替诺福韦治疗慢性乙型肝炎患者疗效及安全性分析

Efficacy and safety of tenofovir in the treatment of patients with chronic hepatitis B

目的观察比较应用替诺福韦(TDF)和恩替卡韦(ETV)治疗慢性乙型肝炎(CHB)患者的疗效和安全性。方法 2015年1月～2016年12月我中心收治的初始治疗的CHB患者60例,采用随机数字表法将患者分为两组,每组30例,分别给予TDF或ETV治疗,观察96 w,比较两组血清HBV DNA和丙氨酸氨基转移酶(ALT)水平和阴转率或复常率及不良反应发生情况。结果在治疗前、治疗第12 w、24 w、48 w、72 w和96 w,TDF治疗组患者血清HBV DNA水平分别为(7.5±0.9)lg IU/mL、(1.7±1.4)lg IU/mL、(1.1±1.0)lg IU/mL、(1.0±0.8)lg IU/mL、(0.7±0.6)lg IU/mL和(0.6±0.5)lg IU/mL,ETV治疗组则分别为(6.8±1.5)lg IU/mL、(2.1±1.1)lg IU/mL、(1.8±1.1)lg IU/mL、(1.0±0.7)lg IU/mL、(0.8±0.8)lg IU/mL和(0.9±0.8)lg IU/mL,在治疗24 w前,TDF治疗组血清HBV DNA水平显著低于ETV治疗组,差异具有统计学意义(P<0.05); TDF治疗组血清ALT水平分别为(205.8±23.8) U/L、(80.7±8.6) U/L、(49.7±12.5)U/L、(46.2±6.7)U/L、(42.5±6.5)U/L (41.8±2.4)U/L,ETV治疗组则分别为(199.0±25.9) U/L、(99.8±11.0)U/L、(59.3±9.4)U/L、(53.9±8.8)U/L、(44.62±7.4)U/L和(42.7±4.5)U/L,在治疗24 w前,TDF组血清ALT水平显著低于ETV组(P<0.05);在治疗第12 w、24 w、48 w、72 w和96w,TDF组病毒学应答率分别为50.0%、70.0%、73.3%、80.0%和96.7%,而ETV组则分别为23.3%、56.7%、60.0%、70.0%和93.3%,在治疗12 w时,TDF组显著高于ETV组(P<0.05);TDF组血清ALT复常率分别为63.3%、96.7%、96.7%、100.0%和100.0%,ETV组则分别为50.0%、86.7%、96.7%、96.7%和100.0%,两组无统计学差异(P>0.05)。结论在当前情况下,应用TDF或ETV任一药物治疗CHB初治患者,均有很好的近期疗效,TDF显示出更早的病毒学应答率,值得进一步观察。

Objective To observe the efficacy and safety of tenofovir(TDF)in the treatment of patients with chronic hepatitis B(CHB).Methods Sixty naive patients with CHB were enrolled in our hospital between January 2015 and December 2016,and were randomly divided into two groups,with 30 patients in each group.30 patients with CHB were given TDF and the other 30 patients with CHB were given entecavir(ETV)treatment for 96 weeks.Serum alanine aminotransferase(ALT)and HBV DNA levels,as well as virological and biochemical response rates were compared between the two groups.Results Before treatment and at the end of 12 w,24 w,48 w,72 w and 96 w of treatment,serum HBV DNA levels in TDF-treated group were(7.5±0.9)lg IU/mL,(1.7±1.4)lg IU/mL,(1.1±1.0)lg IU/mL,(1.0±0.8)lg IU/mL,(0.7±0.6)lg IU/mL and(0.6±0.5)lg IU/mL,and in ETVtreated group were(6.8±1.5)lg IU/mL,(2.1±1.1)lg IU/mL,(1.8±1.1)lg IU/mL,(1.0±0.7)lgIU/mL,(0.8±0.8)lg IU/mL and(0.9±0.8)lg IU/mL,suggesting that at the first 24 w treatment,serum HBV DNA levels in TDFtreated group were significantly lower than in ETV-treated group(P<0.05);serum ALT levels in TDF-treated group were(205.8±23.8)U/L,(80.7±8.6)U/L,(49.7±12.5)U/L,(46.2±6.7)U/L,(42.5±6.5)U/L and(41.8±2.4)U/L,and in ETV-treated group were(199.0±25.9)U/L,(99.8±11.0)U/L,(59.3±9.4)U/L,(53.9±8.8)U/L,(44.62±7.4)U/L and(42.7±4.5)U/L,respectively,showing than at the first 24 w,serum ALT levels in TDF-treated group decreased more obviously than in ETV-treated group(P<0.05);at the end of 12 w,24 w,48 w,72 w and 96 w,the virologic response rates in TDF-treated group were 50.0%,70.0%,73.3%,80.0%and 96.7%,while in ETV-treated group were 23.3%(P<0.05),56.7%,60.0%,70.0%and 93.3%,respectively;serum ALT normalization rates in TDF-treated group were 63.3%,96.7%,96.7%,100.0%and 100.0%,while in ETV-treated group were 50.0%,86.7%,96.7%,96.7%and 100.0%,showing no significantly different between the two groups(P>0.05).Conclusion Both TDF and ETV might be the optimal option for treatment of naive patients with CHB at present,showing promising efficacy and good safety,which worth further and long-term investigation.