METHODS: A literature search in PubMed, Science Direct and Cochrane Central Register of Controlled Trials was conducted for randomised clinical trials of tofogliflozin by applying predetermined inclusion and exclusion criteria.
RESULTS: A total number of four randomised clinical trials, including 226 subjects, were included in the review. There was a significant decrease in aspartate aminotransferase (AST) and alanine transaminase (ALT) levels in the tofogliflozin group as compared to the control or active comparator groups. Additionally, gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP) and magnetic resonance imaging proton density fat fraction (MRI-PDFF) levels were also significantly decreased in the tofogliflozin group. However, no significant difference was observed in levels of adiponectin.
CONCLUSIONS: Overall, an improvement in levels of hepatic parameters was observed in T2DM patients with concurrent liver disorders. However, a large number of clinical trials are needed to prove the efficacy of tofogliflozin on hepatic outcomes in patients with T2DM.
方法:在PubMed,通过应用预定的纳入和排除标准,对托福列净的随机临床试验进行了ScienceDirect和Cochrane中央对照试验注册。
结果:总共四项随机临床试验,包括226个科目,包括在审查中。与对照组或活性比较组相比,tofogliflozin组的天冬氨酸转氨酶(AST)和丙氨酸转氨酶(ALT)水平显着降低。此外,γ-谷氨酰转移酶(GGT),托福列净组的碱性磷酸酶(ALP)和磁共振成像质子密度脂肪分数(MRI-PDFF)水平也显著降低.然而,脂联素水平无显著差异。
结论:总体而言,在合并肝脏疾病的T2DM患者中观察到肝脏参数水平改善.然而,需要大量临床试验来证明托福列净对T2DM患者肝脏结局的疗效.