Liang Shi-Bing, Hou Wen-Bin, Zheng Ruo-Xiang, Liang Chang-Hao, Yan Li-Jiao, Wang Hao-Nan, Cao Hui-Juan, Han Mei, Robinson Nicola, Liu Jian-Ping
Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.
School of Basic Medicine, Guangzhou University of Chinese Medicine, Guangzhou, China.
Integr Med Res. 2022 Mar;11(1):100772. doi: 10.1016/j.imr.2021.100772. Epub 2021 Aug 21.
Compound glycyrrhizin injection (CGI) is a preparation with glycyrrhizin as the main active ingredient extracted from licorice. As clinical trials suggest that CGI is effective in improving liver function for acute icteric hepatitis in children (AIHC), this systematic review aimed to evaluate and verify its therapeutic effects and safety.
Six electronic databases were searched from their inception to 15 May 2021. Randomized controlled trials (RCTs) assessing therapeutic effects and safety of CGI for AIHC were included. The risk of bias for each trial was assessed using the Cochrane Risk of Bias Tool 2.0. Primary outcomes were indexes related to liver function, including total bilirubin (TBiL), alanine aminotransferase (ALT) and aspartate transaminase (AST). RevMan 5.4 software was used for data analyses. The certainty of the evidence was assessed using the online GRADEpro tool.
Six RCTs involving 608 children were included. The overall bias was assessed as having "high risk of bias" in all trials. All trials compared the combination of CGI and conventional western medicine (CWM) with CWM alone. Regarding the effects of CGI for AIHC, results showed that CGI plus CWM was superior to CWM alone in reducing the levels of TBiL (mean difference (MD) = -8.19 mmol/L, 95% CI -9.86 to -6.53), ALT (MD = -24.09 U/L, 95% CI -30.83 to -17.34) and AST (MD = -18.67 U/L, 95% CI -21.88 to -15.45). No trial reported adverse events. The certainty of the evidence for outcomes were all evaluated as low or very low.
CGI may have adjuvant therapeutic effects on improving the liver function of children with AIHC. There is no evidence to determine the safety of CGI for AIHC. As current evidence is weak, further well-designed RCTs are required for verification of the therapeutic effects of CGI.
复方甘草酸苷注射液(CGI)是以甘草中提取的甘草酸苷为主要活性成分的制剂。由于临床试验表明CGI对儿童急性黄疸型肝炎(AIHC)改善肝功能有效,本系统评价旨在评估和验证其治疗效果及安全性。
检索了6个电子数据库,检索时间从建库至2021年5月15日。纳入评估CGI治疗AIHC的疗效和安全性的随机对照试验(RCT)。使用Cochrane偏倚风险工具2.0评估每个试验的偏倚风险。主要结局是与肝功能相关的指标,包括总胆红素(TBiL)、丙氨酸氨基转移酶(ALT)和天冬氨酸氨基转移酶(AST)。使用RevMan 5.4软件进行数据分析。使用在线GRADEpro工具评估证据的确定性。
纳入6项涉及608名儿童的RCT。所有试验的总体偏倚被评估为“高偏倚风险”。所有试验均将CGI与传统西药(CWM)联合用药与单纯CWM进行比较。关于CGI对AIHC的疗效,结果显示CGI联合CWM在降低TBiL水平(平均差(MD)=-8.19 mmol/L,95%CI -9.86至-6.53)、ALT水平(MD=-24.09 U/L,95%CI -30.83至-17.34)和AST水平(MD=-18.67 U/L,95%CI -21.88至-15.45)方面优于单纯CWM。没有试验报告不良事件。结局证据的确定性均被评估为低或极低。
CGI可能对改善AIHC患儿的肝功能有辅助治疗作用。没有证据确定CGI对AIHC的安全性。由于目前证据不足,需要进一步设计良好的RCT来验证CGI的治疗效果。