1.The interval of rescue treatment does not affect the efficacy and safety of Helicobacter pylori eradication: A prospective multicenter observational study.
Minjuan LIN ; Junnan HU ; Jing LIU ; Juan WANG ; Zhongxue HAN ; Xiaohong WANG ; Zhenzhen ZHAI ; Yanan YU ; Wenjie YUAN ; Wen ZHANG ; Zhi WANG ; Qingzhou KONG ; Boshen LIN ; Yuming DING ; Meng WAN ; Wenlin ZHANG ; Miao DUAN ; Shuyan ZENG ; Yueyue LI ; Xiuli ZUO ; Yanqing LI
Chinese Medical Journal 2025;138(12):1439-1446
BACKGROUND:
The effect of the interval between previous Helicobacter pylori (H. pylori) eradication and rescue treatment on therapeutic outcomes remains unknown. The aim of this study was to investigate the association between eradication rates and treatment interval durations in H. pylori infections.
METHODS:
This prospective observational study was conducted from December 2021 to February 2023 at six tertiary hospitals in Shandong, China. We recruited patients who were positive for H. pylori infection and required rescue treatment. Demographic information, previous times of eradication therapy, last eradication therapy date, and history of antibiotic use data were collected. The patients were divided into four groups based on the rescue treatment interval length: Group A, ≥4 weeks and ≤3 months; Group B, >3 and ≤6 months; Group C, >6 and ≤12 months; and Group D, >12 months. The primary outcome was the eradication rate of H. pylori . Drug compliance and adverse events (AEs) were also assessed. Pearson's χ2 test or Fisher's exact test was used to compare eradication rates between groups.
RESULTS:
A total of 670 patients were enrolled in this study. The intention-to-treat (ITT) eradication rates were 88.3% (158/179) in Group A, 89.6% (120/134) in Group B, 89.1% (123/138) in Group C, and 87.7% (192/219) in Group D. The per-protocol (PP) eradication rates were 92.9% (156/168) in Group A, 94.5% (120/127) in Group B, 94.5% (121/128) in Group C, and 93.6% (190/203) in Group D. There was no statistically significant difference in the eradication rates between groups in either the ITT ( P = 0.949) or PP analysis ( P = 0.921). No significant differences were observed in the incidence of AEs ( P = 0.934) or drug compliance ( P = 0.849) between groups.
CONCLUSION:
The interval duration of rescue treatment had no significant effect on H. pylori eradication rates or the incidence of AEs.
REGISTRATION
ClinicalTrials.gov , NCT05173493.
Humans
;
Helicobacter Infections/drug therapy*
;
Helicobacter pylori/pathogenicity*
;
Male
;
Female
;
Prospective Studies
;
Middle Aged
;
Anti-Bacterial Agents/adverse effects*
;
Adult
;
Aged
;
Treatment Outcome
;
Proton Pump Inhibitors/therapeutic use*
2.Role of antibiotic eluting absorbable calcium sulfate in phaseⅠrevision treatment of periprosthetic knee infection.
Xiao-Bo CHEN ; Shuai-Lei LI ; Ai-Bin LIU ; Hao CHAI ; Yong-Qiang SUN
China Journal of Orthopaedics and Traumatology 2025;38(6):580-586
OBJECTIVE:
To explore the role of antibiotic-eluting absorbable calcium sulfate in treating periprosthetic infection after one-stage revision of knee arthroplasty.
METHODS:
A retrospective analysis was performed on 36 patients(36 knees)who underwent phaseⅠrevision for periprosthesis infection after total knee arthroplasty from January 2018 to March 2022. All patients were underwent knee cavity puncture before operation and had positive results of aseptic body fluid culture, 21 patients received revision combined with antibiotic loaded calcium sulfate at stageⅠ(calcium sulfate group) during operation, and 15 patients underwent renovation at stageⅠ(revision group). There were 9 males and 12 females in calcium sulfate group, aged from 54 to 76 years old with an average of(67.6±6.2) years old. There were 15 patients in revision group, including 4 males and 11 females, aged from 60 to 75 years old with average of (69.6±4.1) years old. The levels of serum C-reactive protein (CRP), interleukin-6 (IL-6) at 7, 14, 30 and 90 days after operation were compared between two groups, and the rate of end-infection control at follow-up were compared. The systemic antibiotic application time, hospital stay and postoperative complications were observed between two groups.
RESULTS:
Calcium sulfate group were followed up for 12 to 29 months with an average of(18.9±4.2) months, and the infection control rate was 90.5%;while revision group were followed up 18 to 29 months with average of (21.6±3.7) months, and the infection control rate was 86.7% (13/15). There were no significant differences in follow-up time and infection control rate between two groups(P>0.05). Postoperative levels of CRP and IL-6 at 7, 14 and 30 days in calcium sulfate group were (32.79±11.48), (15.50±6.52), (9.36±3.32) mg·L-1 and (17.31±6.15) pg·ml-1, respectively;which were lower than those in revision group (40.65±11.32), (30.15±10.57), (18.97±5.86) mg·L-1 and (25.54±6.73) pg·ml-1, had statistical differences(P<0.05). There were no significant differences in IL-6 levels at 7 and 14 days after operation and CRP levels at 90 days after operation between two groups (P>0.05). The hospitalization time and systemic antibiotic application time in calcium sulfate group were (18.4±2.2) and (63.5±21.4) d, respectively;which were better than those in revision group (20.5±2.4) and (82.7±16.9) d, and had statistical differences(P<0.05). No significant wound complications and hypercalcemia were observed in calcium sulfate group.
CONCLUSION
Antibiotic eluted absorbable calcium sulfate could be used to treat periprosthetic knee infection, significantly reducing CRP levels in the early postoperative period, shortening hospital stay and systemic antibiotic application time, but it does not significantly improve the control rate of revision infection at stageⅠ.
Humans
;
Male
;
Female
;
Aged
;
Prosthesis-Related Infections/surgery*
;
Middle Aged
;
Calcium Sulfate/administration & dosage*
;
Arthroplasty, Replacement, Knee/adverse effects*
;
Retrospective Studies
;
Anti-Bacterial Agents/therapeutic use*
;
Interleukin-6/blood*
;
C-Reactive Protein/metabolism*
;
Reoperation
;
Knee Prosthesis/adverse effects*
3.Literature review and experience in treatment of multidrug-resistant bacterial infection in operative area after cochlear implantation.
Wenwei LUO ; Peina WU ; Yuanpu LAI ; Yong CUI ; Hongming HUANG
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2025;39(5):453-456
Objective:Multi-drug resistant bacterial infection(MRSA) complications occurring in cochlear implant recipients is rare and of serious consequence. This paper aimed to summarize the treatment experience of a patient with MRSA infection after cochlear implantation. A patient with nasopharyngeal malignant tumor after radiotherapy developed to severe sensorineural deafness. She suffered MRSA infection nine days after cochlear implantation. Since the wound failed to heal after weeks of topical and systemic sensitive antibiotic therapy, the patient underwent surgery for wound debridement. The stimulator-receiver and the electrode of the implant was removed, negative pressure wound therapy was applied, and systemic anti-infection treatment with sensitive antibiotics for weeks, the patients recovered and was discharged from hospital 69 days after infection.
Humans
;
Cochlear Implantation/adverse effects*
;
Female
;
Drug Resistance, Multiple, Bacterial
;
Staphylococcal Infections/therapy*
;
Methicillin-Resistant Staphylococcus aureus
;
Cochlear Implants
;
Anti-Bacterial Agents/therapeutic use*
;
Postoperative Complications
;
Middle Aged
4.Thesium chinense Turcz. alleviates antibiotic-associated diarrhea in mice by modulating gut microbiota structure and regulating the EGFR/PI3K/Akt signaling pathway.
Haonan XU ; Fang ZHANG ; Yuying HUANG ; Qisheng YAO ; Yueqin GUAN ; Hao CHEN
Journal of Southern Medical University 2025;45(2):285-295
OBJECTIVES:
To investigate the therapeutic mechanism of Thesium chinense Turcz. (TCT) for antibiotic-associated diarrhea (AAD).
METHODS:
Network pharmacology, KEGG pathway enrichment analysis and molecular docking were used to identify the shared targets and genes of TCT and AAD, the key signaling pathways and the binding between the active components in TCT and the core protein targets. In a Kunming mouse model of AAD established by intragastric administration of lincomycin hydrochloride, the effects of daily gavage of 1% carboxymethyl cellulose sodium or TCT gel solutions at 1.5 g/kg and 3 g/kg (n=10) on body weight and diarrhea were observed. HE staining, ELISA, 16S rRNA sequencing, and Western blotting were used to examine pathologies, expression levels of IL-6 and TNF-α, changes in gut microbiota, and protein expressions of EGFR, p-EGFR, PI3K, p-PI3K, Akt, and p-Akt in the colon tissues of the mice.
RESULTS:
We identified a total of 66 active components of TCT and 68 core targets including EGFR, STAT3 and PIK3CA. KEGG pathway enrichment analysis suggested that the therapeutic effects of TCT was mediated primarily through the PI3K/Akt signaling pathway. Molecular docking showed that EGFR had the highest binding affinity with coniferin, and the EGFR-coniferin complex maintained a stable conformation at 10 ns, whose stability was also confirmed by Gibbs free energy analysis. In the mouse models of AAD, treatment with TCT significantly improved colonic tissue morphology, decreased colonic levels of TNF-α and IL-6, increased gut microbiota diversity, and modulated the relative abundances of the key genera including Lactobacillus and Bacteroides. TCT treatment also markedly reduced protein expressions of p-EGFR, p-PI3K and p-Akt in the colon tissues of the mice.
CONCLUSIONS
TCT can alleviate AAD in mice by modulating gut microbiota composition, regulating the EGFR/PI3K/Akt signaling pathway, and reducing TNF‑α and IL-6 expressions.
Animals
;
Gastrointestinal Microbiome/drug effects*
;
Signal Transduction/drug effects*
;
Mice
;
ErbB Receptors/metabolism*
;
Proto-Oncogene Proteins c-akt/metabolism*
;
Diarrhea/drug therapy*
;
Phosphatidylinositol 3-Kinases/metabolism*
;
Anti-Bacterial Agents/adverse effects*
;
Drugs, Chinese Herbal/therapeutic use*
;
Molecular Docking Simulation
5.Characteristics and therapeutic strategies of Pott's puffy tumor.
Huiyi DENG ; Zhipeng CHEN ; Xifu WU ; Qintai YANG
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2024;38(1):83-90
Objective:To explore the characteristics and therapeutic strategies of Pott's puffy tumor(PPT). Methods:The clinical data of two patients with PPT were retrospectively analyzed and combined with the literature, focusing on the comprehensive analysis of perioperative diagnosis and treatment strategies. Both patients underwent muti-disciplinary treatment, including timely administration of sufficient antibiotics capable of penetrating the blood-brain barrier. Early removal of PPT lesions was performed using a combined internal and external approach under nasal endoscopic guidance. Results:After standardized perioperative management, the symptoms of the two patients were completely relieved, with no recurrence after one=year follow=up. Postoperative complications such as frontal pain, numbness, local depression, or scar hyperplasiawere not present. Conclusion:PPT, being relatively rare and severe, requires careful attention. Key strategies for standardized perioperative management include multi-disciplinary consultation, timely and adequate antibiotic administration, and surgical intervention using a combined intranasal and extranasal endoscopic approach for lesion removal.
Humans
;
Pott Puffy Tumor/complications*
;
Retrospective Studies
;
Tomography, X-Ray Computed
;
Endoscopy/adverse effects*
;
Postoperative Complications
;
Anti-Bacterial Agents/therapeutic use*
;
Frontal Sinusitis/complications*
6.Distribution and Drug Resistance of Pathogens in Oral Mucositis Associated with Chemotherapy in Patients with Malignant Hematopathy.
Jin QIU ; Zi-Hao ZHANG ; Xiao-Ting LIU ; Cheng-Long LIU ; Si-Yi ZHU ; Zhao-Qu WEN
Journal of Experimental Hematology 2023;31(1):274-279
OBJECTIVE:
To analyze the distribution and drug resistance of pathogens in oral mucositis associated with chemotherapy in hospitalized patients with malignant hematopathy, so as to provide scientific evidences for rational selection of antibiotics and infection prevention and control.
METHODS:
From July 2020 to June 2022, 167 patients with malignant hematopathy were treated with chemical drugs in the Department of Hematology, Hainan Hospital, and secretions from oral mucosal infected wounds were collected. VITEK2 COMPECT automatic microbial identification system (BioMerieux, France) and bacterial susceptibility card (BioMerieux) were used for bacterial identification and drug susceptibility tests.
RESULTS:
A total of 352 strains of pathogens were isolated from 167 patients, among which 220 strains of Gram-positive bacteria, 118 strains of Gram-negative bacteria and 14 strains of fungi, accounted for 62.50%, 33.52% and 3.98%, respectively. The Gram-positive bacteria was mainly Staphylococcus and Streptococcus, while Gram-negative bacteria was mainly Klebsiella and Proteus. The resistance of main Gram-positive bacteria to vancomycin, ciprofloxacin and gentamicin was low, and the resistance to penicillin, cefuroxime, ampicillin, cefotaxime, erythromycin and levofloxacin was high. The main Gram-negative bacteria had low resistance to gentamicin, imipenem and penicillin, but high resistance to levofloxacin, cefotaxime, cefuroxime, ampicillin and vancomycin. The clinical data of oral mucositis patients with oral ulcer (severe) and without oral ulcer (mild) were compared, and it was found that there were statistically significant differences in poor oral hygiene, diabetes, sleep duration less than 8 hours per night between two groups (P<0.05).
CONCLUSION
Gram-positive bacteria is the main pathogen of oral mucositis in patients with malignant hematopathy after chemotherapy. It is sensitive to glycopeptide antibiotics and aminoglycosides antibiotics. Poor oral hygiene, diabetes and sleep duration less than 8 hours per night are risk factors for oral mucositis with oral ulcer (severe).
Humans
;
Vancomycin/therapeutic use*
;
Cefuroxime
;
Levofloxacin
;
Oral Ulcer/drug therapy*
;
Drug Resistance, Bacterial
;
Anti-Bacterial Agents/adverse effects*
;
Ampicillin
;
Penicillins
;
Cefotaxime
;
Gram-Positive Bacteria
;
Gram-Negative Bacteria
;
Gentamicins
;
Stomatitis/drug therapy*
7.Efficacy of high-dose dual therapy for Helicobacter pylori infection eradication in servicemen: a randomized controlled trial.
Xiao Mei ZHANG ; Han Chen MIN ; Jing CHEN ; Jun Li ZHI ; Hong Xia DONG ; Jin Yan KONG ; Jiang Yun MENG ; Gang SUN ; Zi Kai WANG ; Fei PAN ; Li Hua PENG ; Yun Sheng YANG
Chinese Journal of Internal Medicine 2023;62(5):520-525
Objective: To assess the efficacy and cost-effectiveness of high-dose dual therapy compared with bismuth-containing quadruple therapy for treating Helicobacter pylori(H.pylori) infection in servicemen patients. Methods: A total of 160 H. pylori-infected, treatment-naive servicemen, including 74 men and 86 women, aged from 20 years to 74 years, with a mean (SD) age of 43 (13) years, tested in the First Center of Chinese PLA General Hospital from March 2022 to May 2022 were enrolled in this open-label, randomized controlled clinical trial. Patients were randomly allocated into 2 groups: the 14-day high-dose dual therapy group and the bismuth-containing quadruple therapy group. Eradication rates, adverse events, patient compliance, and drug costs were compared between the two groups. The t-test was used for continuous variables, and the Chi-square test for categorical variables. Results: No significant difference in H. pylori eradication rates were found between high-dose dual therapy and bismuth-containing quadruple therapy by ITT, mITT and PP analysis[ITT:90.0% (95%CI 81.2%-95.6%) vs. 87.5% (95%CI 78.2%-93.8%), χ2=0.25, P=0.617;mITT:93.5% (95%CI 85.5%-97.9%) vs. 93.3% (95%CI 85.1%-97.8%), χ2<0.01, P=1.000; PP: 93.5% (95%CI 85.5%-97.9%) vs. 94.5% (95%CI 86.6%-98.5%), χ2<0.01, P=1.000 ]. The dual therapy group exhibited significantly less overall side effects compared with the quadruple therapy group [21.8% (17/78) vs. 38.5% (30/78), χ2=5.15,P=0.023]. There were no significant differences in the compliance rates between the two groups [98.7%(77/78) vs. 94.9%(74/78), χ2=0.83,P=0.363]. The cost of medications in the dual therapy was 32.0% lower compared with that in the quadruple therapy (472.10 RMB vs. 693.94 RMB). Conclusions: The dual regimen has a favorable effect on the eradication of H. pylori infection in servicemen patients. Based on the ITT analysis, the eradication rate of the dual regimen is grade B (90%, good). Additionally, it exhibited a lower incidence of adverse events, better compliance and significantly reduced cost. The dual regimen is expected to be a new choice for the first-line treatment of H. pylori infection in servicemen but needs further evaluation.
Male
;
Humans
;
Female
;
Young Adult
;
Adult
;
Helicobacter Infections
;
Helicobacter pylori
;
Bismuth
;
Anti-Bacterial Agents/therapeutic use*
;
Amoxicillin/adverse effects*
;
Drug Therapy, Combination
;
Treatment Outcome
;
Proton Pump Inhibitors/therapeutic use*
8.Dwelling time and complications of umbilical venous catheterization with different tip positions in preterm infants: a multicenter prospective cohort study.
Zi Xin YANG ; Hong Yan WANG ; Xu ZHENG ; Lu CHEN ; Juan DU ; Bin YI ; Ming Yan HEI
Chinese Journal of Pediatrics 2023;61(1):43-48
Objective: To compare the dwelling time and complications of low lying umbilical venous catheterization (UVC) in preterm infants with that of central UVC. Methods: This was a prospective cohort study. A total of 3 020 preterm infants from 44 neonatal intensive care units (NICU) who had UVC inserted from October 2019 to August 2021 were enrolled. Demographic and general baseline data, dwelling time of UVC and reasons for removal, complications and their occurrence time were collected. According to the position of the catheter tip, the preterm infants were divided into low lying UVC group (insertion depth of 3-5 cm) and central UVC group (the catheter tip was close to the entrance of right atrium, or at the 8th-9th thoracic vertebra level). The Mann-Whitney U test was used to compare the dwelling time and incidence of complications (cases/1 000 catheter days), and the independent t test and Chi-square test were used to compare the characteristics between the 2 groups. The receiver operating characteristic (ROC) curve was used to analyze the optimal cut-off value of UVC dwelling time. Results: Among the included 3 020 preterm infants, 1 624 (53.8%) were males, the gestational age was 29.9 (28.4, 31.6) weeks, the birth weight was (1 264±301) g, and 2 172 (71.9%) premature babies had central UVC. There were no significant differences in the proportion of males, the gestational age and the birth weight of neonates between the 2 groups (all P>0.05). There were also no significant differences in the rate of maternal history, PPROM>18 hours, chorioamnionitis, antenatal antibacterial angents exposure and antibacterial angents usage through UVC (all P>0.05). The dwelling time of central UVC was longer than that of low lying UVC (7 (6, 10) vs. 4 (3, 7) days, U=23.42, P<0.001). The complication incidence of central and low lying UVC were 20.0 and 70.8 cases/1 000 catheter days, respectively. The top 3 complications of central UVC were occlusion, catheter tip migration, and CLABSI (9.3, 3.5, 3.0 cases/1 000 catheter days). The top 3 complications of low lying UVC were catheter occlusion, CLABSI, and catheter tip migration (45.8, 6.3, 5.4 cases/1 000 catheter days). The ROC curve of UVC dwelling time and complications showed that the cut-off values of central UVC and low lying UVC were 6.5 and 4.5 days, respectively. The 2 groups both showed a trend of increases in the 3 complications with the prolonged dwelling time. Cox regression analysis showed that the overall difference in the proportion of occlusion between the central UVC and low lying UVC groups was statistically significant (χ2=30.18, P=0.024). There were both no significant differences in catheter tip migration and CLABSI (both P>0.05). Conclusions: The most common UVC complication in preterm infants is occlusion. It is not recommended to keep a low lying UVC for longer than 4.5 days. During the whole dwelling period, a close monitoring for UVC complications is required.
Pregnancy
;
Male
;
Infant, Newborn
;
Humans
;
Female
;
Infant
;
Infant, Premature
;
Birth Weight
;
Prospective Studies
;
Catheterization, Central Venous/adverse effects*
;
Anti-Bacterial Agents
;
Catheterization, Peripheral/adverse effects*
;
Retrospective Studies
9.Clinical Analysis of Colistin Sulfate in the Treatment of Hematonosis Infected by Multidrug-Resistant Gram-Negative Bacteria.
Yuan-Bing WU ; Shan-Shan JIANG ; Ya-Xue WU ; Dong-Yang LI ; Qian LI ; Xing WANG ; Bin LIU ; Hai-Yan BAO ; Xiao-Hui HU
Journal of Experimental Hematology 2023;31(6):1878-1884
OBJECTIVE:
To investigate the efficacy and safety of colistin sulfate in the treatment of hematonosis patients infected by multidrug-resistant (MDR) gram-negative bacteria (GNB), and discuss the possible factors that affect the efficacy of colistin sulfate.
METHODS:
The clinical data of 85 hematologic patients infected with MDR GNB in the Soochow Hopes Hematonosis Hospital from April 2022 to November 2022 were collected and divided into clinically effective group with 71 cases and ineffective group with 14 cases according to the therapeutic efficacy of colistin sulfate. The age, gender, type of hematologic disease, status of hematopoietic stem cell transplantation, infection sites, type of pathogen, timing of administration, daily dose and duration of colistin sulfate, and combination with other antibacterial agents of patients in two groups were compared. Logistic regression was used to analyze on the meaningful variables to study the influencing factors of colistin sulfate. The adverse reactions of colistin sulfate were also evaluated.
RESULTS:
There were no significant differences in age, gender, type of hematologic disease, hematopoietic stem cell transplantation status, infection sites and pathogen type between the effective group and the ineffective group (P>0.05). Compared with the medication time more than 7 days, meropenem used within 7 days in the clinical effective group, and timely replacement with colistin sulfate could obtain better efficacy, the difference was statistically significant (P=0.018). The duration of tigacycline before colistin sulfate did not affect the efficacy, and there was no significant difference in efficacy between the effective and ineffective groups. The therapeutic effect of colistin sulfate at daily dose of 500 000 U q8h was better than that of 500 000 U q12h, the difference was statistically significant (P=0.035). The time of colistin sulfate use in the clinically effective group was longer than that in the ineffective group, which had a statistical difference (P=0.003). Compared with the clinical ineffective group, the efficacy of combination regimens with colistin sulfate was better than that of colistin sulfate monotherapy, and the difference was statistically significant (P=0.013). Multivariate logistic regression analysis was performed on the indicators with statistical differences in the two groups of patients, which suggested that the use time of colistin sulfate (B: 2.358; OR: 10.573; CI: 1.567-71.361; P=0.015) and the combination of colistin sulfate (B: 1.720; OR: 5.586; CI: 1.210-25.787; P=0.028) were influential factors in the efficacy of colistin sulfate. During the treatment, the incidence of nephrotoxicity, hepatotoxicity and peripheral neurotoxicity were 5.9%, 1.2% and 1.2%, respectively.
CONCLUSION
The use of colistin sulfate improves the clinical efficacy of MDR GNB infections in hematological patients, and the timing of colistin sulfate administration and the combination of drugs are independent factors affecting its clinical efficacy, and the safety during treatment is high.
Humans
;
Colistin/adverse effects*
;
Anti-Bacterial Agents/therapeutic use*
;
Meropenem/adverse effects*
;
Treatment Outcome
;
Gram-Negative Bacteria
;
Hematologic Diseases
10.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

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