This study aims to systematically evaluate the clinical efficacy and safety of Kushen Gelatum combined with antibiotics for treating bacterial vaginosis. The randomized controlled trial(RCT) of Kushen Gelatum for treating bacterial vaginosis were retrieved from CNKI, Wanfang, VIP, SinoMed, PubMed, and Cochrane Library with the time interval from inception to January 2023. Data were extracted from the included RCT by 2 investigators, including the sample size, characteristics of patients, interventions and controls, outcome indicators, and adverse effects. The Cochrane collaboration network's bias risk assessment tool was used for methodolo-gical quality evaluation of the included trials. RevMan 5.4 was employed to perform the Meta-analysis. A total of 19 RCTs were inclu-ded, involving 1 980 patients with bacterial vaginosis. Meta-analysis showed that, compared with nitroimidazoles alone, Kushen Gelatum + nitroimidazoles improved the total response rates in terms of clinical symptoms and laboratory tests(RR=1.24, 95%CI[1.13, 1.36], P<0.000 01), laboratory tests(RR=1.16, 95%CI[1.06, 1.26], P=0.000 9), and clinical symptoms(RR=1.26, 95%CI[1.08, 1.46], P=0.003), and reduced the leukocyte esterase positive rate(RR=0.29, 95%CI[0.17, 0.48], P<0.000 01) and the recurrence rate(RR=0.37, 95%CI[0.23, 0.58], P<0.000 1). Compared with lincomycin antibiotics(clindamycin) alone, Kushen Gelatum + lincomycin antibiotics(clindamycin) improved the total response rates in terms of clinical symptoms and laboratory tests(RR=1.18, 95%CI[1.06, 1.31], P=0.003) and laboratory tests(RR=1.27, 95%CI[1.04, 1.54], P=0.02), reduced the recurrence rate(RR=0.20, 95%CI[0.05, 0.75], P=0.02), and shortened the time to relief of burning sensation(MD=-1.70, 95%CI[-2.15,-1.26], P<0.000 01), vaginal itching(MD=-0.82, 95%CI[-1.30,-0.34], P=0.000 8), and abnormal leucorrhea(MD=-1.52, 95%CI[-1.98,-1.06], P<0.000 01). Compared with nitroimidazoles + probiotics, Kushen Gelatum + nitroimidazoles + probiotics improved the total response rate in terms of clinical symptoms and laboratory tests(RR=1.18, 95%CI[1.02, 1.36], P=0.03) and reduced the recurrence rate(RR=0.27, 95%CI[0.09, 0.76], P=0.01). Kushen Gelatum combined with antibiotics demonstrates a potential therapeutic effect on bacterial vaginosis, whereas the number and quality of the relevant clinical studies remain to be improved. The process of clinical trial should be standardized to improve the quality of evidence, so as to provide strong evidence to guide the application of Kushen Gelatum in clinical practice.
Female ; Humans ; Anti-Bacterial Agents/adverse effects* ; Clindamycin/adverse effects* ; Vaginosis, Bacterial/chemically induced* ; Nitroimidazoles/adverse effects*

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: 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*

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

Bacterial Proteins ; Humans ; Metronidazole/pharmacology* ; Mycobacterium tuberculosis ; NAD ; Nitroreductases ; Tuberculosis, Lymph Node

OBJECTIVES: This study aimed to understand the nationwide patterns of antibiotic prescription after tooth extraction in adult patients.MATERIALS AND METHODS: This study analyzed dental records from the National Health Insurance Service–National Sample Cohort (NHIS–NSC) database on 503,725 tooth extractions performed in adults (≥19 years) during 2011–2015. Patient sex, age, household income, systemic disease (diabetes mellitus and hypertension), type of dental institution, region of dental institution, year of prescription, and type of tooth extraction procedure were considered. The antibiotic prescription rate and broad-spectrum antibiotic prescription frequency were analyzed using chi-squared tests. Factors affecting the prescription of broad-spectrum antibiotics were evaluated using multivariate logistic regression analysis.RESULTS: The rate of antibiotic prescription after tooth extraction was 81.85%. Penicillin was most commonly prescribed (45.25%), followed by penicillin with beta-lactamase inhibitors (18.76%), metronidazole (12.29%), and second- to fourth-generation cephalosporins (11.52%). The proportion of broad-spectrum antibiotics used among all prescribed antibiotics was 45.88%.CONCLUSION: The findings of this study demonstrate that the rate of antibiotic prescription after tooth extraction is higher in Korea than in other countries. Furthermore, broad-spectrum antibiotics are used more frequently, which may indicate unnecessary drug prescription, an important contributor to antibiotic resistance.
Adult ; Anti-Bacterial Agents ; beta-Lactamase Inhibitors ; Cephalosporins ; Cohort Studies ; Dental Records ; Drug Prescriptions ; Drug Resistance, Microbial ; Family Characteristics ; Humans ; Korea ; Logistic Models ; Metronidazole ; National Health Programs ; Penicillins ; Prescriptions ; Tooth Extraction ; Tooth

Objective To study the identification method for 4'-F-4-methylaminorex （4'-F-4-MAR） in samples without reference substance. Methods Gas chromatography-mass spectrometry （GC-MS）, ultra-high-performance liquid chromatography-quadrupole time-of-flight-mass spectrometry （UPLC-QTOF-MS）, nuclear magnetic resonance （NMR） and Fourier transform infrared （FTIR） were comprehensively used for the structure identification of 4'-F-4-MAR in samples. Results Under the positive electrospray ionization （ESI⁺） mode, quasi-molecular ion in the first order mass spectrometry of the unknown compound was 195.092 6 and its molecular formula was inferred to be C₁₀H₁₁FN₂O. The fragment ions in the mass spectrometry of the unknown compound were compared with the related fragment ions of 4,4'-dimethylaminorex （4,4'-DMAR） in literature. It was found that the main fragment ions of the unknown compound were all 4 bigger than the corresponding fragment ions of 4,4'-DMAR. Therefore, the unknown compound was inferred to be a 4,4'-DMAR analogue with a methyl substituted by a fluorine in the benzene ring. The equivalent protons at δ=7.30 and δ=7.06 in ¹H-nuclear magnetic resonance （¹H-NMR） spectra and the characteristic spin-spin coupling constants （¹J_C-F=245.2 Hz, ²J_C-F=21.3 Hz, ³J_C-F=8.1 Hz） for ¹³C-¹⁹F interactions in carbon spectra, further proved that the fluorine substituted methyl at the para-position of the benzene ring. Finally, the unknown compound was determined as 4'-F-4-MAR. Conclusion A method that comprehensively used the identification materials 4'-F-4-MAR in GC-MS, UPLC-QTOF-MS, NMR and FTIR is established and the fragmentation mechanism of fragmentation ions of 4'-F-4-MAR created under the two modes -- electron impact （EI） and electrospray ionization under collision induced dissociation （ESI-CID） is deduced. The information will assist forensic science laboratories in identifying this compound or other substances with similar structure in their case work.
Aminorex ; Chromatography, High Pressure Liquid ; Gas Chromatography-Mass Spectrometry ; Mass Spectrometry ; Nitroimidazoles ; Spectrometry, Mass, Electrospray Ionization

BACKGROUND/AIMS: This nationwide, multicenter prospective randomized controlled trial aimed to compare the efficacy and safety of 10-day concomitant therapy (CT) and 10-day sequential therapy (ST) with 7-day clarithromycin-containing triple therapy (TT) as first-line treatment for Helicobacter pylori infection in the Korean population. METHODS: Patients with H. pylori infection were assigned randomly to 7d-TT (lansoprazole 30 mg, amoxicillin 1 g, and clarithromycin 500 mg twice daily for 7 days), 10d-ST (lansoprazole 30 mg and amoxicillin 1 g twice daily for the first 5 days, followed by lansoprazole 30 mg, clarithromycin 500 mg, and metronidazole 500 mg twice daily for the remaining 5 days), or 10d-CT (lansoprazole 30 mg, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg twice daily for 10 days). The primary endpoint was eradication rate by intention-to-treat (ITT) and per-protocol (PP) analyses. RESULTS: A total of 1,141 patients were included. The 10d-CT protocol achieved a markedly higher eradication rate than the 7d-TT protocol in both the ITT (81.2% vs 63.9%) and PP analyses (90.6% vs 71.4%). The eradication rate of the 10d-ST protocol was superior to that of the 7d-TT protocol (76.3% vs 63.9%, ITT analysis; 85.0% vs 71.4%, PP analysis). No significant differences in adherence or serious side effects were found among the three treatment arms. CONCLUSIONS: The 10d-CT and 10d-ST regimens were superior to the 7d-TT regimen as standard first-line treatment in Korea.
Amoxicillin ; Arm ; Clarithromycin ; Disease Eradication ; Helicobacter pylori ; Helicobacter ; Humans ; Korea ; Lansoprazole ; Metronidazole ; Prospective Studies

Antibiotic resistance is the most important factor leading to the failure of eradication regimens. This review focuses on the prevalence of Helicobacter pylori primary and secondary resistance to clarithromycin, metronidazole, amoxicillin, levofloxacin, tetracycline, and multidrug in Vietnam. We searched the PubMed, EMBASE, Vietnamese National Knowledge Infrastructure, and Vietnamese Biomedical databases from January 2000 to December 2016. The search terms included the following: H. pylori infection, antibiotic (including clarithromycin, metronidazole, amoxicillin, levofloxacin, tetracycline, and multidrug) resistance in Vietnam. The data were summarized in an extraction table and analyzed manually. Finally, Excel 2007 software was used to create charts. Ten studies (three studies in English and seven in Vietnamese) were included in this review. A total of 308, 412, 523, 408, 399, and 268 H. pylori strains were included in this review to evaluate the prevalence of H. pylori primary resistance to amoxicillin, clarithromycin, metronidazole, levofloxacin, tetracycline, and multidrug resistance, respectively. Overall, the primary resistance rates of amoxicillin, clarithromycin, metronidazole, levofloxacin, tetracycline, and multidrug resistance were 15.0%, 34.1%, 69.4%, 27.9%, 17.9% and 48.8%, respectively. Secondary resistance rates of amoxicillin, clarithromycin, metronidazole, levofloxacin, tetracycline, and multidrug resistance were 9.5%, 74.9%, 61.5%, 45.7%, 23.5% and 62.3%, respectively. In Vietnam, primary and secondary resistance to H. pylori is increasing over time and affects the effectiveness of H. pylori eradication.
Amoxicillin ; Asian Continental Ancestry Group ; Bismuth ; Clarithromycin ; Drug Resistance, Microbial ; Drug Resistance, Multiple ; Helicobacter pylori ; Helicobacter ; Humans ; Levofloxacin ; Metronidazole ; Prevalence ; Tetracycline ; Vietnam

A clinical suspicion of intestinal spirochetosis is required when patients have long lasting complaints of abdominal pain, diarrhea, rectal bleeding, weight loss, and nausea. An endoscopy with biopsies needs to be performed to confirm the diagnosis of intestinal spirochetosis. The diagnosis of intestinal spirochetosis is based on histological appearance. Intestinal spirochetosis can also be associated with other intestinal infections and juvenile polyps (JPs). JPs seem to be more frequent in patients with intestinal spirochetosis than in patients without intestinal spirochetosis. Intestinal spirochetosis in children should be treated with antibiotics. Metronidazole is the preferred option. In this article, we describe 4 cases of intestinal spirochetosis in a pediatric population and provide a review of the literature over the last 20 years. Intestinal spirochetosis is a rare infection that can cause a variety of severe symptom. It is diagnosed based on histological appearance.
Abdominal Pain ; Anti-Bacterial Agents ; Biopsy ; Child ; Coinfection ; Diagnosis ; Diarrhea ; Endoscopy ; Hemorrhage ; Humans ; Metronidazole ; Nausea ; Polyps ; Spirochaetales Infections ; Weight Loss