Bismuth, esomeprazole, metronidazole, and minocycline or tetracycline as a first-line regimen for Helicobacter pylori eradication: A randomized controlled trial / 中华医学杂志(英文版)

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.

The exposure of antibiotics on the eradication of bismuth quadruple therapy in H.pylori infection / 中华内科杂志

Objective:To analyze the impact of previous exposure to macrolide, quinolones and nitroimidazole antibiotics on eradication rate of bismuth quadruple therapy (BQT) in newly diagnosed patients with Helicobacter pylori( H. pylori). Methods:A total of 469 patients with H. pylori initially treated at the Third Hospital of Peking University from September 2017 to August 2020 were retrospectively recruited. The therapeutic regimens were BQT containing clarithromycin/levofloxacin/metronidazole recommended by Chinese guidelines. Clinical data were collected, including general demographic data, exposure history of antibiotics, CYP2C16 metabolic pattern, endoscopic diagnosis, bacterial density, H.pylori resistance, eradication results, etc. Univariate analysis, Chi-square test, Fisher exact probability test, Kruskal-Wallis H test and Logistic regression model were used as statistical methods. Results:Among different eradication therapies, univariate and multivariate analyses suggested that previous exposure to macrolides ( OR=3.37,95 %CI 1.04-10.98, P<0.05) was relevant to the decreased eradication rate of BQT containing clarithromycin. This may be due to increased resistance to clarithromycin ( OR=6.12,95 %CI 3.99-9.40, P<0.01).The previous exposure to quinolones ( OR=3.65, 95 %CI 1.27-10.49, P<0.05) was relevant to the decreased eradication rate of BQT containing levofloxacin, which was probably explained by the increased resistance to levofloxacin ( OR=2.50, 95 %CI 1.69-3.71, P<0.01). But the previous history of nitroimidazole did not impact the efficacy of BQT containing metronidazole. Conclusions:In patients newly diagnosed with H.pylori infection, the previous exposure to macrolide or quinolones antibiotics is related to lower eradiation rates of H. pylori. Although the exposure to nitroimidazole also indicates drug resistance to metronidazole, the clinical efficacy of BQT with metronidazole 400 mg four times a day is not affected.

Multi-center, randomized, double-blind, positive drug prallel-group controlled phase Ⅲ clinical study on ilaprazole sodium for injection in the treatment of peptic ulcer bleeding / 中华消化杂志

Objective To evaluate the efficacy and safety of ilaprazole sodium for injection in the treatment of peptic ulcer bleeding.Methods It was designed as a multi-center,stratified randomized,double-blind,positive drug parallel controlled and non-inferiority study.From October 2014 to April 2015,at 40 hospitals,patients with peptic ulcer hemorrhage confirmed by gastroendoscopy were enrolled and divided into the ilaprazde sodium group (10 mg ilaprazole sodium for injection every 24 h,the first dose doubled) and the positive control group (40 mg of omeprazole sodium for injection every 12 h).The course of both treatment was 72 h.The hemostasis rate of overall group at 72 h,the clinical rebleeding rate at four to seven days,the blood transfusion rate,the incidence of switching to other treatments and the incidence of adverse reactions were compared between the two groups.A chi-square test or Fisher's exact probability method were performed for statistical analysis.Results A total of 533 patients with peptic ulcer bleeding were enrolled,355 patients in the ilaprazole sodium group and 178 patients in the positive control group.The hemostasis rates of ilaprazole sodium group and positive control group at 72 h were 97.69 ％ (339/347) and 97.14 ％ (170/175),respectively,and the difference was not statistically significant (P＞0.05).There were no rebleeding patients in both groups at four to seven days.The blood transfusion rates of ilaprazole sodium group and positive control group were 5.07 ％ (18/355) and 3.37 ％ (6/178).The incidence of switching to other treatments was 0.56％ (2/355) and 0.56％ (1/178),respectively,and the differences were not statistically significant (both P＞ 0.05).The incidence of adverse reactions in the ilaprazole sodium group was 3.94％ (14/355),which was lower than that of positive control group (8.43％,15/178).And the difference was statistically significant (Fisher's exact probability method,P=0.042).Conclusions The efficacy of ilaprazole sodium for injection in the treatment of peptic ulcer bleeding is similar to that of omeprazole sodium for injection.Moreover,the smaller the dose,the lower the frequency of administration and the better the safety.

The changes of main upper gastrointestinal diseases and Helicobacter pylori infection status in the past thirty five years / 中华内科杂志

Objective To study the spectrum of upper gastrointestinal diseases and infection rate of Helicobacter pylori(Hp) in our hospital during the past 35 years.Methods Patients who were 16 or older with duodenal ulcer,gastric ulcer,reflux esophagitis,gastric cancer and esophageal cancer diagnosed by gastroscopy and pathology were retrospectively enrolled in our study from January 1980 to December 2014.Patients with chronic superficial gastritis,chronic atrophic gastritis or Hp infection from January 1989to December 2014 were also included in our study according to the same diagnostic criteria.The incidences of diseases and the infection rates of Hp were studied.Results A total of 213 495 patients underwent gastroscopy in our department during the past 35 years.The overall diagnostic rates of duodenal ulcer,gastric ulcer,reflux esophagitis,gastric cancer and esophageal cancer were 9.87％,3.79％,6.66％,1.59％ and 0.66％ respectively.There were 183 426 patients receiving gastroscopy in our department from January 1989to December 2014.The overall endoscopic diagnosis rates of chronic superficial gastritis and chronic atrophic gastritis were 49.83％ and 22.43％ respectively.The overall infection rate of Hp was 36.18％,which had a declining trend consistent with peptic ulcer (all P =0.000).Yet,the prevalence of reflux esophagitis,chronic superficial gastritis and chronic atrophic gastritis were increasing (all P =0.000).The diagnostic rates of gastric cancer and esophageal cancer were persistent (P =0.266,P =0.156).Conclusions The Hp infection during years has been decreasing,consistent with the declining tendency of peptic ulcer.On the other hand,reflux esophagitis,chronic superficial gastritis and chronic atrophic gastritis show an ascendant trend.The proportion of patients with gastric cancer and esophageal cancer is relatively stable.

The endoscopic and clinical features of Indigo Naturalis-associated ischemic lesions of colonic mucosa / 中华内科杂志

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 arc necessary in these patients.