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普罗布考治疗非酒精性脂肪性肝炎:一项双盲随机对照研究。

Probucol in the treatment of non-alcoholic steatohepatitis: a double-blind randomized controlled study.

作者信息

Merat Shahin, Malekzadeh Reza, Sohrabi Masoud Reza, Sotoudeh Masoud, Rakhshani Nasser, Sohrabpour Amir Ali, Naserimoghadam Siavosh

机构信息

Digestive Disease Research Center, Shariati Hospital, Tehran University of Medical Sciences, Kargar Shomali Avenue, Tehran, Iran.

出版信息

J Hepatol. 2003 Apr;38(4):414-8. doi: 10.1016/s0168-8278(02)00441-5.

DOI:10.1016/s0168-8278(02)00441-5
PMID:12663231
Abstract

BACKGROUND/AIMS: A final step in the pathology of non-alcoholic steatohepatitis (NASH) is oxidative damage to hepatocytes. Probucol is a lipid-lowering agent with strong antioxidant properties. We designed a double-blind randomized controlled study to evaluate the effects of probucol in NASH.

METHODS

Thirty cases of biopsy-proven NASH were included. Subjects were randomly allocated to either the treatment group or to the control group by a 2:1 ratio. The treatment group was given 500 mg of probucol daily for 6 months, and the control group, an identically appearing placebo.

RESULTS

Twenty-seven cases completed the study. The mean aspartate transaminase (AST) and alanine transaminase (ALT) levels changed from 81.9 to 36.2 and 102.2 to 44.7 in the treatment group and from 57.6 to 49.6 and 96.8 to 96.2 in the control group, respectively. The decrease in ALT level in the treatment group as compared to the control group was significant at the P<0.005 level (95% confidence interval: 20.2-93.7 IU). Both AST and ALT levels dropped to normal in nine cases of the treatment group (50%) but none of the control group (P=0.01).

CONCLUSIONS

Probucol appears to be significantly effective in decreasing the ALT levels in patients with NASH.

摘要

背景/目的:非酒精性脂肪性肝炎(NASH)病理过程的最后一步是肝细胞的氧化损伤。普罗布考是一种具有强大抗氧化特性的降脂药物。我们设计了一项双盲随机对照研究来评估普罗布考对NASH的影响。

方法

纳入30例经活检证实的NASH患者。受试者按2:1的比例随机分为治疗组或对照组。治疗组每天服用500毫克普罗布考,持续6个月,对照组服用外观相同的安慰剂。

结果

27例患者完成了研究。治疗组的平均天冬氨酸转氨酶(AST)和丙氨酸转氨酶(ALT)水平分别从81.9降至36.2,从102.2降至44.7;对照组分别从57.6降至49.6,从96.8降至96.2。治疗组ALT水平较对照组下降显著,P<0.005(95%置信区间:20.2 - 93.7 IU)。治疗组9例患者(50%)的AST和ALT水平均降至正常,而对照组无一例(P = 0.01)。

结论

普罗布考似乎对降低NASH患者的ALT水平有显著效果。

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