AIM:To evaluate the efficacy and safety of esomeprazole-based triple therapy compared with lansoprazole therapy as first-line eradication therapy for patients with Helicobacter pylori(H.pylori)in usual post-marketing ...AIM:To evaluate the efficacy and safety of esomeprazole-based triple therapy compared with lansoprazole therapy as first-line eradication therapy for patients with Helicobacter pylori(H.pylori)in usual post-marketing use in Japan,where the clarithromycin(CAM)resistance rate is 30%.METHODS:For this multicenter,randomized,openlabel,non-inferiority trial,we recruited patients(≥20years of age)with H.pylori infection from 20 hospitals in Japan.We randomly allocated patients to esomeprazole therapy(esomeprazole 20 mg,CAM 400 mg,amoxicillin(AC)750 mg for the first 7 d,with all drugs given twice daily)or lansoprazole therapy(lansoprazole30 mg,CAM 400 mg,AC 750 mg for the first 7 d,with all drugs given twice daily)using a minimization method with age,sex,and institution as adjustment factors.Our primary outcome was the eradication rate by intention-to-treat(ITT)and per-protocol(PP)analyses.H.pylori eradication was confirmed by a urea breath test from 4 to 8 wk after cessation of therapy.RESULTS:ITT analysis revealed the eradication rates of 69.4%(95%CI:61.2%-76.6%)for esomeprazole therapy and 73.9%(95%CI:65.9%-80.6%)for lansoprazole therapy(P=0.4982).PP analysis showed eradication rate of 76.9%(95%CI:68.6%-83.5%)for esomeprazole therapy and 79.8%(95%CI:71.9%-86.0%)for lansoprazole therapy(P=0.6423).There were no differences in adverse effects between the two therapies.CONCLUSION:Esomeprazole showed non-inferiority and safety in a 7 day-triple therapy for eradication of H.pylori compared with lansoprazole.展开更多
This clinical trial aimed to evaluate the efficacy and safety of a novel wound dressing composed of hyaluronic acid (HA) and collagen (Col) containing epidermal growth factor (EGF), referred to as EGF-wound dressing. ...This clinical trial aimed to evaluate the efficacy and safety of a novel wound dressing composed of hyaluronic acid (HA) and collagen (Col) containing epidermal growth factor (EGF), referred to as EGF-wound dressing. EGF-wound dressing was prepared by freeze-drying a mixed aqueous solution of high-molecular-weight HA, low-molecular-weight HA and heat-denatured Col containing EGF. EGF-wound dressing was applied to skin defects, such as intractable skin ulcers, burn ulcers, traumatic skin defects and skin donor-site wounds. The dressing was changed twice a week for a period of 6 weeks or longer, if necessary. The primary endpoints were size of wound area, formation of granulation tissue, extent of epithelialization, infection control and macroscopic appearance. Effectiveness, safety and overall clinical evaluation were scored by plastic surgeons, as authorized by the Japanese Society of Plastic and Reconstructive Surgery. This study was registered with the University Hospital Medical Information Network (UMIN0000005264). Healthy granulation tissue and rapid epithelialization were observed for a given period after application of EGF-wound dressing onto the wounds. Most cases were assessed as having achieved good or excellent results. This clinical study demonstrated that EGF-wound dressing was beneficial in the treatment of various skin defects.展开更多
文摘AIM:To evaluate the efficacy and safety of esomeprazole-based triple therapy compared with lansoprazole therapy as first-line eradication therapy for patients with Helicobacter pylori(H.pylori)in usual post-marketing use in Japan,where the clarithromycin(CAM)resistance rate is 30%.METHODS:For this multicenter,randomized,openlabel,non-inferiority trial,we recruited patients(≥20years of age)with H.pylori infection from 20 hospitals in Japan.We randomly allocated patients to esomeprazole therapy(esomeprazole 20 mg,CAM 400 mg,amoxicillin(AC)750 mg for the first 7 d,with all drugs given twice daily)or lansoprazole therapy(lansoprazole30 mg,CAM 400 mg,AC 750 mg for the first 7 d,with all drugs given twice daily)using a minimization method with age,sex,and institution as adjustment factors.Our primary outcome was the eradication rate by intention-to-treat(ITT)and per-protocol(PP)analyses.H.pylori eradication was confirmed by a urea breath test from 4 to 8 wk after cessation of therapy.RESULTS:ITT analysis revealed the eradication rates of 69.4%(95%CI:61.2%-76.6%)for esomeprazole therapy and 73.9%(95%CI:65.9%-80.6%)for lansoprazole therapy(P=0.4982).PP analysis showed eradication rate of 76.9%(95%CI:68.6%-83.5%)for esomeprazole therapy and 79.8%(95%CI:71.9%-86.0%)for lansoprazole therapy(P=0.6423).There were no differences in adverse effects between the two therapies.CONCLUSION:Esomeprazole showed non-inferiority and safety in a 7 day-triple therapy for eradication of H.pylori compared with lansoprazole.
文摘This clinical trial aimed to evaluate the efficacy and safety of a novel wound dressing composed of hyaluronic acid (HA) and collagen (Col) containing epidermal growth factor (EGF), referred to as EGF-wound dressing. EGF-wound dressing was prepared by freeze-drying a mixed aqueous solution of high-molecular-weight HA, low-molecular-weight HA and heat-denatured Col containing EGF. EGF-wound dressing was applied to skin defects, such as intractable skin ulcers, burn ulcers, traumatic skin defects and skin donor-site wounds. The dressing was changed twice a week for a period of 6 weeks or longer, if necessary. The primary endpoints were size of wound area, formation of granulation tissue, extent of epithelialization, infection control and macroscopic appearance. Effectiveness, safety and overall clinical evaluation were scored by plastic surgeons, as authorized by the Japanese Society of Plastic and Reconstructive Surgery. This study was registered with the University Hospital Medical Information Network (UMIN0000005264). Healthy granulation tissue and rapid epithelialization were observed for a given period after application of EGF-wound dressing onto the wounds. Most cases were assessed as having achieved good or excellent results. This clinical study demonstrated that EGF-wound dressing was beneficial in the treatment of various skin defects.
