Hou Man-Ting, Ding Kai-Xin, He Ting-Ting, Yang Yan, Bai Zhao-Fang, Xiao Xiao-He
School of Chinese Medicine, Southern Medical University Guangzhou 510515, China Department of Hepatology,the Fifth Medical Center of Chinese PLA General Hospital Beijing 100039, China.
Department of Hepatology,the Fifth Medical Center of Chinese PLA General Hospital Beijing 100039, China.
Zhongguo Zhong Yao Za Zhi. 2022 Jan;47(1):224-234. doi: 10.19540/j.cnki.cjcmm.20210728.501.
The present study evaluated the clinical efficacy and safety of Liuwei Wuling Tablets combined with conventional drugs for the treatment of liver fibrosis and cirrhosis in chronic hepatitis B. CNKI, Wanfang, VIP, CBM, PubMed, EMbase and Cochrane Library were searched for the relevant randomized controlled trials(RCTs) published from database inception to February 2021. All the retrieved papers were independently screened, extracted and evaluated by two researchers, followed by Meta-analysis by Review Manager 5.4. Finally, 18 RCTs were included, involving 2 168 patients(1 106 in the treatment group and 1 062 in the control group). The Meta-analysis results showed that compared with conventional drugs alone, Liuwei Wuling Tablets combined with conventional drugs could increase the effective rate of clinical treatment by reducing serum hyaluronic acid(HA), laminin(LN), procollagen type Ⅲ(PCⅢ), and type Ⅳ collagen(Ⅳ-C) to improve liver function, decreasing the levels of total bilirubin(TBiL), alanine amino-transferase(ALT), and aspartate aminotransferase(AST), and improving the negative conversion ratio of hepatitis B virus(HBV) DNA. In terms of safety, there were no serious adverse reactions in the treatment group and the control group. The results showed that Liuwei Wuling Tablets combined with antiviral or other conventional liver-protecting drugs could improve liver function, treat liver cirrhosis, and reduce liver fibrosis with high safety. However, due to the influence of literature quality and quantity, multi-center and high-quality RCTs with large sample size are needed for verification.
本研究评估了六味五灵片联合常规药物治疗慢性乙型肝炎肝纤维化和肝硬化的临床疗效及安全性。检索了中国知网、万方、维普、中国生物医学文献数据库、PubMed、EMbase和Cochrane图书馆，查找从建库至2021年2月发表的相关随机对照试验（RCT）。所有检索到的文献由两名研究人员独立进行筛选、提取和评估，随后使用RevMan 5.4进行Meta分析。最终纳入18项RCT，涉及2168例患者（治疗组1106例，对照组1062例）。Meta分析结果显示，与单用常规药物相比，六味五灵片联合常规药物可提高临床治疗有效率，降低血清透明质酸（HA）、层粘连蛋白（LN）、Ⅲ型前胶原（PCⅢ）和Ⅳ型胶原（Ⅳ-C）水平以改善肝功能，降低总胆红素（TBiL）、丙氨酸氨基转移酶（ALT）和天冬氨酸氨基转移酶（AST）水平，并提高乙肝病毒（HBV）DNA阴转率。在安全性方面，治疗组和对照组均未出现严重不良反应。结果表明，六味五灵片联合抗病毒或其他常规保肝药物可改善肝功能，治疗肝硬化，减轻肝纤维化，且安全性高。然而，由于文献质量和数量的影响，尚需多中心、大样本量的高质量RCT进行验证。
