A one-year trial of lamivudine for chronic hepatitis B
A one-year trial of lamivudine for chronic hepatitis B
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DOI：
10.1056/nejm199807093390201
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发表时间：
1998-07-09
影响因子：
158.5
通讯作者：
Gray, DF
中科院分区：
文献类型：
--
作者：
Lai, CL;Chien, RN;Gray, DF
背景和方法在初步试验中，拉米夫定，一种口服核苷类似物，已显示出治疗慢性B型肝炎的前景。我们对358例中国慢性B型肝炎患者进行了为期一年的拉米夫定双盲试验。这些患者被随机分配接受25 mg拉米夫定（142例），100 mg拉米夫定（143例），或安慰剂（73例）口服每日一次。患者在进入研究前和完成指定的治疗方案后进行肝活检。主要终点是Knodell坏死性炎症评分至少降低2分。结果接受100 mg拉米夫定的患者中有56%的患者肝脏坏死性炎症活动改善2分或更多，接受25 mg拉米夫定的患者中有49%的患者，接受安慰剂的患者中有25%的患者（P
Background and Methods In preliminary trials, lamivudine, an oral nucleoside analogue, has shown promise for the treatment of chronic hepatitis B. We conducted a one-year, double-blind trial of lamivudine in 358 Chinese patients with chronic hepatitis B. The patients were randomly assigned to receive 25 mg of lamivudine (142 patients), 100 mg of lamivudine (143), or placebo (73) orally once daily. The pa tients underwent liver biopsies before entering the study and after completing the assigned treatment regimen. The primary end point was a reduction of at least two points in the Knodell necroinflammatory score.Results Hepatic necroinflammatory activity improved by two points or more in 56 percent of the patients receiving 100 mg of lamivudine, 49 percent of those receiving 25 mg of lamivudine, and 25 percent of those receiving placebo (P