[秋水仙碱治疗纤维化肝病——一项随机双盲研究报告]。

M Reinhardt, D Jorke, G Jahn, B Krombholz, A Müller, G Machnik, H Kunath
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引用次数: 0

摘要

本文报道了一项为期三年的秋水仙碱治疗纤维化肝病的双盲研究结果。本研究包括74个先证者;其中37人在随机分组后接受了每周5天的4 × 0,25 mg/d秋水仙碱治疗,37人接受安慰剂治疗。53名先证者治疗12个月,其中43名治疗24个月,24名先证者治疗36个月。根据纤维化的组织学分级形成3个诊断组:慢性肝炎(无结构转化);结构性肝转化/中度肝硬化;严重肝硬化。其中38例是由酒精引起的。研究了45项数据(临床结果、肝脏学诊断和结缔组织代谢和形态学数据)。生物特征评估采用Friedman的阶段变异分析。40名先证者在1年后进行了再活检,4名先证者在2年后进行了再活检。4项数据(血清白蛋白、γ - gt、ALAT、KP)显示秋水仙碱组和安慰剂组有显著变化。在两个治疗组中,纤维化等级的形态学监测(再活检)显示改善,无变化,恶化的频率大致相同。在这项研究中,秋水仙碱对纤维化肝病的病程没有疗效。鉴于近期文献的矛盾和秋水仙碱剂量可能不足,作者建议进一步研究秋水仙碱治疗早期即可逆性纤维化肝脏疾病。
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[Colchicine therapy of fibrosing liver diseases--report of a randomized double-blind study].

It is reported on results of a double blind study of colchicine therapy in fibrotic liver diseases over a period of three years. The study includes 74 probands; 37 of them had been treated after randomization for five days a week with 4 X 0,25 mg/d colchicine, 37 with placebo. 53 probands attained the 12th month of treatment, 43 of them 24th, 24 probands were in the study for 36 months. 3 diagnoses groups had been formed with regard to the histological grades of fibrosis: chronic hepatitis (without structural transformation); structural liver transformation/moderate liver cirrhosis; severe liver cirrhosis. In 38 cases the disease was caused by alcohol. 45 data had been studied (clinical results, paraclinical data concerning hepatological diagnostic and connective tissue metabolism and morphologic data). The biometric evaluation was carried out with the stage variant analysis by Friedman. Rebiopsies have been carried out in 40 probands after 1 year, in 4 probands after 2 years. 4 data (Serumalbumine, Gamma-GT, ALAT, KP) showed significant changes in the colchicine-group as well as in the placebo-group. In both therapy groups the morphologic supervisions of the fibrosis grades (rebiopsies) showed improvements, no changes, and deterioration about in the same frequency. In this study there was no effectiveness of colchicine on the course of fibrotic liver diseases to be stated. Concerning the contradictions in the recent literature and probable the insufficient colchicine dose, the authors recommend further studies on colchicine therapy in liver diseases with incipient i.e. reversible fibrosis.

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