Endoscopy Center, Department of Gastroenterology, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai, China.
Department of Gastroenterology, Xingtai People's Hospital, Xingtai, China.
Front Endocrinol (Lausanne). 2023 Mar 29;14:1111430. doi: 10.3389/fendo.2023.1111430. eCollection 2023.
Pioglitazone is considered a potential therapy for non-alcoholic fatty liver disease (NAFLD). However, different effects of pioglitazone on NAFLD have been demonstrated in diabetic and non-diabetic patients. Herein, a meta-analysis of randomized, placebo-controlled trials was carried out to indirectly compare pioglitazone in NAFLD patients with . without type 2 diabetes.
Randomized controlled trials (RCTs) of pioglitazone . placebo involving NAFLD patients with or without type 2 diabetes/prediabetes collected from databases were enrolled into this analysis. Methodological quality was employed to evaluate the domains recommended by the Cochrane Collaboration. The analysis covered the changes in histology (fibrosis, hepatocellular ballooning, inflammation, steatosis), liver enzymes, blood lipids, fasting blood glucose (FBS), homeostasis model assessment-IR (HOMA-IR), weight and body mass index (BMI) before and after treatment, and adverse events.
The review covered seven articles, with 614 patients in total, of which three were non-diabetic RCTs. No difference was found in patients with . without type 2 diabetes in histology, liver enzymes, blood lipids, HOMA-IR, weight, BMI, and FBS. Moreover, no significant difference was revealed in adverse effects between NAFLD patients with diabetes and without DM, except the incidence of edema that was found to be higher in the pioglitazone group than in the placebo group in NAFLD patients with diabetes.
Pioglitazone could exert a certain effect on alleviating NAFLD, which was consistent between non-diabetic NAFLD patients and diabetic NAFLD patients in improving histopathology, liver enzymes, and HOMA-IR and reducing blood lipids. Furthermore, there were no adverse effects, except the incidence of edema which is higher in the pioglitazone group in NAFLD patients with diabetes. However, large sample sizes and well-designed RCTs are required to further confirm these conclusions.
吡格列酮被认为是治疗非酒精性脂肪性肝病（NAFLD）的一种潜在疗法。然而，吡格列酮在糖尿病和非糖尿病患者中的疗效不同。本研究对糖尿病和非糖尿病 NAFLD 患者进行了间接比较，采用了一项随机、安慰剂对照试验的荟萃分析。
我们纳入了数据库中涉及有或无 2 型糖尿病/糖尿病前期的 NAFLD 患者的吡格列酮与安慰剂的随机对照试验（RCT）。采用 Cochrane 协作组推荐的领域评价方法学质量。分析涵盖了治疗前后组织学（纤维化、肝细胞气球样变、炎症、脂肪变性）、肝酶、血脂、空腹血糖（FBS）、稳态模型评估胰岛素抵抗（HOMA-IR）、体重和体重指数（BMI）以及不良事件的变化。
综述共纳入了 7 篇文章，共 614 例患者，其中 3 项为非糖尿病 RCT。糖尿病和非糖尿病患者在组织学、肝酶、血脂、HOMA-IR、体重、BMI 和 FBS 方面均无差异。此外，糖尿病和非糖尿病 NAFLD 患者之间不良事件的发生率也无显著差异，除了糖尿病 NAFLD 患者中吡格列酮组的水肿发生率高于安慰剂组。
吡格列酮可缓解非酒精性脂肪性肝病，对改善组织病理学、肝酶和 HOMA-IR、降低血脂方面，非糖尿病性 NAFLD 患者与糖尿病性 NAFLD 患者效果一致。此外，除了糖尿病性 NAFLD 患者中吡格列酮组的水肿发生率较高外，无其他不良事件。但需要更大样本量和精心设计的 RCT 来进一步证实这些结论。
