恩替卡韦与拉米夫定用于初治慢性乙型肝炎患者的疗效和安全性：中国的一项随机、双盲试验。
Efficacy and safety of entecavir compared to lamivudine in nucleoside-naïve patients with chronic hepatitis B: a randomized double-blind trial in China.
机构信息
Shanghai Jing An Qu Central Hospital, No. 259 Xikang Rd, Shanghai, 200040, China,
出版信息
Hepatol Int. 2007 Sep;1(3):365-72. doi: 10.1007/s12072-007-9009-2. Epub 2007 Jul 31.
BACKGROUND/AIMS: Chronic hepatitis B has a high prevalence (>8%) in China. We compared the safety and efficacy of entecavir with that of lamivudine for the treatment of patients with chronic hepatitis B in China.
METHODS
A total of 519 nucleoside-naive Chinese patients with chronic hepatitis B were randomized (1:1) and treated with entecavir 0.5 mg/d or lamivudine 100 mg/d. The primary endpoint was serum HBV DNA <0.7 MEq/ml by bDNA assay and alanine aminotransferase <1.25 x upper limit of normal (ULN) at week 48. Patients with missing week 48 measurements were considered non-responders.
RESULTS
About 90% (231/258) of entecavir-treated versus 67% (174/261) of lamivudine-treated patients achieved the primary endpoint (P < 0.0001). The mean reduction from baseline in HBV DNA was greater with entecavir than lamivudine (5.90 vs. 4.33 log(10) copies/ml, P < 0.0001). Greater proportions of entecavir-treated patients achieved undetectable HBV DNA (<300 copies/ml) by polymerase chain reaction assay (76% vs. 43%, P < 0.0001) and alanine aminotransferase normalization (</=1 x ULN, 90% vs. 78%, P = 0.0003). Entecavir and lamivudine achieved comparable rates of HBeAg seroconversion (15% and 18%, respectively). Safety was comparable between the two treatments.
CONCLUSIONS
For nucleoside-naïve Chinese patients with chronic hepatitis B, entecavir achieves superior virological and biochemical benefit over lamivudine, with a comparable safety profile.
背景/目的：慢性乙型肝炎在中国的发病率较高（>8%）。我们比较了恩替卡韦和拉米夫定治疗中国慢性乙型肝炎患者的安全性和疗效。
方法
共有 519 名初治的中国慢性乙型肝炎患者被随机（1:1）分为恩替卡韦 0.5mg/d 或拉米夫定 100mg/d 组。主要终点是用 bDNA 法检测血清 HBV DNA <0.7 MEq/ml 和丙氨酸氨基转移酶（ALT）<1.25 x 正常值上限（ULN）在第 48 周。未测到第 48 周的患者被认为是无应答者。
结果
约 90%（231/258）的恩替卡韦治疗组和 67%（174/261）的拉米夫定治疗组达到了主要终点（P<0.0001）。与拉米夫定相比，恩替卡韦治疗组的 HBV DNA 平均下降幅度更大（5.90 对 4.33 log(10)拷贝/ml，P<0.0001）。更多的恩替卡韦治疗组患者达到了用聚合酶链反应（PCR）法检测不到 HBV DNA（<300 拷贝/ml）（76% vs. 43%，P<0.0001）和 ALT 正常化（</=1 x ULN，90% vs. 78%，P=0.0003）。恩替卡韦和拉米夫定的 HBeAg 血清学转换率相当（分别为 15%和 18%）。两种治疗的安全性相当。
结论
对于初治的中国慢性乙型肝炎患者，恩替卡韦在病毒学和生化学方面优于拉米夫定，且安全性相当。
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