Dajani Asad Izziddin, Popovic Branko
ADSC, Medcare Hospital and Saudi German Hospital, Sharjah, Al Khan, PO Box 6328, United Arab Emirates.
Sanofi-Aventis Deutschland GmbH, CHC Global Medical Affairs, Frankfurt am Main 65926, Germany.
World J Clin Cases. 2020 Nov 6;8(21):5235-5249. doi: 10.12998/wjcc.v8.i21.5235.
Essential phospholipids (EPL) are used for the supportive treatment of non-alcoholic fatty liver disease (NAFLD), but data are mostly from small-scale studies.
To evaluate the efficacy of EPL treatment in adult patients with NAFLD and type 2 diabetes and/or obesity.
The MEDLINE, PubMed, Embase, and Cochrane databases were searched up to March 2019 for clinical trials and comparative observational studies. Eligible studies were those published in English or Chinese that enrolled adult patients (≥ 18 years) with NAFLD and type 2 diabetes mellitus and/or obesity receiving EPL as monotherapy or as add-on therapy to existing therapy, and that included at least one of the efficacy outcomes of interest. A variety of studies were identified; thus, direct, indirect and cohort meta-analyses were performed. Mean difference (MD) and 95% confidence interval (CI) were calculated for continuous variables, and relative risk with 95%CI for disease response and recovery. A random-effects model was used to address between-study heterogeneity.
Ten studies met the inclusion criteria ( = 22-324). EPL treatment duration ranged from 4 to 72 wk. In the direct meta-analysis (four randomized controlled trials), compared with antidiabetic therapy alone, EPL plus antidiabetic therapy was associated with a significantly greater reduction in [alanine aminotransferase (ALT); MD: 11.28 U/L (95%CI: -17.33, -5.23), = 0.0003], triglyceride [MD: -49.33 mg/dL (95%CI: -66.43, -32.23), < 0.0001] and total cholesterol levels [MD: -29.74 mg/dL (95%CI: -38.02, -21.45), < 0.0001]. There was also a significant increase in the rate of overall improvement [relative risk 1.50 (95%CI: 1.26-1.79), < 0.0001], and risk of no disease ( = 0.0091), and a reduction in moderate disease ( = 0.0187); there were no significant differences in severe disease, mild disease, or significant improvement. In the cohort meta-analysis of three non-randomized clinical trials, the MD in ALT levels was -16.71 U/L (95%CI: -24.94, -8.49) and 23% of patients had improved disease. In the cohort meta-analysis of five randomized trials, MD in ALT levels was -28.53 U/L (95%CI: -35.42, -21.65), and 87% (95%CI: 81%, 93%) and 58% (95%CI: 46%, 70%) of patients showed clinical improvement and significant clinical improvement.
This analysis provides evidence for a benefit of EPL in patients with NAFLD and diabetes and/or obesity. Further large-scale trials are warranted.
必需磷脂(EPL)用于非酒精性脂肪性肝病(NAFLD)的支持性治疗,但数据大多来自小规模研究。
评估EPL治疗成年NAFLD合并2型糖尿病和/或肥胖患者的疗效。
检索MEDLINE、PubMed、Embase和Cochrane数据库至2019年3月的临床试验和比较观察性研究。符合条件的研究为以英文或中文发表的,纳入成年(≥18岁)NAFLD合并2型糖尿病和/或肥胖患者,接受EPL作为单一疗法或作为现有疗法的附加疗法,且包括至少一项感兴趣的疗效指标的研究。识别出了多种研究;因此,进行了直接、间接和队列荟萃分析。计算连续变量的平均差(MD)和95%置信区间(CI),以及疾病反应和恢复的95%CI相对风险。采用随机效应模型处理研究间的异质性。
10项研究符合纳入标准(n = 22 - 324)。EPL治疗持续时间为4至72周。在直接荟萃分析(4项随机对照试验)中,与单独抗糖尿病治疗相比,EPL联合抗糖尿病治疗与[丙氨酸氨基转移酶(ALT)]显著更大幅度降低相关[MD:11.28 U/L(95%CI:-17.33,-5.23),P = 0.0003],甘油三酯[MD:-49.33 mg/dL(95%CI:-66.43,-32.23),P < 0.0001]和总胆固醇水平[MD:-29.74 mg/dL(95%CI:-38.02,-21.45),P < 0.0001]。总体改善率也显著增加[相对风险1.50(95%CI:1.26 - 1.79),P < 0.0001],无疾病风险(P = 0.0091),中度疾病减少(P = 0.0187);在重度疾病、轻度疾病或显著改善方面无显著差异。在3项非随机临床试验的队列荟萃分析中,ALT水平的MD为-16.71 U/L(95%CI:-24.9 ,