水飞蓟宾胶囊对比护肝片改善脂肪肝相关生化指标有效性和安全性的系统评价  

Systematic Review of Efficacy and Safety of Silibinin Capsules and Hugan Tablets in Improving Fatty Liver-Related Biochemical Indicators

作　　者：潘慧杰[1] 张碧华[2] 王洋[2] 李琼[2] 郑宇静[2] 郑子恢[2] 张亚同[2] PAN Huijie;ZHANG Bihua;WANG Yang;LI Qiong;ZHENG Yujing;ZHENG Zihui;ZHANG Yatong(Dept.of Laboratory,Beijing Hospital,National Center of Gerontology,Institute of Geriatric Medicine,Chinese Academy of Medical Sciences,Beijing 100730,China;Dept.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 Hospital),Beijing 100730,China)

机构地区：[1]北京医院检验科,国家老年医学中心,中国医学科学院老年医学研究院,北京100730 [2]北京医院药学部,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),北京100730

出　　处：《中国医院用药评价与分析》2022年第1期64-69,共6页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：国家重点研发计划(No.2020YFC2009001)。

摘　　要：目的:基于系统评价,比较水飞蓟宾胶囊与护肝片在改善脂肪肝相关生化指标方面的有效性和安全性。方法:计算机检索万方数据库、中国生物医学文献数据库、中国知网、the Cochrane Library、Embase和PubMed等数据库,纳入水飞蓟宾胶囊与护肝片治疗脂肪肝的随机对照试验(研究组的治疗方案为水飞蓟宾胶囊,对照组为护肝片),检索时间为建库至2021年10月。提取资料、选取文献并评价纳入文献的偏倚风险后,采用RevMan 5.4软件进行Meta分析。结果:共纳入9篇文献,包括700例患者(研究组患者384例,对照组患者316例)。Meta分析结果显示,研究组患者的总有效率(OR=4.39,95%CI=2.95~6.55,P<0.00001)、显效率(OR=2.27,95%CI=1.56~3.32,P<0.0001)、治愈率(OR=2.67,95%CI=1.67~4.28,P<0.0001)、丙氨酸转氨酶水平(MD=-12.16,95%CI=-15.06~-9.26,P<0.00001)、天冬氨酸转氨酶水平(MD=-12.32,95%CI=-15.26~-9.39,P<0.00001)、三酰甘油水平(MD=-0.46,95%CI=-0.69~-0.22,P<0.0001)和总胆固醇水平(MD=-1.27,95%CI=-2.17~-0.37,P=0.006)均显著优于对照组,差异均有统计学意义;研究组患者的不良反应发生率较对照组显著降低,差异有统计学意义(OR=0.26,95%CI=0.09~0.78,P=0.02)。结论:现有证据表明,相比于护肝片,水飞蓟宾胶囊在改善脂肪肝相关生化指标方面更有效,安全性更高。因选取的文献数量和文献质量的限制,上述结论有待今后更多高质量的随机对照试验予以验证。OBJECTIVE:To systematically evaluate the efficacy and safety of Silibinin capsules and Hugan tablets in improving fatty liver-related biochemical indicators.METHODS:Wanfang Data,CBM,CNKI,the Cochrane Library,Embase and PubMed database were retrieved to collect the randomized controlled trials of Silybin capsule and Hugan tablets in the treatment of fatty liver(the study group was treated with Silibinin capsules and the control group received Hugan tablets).The retrieval time was from the establishment of the database to Oct.2021.After extracting data,selecting literature and evaluating the risk of bias for the included literature,RevMan 5.4 software was used for Meta analysis.METHODS:Totally 9 literature were enrolled,including 700 patients(384 patients in the study group and 316 patients in the control group).Meta-analysis results showed that the total effective rate(OR=4.39,95%CI=2.95-6.55,P<0.00001),significant effective rate(OR=2.27,95%CI=1.56-3.32,P<0.0001),recovery rate(OR=2.67,95%CI=1.67-4.28,P<0.0001),alanine aminotransferase(MD=-12.16,95%CI=-15.06--9.26,P<0.00001),aspartate aminotransferase(MD=-12.32,95%CI=-15.26--9.39,P<0.00001),triglyceride level(MD=-0.46,95%CI=-0.69--0.22,P<0.0001)and total cholesterol level(MD=-1.27,95%CI=-2.17--0.37,P=0.006)in the study group were significantly better than those in the control group,with statistically significant difference.The incidence of adverse drug reactions in the study group was significantly lower than that in the control group,the difference was statistically significant(OR=0.26,95%CI=0.09-0.78,P=0.02).CONCLUSIONS:Available evidence suggests that Silymarin capsules are more effective and safer than Hugan tablets in improving fatty liver-related biochemical indicators.Due to the limitations of quantity and quality of the included literature,the above findings need to be validated by more high-quality randomized controlled trials in the future.

关 键 词：水飞蓟宾胶囊 护肝片 脂肪肝 META分析 随机对照试验 

分 类 号：R975[医药卫生—药品]