恩替卡韦联合复方鳖甲软肝片治疗慢性乙型肝炎肝纤维化的Meta分析  

Meta-analysis of entecavir combined with compound Biejia Ruangan tablet in the treatment of chronic hepatitis B liver fibrosis

作　　者：景文娟 杨勇 陈良[2] 辛文秀 JING Wen-juan;YANG Yong;CHEN Liang(Department of Pharmacy,People's Hospital of Sha-ya County,Aksu 842200,China)

机构地区：[1]新疆维吾尔自治区阿克苏地区沙雅县人民医院药剂科,842200 [2]新疆医科大学附属中医医院药学部,新疆维吾尔自治区乌鲁木齐市830000 [3]浙江省肿瘤医院药学部,浙江省杭州市310022

出　　处：《临床合理用药杂志》2020年第18期1-7,10,共8页Chinese Journal of Clinical Rational Drug Use

摘　　要：目的评价恩替卡韦(ETV)联合复方鳖甲软肝片(FFBJRGP)治疗慢性乙型肝炎(CHB)肝纤维化(HF)的临床疗效。方法计算机检索中国知网(CNKI)、维普网(VIP)、万方数据知识服务平台(WANGFANG DATA)、The Cochrane Library、PubMed、EMBASE,筛选已发表的ETV联合FFBJRGP与单用ETV治疗CHB HF的临床随机对照试验(RCT),检索时间为建库至2018年10月。对照组给予ETV治疗,干预组给予ETV联合FFBJRGP治疗;采用Rev-Man 5.3软件进行Mate分析。结果最终纳入31篇文献,包括3437例CHB HF患者,其中干预组1734例,对照组1703例。Meta分析结果显示,干预组血清透明质酸(HA)水平低于对照组〔SMD=-1.18,95%CI(-1.92,-1.01),P<0.00001〕。干预组血清层粘连蛋白(LN)水平低于对照组〔SMD=-0.88,95%CI(-1.14,-0.62),P<0.00001〕。干预组血清Ⅲ型前胶原(PC-Ⅲ)水平低于与对照组〔SMD=-1.14,95%CI(-1.9740,-0.88),P<0.00001〕。干预组血清Ⅳ型胶原(Ⅳ-C)水平低于对照组〔SMD=-1.19,95%CI(-1.44,-0.93),P<0.00001〕。干预组肝硬度测定值(LSM)低于对照组〔SMD=-0.79,95%CI(-1.29,-0.28),P=0.002〕。干预组血清丙氨酸氨基转移酶(ALT)水平低于对照组〔SMD=-0.68,95%CI(-1.05,-0.31),P=0.0003〕。干预组血清天冬氨酸氨基转移酶(AST)水平低于对照组〔SMD=-0.84,95%CI(-1.25,-0.43),P<0.0001〕。干预组血清总胆红素(TBiL)水平低于对照组〔SMD=-0.70,95%CI(-1.11,-0.30),P=0.0007〕。两组乙型肝炎病毒(HBV)DNA转阴率比较,差异无统计学意义〔RR=1.06,95%CI(0.99,1.13),P=0.10〕。干预组临床总有效率高于对照组〔RR=1.23,95%CI(1.14,1.32),P<0.00001〕。两组不良反应发生率比较,差异无统计学意义〔RR=0.91,95%CI(0.49,1.70),P=0.76〕。结论现有证据表明,ETV联合FFBJRGP治疗CHB HF临床疗效较好,可以抑制HF,明显改善患者肝功能,且安全性较高。Objective To evaluate the clinical effect of ETV combined with FFBJRGP in the treatment of chronic hepatitis B(CHB)with liver fibrosis(HF).Methods Computer retrieval of CNKI,VIP,WANGFANG DATA,the Cochrane Library,PubMed,EMBASE,screening the published clinical randomized controlled trial(RCT)of ETV combined with FFBJRGP and ETV alone in the treatment of CHB HF.The retrieval time is from the establishment of the database to October 2018.The control group was treated with ETV,the intervention group was treated with ETV and FFBJRGP,and the software Rev-Man 5.3 was used for mate analysis.Results 3437 patients with CHB HF were included in 31 articles,including 1734 in the intervention group and 1703 in the control group.The results of Meta analysis showed that the serum HA level in the intervention group was lower than the control group〔SMD=-1.18,95%CI(-1.92,-1.01),P<0.00001〕.The level of LN in the intervention group was lower than the control group〔SMD=-0.88,95%CI(-1.14,-0.62),P<0.00001〕.The level of serum PC-Ⅲin the intervention group was lower than the control group〔SMD=-1.14,95%CI(-1.9740,-0.88),P<0.00001〕.The level of serum IV-C in the intervention group was lower than the control group〔SMD=-1.19,95%CI(-1.44,-0.93),P<0.00001〕.LSM in the intervention group was lower than the control group〔SMD=-0.79,95%CI(-1.29,-0.28),P=0.002〕.The serum ALT level in the intervention group was significantly lower than the control group〔SMD=-0.68,95%CI(-1.05,-0.31),P=0.0003〕.The serum ast level of the intervention group was lower than that of the control group〔SMD=-0.84,95%CI(-1.25,-0.43),P<0.0001〕.The level of TBiL in the intervention group was lower than the control group〔SMD=-0.70,95%CI(-1.11,-0.30),P=0.0007〕.There was no significant difference in the negative rate of HBV DNA between the two groups〔RR=1.06,95%CI(0.99,1.13),P=0.10〕.The total clinical effective rate of the intervention group was higher than the control group〔RR=1.23,95%CI(1.14,1.32),P<0.00001〕.There was no significant differe

关 键 词：乙型肝炎 慢性 肝硬化 恩替卡韦 复方鳖甲软肝片 META分析 

分 类 号：R512.62[医药卫生—内科学] R575.2[医药卫生—临床医学]