摘要
目的对替比夫定（LDT）初始单用及联用阿德福韦酯（ADV）治疗HBeAg阳性慢性乙型肝炎（CHB）抗病毒的长期效果、安全性进行回顾性研究。方法将140例HBeAg阳性慢性乙型肝炎患者随机分为初始单用组（LDT，75例）和初始联用组（LDT加ADV，65例）。初始单用组给予LDT600rag，口服，1次／d；初始联用组给予LDT600mg联合ADV10nag，口服，1次／d。疗程最短96周、最长240周。观察两组疗效、耐药发生率、不良反应情况，检测不同时段HBV血清学标志物、HBVDNA定量、肝功能、肾功能、肌酶等。计量资料比较用t检验；计数资料比较采用x2检验。结果12周时HBVDNA下降≥2log10拷贝／ml的百分比，单用组及联用组分别为86．7％（65／75）、92．3％（60／65），24周HBVDNA阴转率分别为62．戳、61．5％，48周HBVDNA阴转率分别为76．0%、81．5％，96周HBVDNA阴转率分别为80．0%、89．2%，至240周HBVDNA阴转率分别为93．3％、88．90／o，两组间比较，各时间点尸值均〉0．05，差异均无统计学意义，两组均有较高的早期、快速、持久HBVDNA阴转率；单用组HBVDNA阴转率24周与96周及以上各时间点比较，差异均有统计学意义（x2值分别为5．51、3．86、5．81、9．87，P值均〈0．05），联用组HBVDNA阴转率24周与48周及以上各时间点比较，差异均有统计学意义（石。值分别为6．38、6．38、10．19、4．11，P值均〈0．05）。单用组、联用组HBeAg血清学转换率在48周分别为29．3％、30．8％，96周分别为42．70／0、40．O％，144周分别为55．毗、43．3％，192周分别为55．8％、66．7％，240周分别为63．3％、66．70%，两组间各时点两两比较差异无统计学意义p值均〉0．05）；两组组内24周与48周比较，差异无统计学意义（P〉0．05），但在24周与96周分别比较（x2值分别为11．46、4．31），与144周分别比较（x。值分别为21．05、4．05
Objective To prospectively observe the long-term antiviral efficacy and safety of telbivudine （LDT） administered as a monotheraov and as a combination therapy with adefovir dioivoxil（ADV） in patients diagnosed with chronic hepatitis B （CHB） and positivity for hepatitis B e antigen （HBeAg）. Methods A total of 140 patients with HBeAg-positive CHB were randomly divided into treatment groups for LDT monotherapy （11 = 75; 600 mg orally, once daily） and LDT＋ADV combination therapy （n = 65; LDT 600 mg plus ADV 10 mg orally, once daily）. The shortest treatment course was 96 weeks and the longest was 240 weeks. At treatment weeks 12, 24, 48, 96, 144, 192, and 240 patients were tested for hepatitis B virus （HBV） DNA, HBeAg seroconversion and ALT normalization time; in addition, the incidencc and type of adverse drug reactions were recorded. Data were statistically analyzed to determine the significance of differences observed between groups. Results The rate of patients experiencing ≥ 2 log I-IBV DNA reduction was higher in the LDT ＋ ADV group （92.3%（60/65） vs. LDT： 86.7%（65/75）,Z2 = 1.58）. The HBV DNA negative rates of the LDT and LDT ＋ ADV groups were 62.7% and 61.5% （2,2 = 0.01） at week 24, 76.0% and 81.5% （x2 = 0.63） at week 48, 80.0% and 89.2% （x2 = 2.2） at week 96, 78.3% and 93.3% （x2 = 3.24） at week 144, 83.7% and 91.7% （x2 = 0.47） at week 192, and 93.3% and 88.9% at week 240 （comparison between two groups for each point P 〉 0.05）; both groups showed higher early and rapid sustained HBV DNA negative rates. For the HBeAg seroconvcrsion, the rates of the LDT and LDT ＋ ADV groups were 17.3% and 23.1% （x2 = 0.71） at week 24, 29.3% and 30.8% （x2 = 0.03） at week 48, 42.7% and 40.0% （x2 = 0.10） at week 96, 55.0% and 43.3% （x2 = 1.08） at week 144, 55.8% and 66.7% （2J = 0.45） at week 192, and 63.3% and 66.7% at week 240; however, pairwise comparison showed no statistically significant differences between the groups （P 〉 0.05
出处
《中华肝脏病杂志》
CAS
CSCD
北大核心
2014年第3期181-184,共4页
Chinese Journal of Hepatology
关键词
肝炎
乙型
慢性
肝炎e抗原
乙型
治疗学
Hepatitis B, chronic
Hepatitis B e antigens
Therapeutics
