复方甘草酸苷注射液改善慢性乙型肝炎肝损伤疗效和安全性的系统评价与Meta分析

Systematic review and Meta-analysis of efficacy and safety of Compound Glycyrrhizin Injection in improving chronic hepatitis B liver damage

为系统评价复方甘草酸苷注射液(Compound Glycyrrhizin Injection,CGI)改善慢性乙型肝炎(chronic hepatitis B,CHB)肝损伤的有效性和安全性。该研究系统检索了PubMed、Web of Science、CBM、CNKI、Wanfang和VIP数据库,检索时限为建库至2020年2月10日。纳入CGI治疗CHB的随机对照试验(randomized controlled trial,RCT),由2名作者独立对纳入研究进行资料提取,并采用Cochrane偏倚风险评价工具对纳入研究进行方法学质量评价。应用RevMan 5.3软件进行数据统计分析。最终纳入18项双臂RCT,1915例受试者。所有纳入研究的方法学质量总体不高。对于CGI vs甘草酸二铵,CGI在提高临床总有效率上优于对照组,而在提高ALT复常率、降低ALT及AST水平上2组无统计学差异;对于CGI vs甘草酸二铵+其他一般保肝药,CGI在降低AST水平上优于对照组,而在降低ALT水平和提高临床总有效率上2组无统计学差异;对于CGI+其他常用药(包括能量合剂、谷胱甘肽、维生素及门冬氨酸钾镁等)vs甘草酸二铵+其他常用药,CGI联合其他常用药在降低ALT及AST水平、提高临床总有效率上均优于对照组,而在提高ALT复常率上2组无统计学差异;对于CGI+其他常用药vs其他常用药,CGI联合其他常用药在降低ALT及AST水平、提高临床总有效率上均优于对照组;对于CGI+维生素vs甘草酸二铵+门冬氨酸钾镁+维生素,在降低AST水平上2组无统计学差异。少数纳入研究报告了CGI单独或联合其他药物使用过程中会引起轻度不良反应。研究结果表明,CGI对改善CHB肝损伤具有一定疗效,目前证据尚不足以证明CGI会引起较严重安全性问题。未来仍需更多严格设计、足够样本量并严格实施的RCT进一步评价CGI改善CHB肝损伤的效果。

To evaluate the efficacy and safety of Compound Glycyrrhizin Injection(CGI)in improving liver damage in chronic hepatitis B(CHB).PubMed,Web of Science,SinoMed,CNKI,Wanfang and VIP databases were retrieved from their inception to February 10,2020.The randomized controlled trial(RCT)of CGI in the treatment of CHB was included.Data were independently extracted by two authors,and the methodological quality was evaluated using the Cochrane bias risk assessment tool by other two authors.Statistical analysis was performed using RevMan 5.3 software.A total of 18 two-armed RCTs were included,involving 1915 participants.The methodological quality of all studies included was generally low.In the comparison between CGI and diammonium glycyrrhizinate,the results showed that CGI was superior to the control group in improving the overall clinical effectiveness,but there was no statistical difference between the two groups in increasing ALT normalization rate,reducing ALT and AST level.In the comparison between CGI and diammonium glycyrrhizinate+other general hepatoprotective drugs,the results showed that CGI was superior to the control group in reducing AST level,while there was no statistical difference between the two groups in reducing ALT level and increasing overall clinical effectiveness.In the comparison between CGI+other commonly used drugs(including energy mixture,glutathione,vitamins,potassium magnesium aspartate)and diammonium glycyrrhizinate+other commonly used drugs,the results showed that CGI combined with other commonly used drugs was better than the control group in reducing ALT and AST level and improving the clinical total effective rate,and there was no statistical difference between the two groups in increasing the rate of ALT normalization.In the comparison between CGI+other commonly used drugs and other commonly used drugs,the results showed that CGI combined with other commonly used drugs was superior to the control group in reducing ALT and AST level and improving the overall clinical effectiveness.In the comparison between CGI+vitamins and diammonium glycyrrhizinate+potassium magnesium aspartate+vitamins,the results showed no statistical difference between the two groups in reducing AST level.A small number of studies included reported that CGI caused mild adverse reactions when used alone or in combination with other drugs.Based on the results,CGI has a certain effect in improving CHB liver damage,but the evidence is not enough to prove that CGI would cause serious adverse events.In the future,more well-designed and strictly-enforced RCT with an adequate sample size are needed to further evaluate the effect CGI in alleviating CHB liver damage.