博路定和其他抗乙肝病毒核苷酸类药物治疗HBeAg阳性慢性乙型肝炎疗效和安全性的Meta分析

Meta-analysis of Curative Effects and Safeties of Baraclude Versus Other Nucleoside Drugs for Treatment of HBeAg-positive Chronic Hepatitis B

目的:评价博路定和其他抗乙肝病毒核苷酸类药物对核苷初治的乙型肝炎e抗原(HBeAg)阳性慢性乙型肝炎(CHB)患者的疗效和安全性。方法:计算机检索PubMed、Mestre、中国期刊全文数据库(CNKI)、中文科技期刊数据库(VIP)、万方数据库(建库至2015年10月)公开发表的有关博路定和其他抗乙肝病毒核苷酸类药物对核苷初治的HBeAg阳性CHB患者疗效的随机对照试验(RCTs),并追查已获文献的参考文献。由两名研究者独立筛选文献,提取数据,按照改良后Jadad评分标准进行质量评价。采用Rev Man5.2软件进行Meta分析。结果:最终纳入11个RCTs,共2326例患者。Meta分析结果显示,治疗48周时,博路定组在血清丙氨酸氨基转氨酶(ALT)复常率[OR=1.42,95%CI(1.17,1.73)],HBeAg转阴率[OR=1.35,95%CI(1.08,1.69)]方面均显著高于ADV组,差异有统计学意义(P<0.05)。博路定和其他抗乙肝病毒核苷酸类药物组在血清乙型肝炎病毒(HBV)-DNA转阴率[OR=1.36,95%CI(0.80,2.32)]和不良反应发生率[OR=1.08,95%CI(0.60,1.93)]方面比较,差异无统计学意义(P>0.05)。结论:核苷初治的HBeAg阳性CHB患者治疗48周时,博路定促使ALT复常和清除HBeAg方面的疗效均优于其他抗乙肝病毒核苷酸类药物,但在降低血清HBV-DNA、安全性方面相似。

Objective:To evaluate the curative effects and safeties of baraclude and other nucleotide drugs for treatment of HBeAg positive chronic hepatitis B (CHB) resistant to nucleosides. Methods:Randomized controlled trials (RCTs) of baraclude and other nucleotide drugs for treatment of HBeAg positive chronic hepatitis B (CHB) resistant to nucleosides published in PubMed, Mestre, CNKI, Chinese Science and Technology Periodical Database (VIP) and ChinaInfo (from the establilshment to October 2015) were searched, of which the references were traced. The literatures were screened by two researchers independently, from which data were extracted and evaluated for quality according to the modified Jadad scoring criteria. Meta-analysis was performed by using RevMan5.2 software. Results:A total of 11 RCTs were screened, which 2326 patients were included. Meta-analysis showed that the normalization rate of serum alanine aminotransferase (ALT) [(OR = 1.42, 95% CI (1.17,1.73)] and negative conversion rate of HBeAg [(OR = 1.35, 95% CI (1.08,1.69)] in baraclude group 48 weeks after treatment were significantly higher than those in ADV group (P < 0.05). However, the negative conversion rate of HBV-DNA [(OR = 1.36, 95% CI (0.80,2.32)] and the adverse reaction rate [(OR = 1.08, 95% CI (0.60,1.93)] in baraclude group showed no significant difference with those in other nucleoside drug groups (P > 0. 05). Conclusion:The curative effect of baraclude was superior to other nucleoside drugs in promoting the normalization of ALT and clearance of HBeAg, while showed no significant difference in decreasing serum HBV DNA level and in safety.