扶正化瘀胶囊联合常规护肝治疗肝纤维化有效性与安全性的系统评价与Meta分析

The efficacy and safety of Fuzheng Huayu Capsule combined with routine liver protection treatment in liver fibrosis:a systematic review and Meta-analysis

关键词:  扶正化瘀胶囊  肝纤维化  随机对照试验  系统评价  Meta分析

Key words:  Fuzheng Huayu Capsule  liver fibrosis  randomized controlled trial  systematic review  Meta-analysis

摘要:

[目的] 系统评价扶正化瘀胶囊联合常规护肝治疗肝纤维化的有效性与安全性。[方法] 计算机检索PubMed、EMbase、the Cochrane Library、中国知识基础设施工程（CNKI）、万方数据知识服务平台（WanFang Data）、维普网（VIP）及中国生物医学文献服务系统（SinoMed）数据库，全面搜集扶正化瘀胶囊联合常规护肝治疗肝纤维化的临床随机对照试验（RCT），检索时限为各数据库从建库起至2020年4月。2名研究人员独立筛选文献、提取数据及评估偏倚风险，采用Cochrane协作网的RevMan 5.3软件进行数据分析。[结果] 最终纳入12项RCT，共1 032例患者。Meta分析结果显示：在临床疗效方面，扶正化瘀胶囊联合常规护肝治疗优于单用常规护肝治疗；在纤维化血清学指标方面，扶正化瘀胶囊联合常规护肝治疗优于单用常规护肝治疗；在肝功能指标丙氨酸氨基转移酶（ALT）、天冬氨酸氨基转移酶（AST）、总胆红素（TBIL）、白蛋白（ALB）方面，扶正化瘀胶囊联合常规护肝治疗优于单用常规护肝治疗，而在肝功能指标球蛋白（GLB）方面，扶正化瘀胶囊联合常规护肝治疗与单用常规护肝治疗效果相当；在肝脾超声指标方面，扶正化瘀胶囊联合常规护肝治疗优于单用常规护肝治疗，且无严重不良反应发生。[结论] 基于目前证据，在常规护肝治疗的基础上，加用扶正化瘀胶囊治疗肝纤维化可进一步提高临床疗效，改善肝纤维化血清学指标及ALT、AST、TBIL、ALB水平和肝脾超声指标（门脉主干内径、脾静脉内径、脾脏厚度），且无严重不良反应发生，但在改善GLB水平方面与单用常规护肝治疗效果相当。但由于纳入研究质量整体偏低，研究结果仍需通过标准的多中心大规模双盲RCT进行验证。

Abstract:

[Objective] To systematically evaluate the efficacy and safety of Fuzheng Huayu Capsule combined with routine liver protection treatment for liver fibrosis. [Methods] A systematical retrieval was performed through PubMed,EMbase,Cochrane Library,CNKI,WanFang,VIP and SinoMed from the establishment to April 2020. Randomized controlled trials of Fuzheng Huayu Capsule combined with routine liver protection treatment for liver fibrosis were retrieved. Two researchers independently screened the literature,extracted the data and assessed the risk of bias. The RevMan 5.3 software of Cochrane collaboration was used for data analysis. [Results] A total of 12 studies involving 1 032 patients were included. Meta-analysis showed that in the clinical efficacy,Fuzheng Huayu Capsule combined with routine liver protection treatment was superior to routine liver protection treatment alone. In the serological indexes of fibrosis,Fuzheng Huayu Capsule combined with conventional liver protection treatment was superior to conventional liver protection treatment alone. In the liver function indexes(ALT,AST,TBiL and ALB),Fuzheng Huayu Capsule combined with routine liver protection treatment was superior to routine liver protection treatment alone. In the liver function indexes(GLB),Fuzheng Huayu Capsule combined with routine liver care therapy was equivalent to routine liver care therapy alone. In the ultrasound indexes of liver and spleen,Fuzheng Huayu Capsule combined with conventional liver protection treatment was superior to conventional liver protection treatment alone,and no serious adverse reactions occurred. [Conclusion] Based on the current evidence,on the basis of conventional liver protection treatment,Fuzheng Huayu Capsule can further improve the clinical efficacy,improve the serum indexes of liver fibrosis,ALT,AST,TBIL,ALB levels and liver and Spleen Ultrasound indicators (portal vein diameter,splenic vein diameter,spleen thickness),and no serious adverse reactions occurred. However, in improving the level of GLB,Fuzheng Huayu Capsule can improve the level of liver fibrosis The treatment of routine liver protection is equivalent. However,due to the overall low quality of the included studies,the results still need to be verified by standard multi-center large-scale double-blind randomized controlled clinical trials.