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

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*

We conducted pharmacovigilance data mining for a β-lactam antibiotics, amoxicillin, and compare the adverse events (AEs) with the drug labels of 9 countries including Korea, USA, UK, Japan, Germany, Swiss, Italy, France, and Laos. We used the Korea Adverse Event Reporting System (KAERS) database, a nationwide database of AE reports, between December 1988 and June 2014. Frequentist and Bayesian methods were used to calculate disproportionality distribution of drug-AE pairs. The AE which was detected by all the three indices of proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC) was defined as a signal. The KAERS database contained a total of 807,582 AE reports, among which 1,722 reports were attributed to amoxicillin. Among the 192,510 antibiotics-AE pairs, the number of amoxicillin-AE pairs was 2,913. Among 241 AEs, 52 adverse events were detected as amoxicillin signals. Comparing the drug labels of 9 countries, 12 adverse events including ineffective medicine, bronchitis, rhinitis, sinusitis, dry mouth, gastroesophageal reflux, hypercholesterolemia, gastric carcinoma, abnormal crying, induration, pulmonary carcinoma, and influenza-like symptoms were not listed on any of the labels of nine countries. In conclusion, we detected 12 new signals of amoxicillin which were not listed on the labels of 9 countries. Therefore, it should be followed by signal evaluation including causal association, clinical significance, and preventability.
Amoxicillin* ; Anti-Bacterial Agents ; Bayes Theorem ; Bronchitis ; Crying ; Data Mining ; Drug-Related Side Effects and Adverse Reactions* ; France ; Gastroesophageal Reflux ; Germany ; Hypercholesterolemia ; Italy ; Japan ; Korea* ; Laos ; Mouth ; Odds Ratio ; Patient Safety ; Pharmacovigilance ; Rhinitis ; Sinusitis

BACKGROUND/AIMS: Trends in successful eradication of Helicobacter pylori using first-line triple therapy, consisting of a proton pump inhibitor, amoxicillin, and clarithromycin, have been understudied. We evaluated H. pylori eradication rates at a single center over the last 10 years and identified risk factors related to eradication failure. METHODS: This study included 1,413 patients who were diagnosed with H. pylori infection and received 7 days of triple therapy between January 2003 and December 2012. We investigated H. pylori eradication rates retrospectively with respect to the year of therapy, as well as demographic and clinical factors. H. pylori eradication was confirmed by a 13C-urea breath test or a rapid urease test at least 4 weeks after the completion of triple therapy. RESULTS: The overall H. pylori eradication rate was 84.9%. Annual eradication rates from 2003 to 2012 were 93.5%, 80.0%, 87.2%, 88.5%, 92.0%, 88.3%, 85.7%, 84.1%, 83.7%, and 78.8%, respectively, by per-protocol analysis. The eradication rate with first-line triple therapy decreased during the last 10 years (p = 0.015). Multivariate analysis showed that female gender (odds ratio [OR], 1.69; 95% confidence interval [CI], 1.12 to 2.55) and smoking (OR, 1.61; 95% CI, 1.05 to 2.47) were associated with the failure of H. pylori eradication therapy. CONCLUSIONS: The efficacy of first-line triple therapy for H. pylori infection has decreased over the last 10 years, suggesting an increase in antibiotic-resistant H. pylori strains. Thus, other first-line therapies may be necessary for H. pylori eradication in the near future.
Adolescent ; Adult ; Aged ; Aged, 80 and over ; Amoxicillin/therapeutic use ; Anti-Bacterial Agents/adverse effects/*therapeutic use ; Breath Tests ; Chi-Square Distribution ; Clarithromycin/therapeutic use ; Drug Resistance, Bacterial ; Drug Therapy, Combination ; Female ; Helicobacter Infections/diagnosis/*drug therapy/microbiology ; Helicobacter pylori/*drug effects ; Humans ; Linear Models ; Logistic Models ; Male ; Middle Aged ; Multivariate Analysis ; Odds Ratio ; Proton Pump Inhibitors/adverse effects/*therapeutic use ; Republic of Korea ; Retrospective Studies ; Risk Factors ; Sex Factors ; Smoking/adverse effects ; Time Factors ; Treatment Failure ; Young Adult

Myocarditis often occurs due to viral infections and postviral immune-mediated responses. Hypersensitivity myocarditis is a rare form of myocarditis. Numerous drugs can induce myocarditis, which is typically reversible after withdrawal of the causative agent. Here, we report a case of hypersensitivity myocarditis that was probably triggered by amoxicillin and that resolved completely with heart failure management as well as discontinuation of the drug. A 68-year-old woman presented with acute chest pain mimicking acute coronary syndromes, but the coronary angiography was normal. A recent history of taking medications, skin rash, and peripheral eosinophilia suggested a diagnosis of hypersensitivity myocarditis, which was confirmed by cardiac magnetic resonance imaging and endomyocardial biopsy.
Aged ; Amoxicillin/*adverse effects ; Anti-Bacterial Agents/*adverse effects ; *Biopsy ; Drug Hypersensitivity/*diagnosis/drug therapy/etiology/pathology ; Electrocardiography ; Female ; Glucocorticoids/therapeutic use ; Humans ; *Magnetic Resonance Imaging ; Myocarditis/chemically induced/*diagnosis/drug therapy/pathology ; Myocardium/*pathology ; Predictive Value of Tests ; Prednisolone/therapeutic use ; Risk Factors ; Treatment Outcome

BACKGROUNDA prior study showed significant antibiotic resistance to quinolone in our population. In this study we aimed to evaluate and compare the efficacy of a single versus a combined prophylactic antibiotic regimen before transrectal ultrasound-guided prostate biopsy (TRUGPB).

METHODSA prospective randomized study was conducted at a university hospital. Patients undergoing TRUGPB were randomized into an amoxicillin-clavulanate alone (1 mg; one dose before and two doses after biopsy) or an amoxicillin-clavulanate + ciprofloxacin group (250 mg; one dose before and two doses after biopsy). Patients were surveyed for infection symptoms by phone on days 3 and 30 after TRUGPB. We defined an infective complication as the occurrence of symptoms including fever, chills or rigor within 30 days after prostate biopsy, requiring medical treatment or hospitalization, aided by a territory-wide electronic medical record system.

RESULTSBetween November 2007 and July 2009, 367 patients were randomized to either amoxicillin-clavulanate alone or amoxicillin-clavulanate + ciprofloxacin group. The infection rates after TRUGPB were 3.91% in the former group (7 out of 179 patients) versus 0.53% (1 out of 188 patients) in the latter. Sixty-three percent (5/8) of patients with infective complications needed hospitalization. There was no intensive care unit admission or mortality during the study period.

CONCLUSIONSCombining prophylactic antibiotics with amoxicillin-clavulanate + ciprofloxacin significantly reduced the incidence of infective complications after TRUGPB. We recommended a combination regimen, especially in centre with high incidence of post-TRUGPB infection.

Amoxicillin ; therapeutic use ; Anti-Bacterial Agents ; therapeutic use ; Antibiotic Prophylaxis ; methods ; Biopsy, Needle ; adverse effects ; methods ; Ciprofloxacin ; therapeutic use ; Clavulanic Acid ; therapeutic use ; Humans ; Male ; Prostate ; diagnostic imaging ; pathology ; surgery ; Rectum ; Ultrasonography

INTRODUCTIONThis study aimed to compare the efficacy and safety of quadruple therapy containing doxycycline and routine quadruple therapy for Helicobacter (H.) pylori rescue eradication in patients who had failed the one-week triple therapy.

METHODSPatients who failed the first-line eradication therapy were allocated into two groups. Group A patients (n = 43) were administered esomeprazole 20 mg, bismuth potassium citrate 220 mg, amoxicillin 1 g and doxycycline 100 mg, all bid for ten days, while Group B patients (n = 42) were administered esomeprazole 20 mg bid, bismuth potassium citrate 220 mg bid, metronidazole 400 mg bid and tetracycline 750 mg q.6h, for ten days. The results of H. pylori eradication were assessed with 13C urea breath test four weeks after the therapy, and the side effects were recorded.

RESULTSA total of 85 patients (average age 46.9 years) were enrolled in the study. Successful eradication rate for H. pylori was 72.5% in Group A and 64.1% in Group B, with no significant difference between the two groups. 11.6% (5/43) of patients from group A and 31.0% (13/42) from group B reported at least one adverse event. The adverse events of all 18 patients disappeared after the therapy ceased.

CONCLUSIONQuadruple therapy containing doxycycline is as effective as routine quadruple therapy for H. pylori rescue eradication. The regimen is well tolerated by most patients and causes fewer adverse events than routine quadruple therapy. Hence, it may be recommended as a suitable alternative H. pylori rescue regimen in China.

Adolescent ; Adult ; Aged ; Amoxicillin ; adverse effects ; therapeutic use ; Anti-Bacterial Agents ; adverse effects ; therapeutic use ; Anti-Ulcer Agents ; adverse effects ; therapeutic use ; Breath Tests ; Doxycycline ; adverse effects ; therapeutic use ; Drug Therapy, Combination ; Esomeprazole ; adverse effects ; therapeutic use ; Female ; Helicobacter Infections ; drug therapy ; prevention & control ; Helicobacter pylori ; drug effects ; Humans ; Male ; Metronidazole ; adverse effects ; therapeutic use ; Middle Aged ; Organometallic Compounds ; adverse effects ; therapeutic use ; Tetracycline ; adverse effects ; therapeutic use ; Treatment Outcome ; Young Adult

OBJECTIVETo evaluate the clinical effect of a 10-day sequential therapy which was made up of omeprazole, clarithromycin, amoxicillin-clavulanate and metronidazole for the eradication of Helicobacter pylori (Hp) infection in children.

METHODA total of 214 children with abdominal pain, who were confirmed to have Hp infection through endoscopy, biopsy, and Hp culture. The 214 cases were randomly divided into four groups. A 10-day sequential therapy group accepted omeprazole 0.8 - 1.0 mg/(kg·d) plus amoxicillin-clavulanate 50 mg/(kg·d) for five days and omeprazole 0.8 - 1.0 mg/(kg·d), clarithromycin 20 mg/(kg·d) and metronidazole 20 mg/(kg·d) for the remaining five days. The 7-day triple therapy group, 10-day triple therapy group and 14-day triple therapy group received omeprazole 0.8 - 1.0 mg/(kg·d), amoxicillin-clavulanate 50 mg/(kg·d) and clarithromycin 20 mg/(kg·d) for 7 days,10 days,14 days, respectively. All drugs were given twice daily. All these patients received (13)C urea breath test ((13)C-UBT) four weeks after the treatment.

RESULTFinally, 199 patients were followed up, and the total rate of loss to follow-up was 7.0% (15/214). Hp eradication rate was 85.2% and 90.2% in the 10-day sequential therapy group on intention to treat (ITT) and per protocol (PP) analyses, 66.0% and 71.4% in the 7-day triple therapy group on ITT and PP analyses; 60.0% and 67.3% in 10-day triple therapy group on ITT and PP analyses, and 78.8% and 82.0% in patients who received the 10-day sequential regimen on ITT and PP analyses, respectively. By ITT analysis, there was significantly difference between the 10-day sequential therapy group and 7-day or 10-day triple therapy group (P < 0.05), while no significant difference was found between the 10-day sequential therapy group and 14-day triple therapy group (P > 0.05). The results of the ITT analysis and the PP analysis were the same. The four groups had neither significant difference in abdominal pain relief (P > 0.05) nor in incidence of adverse reactions (P > 0.05).

CONCLUSIONThe 10-day sequential regimen was significantly more effective than both 7-day triple regimen and 10-day triple regimen, while had the same eradication rate compared with the 14-day sequential therapy. But 10-day triple regimen to eradicate Hp infection in children had the advantages such as short course of treatment and better compliance.

Administration, Oral ; Adolescent ; Amoxicillin ; administration & dosage ; adverse effects ; Anti-Bacterial Agents ; administration & dosage ; adverse effects ; Anti-Ulcer Agents ; administration & dosage ; Breath Tests ; methods ; Child ; Child, Preschool ; Clarithromycin ; administration & dosage ; adverse effects ; Drug Administration Schedule ; Drug Therapy, Combination ; Female ; Helicobacter Infections ; drug therapy ; Helicobacter pylori ; drug effects ; isolation & purification ; Humans ; Male ; Metronidazole ; administration & dosage ; adverse effects ; Microbial Sensitivity Tests ; Omeprazole ; administration & dosage ; adverse effects ; Time Factors ; Treatment Outcome

Amoxicillin, an antibiotic that is widely prescribed for various infections, is associated with a very low rate of drug-induced liver injury; hepatitis and cholestasis are rare complications. Here we present a case of a 39-year-old woman who was diagnosed with abdominal actinomycosis and received amoxicillin treatment. The patient displayed hepatocellular and bile-duct injury, in addition to elevated levels of liver enzymes. The patient was diagnosed with amoxicillin-induced cholestatic hepatitis. When amoxicillin was discontinued, the patient's symptoms improved and her liver enzyme levels reduced to near to the normal range.
Actinomycosis/drug therapy ; Adult ; Alanine Transaminase/blood ; Alkaline Phosphatase/blood ; Amoxicillin/*adverse effects ; Anti-Bacterial Agents/*adverse effects ; Aspartate Aminotransferases/blood ; Cholestasis/*chemically induced ; Drug-Induced Liver Injury/*diagnosis/etiology ; Female ; Humans ; Liver/enzymology

BACKGROUND/AIMS: We can expect to reduce costs and decrease adverse events by using low-dose triple therapy for H. pylori eradication. However, the efficacy of low-dose triple therapy for Koreans is questionable. In this study, we compared the efficacy of low-dose triple therapy with standard-dose triple therapy. METHODS: We enrolled 480 patients who were diagnosed as suffering with H. pylori infection via endoscopy with biopsy or CLO testing. Thirty patients were excluded due to malignancy or having undergone previous antibiotics medication. Two hundred and eighty patients received standard-dose triple therapy (pantoprazole 40 mg b.d, amoxicillin 1,000 mg b.d., and clarithromycin 500 mg b.d.), and 170 patients received low-dose triple therapy (pantoprazole 40 mg b.d., amoxicillin 750 mg b.d., and clarithromycin 250 mg b.d.). Eradication was evaluated 4~6 weeks after administering the medication. RESULTS: The H. pylori eradication rate was 77.9% in the standard-dose group, and 74.7% in the low-dose group. There was no significant difference in the H. pylori eradication rate between the two groups (p=0.444). The adverse events were significantly more frequent in the standard-dose group. One patient each in both groups discontinued medication because of an adverse event. CONCLUSIONS: The efficacy of low-dose therapy is similar to standard-dose therapy, and the adverse events are less frequent with low-dose therapy. This suggests that low-dose therapy would be preferred when considering the cost- benefit and low rate of adverse drug events.
Amoxicillin ; Anti-Bacterial Agents ; Biopsy ; Clarithromycin ; Drug-Related Side Effects and Adverse Reactions ; Endoscopy ; Helicobacter pylori* ; Helicobacter* ; Humans