A randomized, multicenter and noninferiority study of amoxicillin plus berberine vs tetracycline plus furazolidone in quadruple therapy for Helicobacter pylori rescue treatment.

OBJECTIVE: Helicobacter pylori (H. pylori) infection is closely associated with gastric ulcers and gastric adenocarcinomas. We aimed to assess the efficacy and safety of a quadruple regimen with amoxicillin plus berberine vs tetracycline plus furazolidone in rescue therapy for H. pylori eradication. METHODS: We conducted a randomized, open-label, multicenter, noninferiority trial. Patients with previous treatment failures recruited from five centers were randomized (1:1) to receive a regimen with esomeprazole and bismuth plus either berberine and amoxicillin (the BA group) or tetracycline and furazolidone (the TF group) for 14 days. Their H. pylori infection status was confirmed 4-8 weeks after treatment. The primary outcome was the eradication rate. The secondary outcomes included the rates of symptom improvement, compliance, and adverse events. This study was registered at ClinicalTrials.gov (NCT03609892). RESULTS: Altogether 658 participants were consecutively enrolled. An intention-to-treat analysis demonstrated that the two regimens achieved a similar eradication rate (76.3% vs 77.5%; P = 0.781). The per-protocol analysis reached a similar result (81.5% vs 85.0%; P = 0.278). The eradication rate reached in the BA group was greater than the pre-established margin of noninferiority, at -10% (the lower bounds of the 95% CI were -7.66% and -9.43%, respectively). The rate of adverse events was lower for the BA group than the TF group (18.5% vs 26.1%, P = 0.024). Rates of compliance and symptom improvement were similar for the two therapies. CONCLUSION: The efficacy of both regimens in rescue treatment for H. pylori eradication was satisfactory, 14-day BA-based quadruple therapy is noninferior to the TF-based therapy.

[Study on the pulmonary fibrogenetic effect induced by rush-mat dust in rats].

OBJECTIVE: To investigate the fibrogenetic effects induced by rush-mat dust in rats. METHODS: SD rats were treated with 50 mg of rush-mat dust per rat by intra-tracheal instillation, sacrificed 3, 6, and 12 months respectively after exposure. The lung tissue and lung lymph-node were taken out for pathological and electron microscopic examination. The content of collagen and ceruloplasmin (CP) in lung tissues were also determined. RESULTS: After treatment for 12 months, fresh wet lung weight in rush-mat dust group [(2.69 +/- 0.22) g] was higher than those in saline group [(1.87 +/- 0.25) g], TiO(2) group [(2.25 +/- 0.26) g], but lower than that in SiO(2) group [(11.41 +/- 1.63) g]; dry lung weight in rush-mat dust group [(0.47 +/- 0.03) g] was higher than those in saline group [(0.32 +/- 0.03) g], TiO(2) group [(0.41 +/- 0.08) g], but lower than that in SiO(2) group [(2.06 +/- 0.28) g]; lung collagen content in rush-mat dust group [(103.08 +/- 14.79) mg] was higher than those in saline group [(75.96 +/- 13.91) mg, TiO(2) group [(85.84 +/- 17.62) mg], but lower than that in SiO(2) group [(497.50 +/- 100.80) mg]; CP content in rush-mat dust group [(18.03 +/- 1.87) U/L] was higher than those in saline group [(15.05 +/- 2.24) U/L], TiO(2) group [(16.92 +/- 1.67) U/L], but lower than that in SiO(2) group [(25.37 +/- 3.58) U/L], P < 0.05 or P < 0.01. Pathological examination showed lung macrophage alveolitis, broadening of alveolar interval, one to two grade of silicotic nodes and increased amount of type II epithelial cell in alveolar as well as slight collagenous fibrosis in lung tissue of rush-mat dust group. Under electron microscope, primary and secondary lysosome and medullary sheath-like phagocytic residual body were found in lung tissue of rush-mat dust group, meanwhile the amount of type II alveolar epithelial cell and collagen fiber were slightly increased but these changes were less than those of quartz group. CONCLUSION: The rush-mat dusts have slight pulmonary fibrogenetic effect on rat.

Study on canceration law of gastric mucosal dysplasia based on syndromes of Chinese medicine.

OBJECTIVE: To study the syndrome evolution law of Chinese medicine (CM) in the patients with gastric mucosal dysplasia. METHODS: Three hundred and twenty four gastric mucosal dysplasia patients with deficiency and excess correlation syndromes were enrolled by a multi-center collaboration for two years' clinical follow-up to detect the levels of tumor supplied group of factors (TSGF) and carcino-embryonic antigen (CEA). RESULTS: Among the 324 cases, 29 cases turned cancer in the two years, and the canceration rate was 9.0%. The three syndromes with higher canceration rate were the damp-heat accumulating Wei syndrome concurring or combining with asthenia-cold in Pi and Wei syndrome for 16.7%; stagnation in Wei collaterals syndrome concurring or combining with asthenia of both qi and yin syndrome for 13.2%; stagnation of Gan and Wei qi syndrome concurring or combining with asthenia-cold in Pi and Wei syndrome for 8.0%, respectively. Among the three syndromes, the highest level of TSGF occurred in the former two syndromes. In the half year before carcinogenesis, the syndromes of the patients took on deficiency and excess concurrent syndromes, and the deficiency syndromes involving the qi and blood deficiency syndrome and the Shen deficiency syndrome accounting for 48.0%. CONCLUSIONS: Gastric mucosal dyspalsia canceration syndromes took on the polymorphism of excess and deficiency concurrent syndromes and had the characteristics of deficiency syndromes involving qi and blood deficiency syndrome and Shen-yin-yang deficiency syndrome.