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500毫克微粒化纯化黄酮成分(Daflon)治疗痔病:与安慰剂相比的疗效验证

Daflon 500 mg in the treatment of hemorrhoidal disease: a demonstrated efficacy in comparison with placebo.

作者信息

Godeberge P

机构信息

Hôpital Rothschild, Paris, France.

出版信息

Angiology. 1994 Jun;45(6 Pt 2):574-8.

PMID:8203790
Abstract

Hemorrhoidal disease (HD) is a trophic disorder of the anal canal characterized by recurrent, self-resolving acute episodes. The author reports the results of a double-blind, placebo-controlled trial of the efficacy of Daflon 500 mg in the treatment of acute and chronic symptoms of hemorrhoids. One hundred and twenty outpatients (54 men, 66 women) suffering from an acute episode of HD during the previous two months were included. They received Daflon 500 mg (group D, n = 60) or placebo (group P, n = 60) two tablets daily for two months. The patients were examined at entry (T0) and at two months (T2). At T0, the two groups did not differ in terms of age, sex, weight, height, history of symptoms of HD; 7 patients were excluded from analysis because of treatment failure (group D, n = 2; group P, n = 3), or lost to follow-up (group P, n = 2). In group D, 40% of patients had an attack during the trial with a mean duration of 2.6 days and a mean severity of 1.1 scored on a scale from 1 to 3. These values were significantly different (P < 0.01) from the corresponding values in the P group: 70%, 4.6 days and 1.6 respectively. Each symptom and sign was scored on a scale of severity. The overall symptom score, scored from 0 to 15, decreased from 6.6 (group D) and 6.1 (group P) (NS) to 1.1 and 4.0 respectively (P < 0.01) at the end of treatment.(ABSTRACT TRUNCATED AT 250 WORDS)

摘要

痔病(HD)是一种肛管的营养障碍性疾病,其特征为反复出现且可自行缓解的急性发作。作者报告了一项关于500毫克微粒化纯化黄酮成分(Daflon)治疗痔疮急性和慢性症状疗效的双盲、安慰剂对照试验结果。纳入了120名在前两个月内患有HD急性发作的门诊患者(54名男性,66名女性)。他们每天服用两片500毫克Daflon(D组,n = 60)或安慰剂(P组,n = 60),持续两个月。在入组时(T0)和两个月时(T2)对患者进行检查。在T0时,两组在年龄、性别、体重、身高、HD症状史方面无差异;7名患者因治疗失败(D组,n = 2;P组,n = 3)或失访(P组,n = 2)而被排除在分析之外。在D组中,40%的患者在试验期间发作,平均持续时间为2.6天,平均严重程度在1至3分的量表上得分为1.1分。这些值与P组的相应值(70%、4.6天和1.6分)有显著差异(P < 0.01)。每个症状和体征都按严重程度进行评分。从0到15评分的总体症状评分在治疗结束时分别从6.6(D组)和6.1(P组)(无统计学差异)降至1.1和4.0(P < 0.01)。(摘要截短至250字)

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