Polaprezinc combined with clarithromycin-based triple therapy for Helicobacter pylori-associated gastritis: A prospective, multicenter, randomized clinical trial.

The efficacy and safety of polaprezinc combined with triple therapy was compared with triple therapy alone in the eradication of Helicobacter pylori. A randomized, parallel-group, open-label, controlled, prospective multicenter study was conducted in 11 cities in China. Treatment-naive patients with H. pylori-associated gastritis were randomly assigned to one of three arms for a 14-day treatment: Arm A triple therapy (omeprazole 20 mg, amoxicillin 1 g, and clarithromycin 500 mg, each twice daily) plus polaprezinc 75 mg twice daily; Arm B triple therapy plus polaprezinc 150 mg twice daily, or Arm C triple therapy alone. The rate of H. pylori eradication was the primary endpoint. Secondary endpoints were symptom improvement and lower incidence of adverse events. 303 patients completed the study- 106, 96, and 101 patients in Arms A, B, and C, respectively. Intention-to-treat (ITT) analysis showed that the rate of H. pylori eradication was significantly higher for Arms A (77.0%) and B (75.9%) compared to Arm C (58.6%) (P < 0.01), whereas there was no difference between Arms A and B (P = 0.90). Per-protocol (PP) analysis showed that the rate of H. pylori eradication was significantly higher for Arms A (81.1%) and B (83.3%) compared to Arm C (61.4%) (P < 0.01), whereas there was no significant difference between Arms A and B (P = 0.62). All three groups reported significant symptom improvement at 7, 14, and 28 days after treatment, compared to baseline (P < 0.0001). The adverse event rate for Arm B (5.1%) was higher than for Arms A (2.8%) (P = 0.04) and C (1.9%) (P = 0.02). There were no serious adverse events in any group. It appears that standard dose polaprezinc combined with triple therapy can significantly improve the H. pylori eradication rate, without an increase in toxicity.

The performance of three-sample qualitative immunochemical fecal test to detect colorectal adenoma and cancer in gastrointestinal outpatients: an observational study.

BACKGROUND: Repeated qualitative fecal immunochemical test (qlFIT) is a clinical strategy widely used to detect lower gastrointestinal lesions, but its diagnostic power has not been assessed in opportunistic screening for colorectal neoplasia. OBJECTIVE: This study aimed to determine the performance of three-sample qlFIT in screening for colorectal cancer and its precursors in high-risk participants. METHODS: 513 gastrointestinal outpatients yielded three qlFITs before a standard colonoscopy. We evaluated the diagnostic value of one, two, and three positive qlFITs serving as the positivity threshold. The risk factors of colorectal neoplasia to yield positive qlFITs were also determined. RESULTS: 52 patients were diagnosed with colorectal cancer and 70 with advanced adenomatous polyp. For colorectal cancer, the sensitivity and specificity of one positive qlFIT were 90.4% and 53.8%, of two were 80.8% and 75.1%, and of three were 53.9% and 88.5%, respectively. For advanced adenomatous polyp, the sensitivity and specificity of one positive qlFIT were 81.4% and 54.2%, of two were 50.0% and 72.5%, and of three were 28.6% and 86.2%. Left-sided location (OR 2.50, 95%CI 1.26-4.95) and advanced histology of tumors (OR 3.08, 95%CI 1.58-6.01) were independently associated with positive qlFITs. CONCLUSIONS: Three-sample qlFIT is a reasonably good method to detect colorectal neoplasia in high-risk population. Tumors in the left side or with advanced pathological features are more likely to produce positive qlFITs.

[An analysis of adverse drug reactions of thalidomide in treatment of immune-related bowel diseases].

OBJECTIVE: To investigate the safety of thalidomide in the treatment of immune-related bowel diseases for providing clinical reference. METHODS: Thirty-five patients with immune-related bowel diseases (31 Crohn's disease, 2 ulcerative colitis and 2 Behcet's disease) treated with thalidomide were enrolled in this study. The incidence, type, severity, duration of thalidomide related adverse drug reaction (ADR) and the dose-effect relationship of neurotoxicity were analyzed. RESULTS: All the patients were treated with a mean dose of thalidomide (109.29 ± 30.37) mg/d for (18.8 ± 12.4) months, and 33 occurred ADR. The three most frequent ADR were numbness [51.4% (18/35) ], somnolence [48.6% (17/35) ] and dermatitis [37.1% (13/35) ]. The median time to development of these three ADR were 6.50, 0.25, and 1.00 months, respectively. Severe ADR leading to withdrawal accounted for 20.0% (7/35), including reasons of peripheral neuritis (3/7), dermatitis (2/7) and myelosuppression (2/7). The incidence of peripheral neuritis was not significantly related to the maximal and initial dose of thalidomide (P > 0.05). CONCLUSIONS: Although the incidence of ADR was relatively high during the treatment of thalidomide, most of them were mild and well tolerated. Thalidomide can be safely used in patients with immune-related bowel diseases under close monitoring.