安络化纤丸联合恩替卡韦治疗乙型肝炎肝硬化的系统评价

目的:系统评价安络化纤丸联合恩替卡韦改善乙型肝炎肝硬化患者肝纤维化及影像学指标的有效性及安全性。方法:检索中国知网、万方数据库、维普数据库、中国生物医学文献数据库、PubMed、Embase及the Cochrane Library,检索时间截至2021年11月6日,收集安络化纤丸联合恩替卡韦治疗乙型肝炎肝硬化的随机对照试验,采用Cochrane协作网的偏倚风险评估工具评价纳入研究的方法学质量,运用RevMan 5.3软件进行数据合并。结果:纳入26篇符合标准的文献,共2663例患者。Meta分析结果显示,安络化纤丸联合恩替卡韦治疗乙型肝炎肝硬化,在降低患者代偿期透明质酸(HA)水平(MD=-59.97,95%CI=-68.15~-51.79)、层粘连蛋白(LN)水平(MD=-62.20,95%CI=-78.15~-46.25)、Ⅳ型胶原蛋白(Ⅳ-C)水平(MD=-48.02,95%CI=-54.19~-41.85)以及失代偿期HA水平(MD=-145.04,95%CI=-154.92~-135.17)、LN水平(MD=-86.38,95%CI=-105.77~-66.98)、Ⅲ型前胶原水平(MD=-131.05,95%CI=-142.53~-119.56)、Ⅳ-C水平(MD=-108.22,95%CI=-122.49~-93.95),缩小门静脉内径(MD=-0.07,95%CI=-0.14~-0.01),缩小脾厚度(MD=-3.28,95%CI=-4.10~-2.46),提高门静脉内径改善率(RR=1.55,95%CI=1.37~1.75),提高脾静脉内径改善率(RR=1.77,95%CI=1.52~2.06)等方面均明显优于恩替卡韦单药治疗,差异均具有统计学意义(P<0.05)。结论:安络化纤丸联合恩替卡韦治疗乙型肝炎肝硬化,能更有效地降低患者肝纤维化水平,且能改善患者的门脉内径、脾厚度等影像学指标。但由于纳入研究质量低,样本量较少,上述结果仍需设计良好、大样本的随机对照试验进一步验证。

Systematic Review of Anluo Huaxian Pills Combined with Entecavir in the Treatment of Hepatitis B-related Liver Cirrhosis

OBJECTIVE: To systematically evaluate the efficacy and safety of Anluo Huaxian pills combined with entecavir in improving liver fibrosis and imaging indicators in patients with hepatitis B-related liver cirrhosis.METHODS: CNKI,Wanfang Data,VIP,CBM,PubMed,Embase and the Cochrane Library were retrieved to collect the randomized controlled trial of Anluo Huaxian pills combined with entecavir in the treatment of hepatitis B-related liver cirrhosis. The retrieval time was from the establishment of the database to Nov. 6 th,2021. The methodological quality of the included literature was evaluated by using the Cochrane bias risk assessment tool,and data were analyzed by using RevMan 5. 3 software. RESULTS: Totally 26 literature were enrolled,including 2 663 patients. Meta-analysis results showed that Anluo Huaxian pills combined with entecavir in the treatment of hepatitis B-related liver cirrhosis can reduce the hyaluronic acid( HA) level during decorpesated period( MD =-59. 97,95% CI =-68. 15--51. 79),laminin( LN) level( MD =-62. 20,95%CI =-78. 15--46. 25),type Ⅳ collagen( Ⅳ-C) level( MD =-48. 02,95% CI =-54. 19--41. 85) and HA level during decompensated period( MD =-145. 04,95% CI =-154. 92--135. 17),LN level( MD =-86. 38,95% CI =-105. 77--66. 98),type Ⅲ procollagen level( MD =-131. 05,95% CI =-142. 53--119. 56),Ⅳ-C level( MD =-108. 22,95%CI =-122. 49--93. 95),reduce the inner diameter of portal vein( MD =-0. 07,95%CI =-0. 14--0. 01),reduce the thickness of spleen( MD =-3. 28,95%CI =-4. 10--2. 46),increase the improvement rate of portal vein diameter( RR = 1. 55,95% CI = 1. 37-1. 75),and increase the improvement rate of splenic vein diameter( RR = 1. 77,95% CI = 1. 52-2. 06) and other aspects were significantly better than entecavir monotherapy,and the differences were statistically significant( P < 0. 05). CONCLUSIONS: Anluo Huaxian pills combined with entecavir in the treatment of hepatitis B-related liver cirrhosis can more effectively reduce the level of liver fibrosis and improve the imaging indicators such as portal vein internal diameter and spleen thickness in patients.