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法莫替丁与雷尼替丁在内镜诊断为消化性溃疡患者中的安全性和有效性的双盲比较。

Double-blind comparison of the safety and efficacy of famotidine with ranitidine in patients with endoscopically diagnosed peptic ulcer.

作者信息

Sawant P D, Nanivadekar S A, Patel H D, Shroff C P, Oke V G, Jha R J, Bowalekar S K, Navani S R, Raghu C N

机构信息

Department of Gastroenterology, L.T.M. Medical College, Sion, Bombay.

出版信息

J Assoc Physicians India. 1990 Sep;38 Suppl 1:723-6.

PMID:2092029
Abstract

In a double-blind randomised trial, 40 patients with active gastric or duodenal ulcer were treated with a single nocturnal dose of famotidine 40 mg or ranitidine 300 mg for 4 to 8 weeks. Antacid tablets were allowed as additional treatment, only if needed, for pain relief. Endoscopy was repeated after 4 weeks, and if the ulcer had not healed at 6 and/or 8 weeks. Relief of upper gastro intestinal symptoms with which the patient presented and the number of antacid tablets consumed, if any, were recorded on weekly basis. Two patients in famotidine group and 5 patients in ranitidine group did not complete the therapy and were considered dropouts. At the end of therapy, ulcers in 100% of the patients receiving famotidine & 93% of patients receiving ranitidine were healed. This difference was not statistically significant. Relief from ulcer related symptoms was rapid in both the groups. None of the patients in either group reported side effects. Overall opinion of investigator was comparable for both the treatments; however, significantly (P = 0.0334) larger proportion (100%) of patients from famotidine group rated it as an excellent therapy compared to only 73% from ranitidine group. Famotidine provides excellent healing of ulcers and early relief of upper gastrointestinal symptoms in Indian patients with peptic ulcer.

摘要

在一项双盲随机试验中,40例活动性胃溃疡或十二指肠溃疡患者接受治疗,每晚单次服用40毫克法莫替丁或300毫克雷尼替丁,疗程为4至8周。仅在需要缓解疼痛时,允许使用抗酸片作为辅助治疗。4周后重复进行内镜检查,如果溃疡在6周和/或8周时未愈合也进行检查。每周记录患者出现的上消化道症状缓解情况以及服用抗酸片的数量(如有)。法莫替丁组有2例患者和雷尼替丁组有5例患者未完成治疗,被视为脱落病例。治疗结束时,接受法莫替丁治疗的患者中100%的溃疡愈合,接受雷尼替丁治疗的患者中93%的溃疡愈合。这种差异无统计学意义。两组溃疡相关症状的缓解都很快。两组患者均未报告有副作用。研究者对两种治疗的总体评价相当;然而,法莫替丁组中比例显著更高(100%)的患者将其评为优秀治疗,而雷尼替丁组只有73%的患者这样评价。法莫替丁能使印度消化性溃疡患者的溃疡得到良好愈合,并能早期缓解上消化道症状。

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