Mansour-Ghanaei Fariborz, Fallah Mohammad S, Shafaghi Afshin
Gastrointestinal & liver Diseases Research center, Guilan University of Medical Sciences, Rasht, Iran.
Med Sci Monit. 2002 Mar;8(3):PI27-30.
The object of the study was to study the efficacy and safety of furazolidone and tetracycline compared to metronidazole and amoxicillin in an omeprazole based triple therapy in a prospective randomized-blind-clinical trial.
MATERIAL/METHODS: Patients with endoscopically verified active duodenal ulcer disease in the presence of Helicobacter pylori infection were eligible to enter the study. Endoscopy was performed a day before and 6-8 weeks after the cessation of treatment. H. pylori status was assessed by histologic examination (Giemsa stain) of biopsy specimens were taken from the antrum and corpus. H. pylori eradication was defined as absence in histology of the biopsy specimens at the second endoscopy. Ulcer healing was considered as decrease in ulcer size to less than 20% of its primary size. Patients were randomly assigned to receive omeprazole 20 mg, amoxicillin 1000 mg and metronidazole 500 mg (OAM group) or omeprazole 20 mg, tetracycline 500 mg and furazolidone 200 mg (OTF group). All medications were taken twice daily, for 2 weeks.
Out of 111 patients enrolled in the study, 108 completed a course of treatment and underwent a follow-up endoscopy, with 54 patients in each group. H. pylori eradication was achieved in 52 patients (96.3% - 95% CI: 91.27-100) in OTF group and 45 patients (83.3% - 95% CI: 73.35-93.25) in OAM group (P=0.015). Our study showed the superiority of OTF vs. OAM regimen with a 13% increment in eradication rate, with only occasional severe side effect.
In conclusion OTF regimen is a safe, cheaper and effective alternative for OTF regimen and we recommend it to be used especially in developing countries.
在一项前瞻性随机双盲临床试验中,本研究旨在比较以奥美拉唑为基础的三联疗法中,呋喃唑酮和四环素与甲硝唑和阿莫西林相比的疗效和安全性。
材料/方法:经内镜检查证实患有活动性十二指肠溃疡且伴有幽门螺杆菌感染的患者符合进入本研究的条件。在治疗开始前一天以及治疗结束后6 - 8周进行内镜检查。通过对取自胃窦和胃体的活检标本进行组织学检查(吉姆萨染色)来评估幽门螺杆菌状态。幽门螺杆菌根除定义为第二次内镜检查时活检标本组织学检查未发现幽门螺杆菌。溃疡愈合定义为溃疡大小缩小至其初始大小的20%以下。患者被随机分配接受奥美拉唑20毫克、阿莫西林1000毫克和甲硝唑500毫克(OAM组)或奥美拉唑20毫克、四环素500毫克和呋喃唑酮200毫克(OTF组)。所有药物均每日服用两次,持续2周。
在本研究纳入的111名患者中,108名完成了一个疗程的治疗并接受了随访内镜检查,每组各有54名患者。OTF组有52名患者(96.3% - 95%置信区间:91.27 - 100)实现了幽门螺杆菌根除,OAM组有45名患者(83.3% - 95%置信区间:73.35 - 93.25)实现了幽门螺杆菌根除(P = 0.015)。我们的研究表明OTF方案优于OAM方案,根除率提高了13%,且只有偶尔的严重副作用。
总之,OTF方案是一种安全、便宜且有效的OAM方案替代方案,我们建议尤其在发展中国家使用。