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复方甘草酸苷注射液改善慢性乙型肝炎肝损伤疗效及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].

作者信息

Wang Hao-Nan, Liang Shi-Bing, Yao Xiao-Ling, Lai Bao-Yong, Wen Tian-Yuan, Su Ning

机构信息

School of Basic Medicine, Guangzhou University of Chinese Medicine Guangzhou 510006, China.

School of Basic Medicine, Shanxi University of Chinese Medicine Taiyuan 030619, China Center of Evidence-based Medicine, Beijing University of Chinese Medicine Beijing 100029, China.

出版信息

Zhongguo Zhong Yao Za Zhi. 2021 Feb;46(3):694-702. doi: 10.19540/j.cnki.cjcmm.20200705.501.

Abstract

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 1 915 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.

摘要

评估复方甘草酸苷注射液(CGI)改善慢性乙型肝炎(CHB)肝损伤的疗效和安全性。检索PubMed、Web of Science、中国生物医学文献数据库、中国知网、万方数据库和维普数据库,检索时间从建库至2020年2月10日。纳入CGI治疗CHB的随机对照试验(RCT)。由两名作者独立提取数据,另外两名作者使用Cochrane偏倚风险评估工具评估方法学质量。使用RevMan 5.3软件进行统计分析。共纳入18项双臂RCT,涉及1915名参与者。纳入的所有研究的方法学质量普遍较低。在CGI与甘草酸二铵的比较中,结果显示CGI在提高总体临床疗效方面优于对照组,但两组在提高ALT正常化率、降低ALT和AST水平方面无统计学差异。在CGI与甘草酸二铵+其他一般保肝药物的比较中,结果显示CGI在降低AST水平方面优于对照组,而两组在降低ALT水平和提高总体临床疗效方面无统计学差异。在CGI+其他常用药物(包括能量合剂、谷胱甘肽、维生素、门冬氨酸钾镁)与甘草酸二铵+其他常用药物的比较中,结果显示CGI联合其他常用药物在降低ALT和AST水平以及提高临床总有效率方面优于对照组,两组在提高ALT正常化率方面无统计学差异。在CGI+其他常用药物与其他常用药物的比较中,结果显示CGI联合其他常用药物在降低ALT和AST水平以及提高总体临床疗效方面优于对照组。在CGI+维生素与甘草酸二铵+门冬氨酸钾镁+维生素的比较中,结果显示两组在降低AST水平方面无统计学差异。少数纳入研究报告称,CGI单独使用或与其他药物联合使用时会引起轻度不良反应。基于这些结果,CGI在改善CHB肝损伤方面有一定作用,但证据不足以证明CGI会导致严重不良事件。未来,需要更多设计良好、严格实施且样本量充足的RCT来进一步评估CGI在减轻CHB肝损伤方面的效果。

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