甘草酸二铵脂质复合物肠溶胶囊与甘草酸二铵胶囊对照治疗慢性病毒性肝炎687例荟萃分析

摘要

Objective To systematically evaluate the efficacy and safety of diammonium glycyrrhizinate enteric-coated capsules versus diammonium glycyrrihizinate in patients with chronic viral hepatitis.Methods The Chinese Biomedical Literature Database (CBM on CD-ROM) and the China Academic Journals Full-Text Database (Chinese National Knowledge Infrastructure,CNKI) were searched for randomized controlled trials (RCTs) that compared the efficacy and safety of diammonium glycyrrhizinate entetic-coated capsules versus diammonium glycyrrihizinate in treatment (＞ 2 months) of chronic viral hepatitis published between 2005 and 2012.A meta-analysis was performed on the selected RCTs to determine the effects on alanine aminotransferase (ALT) normalization,serum levels of ALT,aspartate aminotransferase (AST),total bilirubin (TBil) and albumin,as well as rates of adverse reactions.Results Nine RCTs,involving 687 patients,were included in the meta-analysis.Compared to the patients treated with diammonium glycyrrihizinate,the patient treated with diammonium glycyrrhizinate enteric-coated capsules had a significantly better recovery rate of ALT (relative risk (RR) =4.15,95％ confidence interval (CI):1.55 to 11.15,P ＜ 0.01) and significantly more robust decreases in ALT (weighted mean difference (WMD) =-32.75,95％ CI:-46.67 to-18.83,P ＜ 0.01) and AST (WMD =-12.70,95％ CI:-21.13 to-4.27,P ＜ 0.01).In contrast,the patients treated with diammonium glycyrrihizinate showed more robust improvements in the TBil level (WMD =-0.74,95％ CI:3.98 to 2.49,P =0.653) and albumin (WMD =1.03,95％ CI:-1.03 to 3.09,P =0.326),but the differences did not reach the threshold for statistical significance (P ＞ 0.05).Only four adverse reactions were reported,all of which were related to the lipid complex nature of the diammonium glycyrrhizin enteric-coated capsules and were mild,including dry mouth,dizziness and mild gastrointestinal discomfort and reactions.Conclusion Diammonium glycyrrhizinate enteric-coated capsules elicited superior anti-inflammatory and liver protection effects than diammonium glycyrrihizinate,and produced only mild side effects that are tolerable to the patients.%目的 根据现有临床研究系统评价甘草酸二铵脂质复合物肠溶胶囊与传统甘草酸制剂甘草酸二铵胶囊治疗慢性病毒性肝炎的疗效及安全性.方法 检索中国生物医学光盘数据库和中国期刊网数据库,纳入自2005年至2012年比较甘草酸二铵脂质复合物肠溶胶囊与甘草酸二铵胶囊治疗慢性病毒性肝炎的疗效及安全性的随机对照试验.并对相关文献进行荟萃分析.结果 共9项随机对照试验入选,共纳入687例患者.荟萃分析结果显示与传统甘草酸二铵胶囊相比,甘草酸二铵脂质体复合物肠溶胶囊可提高慢性病毒性肝炎患者ALT的复常率[相对危险度(RR) =4.15,95％置信区间(CI)为1.55 ～ 11.15,P＜0.01)].甘草酸二铵脂质复合物肠溶胶囊降低血清ALT的效率高于甘草酸二铵胶囊[加权平衡差(WMD) =-32.75,95％ CI为46.67 ～-18.83,P＜0.01)].降低血清AST的效率高于甘草酸二铵胶囊(WMD =-12.70,95％CI为-21.13～ 4.27,P＜0.01).在改善血清胆红素方面有优于甘草酸二铵胶囊的倾向,但差异无统计学意义(WMD=-0.74,95％ CI为3.98 ～ 2.49,P＞0.05).在改善血清白蛋白方面有优于甘草酸二铵胶囊的倾向,但两组间差异无统计学意义(WMD =1.03,95％ CI为1.03～3.09,P＞0.05).结论 与传统口服甘草酸制剂相比,甘草酸二铵脂质复合物肠溶胶囊具有更强的抗炎保肝作用.两者均未发现明显不良反应.