中华实验和临床感染病杂志(电子版)
中華實驗和臨床感染病雜誌(電子版)
중화실험화림상감염병잡지(전자판)
CHINESE JOURNAL OF EXPERIMENTAL AND CLINICAL INFECTIOUS DISEASES(ELECTRONIC VERSION)
2014年
1期
32-36
,共5页
黄明星%吴元凯%时红%揭育胜%李向永%林国莉%崇雨田
黃明星%吳元凱%時紅%揭育勝%李嚮永%林國莉%崇雨田
황명성%오원개%시홍%게육성%리향영%림국리%숭우전
肝炎,乙型,慢性%替比夫定%恩替卡韦
肝炎,乙型,慢性%替比伕定%恩替卡韋
간염,을형,만성%체비부정%은체잡위
Hepatitis B,chronic%Telbivudine%Entecavir
目的:替比夫定(LdT)和恩替卡韦(ETV)是我国常用的强效抗病毒药物,探讨其在慢性乙型肝炎(CHB)中实际临床应用的疗效特点及安全性。方法前瞻性随访观察LdT组50例、ETV组52例的慢性乙型肝炎初治患者144周,比较两组患者治疗12、24、36、48、72、96和144周时HBV DNA定量水平及低于检测下限的比率、HBV DNA低于检测下限的中位时间及观察终点时ALT复常率、HBeAg血清学转换率、完全病毒学应答率(CVR)、病毒学突破率(VBT)指标及不良事件的发生率。结果第12、24、36周HBV DNA定量水平LdT组患者均高于ETV组,HBV DNA低于检测下限的比率ETV组高于LdT组,差异均具有统计学意义(均P<0.05);而第48、72、96、144周则两组差异均无统计学意义。HBV DNA低于检测下限的中位时间;LdT组为24.0(12.0~92.0)周,大于ETV组的12.0(4.0~52.0)周,差异具有统计学意义(P<0.001)。LdT组中有9例(18.0%)CK曾大于3倍正常值上限(3× ULN)以上,而ETV组则仅有2例(3.9%)CK大于3× ULN,差异具有统计学意义(P=0.003)。观察终点比较ALT复常率、HBeAg血清学转换率、CVR和VBT,两组差异均无统计学意义(均P>0.05)。结论 ETV初始单药治疗CHB患者比LdT能更快、更强抑制HBV复制且CK升高率较低,但ETV与LdT抑制HBV的远期疗效(大于36周)及ALT复常率、HBeAg血清学转换率、CVR和VBT比较差异无统计学意义。
目的:替比伕定(LdT)和恩替卡韋(ETV)是我國常用的彊效抗病毒藥物,探討其在慢性乙型肝炎(CHB)中實際臨床應用的療效特點及安全性。方法前瞻性隨訪觀察LdT組50例、ETV組52例的慢性乙型肝炎初治患者144週,比較兩組患者治療12、24、36、48、72、96和144週時HBV DNA定量水平及低于檢測下限的比率、HBV DNA低于檢測下限的中位時間及觀察終點時ALT複常率、HBeAg血清學轉換率、完全病毒學應答率(CVR)、病毒學突破率(VBT)指標及不良事件的髮生率。結果第12、24、36週HBV DNA定量水平LdT組患者均高于ETV組,HBV DNA低于檢測下限的比率ETV組高于LdT組,差異均具有統計學意義(均P<0.05);而第48、72、96、144週則兩組差異均無統計學意義。HBV DNA低于檢測下限的中位時間;LdT組為24.0(12.0~92.0)週,大于ETV組的12.0(4.0~52.0)週,差異具有統計學意義(P<0.001)。LdT組中有9例(18.0%)CK曾大于3倍正常值上限(3× ULN)以上,而ETV組則僅有2例(3.9%)CK大于3× ULN,差異具有統計學意義(P=0.003)。觀察終點比較ALT複常率、HBeAg血清學轉換率、CVR和VBT,兩組差異均無統計學意義(均P>0.05)。結論 ETV初始單藥治療CHB患者比LdT能更快、更彊抑製HBV複製且CK升高率較低,但ETV與LdT抑製HBV的遠期療效(大于36週)及ALT複常率、HBeAg血清學轉換率、CVR和VBT比較差異無統計學意義。
목적:체비부정(LdT)화은체잡위(ETV)시아국상용적강효항병독약물,탐토기재만성을형간염(CHB)중실제림상응용적료효특점급안전성。방법전첨성수방관찰LdT조50례、ETV조52례적만성을형간염초치환자144주,비교량조환자치료12、24、36、48、72、96화144주시HBV DNA정량수평급저우검측하한적비솔、HBV DNA저우검측하한적중위시간급관찰종점시ALT복상솔、HBeAg혈청학전환솔、완전병독학응답솔(CVR)、병독학돌파솔(VBT)지표급불량사건적발생솔。결과제12、24、36주HBV DNA정량수평LdT조환자균고우ETV조,HBV DNA저우검측하한적비솔ETV조고우LdT조,차이균구유통계학의의(균P<0.05);이제48、72、96、144주칙량조차이균무통계학의의。HBV DNA저우검측하한적중위시간;LdT조위24.0(12.0~92.0)주,대우ETV조적12.0(4.0~52.0)주,차이구유통계학의의(P<0.001)。LdT조중유9례(18.0%)CK증대우3배정상치상한(3× ULN)이상,이ETV조칙부유2례(3.9%)CK대우3× ULN,차이구유통계학의의(P=0.003)。관찰종점비교ALT복상솔、HBeAg혈청학전환솔、CVR화VBT,량조차이균무통계학의의(균P>0.05)。결론 ETV초시단약치료CHB환자비LdT능경쾌、경강억제HBV복제차CK승고솔교저,단ETV여LdT억제HBV적원기료효(대우36주)급ALT복상솔、HBeAg혈청학전환솔、CVR화VBT비교차이무통계학의의。
Objective To compare the clinical efifcacy and safety of telbivudine (LdT) and entecavir (ETV) for nucleos(t)ide analogues (NAs) naive patients with chronic HBV infection. Methods LdT group (50 cases) and ETV group (52 cases) were investigated for 144 weeks, prospectively. Quantitative HBV DNA (qHBV DNA), the rate of undetectable HBV DNA (uHBV DNA%) and the median time of HBV DNA negative conversion (mHBV DNA) were determined at 12, 24, 36, 48, 72, 96 and 144 weeks. Serum ALT normalization rate, HBeAg seroconversion rate, viral breakthrough (VBT), the rates of complete viral response (CVR) and the incidences of adverse events of the two groups were determined at the end of follow-up, respectively. Results qHBV DNA and uHBV DNA%were signiifcantly difference at 12, 24 and 36 weeks (all P<0.05), but without signiifcantly difference at 48, 72, 96 and 144 weeks (all P>0.05). The mHBV DNA in LdT treatment group was 24.0 (12.0-92.0) weeks, signiifcantly longer than that of 12.0 (4.0-52.0) weeks of the ETV treatment group (P<0.001). Creatine kinase (CK) in 9 (18.0%) cases of LdT reatment group was more than 3 times upper limit normal (3 × ULN), while only 2 (3.9%) cases in ETV reatment group more than 3 × ULN (P=0.003). There were no significant difference in serum ALT normalization rate, HBeAg seroconversion rate, VBT and CVR between the two groups (all P>0.05). Conclusions ETV monotherapy was faster and more potent in HBV DNA suppression in the early stage (no more than 36 weeks) and showed lower incidences of CK elevated in NAs naive patents when compared to telbivudine, while there is no signiifcant difference in the ALT normalization, HBeAg conversion rate, CVR and VBT.