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利福昔明与乳果糖治疗中度至重度肝性脑病患者的双盲、双模拟对照研究。

Double-blind, double-dummy comparison between treatment with rifaximin and lactulose in patients with medium to severe degree hepatic encephalopathy.

作者信息

Bucci L, Palmieri G C

机构信息

Brera Medical Department, Niguarda Cà Granda Hospital, Milan, Italy.

出版信息

Curr Med Res Opin. 1993;13(2):109-18. doi: 10.1185/03007999309111539.

DOI:10.1185/03007999309111539
PMID:8325041
Abstract

Fifty-eight patients, 30 males and 28 females, aged between 42 and 60 years (mean age 57 years) suffering from cirrhosis of the liver with signs and symptoms of portosystemic encephalopathy were studied. The double-blind study was performed according to a double-dummy experimental design, comparing the antibiotic rifaximin, administered at a dose of 1200 mg/day, with lactulose, administered at a dose of 30 g/day, both for 15 days. At the end of the treatment with the two drugs, there was a significant improvement in the main symptoms of portosystemic encephalopathy (mental state, asterixis, 'A' cancellation test, Reitan test). The improvement, which was also confirmed by a reduction in the overall score attributed to the degree of portosystemic encephalopathy was undoubtedly correlated with the reduction in the levels of serum ammonia concentrations, recorded after only 3 days of treatment. Tolerability of the treatment with rifaximin was decidedly higher with respect to lactulose. The greater rapidity of action and the lack of side-effects with rifaximin recommend the use of this intestinal antibiotic in patients with medium to severe portosystemic encephalopathy.

摘要

对58例年龄在42至60岁(平均年龄57岁)之间、患有肝硬化且伴有门体系统性脑病体征和症状的患者进行了研究,其中男性30例,女性28例。该双盲研究按照双模拟实验设计进行,将每日剂量为1200 mg的抗生素利福昔明与每日剂量为30 g的乳果糖进行比较,两种药物均治疗15天。在用这两种药物治疗结束时,门体系统性脑病的主要症状(精神状态、扑翼样震颤、“A”字划消试验、雷坦试验)有显著改善。这种改善也通过门体系统性脑病程度总体评分的降低得到证实,无疑与治疗仅3天后血清氨浓度水平的降低相关。利福昔明治疗的耐受性明显高于乳果糖。利福昔明作用更快且无副作用,推荐用于中重度门体系统性脑病患者。

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