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熊去氧胆酸治疗原发性胆汁性肝硬化患者。一项瑞典多中心、双盲、随机对照研究。

Ursodeoxycholic acid treatment in patients with primary biliary cirrhosis. A Swedish multicentre, double-blind, randomized controlled study.

作者信息

Eriksson L S, Olsson R, Glauman H, Prytz H, Befrits R, Rydén B O, Einarsson K, Lindgren S, Wallerstedt S, Wedén M

机构信息

Dept. of Medicine, Huddinge Hospital, Sweden.

出版信息

Scand J Gastroenterol. 1997 Feb;32(2):179-86. doi: 10.3109/00365529709000190.

DOI:10.3109/00365529709000190
PMID:9051880
Abstract

BACKGROUND

Ursodeoxycholic acid (UDCA) has been shown to improve serum levels of liver enzymes and bilirubin in primary biliary cirrhosis (PBC). However, it is still uncertain whether UDCA treatment also improves symptoms, liver histology, and survival without liver transplantation.

METHODS

We randomized 116 patients with PBC to receive 0.5 g UDCA (n = 60) or placebo (n = 56) daily for 2 years. During the next 2 years, 80% of the UDCA-treated patients and 65% of the placebo-treated patients continued to take UDCA.

RESULTS

UDCA improved serum enzyme values but not survival, symptoms, serum bilirubin levels, or liver histology. There was no significant difference in response between initially symptomatic and asymptomatic patients.

CONCLUSIONS

UDCA in a dosage of 7.7 mg/kg body weight is of little benefit in PBC. This does not exclude the possibility that larger doses have beneficial effects.

摘要

背景

熊去氧胆酸(UDCA)已被证明可改善原发性胆汁性肝硬化(PBC)患者的血清肝酶和胆红素水平。然而,UDCA治疗是否也能改善症状、肝脏组织学以及无需肝移植情况下的生存率仍不确定。

方法

我们将116例PBC患者随机分为两组,一组每日服用0.5 g UDCA(n = 60),另一组每日服用安慰剂(n = 56),为期2年。在接下来的2年中,80%接受UDCA治疗的患者和65%接受安慰剂治疗的患者继续服用UDCA。

结果

UDCA可改善血清酶值,但对生存率、症状、血清胆红素水平或肝脏组织学无改善作用。初始有症状和无症状患者之间的反应无显著差异。

结论

7.7 mg/kg体重剂量的UDCA对PBC益处不大。但这并不排除更大剂量可能具有有益作用的可能性。

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