摘要
目的系统评价异甘草酸镁联合恩替卡韦治疗慢性乙型肝炎的有效性与安全性,为临床治疗提供循证参考。方法计算机检索Cochrane图书馆、PubMed、Embase、中国期刊全文数据库、中国知网、维普网、万方数据库等,收集异甘草酸镁联合恩替卡韦(试验组)对比恩替卡韦(对照组)治疗慢性乙型肝炎的随机对照试验(RCT),对符合纳入标准的文献进行资料提取,并采用改良Jadad量表评价纳入文献的质量,采用Rev Man 5.3软件对临床总有效率、血清谷丙转氨酶(ALT)降低水平、谷草转氨酶(AST)降低水平、总胆红素(Tbil)降低水平、ADR发生率、HBV-DNA转阴率、HBeAg转阴率、HBeAg/抗-HBe血清转换率等指标进行meta分析,采用TSA 0.9软件进行试验序贯分析。结果共纳入13项RCT,合计1426例患者。Meta分析结果显示,试验组患者总有效率[RR=1.34,95%CI(1.23,1.46),P<0.00001]、血清ALT降低水平[MD=21.07,95%CI(11.36,30.79),P<0.0001]、血清AST降低水平[MD=21.98,95%CI(10.45,33.51),P=0.0002]、血清Tbil降低水平[MD=13.00,95%CI(9.02,16.98),P<0.00001]、HBV-DNA转阴率[RR=1.10,95%CI(1.03,1.17),P=0.004]、HBeAg转阴率[RR=1.34,95%CI(1.09,1.63),P=0.005]均显著高于对照组;两组患者ADR发生率[RR=0.94,95%CI(0.54,1.63),P=0.82]、HBeAg/抗-HBe血清转换率[RR=1.97,95%CI(0.50,7.80),P=0.34]比较差异无统计学意义。TSA分析结果显示,异甘草酸镁联合恩替卡韦治疗慢性乙型肝炎提高总有效率的证据确切。结论异甘草酸镁联合恩替卡韦对比单用恩替卡韦治疗慢性乙型肝炎在提高总有效率,改善血清ALT、AST、Tbil水平,提高HBV-DNA、HBeAg转阴率方面均优于单用恩替卡韦。
Objective To systematically evaluate the therapeutic efficacy of magnesium isoglycyrrhizinate combined with entecavir in the treatment of chronic hepatitis B,to provide evidencebased reference for clinical medication.Methods By retrieving Cochrane library,PubMed,Embase,CJFD,CNKI,VIP and Wanfang database,randomized controlled trials(RCTs)about magnesium isoglycyrrhizinate combined with entecavir(trial group)versus entecavir alone(control group)in the treatment of chronic hepatitis B were collected.After the data extraction and quality evaluation of included studies with modified Jadad scale,meta-analysis was performed for total response rate,the decrease in the serum ALT,AST and Tbil levels,the incidence of ADR,the HBV-DNA and HBeAg negative conversion ratios,and the HBeAg/Anti-HBe seroconversion ratios with Rev Man 5.3 software.TSA 0.9 software was used for trial sequential analysis(TSA).Results Totally 13 RCTs were included,involving 1426 patients.meta-analysis showed that the total response rate[RR=1.34,95%CI(1.23,1.46),P<0.00001],the decrease in the serum ALT level[MD=21.07,95%CI(11.36,30.79),P<0.0001],the decrease in the serum AST level[MD=21.98,95%CI(10.45,33.51),P=0.0002],the decrease in the serum Tbil level[MD=13.00,95%CI(9.02,16.98),P<0.00001],the HBVDNA negative conversion ratios[RR=1.10,95%CI(1.03,1.17),P=0.004]and the HBeAg negative conversion ratios[RR=1.34,95%CI(1.09,1.63),P=0.005]of the trial group were significantly higher than those of the control group.There was no statistical difference in the incidence of ADR[RR=0.94,95%CI(0.54,1.63),P=0.82]or the HBeAg/Anti-HBe seroconversion ratios[RR=1.97,95%CI(0.50,7.80),P=0.34]between the two groups.TSA analysis showed that the evidence for the therapeutic efficacy of magnesium isoglycyrrhizinate combined with entecavir for chronic hepatitis B was reliable.Conclusion In the treatment of chronic hepatitis B,magnesium isoglycyrrhizinate combined with entecavir is better than entecavir alone in improving the total response rate,the serum ALT,AST,and Tbil levels and the negative conversion ratios of HBV-DNA and HBeAg.
作者
尤越
钱磊
徐小菊
范国荣
YOU Yue;QIAN Lei;XU Xiao-ju;FAN Guo-rong(Department of Clinical Pharmacy,Shanghai General Hospital,Shanghai Jiao Tong University,Shanghai 200080)
出处
《中南药学》
CAS
2021年第2期290-297,共8页
Central South Pharmacy
关键词
慢性乙型肝炎
异甘草酸镁
恩替卡韦
系统评价
试验序贯分析
chronic hepatitis B
magnesium isoglycyrrhizinate
entecavir
meta-analysis
trial sequential analysis
