双环醇对非酒精性脂肪性肝病血液生物标志物的影响：系统评价和荟萃分析。
Effect of bicyclol on blood biomarkers of NAFLD: a systematic review and meta-analysis.
机构信息
CAMS Key Laboratory of Antiviral Drug Research, Institute of Medicinal Biotechnology, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Key Laboratory of Biotechnology of Antibiotics, The National Health and Family Planning Commission (NHFPC), Institute of Medicinal Biotechnology, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
出版信息
BMJ Open. 2020 Dec 4;10(12):e039700. doi: 10.1136/bmjopen-2020-039700.
OBJECTIVE
Non-alcoholic fatty liver disease (NAFLD) is a global epidemic without effective therapeutic agents in the clinic. This meta-analysis aimed to assess the efficacy of the marketed hepatoprotectant bicyclol at improving blood biomarkers in patients with NAFLD.
DESIGN
Electronic databases were searched for randomised controlled trials (RCTs) published up to August 2020 using bicyclol to treat NAFLD. The risk of bias, quality of evidence and publication bias were evaluated. Blood biomarkers, including alanine transaminase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), triglyceride (TG) and total cholesterol (TC), were analysed using Review Manager V.5.3 software. Outcomes with significant heterogeneity (I ≥75%) were divided into the bicyclol monotherapy subgroup and combination treatment subgroup.
RESULTS
Twelve RCTs involving 1008 patients were finally included. No serious adverse events were reported in the bicyclol-treated groups. The total effective rate of bicyclol intervention for NAFLD was significantly higher than that of the control group. The decreases in the levels of AST (mean difference (MD) = -15.20; 95% CI -20.51 to -9.90; I=74%), TBIL (MD = -1.72; 95% CI -2.72 to -0.72; I=0%) and TC (MD = -0.52; 95% CI -0.70 to -0.34; I=67%) treated by bicyclol were significantly higher than those in the control group. When a high heterogeneity existed (I ≥75%), subgroup analyses were conducted and revealed significantly decreased ALT levels (MD = -34.07; 95% CI -36.70 to -31.43; I=0%) merely in the bicyclol monotherapy subgroup, while TG level (MD = -0.39; 95% CI -0.45 to -0.33; I=0%) was decreased in the bicyclol combination therapy subgroup.
CONCLUSIONS
The study presents the evidence of bicyclol monotherapy and/or combination therapy for improving liver function and blood lipid biomarkers in patients with NAFLD. This preliminary study predicts that bicyclol might be an alternative drug for NAFLD therapy in the future.
目的
非酒精性脂肪性肝病（NAFLD）是一种全球性疾病，但目前临床上尚无有效的治疗药物。本荟萃分析旨在评估市售保肝药双环醇改善 NAFLD 患者血液生物标志物的疗效。
设计
检索截至 2020 年 8 月发表的使用双环醇治疗 NAFLD 的随机对照试验（RCT）的电子数据库。评估了偏倚风险、证据质量和发表偏倚。使用 Review Manager V.5.3 软件分析包括丙氨酸转氨酶（ALT）、天冬氨酸转氨酶（AST）、总胆红素（TBIL）、甘油三酯（TG）和总胆固醇（TC）在内的血液生物标志物。对具有显著异质性（I≥75%）的结果进行了双环醇单药治疗亚组和联合治疗亚组的划分。
结果
最终纳入了 12 项 RCT，共 1008 例患者。双环醇治疗组均未报告严重不良事件。双环醇干预治疗 NAFLD 的总有效率明显高于对照组。AST（平均差（MD）=-15.20；95%CI-20.51 至-9.90；I=74%）、TBIL（MD=-1.72；95%CI-2.72 至-0.72；I=0%）和 TC（MD=-0.52；95%CI-0.70 至-0.34；I=67%）水平的降低，双环醇治疗组明显高于对照组。当存在高度异质性（I≥75%）时，进行了亚组分析，结果仅显示双环醇单药治疗亚组的 ALT 水平显著降低（MD=-34.07；95%CI-36.70 至-31.43；I=0%），而双环醇联合治疗亚组的 TG 水平（MD=-0.39；95%CI-0.45 至-0.33；I=0%）降低。
结论
本研究提供了双环醇单药和/或联合治疗改善 NAFLD 患者肝功能和血液脂质生物标志物的证据。初步研究预测，双环醇可能成为未来 NAFLD 治疗的替代药物。
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