水飞蓟宾联合多烯磷脂酰胆碱治疗脂肪肝有效性及安全性系统评价  

Efficacy and Safety of Silybin Combined with Polyene Phosphatidylcholine in the Treatment of Fatty Liver:A Systematic Review

作　　者：郑子恢[1] 潘慧杰[2] 何颖 张亚同[1] 张碧华[1] 李琼[1] 胡欣[1] 金鹏飞[1] ZHENG Zihui;PAN Huijie;HE Ying;ZHANG Yatong;ZHANG Bihua;LI Qiong;HU Xin;JIN Pengfei(Department of Pharmacy,Beijing Hospital·National Center of Gerontology·Institute of Geriatric Medicine,Chinese Academy of Medical Sciences·Beijing Key Laboratory of Assessment of Clinical Drugs Risk and Individual Application,Beijing,China 100730;Department of Clinical Laboratory,Beijing Hospital·National Center of Gerontology·Institute of Geriatric Medicine,Chinese Academy of Medical Sciences·Beijing Key Laboratory of Assessment of Clinical Drugs Risk and Individual Application,Beijing,China 100730;Department of Traditional Chinese Medicine,Beijing Hospital·National Center of Gerontology·Institute of Geriatric Medicine,Chinese Academy of Medical Sciences·Beijing Key Laboratory of Assessment of Clinical Drugs Risk and Individual Application,Beijing,China 100730)

机构地区：[1]北京医院·国家老年医学中心·中国医学科学院老年医学研究院·北京市药物临床风险与个体化应用评价重点实验室<北京医院>药学部,北京100730 [2]北京医院·国家老年医学中心·中国医学科学院老年医学研究院·北京市药物临床风险与个体化应用评价重点实验室<北京医院>检验科,北京100730 [3]北京医院·国家老年医学中心·中国医学科学院老年医学研究院·北京市药物临床风险与个体化应用评价重点实验室<北京医院>中医科,北京100730

出　　处：《中国药业》2023年第2期109-116,共8页China Pharmaceuticals

基　　金：国家重点研发计划[2020YFC2009001];国家卫健委药政司委托课题[NHC-YZS-202103]。

摘　　要：目的系统评价水飞蓟宾胶囊联合多烯磷脂酰胆碱胶囊相较单用多烯磷脂酰胆碱胶囊治疗酒精性及非酒精性脂肪性肝病的有效性及安全性。方法计算机检索PubMed、中国知网(CNKI)、万方数据库(WangFang)、中国生物医学文献数据库、The Cochrane Library、Embase数据库,纳入两药联用治疗脂肪肝的随机对照试验(RCT),检索时限为各数据库自建库起至2022年12月。由2名研究人员选取文献、提取资料,评价文献质量,采用Revman 5.4软件进行荟萃分析及系统评价。结果共纳入11项RCT,其中8项未明确随机分组方法,10项未标明是否采用分配隐藏及是否双盲;涉及1043例患者,研究组(水飞蓟宾胶囊联合多烯磷脂酰胆碱胶囊)520例,对照组(单用多烯磷脂酰胆碱胶囊)523例。Meta分析结果,治疗效果,研究组总有效率[OR=4.47,95%CI(2.84,7.03),P<0.01]、显效率[OR=1.93,95%CI(1.37,2.73),P<0.01]及丙氨酸氨基转移酶[ALT,MD=-15.77,95%CI(-21.52,-10.03),P<0.01]、天门冬氨酸氨基转移酶[AST,MD=-14.40,95%CI(-18.34,-10.47),P<0.01]、γ-谷氨酰转移酶[GGT,MD=-12.68,95%CI(-16.80,-8.56),P<0.01]、甘油三酯[TG,MD=-0.55,95%CI(-0.60,-0.51),P<0.01]、总胆固醇[TC,MD=-1.01,95%CI(-1.19,-0.84),P<0.01]、低密度脂蛋白胆固醇[LDL-C,MD=-0.82,95%CI(-1.18,-0.46),P<0.01]和高密度脂蛋白胆固醇[HDL-C,MD=0.08,95 CI(-0.19,0.36),P<0.01]改善幅度均明显优于对照组,且联合治疗分别在降低脂肪性肝病患者的ALT,AST,GGT,TC,LDL-C,以及改善非酒精性脂肪性肝病患者的HDL-C水平方面可能更具优势。研究组与对照组不良反应发生率相当[OR=0.71,95%CI(0.14,3.68),P=0.68>0.05]。结论水飞蓟宾胶囊联合多烯磷脂酰胆碱胶囊治疗酒精性及非酒精性脂肪性肝病的效果明显优于单用多烯磷脂酰胆碱胶囊。但因选取研究的质量和数量限制,上述结论有待日后更多高质量RCT予以验证。Objective To systematically evaluate the efficacy and safety of Silybin Capsules combined with Polyene Phosphatidylcholine Capsules in the treatment of alcoholic and non-alcoholic fatty liver disease compared with those of Polyene Phosphatidylcholine Capsules alone.Methods The randomized controlled trials(RCTs)of the combination of two drugs in the treatment of fatty liver in the PubMed,CNKI,WangFang,China Biology Medicine(CBM),The Cochrane Library and Embase databases from the inception of each database to December 2022 were searched and included.Two researchers selected literature,extracted data,evaluated the quality of literature,and conducted Meta-analysis and systematic evaluation by the Revman 5.4 software.Results Eleven RCTs were included,eight of which had unclear random grouping method,ten of which did not indicate whether to use allocation concealment or double blinding.A total of 1043 patients were involved,520 cases in the study group(Silybin Capsules combined with Polyene Phosphatidylcholine Capsules)and 523 cases in the control group(Polyene Phosphatidylcholine Capsules alone).Meta-analysis results showed that the total effective rate[OR=4.47,95%CI(2.84,7.03),P<0.01],significant effective rate[OR=1.93,95%CI(1.37,2.73),P<0.01],alanine aminotransferase[ALT,MD=-15.77,95%CI(-21.52,-10.03),P<0.01],aspartate aminotransferase[AST,MD=-14.40,95%CI(-18.34,-10.47),P<0.01],γ-glutamyl transferase[GGT,MD=-12.68,95%CI(-16.80,-8.56),P<0.01],triglycerides[TG,MD=-0.55,95%CI(-0.60,-0.51),P<0.01],total cholesterol[TC,MD=-1.01,95%CI(-1.19,-0.84),P<0.01],low-density lipoprotein cholesterol[LDL-C,MD=-0.82,95%CI(-1.18,-0.46),P<0.01]and high-density lipoprotein cholesterol[HDL-C,MD=0.08,95%CI(-0.19,0.36),P<0.01]in the study group were significantly better than those in the control group,and the combined treatment might have an advantage in reducing the levels of ALT,AST,GGT,TC,LDL-C in patients with fatty liver disease and patients with non-alcoholic fatty liver disease(NAFLD),while it might have an advantage in improving

关 键 词：脂肪性肝病 水飞蓟宾胶囊 多烯磷脂酰胆碱胶囊 随机对照试验 Meta分析 

分 类 号：R969.3[医药卫生—药理学]