipopolysaccharide (LPS)-induced septic, and monosodium urate (MSU)-induced peritonitis in mice. To conclude, this is the first report that discovered clinical old medicine GAS as a potent inhibitor of pyroptosis and propose a novel therapeutic strategy for the prevention and treatment of NLRP3-GSDMD mediated diseases.

News (Medical) associated with Bismuth Potassium Citrate

18 Nov 2024

·www.prnewswire.com

TenNor Announces Positive Topline Results from Rifasutenizol Phase III Trial for H. pylori Infection

SUZHOU, China, Nov 18, 2024 /PRNewswire/ -- TenNor Therapeutics, a clinical-stage company dedicated to developing novel therapies to address unmet needs in infectious diseases, announced today the successful completion of a phase III clinical trial of rifasutenizol (TNP-2198) for the treatment of Helicobacter pylori (H. pylori) infection. The study met its primary endpoints, showing multiple advantages of rifasutenizol regimen compared with bismuth-containing quadruple therapy (BQT), the current standard of care. The completed study is a multicenter, randomized, double-blind, controlled phase III clinical trial to evaluate the efficacy and safety of TNP-2198 in combination with amoxicillin and rabeprazole for the treatment of H. pylori infection in treatment-naive patients. The study was conducted in 40 hospitals in China. A total of 700 treatment-naive patients with H. pylori infection confirmed by a positive carbon-13 urea breath test (C-13 UBT) and histological examination were randomly assigned in a 1:1 ratio to receive rifasutenizol triple therapy (rifasutenizol 400 mg, amoxicillin 1 g and rabeprazole 20 mg) or BQT (bismuth potassium citrate 240 mg, clarithromycin 500 mg, amoxicillin 1 g and rabeprazole 20 mg) treatment, twice a day for 14 days. The efficacy endpoint was the C-13 UBT test result 4 to 6 weeks after the end of treatment. Patient compliance was high in the study with a low dropout rate of 3%. H. pylori was successfully cultured in 87% patients. There were no significant differences in demographics or baseline antibiotic resistance characteristics between the two treatment groups that could affect the study outcomes. Resistance rates to clarithromycin, metronidazole, levofloxacin and amoxicillin among H. pylori clinical isolates from this study were 41%, 68%, 35% and 8% respectively, which are consistent with data reported recently by other studies, indicating antibiotic resistance to H. pylori is a serious problem in China. All clinical isolates from the study were susceptible to rifasutenizol. Rifasutenizol triple therapy achieved >90% eradication rate in the modified intention-to-treat (mITT) population, higher than BQT control (92.0% vs. 87.9%, difference 4.1%, non-inferiority test p<0.0001, superiority test p= 0.0338). The rifasutenizol regimen also achieved a higher eradication rate than BQT in the per protocol (PP) population (93.7% vs. 90.3%, difference 3.4%, non-inferiority test p<0.0001, superiority test p=0.0563). In patients infected with H. pylori resistant to any of the current antibiotics, rifasutenizol triple therapy also achieved a higher eradication rate than BQT (90.9% vs. 87.2%, difference 3.7%, non-inferiority test p<0.0001), indicating rifasutenizol regimen is highly effective in patients with antibiotic-resistant H. pylori infections. Rifasutenizol regimen showed better safety and tolerability profile than BQT. The treatment-emergent adverse events (TEAEs), investigational drug related TEAEs, TEAEs with grade 3 or above are all lower in the rifasutenizol arm. Most TEAEs were Grade 1 and no investigational drug related serious adverse events (SAEs) reported. Rifasutenizol is a novel multi-targeting drug candidate with a synergistic mechanism of action against anaerobic and microaerophile bacteria. It has potential to become the first new drug developed specifically for H. pylori infection in more than 30 years. Rifasutenizol could play an important role in supporting the large-scale test-and-treatment strategy to prevent gastric cancers in populations with high gastric cancer risk, as the rifasutenizol regimen does not require drug sensitivity test and can be seamlessly integrated with the UBT testing. TenNor completed 7 phase I-III clinical trials in China and has received Qualified Infectious Disease Product (QIDP) and Fast Track designations from the U.S. Food and Drug Administration (FDA). About TenNor Therapeutics TenNor Therapeutics is a clinical-stage company specialized in the discovery and development of differentiated new drug products for diseases associated with bacterial infection and metabolism. TenNor possesses a unique multi-targeting drug conjugate technology and a strong new drug development portfolio with global IP protection. Several products are currently in late-stage of clinical development targeting H. pylori infection, medical device infections, hepatic encephalopathy and irritable bowel syndrome with diarrhea. The company is committed to address unmet needs in the disease area and provide safe and effective therapies for patients in China and around the world. For more information please visit: . SOURCE TenNor Therapeutics (Suzhou) Limited WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Fast TrackClinical ResultQualified Infectious Disease Product

100 Deals associated with Bismuth Potassium Citrate

External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Duodenal Ulcer	CN	Hunan Er-Kang Pharmaceutical Co., Ltd.	-
Gastritis	CN	Hunan Er-Kang Pharmaceutical Co., Ltd.	-
Stomach Ulcer	CN	Hunan Er-Kang Pharmaceutical Co., Ltd.	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Gastritis	Discovery	CN	Hunan Warrant Pharmaceutical Co., Ltd.	19 Dec 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04198363 (CTgov)	Phase 3	Helicobacter pylori infection	510	vonoprazan+Clarithromycin+Amoxicillin+Bismuth Potassium citrate (Vonoprazan 20 mg)	xhabhweduy(etyftwpemx) = xtzmevibdo bykadvzonl (nwzxvvqwwe, npvpgnrlbe - fpaxmpwhzi) View more	-	07 Sep 2023
				Esomeprazole+Clarithromycin+Amoxicillin+Bismuth Potassium citrate (Esomeprazole 20 mg)	xhabhweduy(etyftwpemx) = omivxlndwx bykadvzonl (nwzxvvqwwe, tkapiaforf - wykooxlvzb) View more
NCT04753437 (CTgov)	Phase 1	Helicobacter pylori infection	44	Amoxicillin+vonoprazan+Clarithromycin+Bismuth potassium citrate (Clarithromycin + Amoxicillin + Bismuth + Vonoprazan)	sztzqxbzcl(jzohnpxcwc) = grczukdtzj fvedgepogm (elhgogwilz, zhojeoggsb - ixtrmrfruq) View more	-	31 Aug 2023
				Amoxicillin+Esomeprazole+Clarithromycin+Bismuth potassium citrate (Clarithromycin + Amoxicillin + Bismuth + Esomeprazole)	sztzqxbzcl(jzohnpxcwc) = xlxxrkvfhe fvedgepogm (elhgogwilz, rigwntqkhc - jlfphgymee) View more
NCT02547038 (CTgov)	Not Applicable	Helicobacter pylori infection	352	pantoprazole+tetracycline+metronidazole+bismuth subcitrate (Pantoprazole+Bismuth+Tetra+Metro)	iymcxkrauk(ifeevedopo) = eljhfvtflh piyvtqdhzu (unfaklxbov, pkhwwerilp - schqtkdubv) View more	-	10 Jun 2019
				pantoprazole+amoxicillin+metronidazole+clarithromycin ((Panto+Amox+Clar+Metr)+(Panto+Amox))	iymcxkrauk(ifeevedopo) = tbljxufzst piyvtqdhzu (unfaklxbov, tsylhlmpxf - klmkzotuky) View more
NCT02978157 (CTgov)	Not Applicable	Helicobacter pylori infection	102	amox+esomeprazole (Esomeprazole+Amox+Levo)	zvjfbfeovo(awrgzipqdb) = ciuiqgyllb zpravjlyos (rkzpnybvyc, qlwbsfoaye - mbbrhqiiee) View more	-	14 Mar 2019
				levofloxacin+amoxicillin+esomeprazole+bismuth (Esomeprazole+Bismuth+Tetra+Levo)	zvjfbfeovo(awrgzipqdb) = zqnmcacjix zpravjlyos (rkzpnybvyc, wybsegluxe - qoajeaxrfr) View more

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