[胶囊美他多辛治疗酒精性肝病：一项随机、双盲、安慰剂对照、多中心研究]
[Capsule metadoxine in the treatment of alcoholic liver disease: a randomized, double-blind, placebo-controlled, multicenter study].
作者信息
Mao Yi-Min, Zeng Min-de, Li You-Ming, Wang Bing-Yuan, Shang Jia, Shi Rui-Hua, Liu Ji-Yong, Lu Lun-Gen, Cao Ai-Ping
机构信息
Renji Hospital Shanghai Jiaotong University School of Medicine,Shanghai 200001, China.
出版信息
Zhonghua Gan Zang Bing Za Zhi. 2009 Mar;17(3):213-6.
OBJECTIVE
To evaluate the efficacy and safety of Capsule metadoxine in the treatment of alcoholic liver disease.
METHODS
A randomized double blind multicenter placebo-controlled clinical study was performed to evaluate the therapeutic effectiveness and safety of capsule metadoxine. Patients in metadoxine group received capsule metadoxine 500mg tid po. Patients in placebo group received placebo 2 pillows tid po. The treatment duration was 6 weeks. Patients were followed up 2 weeks after the treatment. Patients were visited once every 3 weeks during the treatment period. Clinical symptoms and liver function were evaluated in all the patients before treatment, at week 3, week 6 and 2 weeks after therapy. CT scan was done in some patients before treatment and at the end point of therapy.
RESULTS
254 patients were recruited in the study, 126 in metadoxine group and 128 in placebo group. Median ALT, AST, GGT level in metadoxine group were decreased from 80.0 U/L, 59.2 U/L, 123.0 U/L (before treatment) to 41.1 U/L, 36.0 U/L, 57.0 U/L (after 6 weeks therapy). The improvement in liver function was more significant in metadoxine group than in placebo group (P less than 0.05). For the patients who stopped drinking during the study, the total effective rate of improvement in liver function was 82.8% in metadoxine group, much higher than that in placebo group (55.7% , P=0.0000). For the patients who did not stop drinking during the study, the total effective rate of improvement in liver function was 65.4% in metadoxine group, which is not significantly higher than that in placebo group (44.8%, P=0.1767). The CT value ratio of liver to spleen was significantly improved in metadoxine group (P=0.0023), and there was no significant difference between the two groups (P=0.6293). The rate of adverse was 1.6% in both of groups.
CONCLUSION
Capsule metadoxine is an effective and safe treatment for alcoholic liver disease.
目的
评估美他多辛胶囊治疗酒精性肝病的疗效和安全性。
方法
进行一项随机双盲多中心安慰剂对照临床研究，以评估美他多辛胶囊的治疗效果和安全性。美他多辛组患者口服美他多辛胶囊500mg，每日3次。安慰剂组患者口服安慰剂，每日3次，每次2粒。治疗持续时间为6周。治疗后对患者进行2周随访。治疗期间每3周对患者进行一次访视。在治疗前、第3周、第6周和治疗后2周对所有患者评估临床症状和肝功能。部分患者在治疗前和治疗终点进行CT扫描。
结果
本研究共纳入254例患者，美他多辛组126例，安慰剂组128例。美他多辛组谷丙转氨酶（ALT）、谷草转氨酶（AST）、γ-谷氨酰转肽酶（GGT）水平中位数从治疗前的80.0 U/L、59.2 U/L、123.0 U/L降至6周治疗后的41.1 U/L、36.0 U/L、57.0 U/L。美他多辛组肝功能改善较安慰剂组更显著（P<0.05）。对于研究期间戒酒的患者，美他多辛组肝功能改善总有效率为82.8%，远高于安慰剂组（55.7%，P=0.0000）。对于研究期间未戒酒的患者，美他多辛组肝功能改善总有效率为65.4%，显著高于安慰剂组（44.8%，P=0.1767）。美他多辛组肝脾CT值比显著改善（P=0.0023），两组间差异无统计学意义（P=0.6293）。两组不良反应发生率均为1.6%。
结论
美他多辛胶囊是治疗酒精性肝病的一种有效且安全的药物。
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