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[一种新型无类固醇制剂在直肠病学中的多中心临床研究]

[Multicenter clinical study of a novel steroid-free preparation in proctology].

作者信息

Arnold K, Auel H

出版信息

Arzneimittelforschung. 1976;26(1):96-9.

PMID:132941
Abstract

In a multicentre study 15 physicians investigated the therapeutic efficacy and tolerance of Faktu suppositories and ointment (containing the active principle of Albothyl, a condensation product of m-cresolsulfonic acid and formaldehyde) in 585 patients with proctological affections. Highly satisfactory results were achieved in 486 patients (83.1%). The following were found to be the main indications: -treatment of wounds after proctological operations, -fresh and fissures, -bleeding internal haemorrhoids, -anal eczema and anal pruritus, -rhagades and perforated or prolapsed external haemorrhoids (perianal thrombosis). None of the investigators reported any persisting adverse side-effects. 16% of the patients complained of local discomfort of varying intensity such as pruritus, burning or irritation. The symptoms mostly appeared on commencement of the treatment and necessitated discontinuation of therapy in 5.3% only. The extremely favourable effect of Albothyl - the active principle of Faktu - is due to its unique mechanism of action: the markedly acid milieu of the substance. Furthermore the Faktu preparations do not contain any steroids and consequently they can be used without any misgivings over prolonged periods.

摘要

在一项多中心研究中,15名医生对585例直肠疾病患者使用Faktu栓剂和软膏(含有Albothyl的活性成分,间甲酚磺酸与甲醛的缩合产物)的治疗效果和耐受性进行了研究。486例患者(83.1%)取得了非常满意的结果。发现主要适应症如下: - 直肠手术后伤口的治疗, - 肛裂, - 内痔出血, - 肛门湿疹和肛门瘙痒, - 皲裂以及穿孔或脱垂的外痔(肛周血栓形成)。没有一位研究者报告有持续的不良副作用。16%的患者抱怨有不同程度的局部不适,如瘙痒、烧灼感或刺激感。这些症状大多在治疗开始时出现,仅5.3%的患者因此需要停止治疗。Albothyl(Faktu的活性成分)的极佳效果归因于其独特的作用机制:该物质明显呈酸性的环境。此外,Faktu制剂不含任何类固醇,因此可以长期放心使用。

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