替比夫定与干扰素α治疗HBeAg阳性慢性乙型肝炎患者临床疗效的对比观察

Clinical efficacy of telbivudine and interferon in treatment of HBe Ag-positive chronic hepatitis B: a comparative study

目的观察替比夫定(TLD)与干扰素(IFN)α治疗HBe Ag阳性慢性乙型肝炎(CHB)患者的临床疗效及安全性。方法选取2011年4月至2013年10月于福建中医药大学附属厦门第三医院就诊的84例CHB患者,将其分为TLD组和IFNα组,每组各42例。观察两组治疗12、24、48周时ALT复常率、HBV DNA阴转率、HBe Ag血清学转换率、HBe Ag定量情况以及药物的安全性。计量资料组间比较采用t检验,计数资料组间比较采用χ2检验。结果治疗12、24、48周时IFNα组和TLD组ALT复常率比较差异均无统计学意义(21.43%vs 33.33%、35.71%vs 50.00%、66.67%vs 76.19%,P值均>0.05);治疗12、24周时两组HBe Ag血清学转换率比较差异均无统计学意义(9.52%vs 7.14%、23.81%vs 14.29%,P值均>0.05);治疗48周时,两组HBe Ag血清学转换率比较差异有统计学意义(42.86%vs 21.43%,χ2=4.42,P=0.04);治疗12、24、48周时TLD组HBV DNA阴转率高于IFNα组,差异均有统计学意义(11.90%vs 30.95%、26.19%vs 54.76%、52.38%vs 76.19%,χ2值分别为4.53、7.16、5.19,P值分别为0.02、0.01、0.03);IFNα组患者治疗48周时,HBe Ag定量低于TLD组,差异有统计学意义[(189.0±96.2)COI vs(356.3±104.5)COI,t=2.45,P=0.02];两组均未发现明显不良反应。结论 TLD治疗HBe Ag阳性CHB具有强效抗病毒作用,其治疗12、24、48周时HBV DNA阴转率高于IFNα组,但治疗48周时TLD组HBe Ag血清学转换率低于IFNα组。治疗期间两药的安全性和耐受性良好。

Objective To evaluate the clinical efficacy and safety of telbivudine （TLD）and interferon （IFN）αin the treatment of HBeAg-positive chronic hepatitis B （CHB）.Methods A total of 84 CHB patients who were admitted to Xiamen Municipal Third Hospital Affiliated to Fujian University of Traditional Chinese Medicine from April 201 1 to October 2013 were equally and randomly divided into TLD group （treated with TLD）and IFNαgroup （treated with IFNα）.Serum alanine aminotransferase （ALT）normalization rate,HBV DNA clearance rate,HBeAg seroconversion rate,the quantity of HBeAg,and the safety of the two drugs were determined at weeks 12,24,and 48 of treat-ment.Comparison of continuous data between the two groups was made by independent-samples t test,and comparison of categorical data was made by chi-square test.Results There were no significant differences in serum ALT normalization rate between the two groups at weeks 12,24,and 48 of treatment （P〉0.05 ）,and there were no significant differences in HBeAg seroconversion rate between the two groups at weeks 12 and 24 of treatment （P〉0.05 ）.The TLD group had a significantly lower HBeAg seroconversion rate than the IFNαgroup at weeks 48 of treatment （χ2 =4.42,P=0.04）.And the TLD group had a significantly higher HBV DNA clearance rate than the IFNαgroup at weeks 12 （χ2 =4.53,P=0.02）,24 （χ2 =7.16,P=0.01）,and 48 of treatment （χ2 =5.19,P=0.03）.The IFNαgroup had a significantly lower quantity of HBeAg than the TLD group at week 48 of treatment （t=2.45,P=0.02）.No obvious adverse reactions were found in either group.Conclusion For patients with HBeAg-positive CHB,TLD has a strong antiviral effect and leads to a higher HBV DNA clearance rate than IFN at weeks 12,24,and 48 of treatment,but it causes a lower HBeAg seroconversion rate than IFN at week 48 of treatment.Both drugs have good safety and tolerability.