Kashimura H, Suzuki K, Hassan M, Ikezawa K, Sawahata T, Watanabe T, Nakahara A, Mutoh H, Tanaka N
Division of Gastroenterology, Department of Internal Medicine, Institute of Clinical Medicine, IUniversity of Tsukuba, baraki, Japan.
Aliment Pharmacol Ther. 1999 Apr;13(4):483-7. doi: 10.1046/j.1365-2036.1999.00510.x.
To evaluate the efficacy of polaprezinc, a mucosal protective agent, in combination with a 7-day triple therapy containing lansoprazole, amoxycillin and clarithromycin, as a treatment for Helicobacter pylori.
Sixty-six consecutive patients suffering from dyspeptic symptoms with H. pylori infection were randomly allocated to one of two regimens: one group (LAC; n = 31) received lansoprazole 30 mg b.d., amoxycillin 500 mg b.d. and clarithromycin 400 mg b.d. for 7 days. The other group (LACP; n = 35) received the LAC regimen plus polaprezinc 150 mg b.d. for 7 days. H. pylori status was evaluated by rapid urease test, histology and culture at entry and 4 weeks after treatment.
Five patients did not complete the treatment: no follow-up endoscopy was performed on two patients in the LAC group; one patient in the LAC group and two in the LACP group had their treatment stopped due to severe diarrhoea. By per protocol analysis, H. pylori eradication was achieved in 24 of the 28 evaluable patients (86%; 95% CI: 72-100%) after LAC therapy, and in 33 of the 33 evaluable patients (100%) after LACP therapy (P < 0.05). On intention-to-treat analysis, the rates of eradication were 24 of 31 patients (77%; 95% CI: 62-93%) in the LAC group, and 33 of 35 patients (94%; 95% CI: 86-100%) in the LACP group (P < 0.05).
A 7-day triple therapy with lansoprazole, amoxycillin and clarithromycin is effective in H. pylori eradication, but this regimen is significantly improved by the addition of polaprezinc.
评估黏膜保护剂聚普瑞锌联合含兰索拉唑、阿莫西林和克拉霉素的7天三联疗法治疗幽门螺杆菌的疗效。
66例连续患有消化不良症状且感染幽门螺杆菌的患者被随机分配至两种治疗方案之一:一组(LAC组;n = 31)接受兰索拉唑30 mg,每日2次,阿莫西林500 mg,每日2次,克拉霉素400 mg,每日2次,共7天。另一组(LACP组;n = 35)接受LAC方案加聚普瑞锌150 mg,每日2次,共7天。在入组时和治疗后4周通过快速尿素酶试验、组织学和培养评估幽门螺杆菌状况。
5例患者未完成治疗:LAC组2例患者未进行随访内镜检查;LAC组1例患者和LACP组2例患者因严重腹泻停止治疗。根据符合方案分析,LAC治疗后28例可评估患者中的24例(86%;95%CI:72 - 100%)实现了幽门螺杆菌根除,LACP治疗后33例可评估患者中的33例(100%)实现了根除(P < 0.05)。在意向性分析中,LAC组31例患者中的24例(77%;95%CI:62 - 93%)根除率,LACP组35例患者中的33例(94%;95%CI:86 - 100%)根除率(P < 0.05)。
兰索拉唑、阿莫西林和克拉霉素的7天三联疗法对根除幽门螺杆菌有效,但添加聚普瑞锌可显著改善该方案。