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作 者:楼妍 袁军[1,2,3] 付彤飞 许继莹 LOU Yan;YUAN Jun;FU Tongfei;XU Jiying(Hubei University of Traditional Chinese Medicine,Wuhan 4300602,China;Department of Nephrology,Hubei Provincial Hospital of Traditional Chinese Medicine,Wuhan 430061,China;Hubei Institute of Nephropathy,Hubei Institute of Traditional Chinese Medicine,Wuhan 430060,China)
机构地区:[1]湖北中医药大学,湖北武汉430060 [2]湖北省中医院肾病科,湖北武汉430061 [3]湖北省中医药研究院肾病研究所,湖北武汉430060
出 处:《湖北民族大学学报(医学版)》2021年第4期21-27,共7页Journal of Hubei Minzu University(Medical Edition)
基 金:国家自然科学基金项目(82074364);湖北省自然科学基金(2019CFB619);湖北省卫生健康委科研项目(WJ2021M180)。
摘 要:目的系统分析安络化纤丸联用恩替卡韦(ETV)治疗慢性乙肝肝纤维化的疗效。方法检索中国知网(CNKI)、万方数据知识服务平台(WanFangData)、重庆维普全文数据库(VIP)、PubMed、Embase及The Cochrane Library等资料库从建库至2021年5月的所有文献,选用安络化纤丸联用ETV治疗慢性乙型肝炎肝纤维化的随机对照观察(RCT),涉及2名研究人员的文献数据提取和质量评估,应用RevMan 5.4版软件进行荟萃分析。结果最终纳入RCT 25篇,涉及2507例患者。其中观察组1277例,对照组1229例。Meta分析结果提示:安络化纤丸联用ETV在降低血清透明质酸(hyaluronicacid,HA)、层粘连蛋白(laminin,LN)、Ⅲ型前胶原(typeⅢprocollagentype,PC-Ⅲ)、Ⅳ型胶原(typeIVcollagen,Ⅳ-C)、天门冬氨酸氨基转移酶(aspartarteaminotransferase,AST)、丙氨酸氨基转移酶(alanineaminotransferase,ALT)、血清总胆红素(serumtotalbilirubin,TBIL)水平,提高乙肝病毒DNA(HBV-DNA)转阴率、乙肝病毒E抗原(HBeAg)转阴率方面上明显优于单用恩替卡韦。安全性分析结果提示观察组与对照组皆未出现明显严重不良反应,且两组的副作用发生率差异无统计学意义(P>0.05)。结论高疗效性和高安全性并存是安络化纤丸联用ETV治疗慢性乙型肝炎肝纤维化的独特之处;随着现代医学进步,尚需要更多严谨的大样本、高质量的双盲对照试验来充分评估其有效性。Objective To systematically analyze the effect of Anluo Huaxian pill combined with entecavir in the treatment of chronic hepatitis B liver fibrosis.Methods All the documents from the China National Knowledge Network(CNKI),WanFangData Knowledge Service Platform(WanFangData),Chongqing VIP Full-text Database(VIP),PubMed,Embase and The Cochrane Library from the establishment of the database to May 2021 were searched.Results 25 RCTs were included,involving 2507 patients.Among them,there were 1277 cases in the observation group and 1229 cases in the control group.Meta-analysis results suggested that the combination of Anluo Huaxian Pills and Entecavir can reduce serum hyaluronic acid(HA),laminin(LN),typeⅢprocollagen(PC-Ⅲ),typeⅣCollagen(type IV collagen,Ⅳ-C),aspartarte amino transferase(AST),alanine amino transferase(ALT),serum total bilirubin(serum total bilirubin,TBIL)level and increase the negative rate of hepatitis B virus DNA(HBV-DNA)and the negative rate of hepatitis B virus E antigen(HBeAg)were significantly better than entecavir alone.The safety analysis results indicated that there were no obvious serious adverse reactions in the observation group and the control group,and the difference in the incidence of side effects between the two groups was not statistically significant(P>0.05).Conclusion The coexistence of high therapeutic efficacy and high safety is the unique feature of Anluo Huaxian Pill combined with entecavir in the treatment of chronic hepatitis B liver fibrosis.With the progress of modern medicine,more rigorous large-sample,high-quality double-blind controlled trials were needed to fully evaluate its effectiveness.
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