摘要
目的:系统评价水飞蓟宾胶囊治疗脂肪性肝病(FLD)的有效性和安全性。方法:计算机检索PubMed、the Cochrane Library、Embase、中国知网、中国生物医学文献数据库和万方数据库,纳入水飞蓟宾胶囊治疗FLD的随机对照试验(RCT),研究组患者单独使用水飞蓟宾胶囊,对照组不限,检索时间为建库至2022年6月。选取文献、提取资料并评价文献的偏倚风险后,通过RevMan 5.4软件进行Meta分析。结果:共纳入24项RCT研究,包括2356例患者(研究组1193例,对照组1163例)。有效性的Meta分析结果显示,研究组患者的总有效率(OR=5.24,95%CI=3.98~6.90,P<0.00001)、显效率(OR=2.27,95%CI=1.83~2.83,P<0.00001)、B超分级(OR=2.36,95%CI=1.03~5.38,P=0.04)、丙氨酸转氨酶(MD=-14.81,95%CI=-20.65~-8.97,P<0.00001)、天冬氨酸转氨酶(MD=-13.60,95%CI=-18.52~-8.67,P<0.00001)、γ-谷氨酰转肽酶(MD=-22.16,95%CI=-32.56~-11.76,P<0.0001)、三酰甘油(MD=-0.40,95%CI=-0.76~-0.05,P=0.03)、总胆固醇(MD=-0.77,95%CI=-1.20~-0.34,P=0.0004)和总胆红素(MD=-4.33,95%CI=-5.24~-3.41,P<0.00001)等指标水平均显著优于对照组,差异均有统计学意义;安全性的Meta分析结果显示,研究组患者的不良反应发生率略低于对照组,但差异不具有统计学意义(OR=0.93,95%CI=0.50~1.73,P=0.82>0.05)。结论:现有证据表明,水飞蓟宾胶囊治疗FLD安全、有效。因选取的RCT数量和质量限制,上述结论有待今后更多的高质量RCT予以验证。
OBJECTIVE:To systematically evaluate the efficacy of Silybin capsules in the treatment of fatty liver disease(FLD).METHODS:PubMed,the Cochrane Library,Embase,CNKI,CBM and Wanfang Data were retrieved to collect the randomized controlled trial(RCT)of Silybin capsules in the treatment of FLD(the study group was given Silybin capsules alone,while the control group was not limited).The retrieval time was from the establishment of the database to Jun.2022.After literature selection,data extraction and literature bias risk evaluation,Meta-analysis was performed by RevMan 5.4 software.RESULTS:A total of 24 RCTs were extracted,including 2356 patients(1193 cases in the study group and 1163 cases in the control group).The total effective rate(OR=5.24,95%CI=3.98-6.90,P<0.00001),significant effective rate(OR=2.27,95%CI=1.83-2.83,P<0.00001),B-ultrasound classification(OR=2.36,95%CI=1.03-5.38,P=0.04),alanine aminotransferase(MD=-14.81,95%CI=-20.65--8.97,P<0.00001),aspartate aminotransferase(MD=-13.60,95%CI=-18.52--8.67,P<0.00001),γ-glutamyl transpeptidase(MD=-22.16,95%CI=-32.56--11.76,P<0.0001),triacylglycerol(MD=-0.40,95%CI=-0.76--0.05,P=0.03),total cholesterol(MD=-0.77,95%CI=-1.20--0.34,P=0.0004)and total bilirubin(MD=-4.33,95%CI=-5.24--3.41,P<0.00001)in the study group were significantly better than those in the control group,with statistically significant differences.The incidence of adverse drug reactions in the study group was slightly lower than that in the control group,the difference was not statistically significant(OR=0.93,95%CI=0.50-1.73,P=0.82>0.05).CONCLUSIONS:The available evidence suggests that Silybin capsules are safe and effective in the treatment of FLD.Due to the limitations of the number and quality of RCT selected,the above conclusions need to be validated by more high quality RCT in the future.
作者
郑子恢
高峰
赵紫楠
潘慧杰
郭思瑞
张亚同
金鹏飞
ZHENG Zihui;GAO Feng;ZHAO Zinan;PAN Huijie;GUO Sirui;ZHANG Yatong;JIN Pengfei(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;Dept.of Health Service,the Guard Bureau of the Joint Staff Department,Central Military Commission,People’s Republic of China,Beijing 100017,China;Dept.of Clinical Laboratory,Beijing Hospital,National Center of Gerontology,Institute of Geriatric Medicine,Chinese Academy of Medical Sciences,Beijing 100730,China)
出处
《中国医院用药评价与分析》
2022年第6期726-734,共9页
Evaluation and Analysis of Drug-use in Hospitals of China
基金
国家重点研发计划项目(No.2020YFC2009001)
国家卫健委药政司委托课题(No.NHC-YZS-202103)。
作者简介
郑子恢,主管药师。研究方向:医院药学、循证药学。E-mail:12686@qq.com;通信作者:金鹏飞,主任药师。研究方向:医院药学、药物分析。E-mail:j790101@163.com。
