1.Bismuth, esomeprazole, metronidazole, and minocycline or tetracycline as a first-line regimen for Helicobacter pylori eradication: A randomized controlled trial.
Baojun SUO ; Xueli TIAN ; Hua ZHANG ; Haoping LU ; Cailing LI ; Yuxin ZHANG ; Xinlu REN ; Xingyu YAO ; Liya ZHOU ; Zhiqiang SONG
Chinese Medical Journal 2023;136(8):933-940
BACKGROUND:
Given the general unavailability, common adverse effects, and complicated administration of tetracycline, the clinical application of classic bismuth quadruple therapy (BQT) is greatly limited. Whether minocycline can replace tetracycline for Helicobacter pylori ( H . pylori ) eradication is unknown. We aimed to compare the eradication rate, safety, and compliance between minocycline- and tetracycline-containing BQT as first-line regimens.
METHODS:
This randomized controlled trial was conducted on 434 naïve patients with H . pylori infection. The participants were randomly assigned to 14-day minocycline-containing BQT group (bismuth potassium citrate 110 mg q.i.d., esomeprazole 20 mg b.i.d., metronidazole 400 mg q.i.d., and minocycline 100 mg b.i.d.) and tetracycline-containing BQT group (bismuth potassium citrate/esomeprazole/metronidazole with doses same as above and tetracycline 500 mg q.i.d.). Safety and compliance were assessed within 3 days after eradication. Urea breath test was performed at 4-8 weeks after eradication to evaluate outcome. We used a noninferiority test to compare the eradication rates of the two groups. The intergroup differences were evaluated using Pearson chi-squared or Fisher's exact test for categorical variables and Student's t -test for continuous variables.
RESULTS:
As for the eradication rates of minocycline- and tetracycline-containing BQT, the results of both intention-to-treat (ITT) and per-protocol (PP) analyses showed that the difference rate of lower limit of 95% confidence interval (CI) was >-10.0% (ITT analysis: 181/217 [83.4%] vs . 180/217 [82.9%], with a rate difference of 0.5% [-6.9% to 7.9%]; PP analysis: 177/193 [91.7%] vs . 176/191 [92.1%], with a rate difference of -0.4% [-5.6% to 6.4%]). Except for dizziness more common (35/215 [16.3%] vs . 13/214 [6.1%], P = 0.001) in minocycline-containing therapy groups, the incidences of adverse events (75/215 [34.9%] vs . 88/214 [41.1%]) and compliance (195/215 [90.7%] vs . 192/214 [89.7%]) were similar between the two groups.
CONCLUSION:
The eradication efficacy of minocycline-containing BQT was noninferior to tetracycline-containing BQT as first-line regimen for H . pylori eradication with similar safety and compliance.
TRIAL REGISTRATION
ClinicalTrials.gov, ChiCTR 1900023646.
Humans
;
Bismuth/therapeutic use*
;
Metronidazole/therapeutic use*
;
Esomeprazole/pharmacology*
;
Minocycline/pharmacology*
;
Helicobacter pylori
;
Potassium Citrate/therapeutic use*
;
Anti-Bacterial Agents
;
Tetracycline/adverse effects*
;
Helicobacter Infections/drug therapy*
;
Drug Therapy, Combination
;
Amoxicillin
2.Comparison of Epsilometer test and agar dilution method in detecting the sensitivity of Helicobacter pylori to metronidazole.
Xue Li TIAN ; Zhi Qiang SONG ; Bao Jun SUO ; Li Ya ZHOU ; Cai Ling LI ; Yu Xin ZHANG
Journal of Peking University(Health Sciences) 2023;55(5):934-938
OBJECTIVE:
Agar dilution method (ADM) was used as the golden standard to evaluate the consistency of Epsilometer test (E-test) in detecting the sensitivity of Helicobacter pylori (H. pylori) to metronidazole.
METHODS:
From August 2018 to July 2020, patients with H. pylori infection treated for the first time in Peking University Third Hospital for gastroscopy due to dyspepsia were included in this study. Gastric mucosas were taken from the patients with H. pylori infection. H. pylori culture was performed. Both the ADM and E-test were applied to the antibiotic susceptibility of H. pylori to metro-nidazole, and the consistency and correlation between the two methods were validated.
RESULTS:
In the study, 105 clinical isolates of H. pylori were successfully cultured, and the minimum inhibitory concentration ≥ 8 mg/L was defined as drug resistance. Both ADM and the E-test showed high resistance rates to metronidazole, 64.8% and 62.9%, respectively. Among them, 66 drug-resistant strains were detected by ADM and E-test, and 37 were sensitive strains, so the consistency rate was 98.1%. Two strains were evaluated as drug resistance by ADM, but sensitive by the E-test, with a very major error rate of 1.9%. There was zero strain sensitive according to ADM but assessed as resistant by the E-test, so the major error rate was 0%. Taking ADM as the gold standard, the sensitivity of E-test in the detection of metronidazole susceptibility was 97.1% (95%CI: 0.888-0.995), and the specificity was 100% (95%CI: 0.883-1.000). Cohen's kappa analysis showed substantial agreement, and kappa coefficient was 0.959 (95%CI: 0.902-1.016, P < 0.001). Spearmans correlation analysis confirmed this correlation was significant (r=0.807, P < 0.001). The consistency evaluation of Bland-Altman method indicated that it was good, and there was no measured value outside the consistency interval. In this study, cost analysis, including materials and labor, showed a 32.2% higher cost per analyte for ADM as compared with the E-test (356.6 yuan vs. 269.8 yuan).
CONCLUSION
The susceptibility test of H. pylori to metronidazole by E-test presents better agreement with ADM. Because it is less expensive, less labor intensive, and more rapid, it is an easy and reliable method for H. pylori susceptibility testing.
Humans
;
Metronidazole/therapeutic use*
;
Helicobacter pylori
;
Agar/therapeutic use*
;
Disk Diffusion Antimicrobial Tests
;
Microbial Sensitivity Tests
;
Helicobacter Infections/drug therapy*
;
Anti-Bacterial Agents/therapeutic use*
3.Clinical audit of current Helicobacter pylori treatment outcomes in Singapore.
Tiing Leong ANG ; Kim Wei LIM ; Daphne ANG ; Yu Jun WONG ; Malcolm TAN ; Andrew Siang YIH WONG
Singapore medical journal 2022;63(9):503-508
INTRODUCTION:
H. pylori eradication reduces the risk of gastric malignancies and peptic ulcer disease. First-line therapies include 14-day PAC (proton pump inhibitor [PPI], amoxicillin, clarithromycin) and PBMT (PPI, bismuth, metronidazole, tetracycline). Second-line therapies include 14-day PBMT and PAL (PPI, amoxicillin, levofloxacin). This clinical audit examined current treatment outcomes in Singapore.
METHODS:
Clinical data of H. pylori-positive patientswho underwent empirical first- and second-line eradication therapies from 1 January 2017 to 31 December 2018 were reviewed. Treatment success was determined by 13C urea breath test performed at least 4 weeks after treatment and 2 weeks off PPI.
RESULTS:
A total of 963 patients (862 PAC, 36 PMC [PPI, metronidazole, clarithromycin], 18 PBMT, 13 PBAC [PAC with bismuth], 34 others) and 98 patients (62 PMBT, 15 PAL, 21 others) received first-and second-line therapies respectively. A 14-day treatment duration was appropriately prescribed for first- and second-line therapies in 65.2% and 82.7% of patients, respectively. First-line treatment success rates were noted for PAC (seven-day: 76.9%, ten-day: 88.3%, 14-day: 92.0%), PMC (seven-day: 0, ten-day: 75.0%, 14-day: 69.8%), PBMT (ten-day: 100%, 14-day: 87.5%) and PBAC (14-day: 100%). 14-day treatment was superior to seven-day treatment (90.8% vs. 71.4%; P = 0.028). PAC was superior to PMC (P < 0.001) but similar to PBMT (P = 0.518) and PBAC (P = 0.288) in 14-day therapies. 14-day second-line PAL and PBMT had similar efficacy (90.9% vs. 82.4%; P = 0.674).
CONCLUSION
First-line empirical treatment using PAC, PBMT and PBAC for 14 days had similar efficacy. Success rates for second-line PBMT and PAL were similar.
Humans
;
Helicobacter pylori
;
Clarithromycin/therapeutic use*
;
Helicobacter Infections/drug therapy*
;
Metronidazole/therapeutic use*
;
Bismuth/therapeutic use*
;
Singapore
;
Drug Therapy, Combination
;
Amoxicillin/therapeutic use*
;
Proton Pump Inhibitors/therapeutic use*
;
Anti-Bacterial Agents/therapeutic use*
;
Treatment Outcome
;
Clinical Audit
4.Effect of Fuyanshu Capsules combined with antibiotics on inflammatory factors in patients with pelvic inflammatory disease.
Xiao-Ling FENG ; Sha JIANG ; Jing CHEN ; Xun LIU ; Yang ZHANG ; Lu CHEN
China Journal of Chinese Materia Medica 2019;44(12):2637-2643
To investigate the effect of Fuyanshu Capsules combined with Western medicine antibiotics on symptoms and inflammatory factors IL-10 and IL-1β in patients with pelvic inflammatory disease and its possible mechanism. Totally 112 patients with pelvic inflammatory disease of damp-heat stagnation treated since April 2017 to April 2018 were randomly divided into treatment group( group A,57 cases) and control group( group B,55 cases). The treatment group was given Fuyanshu Capsules for 56 d,and levofloxacin hydrochloride tablets and metronidazole tablets for 14 d. The control group was given Fuyanshu Capsules as its analogue. The curative rate,effective rate and inefficiency,serum IL-10 and IL-1β levels were compared between the two groups. The curative effect was evaluated with McCormack score and traditional Chinese medicine( TCM) syndrome score. The recurrence rate and chronic pelvic pain were followed up after one menstrual cycle. It was found that the curative rate and effective rate of group A were higher than those of group B after treatment. After 28 d of treatment,there was a difference in the effective rate of TCM syndrome score between group A and group B( 62. 71% vs 8. 47%,P < 0. 01). After 56 d of treatment,serum IL-10 increased,while IL-1β decreased in group A,which was significantly different from that in group B( P<0. 01). The recurrence rate of PID and chronic pelvic pain in group A were significantly lower than those in group B( P<0. 01). The results showed that Fuyanshu Capsules combined with levofloxacin and metronidazole could alleviate the clinical symptoms and signs of chronic pelvic inflammation of damp-heat stagnation type,reduce the recurrence rate of pelvic inflammation,relieve pelvic pain,and alleviate the inflammation status of patients by regulating the expression of IL-10 and IL-1β in peripheral serum.
Anti-Bacterial Agents
;
therapeutic use
;
Capsules
;
Drugs, Chinese Herbal
;
therapeutic use
;
Female
;
Humans
;
Interleukin-10
;
blood
;
Interleukin-1beta
;
blood
;
Levofloxacin
;
Medicine, Chinese Traditional
;
Metronidazole
;
Pelvic Inflammatory Disease
;
drug therapy
5.Efficacy of bismuth containing quadruple therapies on Helicobacter pylori eradication in patients with history of antibiotic treatment.
Dan TANG ; Lingzhi YUAN ; Chun YUE ; Ting CAI ; Yao YAO ; Fen WANG
Journal of Central South University(Medical Sciences) 2018;43(7):772-778
To investigate the efficacy of bismuth containing quadruple therapies on Helicobacter pylori (Hp) eradication in patients with history of antibiotic treatment.
Methods: Hp infected patients (n=327) were allocated into 3 groups. Group A (n=52), patients had no antibiotic history and they took medicine of proton pump inhibitors (PPI) and livzon triple (clarithromycin, tinidazole, and bismuth); group B (n=80), patients had the antibiotic history except for amoxicillin and clarithromycin, and they were treated with PPI, amoxicillin, clarithromycin, and bismuth; group C (n=195), patients suffered failures of Hp therapy or with history of antibiotic abuse, and they were treated with PPI, doxycycline, furazolidone, and bismuth.
Results: Both the intention-to-treat (ITT) analysis (group A 63.5%, group B 76.2%, group C 82.6%, P<0.05) and the pre-protocol (PP) analysis (group A 76.7%, group B 92.4%, group C 96.4%, P<0.05) showed significant difference among the 3 groups, revealing higher elimination in group B and C. The side-effects (20.2%) were mild and tolerable (group A, 28.0%; group B, 10.7%; group C, 22.0%).
Conclusion: Proton pump inhibitors together with the livzon triple regimen have a low rate of Hp eradication and a higher incidence of adverse reactions. The quadruple therapy containing clarithromycin and metronidazole drugs can achieve the satisfactory outcomes based on patient's antibiotic history. For patients with multiple antibiotics, the quadruple therapy containing furazolidone and doxycycline may achieve the satisfactory outcomes, but the adverse resction would be relatively higher.
Amoxicillin
;
therapeutic use
;
Anti-Bacterial Agents
;
therapeutic use
;
Bismuth
;
therapeutic use
;
Clarithromycin
;
therapeutic use
;
Drug Therapy, Combination
;
methods
;
Furazolidone
;
therapeutic use
;
Helicobacter Infections
;
drug therapy
;
Helicobacter pylori
;
Humans
;
Metronidazole
;
therapeutic use
;
Proton Pump Inhibitors
;
therapeutic use
;
Tinidazole
;
therapeutic use
;
Treatment Outcome
6.First Case Report of Bacteremia Due to Catabacter hongkongensis in a Korean Patient.
Yong Jun CHOI ; Eun Jeong WON ; Soo Hyun KIM ; Myung Geun SHIN ; Jong Hee SHIN ; Soon Pal SUH
Annals of Laboratory Medicine 2017;37(1):84-87
No abstract available.
Aged
;
Anti-Bacterial Agents/pharmacology/therapeutic use
;
Cefotaxime/analogs & derivatives/therapeutic use
;
Cholangiopancreatography, Endoscopic Retrograde
;
Gallstones/surgery
;
Gram-Negative Anaerobic Bacteria/drug effects/genetics/*isolation & purification
;
Gram-Negative Bacterial Infections/*diagnosis/drug therapy/microbiology
;
Humans
;
Male
;
Metronidazole/therapeutic use
;
Microbial Sensitivity Tests
;
RNA, Ribosomal, 16S/chemistry/genetics/metabolism
;
Sequence Analysis, DNA
;
Tomography, X-Ray Computed
7.Incidence and Clinical Outcomes of Clostridium difficile Infection after Treatment with Tuberculosis Medication.
Yu Mi LEE ; Kyu Chan HUH ; Soon Man YOON ; Byung Ik JANG ; Jeong Eun SHIN ; Hoon Sup KOO ; Yunho JUNG ; Sae Hee KIM ; Hee Seok MOON ; Seung Woo LEE
Gut and Liver 2016;10(2):250-254
BACKGROUND/AIMS: To determine the incidence and clinical characteristics of tuberculosis (TB) medication-associated Clostridium difficile infection. METHODS: This multicenter study included patients from eight tertiary hospitals enrolled from 2008 to 2013. A retrospective analysis was conducted to identify the clinical features of C. difficile infection in patients who received TB medication. RESULTS: C. difficile infection developed in 54 of the 19,080 patients prescribed TB medication, representing a total incidence of infection of 2.83 cases per 1,000 adults. Fifty-one of the 54 patients (94.4%) were treated with rifampin. The patients were usually treated with oral metronidazole, which produced improvement in 47 of the 54 patients (87%). Twenty-three patients clinically improved with continuous rifampin therapy for C. difficile infection. There were no significant differences in improvement between patients treated continuously (n=21) and patients in whom treatment was discontinued (n=26). CONCLUSIONS: The incidence of C. difficile infection after TB medication was not low considering the relatively low TB medication dosage compared to other antibiotics. It may not be always necessary to discontinue TB medication. Instead, decisions concerning discontinuation of TB medication should be based on TB status.
Adult
;
Aged
;
Aged, 80 and over
;
Anti-Infective Agents/therapeutic use
;
Antibiotics, Antitubercular/*adverse effects
;
*Clostridium difficile
;
Enterocolitis, Pseudomembranous/chemically induced/drug therapy/*epidemiology
;
Female
;
Humans
;
Incidence
;
Male
;
Metronidazole/therapeutic use
;
Middle Aged
;
Retrospective Studies
;
Rifampin/*adverse effects
;
Treatment Outcome
;
Tuberculosis/*drug therapy
8.Advanced chronic kidney disease: a strong risk factor for Clostridium difficile infection.
Sun Chul KIM ; Min Young SEO ; Jun Yong LEE ; Ki Tae KIM ; Eunjung CHO ; Myung Gyu KIM ; Sang Kyung JO ; Won Yong CHO ; Hyoung Kyu KIM
The Korean Journal of Internal Medicine 2016;31(1):125-133
BACKGROUND/AIMS: It has been suggested that chronic kidney disease (CKD) is a risk factor for Clostridium difficile infection (CDI) and is associated with increased mortality among patients infected with C. difficile. However, recent studies of the clinical impact of CKD on CDI in Asians are still insufficient. We sought to determine the relationship between CKD and CDI in a Korean population. METHODS: This was a single-center, retrospective case-control study. In total, 171 patients with CDI were included as cases and 342 age- and gender-matched patients without CDI were used as controls. We compared the prevalence of CKD in the study sample and identified independent risk factors that could predict the development or prognosis of CDI. RESULTS: Independent risk factors for CDI included stage IV to V CKD not requiring dialysis (odds ratio [OR], 2.90) and end-stage renal disease requiring dialysis (OR, 3.34). Patients with more advanced CKD (estimated glomerular filtration rate < 30) and CDI showed higher in-hospital mortality and poorer responses to the initial metronidazole therapy. CONCLUSIONS: More advanced CKD is an independent risk factor for CDI and is associated with higher in-hospital mortality and poor treatment responses in CDI patients. Thus, in CKD patients, careful attention should be paid to the occurrence of CDI and its management to improve the outcome of CDI.
Aged
;
Anti-Infective Agents/therapeutic use
;
Chi-Square Distribution
;
Clostridium difficile/*pathogenicity
;
Enterocolitis, Pseudomembranous/diagnosis/drug therapy/*microbiology/mortality
;
Female
;
Hospital Mortality
;
Humans
;
Kidney Failure, Chronic/*complications/diagnosis/therapy
;
Logistic Models
;
Male
;
Metronidazole/therapeutic use
;
Middle Aged
;
Multivariate Analysis
;
Odds Ratio
;
Prevalence
;
Renal Dialysis
;
Renal Insufficiency, Chronic/*complications/diagnosis/mortality/therapy
;
Republic of Korea/epidemiology
;
Retrospective Studies
;
Risk Factors
;
Treatment Outcome
9.Efficiency of Moxifloxacin in the Treatment of Helicobacter pylori Infection.
Gut and Liver 2015;9(6):809-810
No abstract available.
Amoxicillin/*therapeutic use
;
Anti-Bacterial Agents/*therapeutic use
;
Anti-Ulcer Agents/*therapeutic use
;
Female
;
Fluoroquinolones/*therapeutic use
;
Helicobacter Infections/*drug therapy
;
Humans
;
Male
;
Metronidazole/*therapeutic use
;
Organometallic Compounds/*therapeutic use
;
Rabeprazole/*therapeutic use
;
Tetracycline/*therapeutic use
10.Analysis of Clostridium difficile associated diarrhea in pediatric patients with antibiotic-associated diarrhea.
Guoping CHENG ; Zihua LI ; Xin DAI ; Zaihua WANG ; Ping CAI ; Li CHEN ; Zhen ZHANG
Chinese Journal of Pediatrics 2015;53(3):220-224
OBJECTIVETo analyze the incidence and treatment of Clostridium difficile infection (CDI) in pediatric patients with antibiotic-associated diarrhea (AAD).
METHODClinical data of totally 577 pediatric patients with AAD seen from January 2012 to January 2014 were collected; those children were divided according to age into 4 groups, 0.25 -1 year, >1 -4 years, >4 -12 years and >12 -18 years old groups, and 220 healthy children were enrolled as controls. CDI was tested by C. Diff Quik Chek Complete (QCC) and BD GeneOhm™ C. Diff Assay (BD-PCR) in all children, and the CDI incidence of four groups was added up. All pediatric patients with AAD were divided into mild, general and severe type according to different symptoms of diarrhea, and grading treatment, the general type and severe type of CDI children were treated with metronidazole and (or) vancomycin, afterwards, the results of grading treatment were analyzed.
RESULTThe number of pediatric patients with AAD were 178, 177, 132 and 90 in 0. 25 - 1 year, > 1 -4 years, > 4 - 12 years and > 12 - 18 years old group, respectively. The positive rate of CDI (22. 0% (39/177)) in > 1 -4 years old AAD patients was very significantly higher compared to the controls (4% (4/91), P < 0. 001), the rate of CDI (21. 2% (28/132)) in > 4 - 12 years old AAD pediatric patients was significantly higher compared to the controls (4% (2/53), P = 0. 004), the rates of CDI in 0. 25 - 1 year and > 12 - 18years old AAD groups were not significantly different from that of the controls (P >0. 05). There were 285 mild type AAD children (no CDI children), 176 general type AAD children (including 47 CDI children), and 116 severe type AAD children (including 81 CDI children). After grading and symptomatic treatment, there were 16 recurrent diarrhea in 128 CDI patients (severe type AAD), and the rest recovered. Two cases were transferred for referral treatment, 2 cases died, and the rest 12 recurrent diarrhea children fully recovered after administration of metronidazole, vancomycin, probiotics and symptomatic treatment.
CONCLUSIONThe > 1 -12 years old AAD children had higher CDI rate than healthy children; administration of metronidazole and (or) vancomycin was effective for CD infection.
Adolescent ; Anti-Bacterial Agents ; therapeutic use ; Case-Control Studies ; Child ; Child, Preschool ; Clostridium Infections ; drug therapy ; Clostridium difficile ; Diarrhea ; microbiology ; Humans ; Incidence ; Metronidazole ; therapeutic use ; Probiotics ; therapeutic use ; Vancomycin ; therapeutic use

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