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泮托拉唑治疗十二指肠溃疡优于雷尼替丁。墨西哥临床经验。泮托拉唑治疗十二指肠溃疡墨西哥研究小组++

[Superiority of pantoprazole over ranitidine in the treatment of duodenal ulcer. Mexican clinical experience. Mexican Study Group of Pantoprazole++ in Duodenal Ulcer].

作者信息

Dibildox M, Rose K, Tomás-Pons J, Fischer R, Gallo S

机构信息

Byk Gulden México.

出版信息

Rev Gastroenterol Mex. 1996 Jul-Sep;61(3):193-8.

PMID:9102740
Abstract

BACKGROUND

Pantoprazole is a new Proton Pump Inhibitor that has demonstrated to be superior to ranitidine in the healing of the acid related diseases.

AIMS

To compare efficacy and tolerability of oral treatment with pantoprazole vs. ranitidine in outpatients with endoscopically confirmed florid duodenal ulcers in Mexican patients.

METHODS

Prospective, multicentric, balanced, randomized, double blind, parallel group comparison clinical trial. Each patient received 40 mg pantoprazole plus placebo or 300 mg ranitidine plus placebo once daily for 2 weeks; if patients had not healed endoscopically by then, treatment was continued for two more weeks, with a final endoscopy.

RESULTS

163 protocol-correct patients were analyzed: 82 for pantoprazole group and 81 for ranitidine group. Healing rates at week 2 were 72% for pantoprazole and 51% for ranitidine (p < 0.01) and correspondingly 95 and 86% at week 4. The percentage of patients suffering from pain declined faster in the pantoprazole group. Both products were well tolerated and safe.

CONCLUSIONS

Pantoprazole is well tolerated and significantly superior to ranitidine in florid duodenal ulcers healing.

摘要

背景

泮托拉唑是一种新型质子泵抑制剂,已证明在治疗酸相关性疾病方面优于雷尼替丁。

目的

比较泮托拉唑与雷尼替丁口服治疗墨西哥门诊患者内镜确诊的活动性十二指肠溃疡的疗效和耐受性。

方法

前瞻性、多中心、均衡、随机、双盲、平行组比较临床试验。每位患者每日一次接受40mg泮托拉唑加安慰剂或300mg雷尼替丁加安慰剂治疗,持续2周;如果届时患者内镜检查未愈合,则再继续治疗2周,并进行最终的内镜检查。

结果

分析了163例符合方案的患者:泮托拉唑组82例,雷尼替丁组81例。泮托拉唑组第2周的愈合率为72%,雷尼替丁组为51%(p<0.01),第4周相应为95%和86%。泮托拉唑组疼痛患者的比例下降更快。两种产品耐受性良好且安全。

结论

泮托拉唑耐受性良好,在活动性十二指肠溃疡愈合方面明显优于雷尼替丁。

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