十二指肠溃疡疾病中采用奥美拉唑、阿莫西林和克拉霉素每日两次、为期10天的三联疗法根除幽门螺杆菌：三项美国多中心、双盲试验的结果

Twice-daily, 10-day triple therapy with omeprazole, amoxicillin, and clarithromycin for Helicobacter pylori eradication in duodenal ulcer disease: results of three multicenter, double-blind, United States trials.

作者信息

Laine L, Suchower L, Frantz J, Connors A, Neil G

机构信息

Department of Medicine, U.S.C. School of Medicine, Los Angeles, California 90033, USA.

出版信息

Am J Gastroenterol. 1998 Nov;93(11):2106-12. doi: 10.1111/j.1572-0241.1998.00602.x.

DOI:10.1111/j.1572-0241.1998.00602.x

PMID:9820381

Abstract

OBJECTIVE

We assessed the safety and efficacy of 10-day twice-daily triple therapy for Helicobacter pylori (H. pylori) in three double-blind, controlled trials in patients with duodenal ulcer disease.

METHODS

H. pylori-infected patients with one or more duodenal ulcer(s) at endoscopy (studies 1, 2) or with a documented duodenal ulcer history and no duodenal ulcer or erosions at endoscopy (study 3) were randomly assigned to 10-day courses of omeprazole 20 mg b.i.d. plus amoxicillin 1 g b.i.d. plus clarithromycin 500 mg b.i.d. (OAC) or placebo plus amoxicillin 1 g b.i.d. plus clarithromycin 500 mg b.i.d. (AC). In studies 1 and 2, patients received an additional 18 days of omeprazole 20 mg q.d. (OAC group) or placebo (AC group). Endoscopy was repeated 4 wk after therapy in studies 1 and 2 and 4-6 wk after therapy in study 3. At baseline, H. pylori was diagnosed by CLOtest plus histology, or by culture. Eradication was defined as no positive biopsy test and two or more negative tests. Patients were defined as compliant if they took 75% or more of each study drug and missed < or = 3 consecutive days of the 10-day therapy.

RESULTS

Intent-to-treat populations of the three studies combined were 241 patients for OAC and 266 for AC. Of all OAC patients combined, 2% stopped study medications due to adverse events, and 93% were compliant. Per-protocol cure rates were 78% to 90% (all studies combined, 84%) for OAC vs 33% to 45% (combined, 39%) for AC (p < 0.001, OAC vs AC); intent-to-treat eradication rates were 69% to 83% (combined, 75%) for OAC vs 32% to 37% (combined, 35%) for AC; (p < 0.001, OAC vs AC).

CONCLUSION

Rigorously designed studies indicate that 10 days of twice-daily triple therapy with omeprazole, amoxicillin, and clarithromycin achieves per-protocol eradication rates of approximately 80% to 90% in the U.S.

摘要

目的

在三项针对十二指肠溃疡疾病患者的双盲对照试验中，我们评估了每日两次、为期10天的幽门螺杆菌三联疗法的安全性和有效性。

方法

在内镜检查时发现有一处或多处十二指肠溃疡的幽门螺杆菌感染患者（研究1、2），或有十二指肠溃疡病史且在内镜检查时无十二指肠溃疡或糜烂的患者（研究3），被随机分配接受为期10天的奥美拉唑20毫克每日两次加阿莫西林1克每日两次加克拉霉素500毫克每日两次（OAC）疗程，或安慰剂加阿莫西林1克每日两次加克拉霉素500毫克每日两次（AC）疗程。在研究1和2中，患者额外接受18天的奥美拉唑20毫克每日一次（OAC组）或安慰剂（AC组）治疗。在研究1和2中，治疗4周后重复内镜检查，在研究3中，治疗4至6周后重复内镜检查。在基线时，通过CLO检测加组织学检查或培养诊断幽门螺杆菌。根除定义为活检检测无阳性且有两次或更多次阴性检测。如果患者服用每种研究药物的量达到75%或更多，且在10天治疗中连续漏服天数≤3天，则定义为依从性好。

结果

三项研究的意向性治疗人群中，OAC组有241例患者，AC组有266例患者。在所有合并的OAC患者中，2%因不良事件停止研究用药，93%依从性好。OAC组的符合方案治愈率为78%至90%（所有研究合并为84%），而AC组为33%至45%（合并为39%）（OAC组与AC组相比，p<0.001）；意向性治疗根除率OAC组为69%至83%（合并为75%），AC组为32%至37%（合并为35%）；（OAC组与AC组相比，p<0.001）。