Tailored therapy guided by genotypic resistance of clarithromycin and levofloxacin detected by polymerase chain reaction in the first-line treatment of Helicobacter pylori infection.

OBJECTIVES: We aimed to explore the efficacy and safety of tailored therapy guided by genotypic resistance in the first-line treatment of Helicobacter pylori (H. pylori) infection in treatment-naive patients. METHODS: Gastric mucosal specimens were taken during gastroscopy, and main mutations of clarithromycin- and levofloxacin-resistant genes were detected by polymerase chain reaction (PCR). Sensitive antibiotics were selected individually for treating H. pylori infection with tailored bismuth-containing quadruple therapy (BQT) consisting of esomeprazole 20 mg twice daily, bismuth potassium citrate 220 mg twice daily, amoxicillin 1 g twice daily, and clarithromycin 500 mg twice daily, or levofloxacin 500 mg once daily, or metronidazole 400 mg four times daily. Safety and patient compliance were assessed 1-3 days after eradication. Treatment outcome was evaluated by urea breath test 4-8 weeks after eradication. RESULTS: One hundred and thirty-two treatment-naive patients with H. pylori infection were included. PCR results suggested resistance rates of 47.7% and 34.9% for clarithromycin and levofloxacin, respectively, and a dual resistance rate of 18.2%. Eradication rates of tailored BQT were 87.1% and 95.8% by intention-to-treat (ITT) analysis and per-protocol (PP) analysis, respectively. There was no statistically significant difference in the efficacy of 7-day clarithromycin-containing, 7-day levofloxacin-containing, and 14-day full-dose metronidazole-containing BQT (ITT analysis: P = 0.488; PP analysis: P = 0.833). The incidence of adverse events was 19.7%, and patient compliance was 97.7%. CONCLUSION: Tailored BQT guided by genotypic resistance can achieve satisfactory efficacy, safety, and patient compliance in the first-line treatment of H. pylori infection.

[Comparison of Epsilometer test and agar dilution method in detecting the sensitivity of Helicobacter pylori to metronidazole].

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.

Bismuth, esomeprazole, metronidazole and amoxicillin or tetracycline as a first-line regimen for Helicobacter pylori eradication: A randomized controlled trial.

BACKGROUND: Due to general unavailability and common side effects of tetracycline, the clinical application of bismuth quadruple therapy (BQT) is greatly limited. Whether amoxicillin can replace tetracycline in BQT remains unknown. This study aimed to compare the eradication rate, safety and compliance between amoxicillin-containing and tetracycline-containing BQT as a first-line regimen for Helicobacter pylori eradication. METHODS: This randomized trial was conducted on 404 naïve patients for H. pylori eradication. The participants were randomly assigned to 14-day amoxicillin-containing (bismuth potassium citrate 110 mg four times/day, esomeprazole 20 mg twice daily, metronidazole 400 mg four times/day and amoxicillin 500 mg four times/day) and tetracycline-containing (tetracycline 500 mg four times/day and the other three drugs used as above) BQT. Safety and compliance were assessed within 3 days after eradication. Urea breath test was performed 4-8 weeks after eradication to evaluate outcome. RESULTS: As for the eradication rates of amoxicillin-containing and tetracycline-containing BQT, the results of both intention-to-treat and per-protocol analyses showed that the difference rate of the lower limit of 95% confidence interval was above -10.0% (intention-to-treat analysis: 81.7% vs. 83.2%, with a rate difference of -1.5% [-6.3% to 9.3%]; per-protocol analysis: 89.0% vs. 91.6%, -2.6% [-4.1% to 9.3%]). The incidence of adverse events in amoxicillin-containing BQT was significantly lower than tetracycline-containing BQT (29.5% vs. 39.7%). Both groups achieved relatively good compliance (92.0% vs. 89.9%). CONCLUSION: The eradication efficacy of amoxicillin-containing BQT was non-inferior to tetracycline-containing BQT as a first-line regimen for H. pylori eradication with better safety and similar compliance.

[Analysis of etiological and related factors responsible for acute gastrointestinal hemorrhage].

OBJECTIVE: To investigate the etiology, related factors and endoscopic characteristics of acute gastrointestinal hemorrhage. METHODS: The data including age, gender, medical and medication history, and endoscopic characteristics of patients receiving emergency treatment for acute gastrointestinal hemorrhage between February 2006 and February 2010 were collected to analyze the etiological profiles of this disorder. RESULTS: (1) A total of 1415 patients with a 2: 1 male-to-female ratio visited our hospital for acute gastrointestinal hemorrhage in the past 4 years. There was a higher mean age of disease onset in men than in women [(51 +/- 20) years old vs (61 +/- 17) years old, P = 0.000]. The numbers of patients were 399, 361, 242 and 413 for 4 respective quarters in order of sequence. (2) And 1030 patients received endoscopy. Among them, there were 897 (87.1%) with upper gastrointestinal hemorrhage and 133 (12.9%) with lower gastrointestinal hemorrhage. Significant differences existed in the mean age of two groups [(51 +/- 20) years old vs (57 +/- 18) years old, P = 0.000]. The male-to-female ratio was 656: 241 and 65:68 for these 2 groups respectively (P = 0.000). The percentage of patient with a history of NSAID (non-steroidal anti-inflammatory drug) treatment was 22.1% (n = 198) and 12.0% (n = 16) for these 2 groups respectively (P < 0.01). (3) The most common causative diseases of upper gastrointestinal hemorrhage were peptic ulcer (n = 546, 60.8%), esophageal & gastric varices hemorrhage (n = 130, 14.5%) and gastric cancer (n = 40, 4.6%). When the patients were divided into 5 groups of < 12 h, 12-24 h, 24-48 h, 48-72 h and > or = 72 h per time window of gastroscopy, their percentages with endoscopically active hemorrhage were 24.1% (20/83), 14.9% (24/161), 9.6% (16/166), 7.5% (8/106) and 7.6% (29/381) for these groups respectively with statistically significant differences. When peptic ulcer was examined by the Forrest classification, the ratio of grade I a- II c decreased gradually while the ratio of grade III increased gradually among 5 groups (chi2 = 80.414, P = 0.040). (4) The most common causative diseases of lower gastrointestinal hemorrhage were ischemic colitis (n = 44, 33.1%), small intestinal hemorrhage (n = 26, 19.5%) and colonic polyps (n = 18, 13.5%). (5) When the patients were divided into > 65 years old group (n = 277) and < or = 65 years old group (n = 620), the ratio of gastric ulcer and cancer in upper gastrointestinal hemorrhage was higher in the former than in the latter [23.5% (n = 65) vs 8.9% (n = 55) & 9.7% (n = 27) vs 2.1% (n = 13), P < 0.01)]. While the ratio of duodenal ulcer was lower in the former than in the latter [22.4% (n = 62) vs 49.7% (n = 308), P < 0.01]. The ratio of small intestinal hemorrhage in lower gastrointestinal hemorrhage was higher in the former than in the latter (all P < 0.01). CONCLUSION: At the lowest in the third quarter, the incidence rate of acute gastrointestinal hemorrhage is higher in males than that in females at a lower age of onset. More common than lower gastrointestinal hemorrhage, upper gastrointestinal hemorrhage has a lower mean age of onset. Peptic ulcer is the most common disorder in upper gastrointestinal hemorrhage. Ischemic colitis is the most common disorder in lower gastrointestinal hemorrhage. The rate of gastric ulcer and gastric cancer in the old age group is higher than that in the young group. Emergency gastroscopy is recommended.

[The endoscopic and clinical features of Indigo Naturalis-associated ischemic lesions of colonic mucosa].

OBJECTIVE: By analysing the clinical features of Indigo Naturalis-associated ischemic lesion of colon mucosa to improve the precautionary and therapeutic level of the disease. METHODS: Thirteen patients diagnosed as Indigo Naturalis-associated ischemic lesion of colon mucosa in Peking University Third Hospital from 2005 to 2010 were reviewed. The endoscopic and clinical features were analysed. RESULTS: The 13 patients with an average age of (60.6 ± 14.1) years old were prescribed Chinese traditional medicine containing Indigo Naturalis for psoriasis or idiopathic thrombocytopenic purpura (ITP). The ratio of males to females was 1:1.6. The typical manifestations were abdominal pain and bloody stool with watering diarrhea before bloody stool in 61.5% patients. Endoscopic and pathological characteristics were coincident with ischemic lesion and more like a chronic index. Vasodilatic medicine was effective and the average hemostatic time was (1.7 ± 0.8) days. The prognosis was well and no recurrence was found during 3 months follow-up. CONCLUSIONS: Patients having psoriasis or ITP treated with Chinese traditional medicine containing Indigo Naturalis have an inclination to colon mucosa lesions, even ischemic lesion. Careful assessment and observation before prescribing are necessary in these patients.