恩替卡韦初治ALT小于2ULN的HBeAg阴性慢性乙型肝炎患者的2年疗效观察Efficacy Observation of 2 Years Entecavir in Patients with Chronic Hepatitis B of HBeAg-Negative and ALT<2ULN
敖飞健,何清,张斌,白冰,唐奇远,李知玉,廖雪姣,唐蔚
AO Feijian,HE Qing,ZHANG Bin,BAI Bing,TANG Qiyuan,LI Zhiyu,LIAO Xuejiao,TANG Wei
摘要(Abstract):
目的研究恩替卡韦治疗ALT小于2ULN(正常值上限)的HBe Ag阴性慢性乙型肝炎患者2年的疗效观察。方法前瞻性研究37例HBe Ag阴性慢性乙型肝炎患者,其中17例是ALT小于2ULN(A组),20例是ALT大于2ULN(B组),均接受恩替卡韦治疗,检测基线、24周、48周、96周时2组的HBV DNA和HBs Ag水平,同时比较治疗前及96周的无创纤维化评分(SZFibro S模型)。结果治疗24周时A组、B组的病毒学应答(HBV DNA<100 IU/m L)分别是15/17、18/20,2组48,96周后病毒学应答没有进一步提高,2组比较无显著性差异。A组治疗前和治疗96周时,HBs Ag水平分别是(3.766±0.775)log10IU/m L和(3.207±0.415)log10IU/m L(P=0.041)。B组治疗前和治疗96周时,HBs Ag水平分别是(3.966±0.665)log 10IU/m L和(3.251±0.385)log10IU/m L(P=0.002)。但2组24周、48周、96周时HBs Ag下降的幅度无显著性差异。A组治疗前和治疗96周的SZFibro S评分分别是(5.75±0.42)和(5.70±0.54)(P=0.752)。B组治疗前和治疗96周的SZFibro S评分分别是(5.96±0.65)和(5.51±0.22)(P=0.007)。结论 ALT水平不影响恩替卡韦治疗HBe Ag阴性慢性乙型肝炎患者的病毒学应答及HBs Ag的下降。ALT水平可能与纤维化评分改善相关。
OBJECTIVE To observe efficacy of 2 years entecavir in patients with chronic hepatitis B of HBe Ag-negative and ALT<2ULN( upper limit of normal). METHODS A total of 37 patients in chronic hepatitis B of HBe Ag-negative and ALT<2ULN were recruited prospectively. All of them were treated with entecavir for 2 years. There were 17 patients with ALT<2ULN( group A),the others were ALT>2ULN( group B). Levels of HBV DNA and HBs Ag were tested at baseline,24 w,48 w and 96 w. The noninvasive liver fibrosis score( SZFibro S'model) of two groups were compared at baseline and 96 w. RESULTS At 24 w of treatment,the virological response( VR,HBV DNA<100 IU / m L) were 15 /17 and 18 /20,in group A and group B,respectively. VR of 2 groups did not improve at 48 w and 96 w. There was no statistically significant difference between VR of the 2 groups. HBs Ag levels of group A were( 3. 766±0. 775) log10 IU / m L and( 3. 207±0. 415) log10 IU / m L at baseline and 96 w( P = 0. 041). In group B,HBs Ag levels were( 3. 966±0. 665) log10 IU / m L and( 3. 251 ± 0. 385) log10 IU / m L at baseline and 96 w( P = 0. 002). There was no statistically significant difference between 2 group's range of HBs Ag decline at 24 w,48 w and 96 w. The score of SZFibro S model of patients in group A were( 5. 75±0. 42) and( 5. 70±0. 54)( P = 0. 752),the score of group B were( 5. 96 ±0. 65) and( 5. 51 ±0. 22)( P = 0.007),at baseline and 96 w. CONCLUSION ALT levels do not affect VR and HBs Ag decline with entecavir in patients with chronic hepatitis B of HBe Ag-negative and ALT<2ULN. The improvement of fibrosis score may be associated with ALT levels.
关键词(KeyWords):
丙氨酸氨基转移酶;肝炎;乙型;慢性;恩替卡韦
ALT;hepatitis B;chronic;entecavir
基金项目(Foundation): 广东省药学会肝炎用药研究基金资助项目(2012G26)
作者(Author):
敖飞健,何清,张斌,白冰,唐奇远,李知玉,廖雪姣,唐蔚
AO Feijian,HE Qing,ZHANG Bin,BAI Bing,TANG Qiyuan,LI Zhiyu,LIAO Xuejiao,TANG Wei
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