甘草酸二铵肠溶胶囊治疗脂肪性肝病疗效Meta分析

Diammonium glycrrhizinate enteric-coated capsules in treatment of patients with fatty liver disease:a Meta-analysis

目的评价甘草酸二铵肠溶胶囊治疗脂肪性肝病的疗效和安全性。方法检索Pubmed、OVID、EMBASE、Cochrance Library、中国知网、万方、维普收录的2014年6月前发表的关于甘草酸二铵肠溶胶囊治疗脂肪性肝病的随机对照试验,采用Revman 5.0软件进行Meta分析。结果共有5个研究(376例患者)纳入评价。甘草酸二铵肠溶胶囊治疗组综合疗效(OR=2.19,95%CI 1.19~4.06,P=0.01)和症状改善情况(OR=3.85,95%CI2.07~7.16,P<0.0001)都优于一般保肝药治疗的对照组;治疗组在改善肝脏酶学指标、降低主要血脂方面优于对照组,丙氨酸氨基转移酶、门冬氨酸氨基转移酶、γ-谷氨酰转肽酶、血清总胆固醇、甘油三酯的权重均数差(WMD)分别为-15.65(95%CI-21^-10.29,P<0.00001)、-17.56(95%CI-25.99^-9.14,P<0.0001)、-7.18(95%CI-11.94^-2.42,P=0.003)、-1.01(95%CI-1.84^-0.18,P=0.02)、-0.77(95%CI-0.92^-0.61,P<0.00001),而高密度脂蛋白、低密度脂蛋白的WMD分别为-0.01(95%CI-0.1~0.14,P>0.05)、0.04(95%CI-0.30~0.38,P>0.05),表明治疗组和对照组在降低HDL-L、LDL-L方面无明显差异;治疗组B超检测肝脏形态改善率为50%,显著高于对照组的26.7%(P=0.0007);治疗组总不良反应发生率为11.19%,略高于对照组的1.44%(P=0.005)。结论甘草酸二铵肠溶胶囊(天晴甘平)可明显改善脂肪性肝病患者的临床症状、肝功能、血脂指标和B超下的肝脏形态。

Objective To evaluate the efficacy and safety of diammonium glycrrhizinate enteric-coated cap- sules in the treatment of patients with fatty liver diseases. Methods All randomized controlled trials of diammo- nium glycrrhizinate for the treatment of patients with fatty liver disease published before June 2014 were collected by searching PuhMed,OVID,EMBASE,Cochrance Library,Chinese National Knowledge Infrastructure （CNKI）, Wan-fang Database and VIP Database. Statistical analyses were performed with RevMan 5.0 software. Results A total of 5 articles involving 376 patients with fatty liver disease were included. The overall efficacy [Odds Ratio （OR）=2.19,95%CI 1.19～4.06,P=0.01] and remission of clinical syndrome （OR=3.85,95%CI 2.07～7.16,P〈0.0001） of patients in treatment group were better than those in the controls;Compared with patients in control group,there were greater improvement of hepatic function indicators and reduction of serum lipid in patients in treatment group ; The weighted mean differences（WMDs） for alanine aminotransferase, aspartate aminotransferase,γ-glutamyl- transpe-ptidase,serum total cholesterol and,serum triglyceridewere -15.65（95%CI -21～-10.29, P〈0.00001）,-17.56 （95%CI -25.99～-9.14, P〈0.0001 ）,-7.18 （95%CI - 11.94～-2.42, P=0.003 ）, - 1.01（95%CI -1.84～-0.18, P=0.02） and -0.77 （95%CI -0.92～-0.61,P〈0.00001）,respectively;But there were no significant differences between the two groups in high density lipoprotein （HDL-L） （WMD=-0.01,95%CI -0.16～0.14,P〉0.05） and low density lipopro- tein （LDL-L）（WMD=0.04,95%CI -0.30～0.38,P〉0.05）;Patients in treatment group had better liver morphology improvement than in controls （50% vs. 26.7%） as revealed by B uhrasound（P=0.0007）;However,the incidence of adverse effect in patients in treatment group was slightly higher than that in controls（11.19% vs. 1.44%,P=0.005）. Conclusion Diammonium glycrrhizinate enteric-coat- ed capsules is effective in improving clinical symptom,liver function,serum lipids and liver morphology in patients with fatty liver diseases.