W Liu1, B Lü, S Xiao. 1. Shanghai Second Medical University, Renji Hospital, Shanghai Institute of Digestive Diseases.
Abstract
UNLABELLED: In order to explore the optimal regimens for the eradication of Helicobacter pylori (Hp), eighty-eight patients with duodenal ulcer (DU) or non-ulcer dyspepsia and Hp infection, defined by culture and histology, received the one-week triple therapy withclarithromycin (Cla), furazolidone (Fur) plus lansoprazole (Lan) or colloidal bismuth subcitrate (CBS). Twenty-eight patients entered the phase one preliminary study, randomized to receive the treatment of Cla 500 mg b.i.d and Fur 200 mg b.i.d plus either CBS 240 mg b.i.d (group I A) or Lan 30 mg b.i.d (group I B). Sixty patients entered the phase two main study, receiving the treatment ofCla 250 mg b.i.d and Fur 100 mg b.i.d plus either CBS 240 mg b.i.d (group II A) or Lan 30 mg q.d (group II B). Five patients (2 in group I A, 2 in group I B, 1 in group II A) were withdrawn because of the side effects of the treatment, and two (in group II A) dropped out. The eradication rates of Hp in group I A, I B, II A, II B were 100.0% (12/12), 91.7% (11/12), 92.6% (25/27) and 90.0% (27/30) respectively. There was no significant difference in the eradication rates of Hp between the treatment groups (P > 0.05). The primary resistant rate of Hp isolates to Cla was 7.5% (4/53) and no patient infected with the strain resistant to Cla succeeded in the eradication of Hp. The healing rates of DU were 94.4% (17/18) in group II A and 100.0% (18/18) in group II B (P > 0.05). The main side effects were nausea, vomiting and taste disturbance. Eighteen of the 28 (64.2%) patients in the phase one study had side effects with a rate significantly higher than that of 5.1% (3/58) in the phase two study (P < 0.001). CONCLUSIONS: (1) Both of the regimens used in the phase two study with low-dose, one week triple therapy are highly effective in the eradication of Hp infection and healing of DU, and are well tolerated. (2) The primary resistance of Hp strains to Cla is the principal factor of treatment failure in these two regimens.
RCT Entities:
UNLABELLED: In order to explore the optimal regimens for the eradication of Helicobacter pylori (Hp), eighty-eight patients with duodenal ulcer (DU) or non-ulcer dyspepsia and Hp infection, defined by culture and histology, received the one-week triple therapy with clarithromycin (Cla), furazolidone (Fur) plus lansoprazole (Lan) or colloidal bismuth subcitrate (CBS). Twenty-eight patients entered the phase one preliminary study, randomized to receive the treatment of Cla 500 mg b.i.d and Fur 200 mg b.i.d plus either CBS 240 mg b.i.d (group I A) or Lan 30 mg b.i.d (group I B). Sixty patients entered the phase two main study, receiving the treatment of Cla 250 mg b.i.d and Fur 100 mg b.i.d plus either CBS 240 mg b.i.d (group II A) or Lan 30 mg q.d (group II B). Five patients (2 in group I A, 2 in group I B, 1 in group II A) were withdrawn because of the side effects of the treatment, and two (in group II A) dropped out. The eradication rates of Hp in group I A, I B, II A, II B were 100.0% (12/12), 91.7% (11/12), 92.6% (25/27) and 90.0% (27/30) respectively. There was no significant difference in the eradication rates of Hp between the treatment groups (P > 0.05). The primary resistant rate of Hp isolates to Cla was 7.5% (4/53) and no patient infected with the strain resistant to Cla succeeded in the eradication of Hp. The healing rates of DU were 94.4% (17/18) in group II A and 100.0% (18/18) in group II B (P > 0.05). The main side effects were nausea, vomiting and taste disturbance. Eighteen of the 28 (64.2%) patients in the phase one study had side effects with a rate significantly higher than that of 5.1% (3/58) in the phase two study (P < 0.001). CONCLUSIONS: (1) Both of the regimens used in the phase two study with low-dose, one week triple therapy are highly effective in the eradication of Hpinfection and healing of DU, and are well tolerated. (2) The primary resistance of Hp strains to Cla is the principal factor of treatment failure in these two regimens.