扶正化瘀胶囊联合核苷类抗病毒药物治疗慢性乙型肝炎的meta分析

目的系统评价扶正化瘀胶囊联合核苷类抗病毒药物治疗慢性乙型肝炎的疗效。方法纳入文献中以核苷类抗病毒药物为对照组,以扶正化瘀胶囊联合核苷类抗病毒药物为试验组。由2名研究者独立评价纳入研究的方法学质量,并采用RevMan 5.1软件进行meta分析。结果共纳入17个随机对照试验,合计1 320例慢性乙型肝炎患者,其中对照组636例,试验组684例,1个研究方法学质量为B级,16个研究方法学质量为C级。meta分析结果显示：肝功能4个指标（丙氨酸转氨酶、天冬氨酸转氨酶、总胆红素、白蛋白）在治疗24周时2组无统计学差异（P〉0.05）,进一步治疗到48周时试验组前3个指标明显下降,最后1个指标明显上升（P〈0.05）。肝纤维化指标（透明质酸、Ⅳ型胶原）在治疗24周时2组有统计差异（P〈0.05）,48周时2个指标值进一步降低（P〈0.05）。解剖学指标（门静脉直径）在治疗24周时2组无统计学差别（P〉0.05）,试验组脾脏厚度有明显减小（P〈0.05）,进一步观察48周后发现门静脉直径开始减小（P〈0.05）,而脾脏厚度进一步减小（P〈0.05）。血清病毒学指标（HBeAg阴转率、HBV-DNA阴转率）在治疗24、48周时均无明显改善（P〉0.05）。结论本系统评价结果表明,扶正化瘀胶囊联合核苷类抗病毒药在治疗48周时能明显改善慢性乙型肝炎患者肝功能、肝纤维化、解剖学指标,但对血清病毒学指标无明显改善作用。

Meta analysis on Fuzhenghuayu capsule combined with nucleoside antiviral drug for chronic hepatitis B

Objective To evaluate the efficacy of Fuzhenghuayu capsule combined with nucleoside antiviral drugs for patients with chronic hepatitis B.Methods The patients in control in included papers were treated with nucleoside antiviral drugs while those in trail group were treated with Fuzhenghuayu capsule combined with nucleoside antiviral drugs.Independent evaluation on the methodological quality of included studies was conducted by two researchers and meta analysis was performed by RevMan5.1 software.Results Totally 17 RCTs,1 320 patients with chronic hepatitis B were enrolled,including 636 in control group and 684 in trial group.The methodological quality of one study was graded as class B,of sixteen studies were as class C.Meta-analysis showed that： there was no significant difference in four indicators（alanine aminotransferase,ALT;aspartate aminotransferase,AST;total bilirubin,TBIL;albumin,ALB）of liver function between the two groups after treating for 24 weeks（P0.05）,however after treating for 48 weeks,the levels of ALT,AST,TBIL were decreased while that of ALB was increased（P0.05）.There were statistical differences in the two indicators of liver fibrosis（hyaluronic acid,HA;Ⅳ-collagen,Ⅳ-C） after treating for 24 weeks between the two groups,and the levels of HA,Ⅳ-C were continued to decrease after treating for 48 weeks（P0.05）.There was no significant difference in the portal vein diameter between the two groups（P0.05） and the spleen thickness was reduced significantly in trail group（P0.05） after treating for 24 weeks;but after treating for 48 weeks,the portal vein diameter was decreased（P0.05） and the thickness of the spleen was further reduced（P0.05）.Serum HBeAg negative conversion rate and HBV-DNA negative conversion rate were not significant improved after treating for 24 and 48 weeks（P0.05）.Conclusion The system evaluation shows that Fuzhenghuayu capsule combined with nucleoside antiviral drugs is effective in the treatment of chronic hepatitis B.It can significantly improve liver function,liver fibrosis,anatomical targets after using for the 48 weeks,however it has no significant improvement for indicators of serum.