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法莫替丁治疗活动性十二指肠溃疡。影响早期愈合因素的多变量分析。

Famotidine therapy for active duodenal ulcers. A multivariate analysis of factors affecting early healing.

作者信息

Reynolds J C

机构信息

University of Pennsylvania, Philadelphia.

出版信息

Ann Intern Med. 1989 Jul 1;111(1):7-14. doi: 10.7326/0003-4819-111-1-7.

DOI:10.7326/0003-4819-111-1-7
PMID:2567589
Abstract

OBJECTIVE

To identify factors that influence the rate of healing of duodenal ulcers.

DESIGN

A stepwise multivariable statistical analysis of patients with duodenal ulcer in a multicenter, prospective, open-label study. Healing was assessed by endoscopy at 4 or 8 weeks. Antacid use and symptoms were recorded in a daily diary.

SUBJECTS

Of 135 patients, ages 19 to 86, 50% had a previous duodenal ulcer, 46.7% smoked, and 34.8% had melena or hematemesis.

INTERVENTIONS

Famotidine, 40 mg orally, at bedtime for 4 or 8 weeks depending on endoscopic evaluation of ulcer healing. Limited antacid use was permitted.

SETTING

Office practices, hospital practices, and university-based medical centers.

MEASUREMENTS AND MAIN RESULTS

Multivariable analysis identified five independent predictors present at the time of diagnosis that influenced ulcer healing. The odds of not healing for each risk factor after simultaneous adjustment of the other risk factors were as follows: alcohol use, 6.5 (CI, 2.0 to 20.7, P less than 0.002); ulcer size greater than 10 mm, 4.2 (CI, 1.5 to 11.6, P less than 0.005), bleeding symptoms. 3.5 (CI, 1.2 to 10.2, P less than 0.03); and a previous duodenal ulcer, 3.1 (CI, 1.05 to 9.0, P less than 0.04). The use of salicylates or nonsteroidal anti-inflammatory drugs before treatment was associated with an improved odds of healing (adjusted odds ratio, 0.2; CI, 0.1 to 0.9, P less than 0.04). The percentage of patients achieving complete ulcer healing after 4 weeks of famotidine decreased inversely with the number of risk factors present, ulcer size, and the quantity of daily alcohol use (P less than 0.001). Fewer than half of those patients who still had severe pain at day 7 achieved healing at 4 weeks (P less than 0.001). In contrast, smoking and 23 other factors had no statistically discernible effect on ulcer healing with famotidine.

CONCLUSIONS

Five variables present at the time of diagnosis independently influenced the rate of ulcer healing at 4 weeks: alcohol use, ulcer size, bleeding symptoms, a previous duodenal ulcer, and previous use of salicylates or nonsteroidal anti-inflammatory drugs.

摘要

目的

确定影响十二指肠溃疡愈合速度的因素。

设计

在一项多中心、前瞻性、开放标签研究中,对十二指肠溃疡患者进行逐步多变量统计分析。在4周或8周时通过内镜检查评估愈合情况。通过每日日记记录抗酸剂的使用情况和症状。

研究对象

135例年龄在19至86岁之间的患者,50%曾患十二指肠溃疡,46.7%吸烟,34.8%有黑便或呕血症状。

干预措施

法莫替丁,40毫克口服,睡前服用4或8周,具体取决于溃疡愈合的内镜评估结果。允许有限度地使用抗酸剂。

研究地点

门诊、医院及大学附属医院。

测量指标及主要结果

多变量分析确定了诊断时存在的五个独立预测因素,这些因素会影响溃疡愈合。在同时调整其他风险因素后,每个风险因素不愈合的几率如下:饮酒,6.5(95%置信区间,2.0至20.7,P<0.002);溃疡大小大于10毫米,4.2(95%置信区间,1.5至11.6,P<0.005);出血症状,3.5(95%置信区间,1.2至10.2,P<0.03);既往十二指肠溃疡,3.1(95%置信区间,1.05至9.0,P<0.04)。治疗前使用水杨酸盐或非甾体类抗炎药与愈合几率提高相关(调整后的优势比,0.2;95%置信区间,0.1至0.9,P<0.04)。法莫替丁治疗4周后实现溃疡完全愈合的患者百分比与存在的风险因素数量、溃疡大小和每日饮酒量呈负相关(P<0.001)。第7天仍有严重疼痛的患者中,不到一半在4周时实现愈合(P<0.001)。相比之下,吸烟和其他23个因素对法莫替丁治疗溃疡愈合无统计学上可辨别的影响。

结论

诊断时存在的五个变量独立影响4周时的溃疡愈合速度:饮酒、溃疡大小、出血症状、既往十二指肠溃疡以及既往使用水杨酸盐或非甾体类抗炎药。

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Ann Intern Med. 1989 Jul 1;111(1):7-14. doi: 10.7326/0003-4819-111-1-7.
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