Lamivudine as initial treatment for chronic hepatitis B in the United States
Lamivudine as initial treatment for chronic hepatitis B in the United States
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DOI：
10.1056/nejm199910213411702
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发表时间：
1999-10-21
影响因子：
158.5
通讯作者：
Brown, NA
中科院分区：
文献类型：
--
作者：
Dienstag, JL;Schiff, ER;Brown, NA
背景：虽然核苷类似物拉米夫定在慢性乙肝患者中的应用前景看好，但美国患者的长期数据缺乏。方法我们随机分配了以前未接受治疗的慢性乙型肝炎患者，每天服用100 mg拉米夫定或安慰剂，持续52周。然后，我们又对他们进行了16周的跟踪调查，以评估治疗后的安全性和反应的持久性。就疗效而言，主要终点是组织学活动指数评分至少降低2分。结果在143例随机患者中，137例进入疗效分析：拉米夫定组66例，安慰剂组71例。其他6名患者在基线访问中被排除在外，因为至少有6个月没有记录的乙肝表面抗原病史。治疗52周后，接受拉米夫定治疗的患者比接受安慰剂治疗的患者更有可能出现组织学反应(52%比23%，P
Background Although the nucleoside analogue lamivudine has shown promise in patients with chronic hepatitis B, long-term data on patients from the United States are lacking.Methods We randomly assigned previously untreated patients with chronic hepatitis B to receive either 100 mg of oral lamivudine or placebo daily for 52 weeks. We then followed them for an additional 16 weeks to evaluate post-treatment safety and the durability of responses. The primary end point with respect to efficacy was a reduction of at least 2 points in the score on the Histologic Activity Index. On this scale, scores can range from 0 (normal) to 22 (most severe abnormalities).Results Of the 143 randomized patients, 137 were included in the efficacy analysis: 66 in the lamivudine group and 71 in the placebo group. The other six patients were excluded at the base-line visit because of the absence of a documented history of hepatitis B surface antigen for at least six months. After 52 weeks of treatment, lamivudine recipients were more likely than placebo recipients to have a histologic response (52 percent vs. 23 percent, P