罗格列酮在2型糖尿病合并非酒精性脂肪性肝病患者中的安全性和有效性。
Safety and effectiveness of rosiglitazone in type 2 diabetes patients with nonalcoholic Fatty liver disease.
作者信息
Wang Chao-Hung, Leung Ching-Hsiang, Liu Sung-Chen, Chung Cheng-Ho
机构信息
Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital, Taipei, Taiwan.
出版信息
J Formos Med Assoc. 2006 Sep;105(9):743-52. doi: 10.1016/S0929-6646(09)60202-3.
BACKGROUND/PURPOSE: Nonalcoholic fatty liver disease (NAFLD) is a common chronic liver disease ranging in severity from steatosis to cirrhosis. Type 2 diabetes mellitus is a cause of primary NAFLD. Thiazolidinediones have been shown to enhance insulin sensitivity, improve glycemic control in type 2 diabetes patients and to improve the histologic markers of nonalcoholic steatohepatitis. This study aims to determine the safety and effectiveness of rosiglitazone in inadequately controlled type 2 diabetes patients with NAFLD.
METHODS
Taiwanese type 2 diabetes patients with inadequate control on insulin secretagogues and metformin, with no history of significant alcohol ingestion, with mildly elevated serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) and a diagnosis of fatty liver determined by ultrasonography were enrolled. Patients were treated for 24 weeks with rosiglitazone, 4-8 mg daily. Primary endpoints were change in AST and ALT levels from baseline and reduction in A1C < 6.5%.
RESULTS
Out of a total of 68 patients, 60 (88.2%) completed the study treatment without serious adverse events. Treatment in two (2.9%) patients was discontinued due to elevated AST or ALT levels to more than three times the upper limit of normal, and noncompliance or loss of follow-up in six (8.8%) patients. Of the 60 patients who completed the study treatment, mean fasting plasma glucose, A1C, fasting plasma insulin, mean ALT and homeostasis model assessment for insulin resistance were all significantly reduced. Normal AST and ALT levels were achieved and maintained for at least three consecutive measurements and through to the end of the study period in 20 (33.3%) patients. Weight increased by a mean of 2.6 +/- 2.4 kg (p < 0.001).
CONCLUSION
Rosiglitazone was reasonably well tolerated in patients with inadequately controlled type 2 diabetes and NAFLD. One-third of patients showed improved liver function after treatment.
背景/目的：非酒精性脂肪性肝病（NAFLD）是一种常见的慢性肝病，严重程度从脂肪变性到肝硬化不等。2型糖尿病是原发性NAFLD的一个病因。噻唑烷二酮类药物已被证明可增强胰岛素敏感性，改善2型糖尿病患者的血糖控制，并改善非酒精性脂肪性肝炎的组织学指标。本研究旨在确定罗格列酮在控制不佳的2型糖尿病合并NAFLD患者中的安全性和有效性。
方法
纳入台湾地区2型糖尿病患者，这些患者对胰岛素促分泌剂和二甲双胍控制不佳，无大量饮酒史，血清天冬氨酸氨基转移酶（AST）和/或丙氨酸氨基转移酶（ALT）轻度升高，且经超声检查确诊为脂肪肝。患者接受罗格列酮治疗24周，每日4 - 8毫克。主要终点为AST和ALT水平相对于基线的变化以及糖化血红蛋白（A1C）降低至<6.5%。
结果
总共68例患者中，60例（88.2%）完成了研究治疗，无严重不良事件。2例（2.9%）患者因AST或ALT水平升高至正常上限的三倍以上而停药，6例（8.8%）患者因不依从或失访而停药。在完成研究治疗的60例患者中，平均空腹血糖、A1C、空腹血浆胰岛素、平均ALT以及胰岛素抵抗的稳态模型评估均显著降低。20例（33.3%）患者连续至少三次测量且直至研究期末AST和ALT水平均达到并维持正常。体重平均增加2.6±2.4千克（p<0.001）。
结论
罗格列酮在控制不佳的2型糖尿病合并NAFLD患者中耐受性较好。三分之一的患者治疗后肝功能得到改善。
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