A randomized controlled trial of lamivudine to treat acute hepatitis B
A randomized controlled trial of lamivudine to treat acute hepatitis B
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DOI：
10.1002/hep.21486
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发表时间：
2007-01-01
期刊：
影响因子：
13.5
通讯作者：
Sarin, S. K.
中科院分区：
文献类型：
--
作者：
Kumar, M.;Satapathy, S.;Sarin, S. K.
抗病毒药物在急性病毒性肝炎B（AVH-B）患者中的作用尚未在对照试验中进行评估。本研究的目的是评价拉米夫定在AVH-B患者中的疗效。血清胆红素超过5 mg/dL的AVH-B患者随机接受拉米夫定100 mg/d（第1组，n = 31）或安慰剂（第2组，n = 40）治疗3个月。如果患者符合3个标准中的2个，则认为他们患有重度AVH-B：（1）肝性脑病;（2）血清胆红素：10.0 mg/dL;和（3）国际标准化比值（INR）≥ 1.6。第4周时，组1（中位数：3.6721 log copies/mL）的HBV DNA水平显著低于组2（中位数：4.2721 log copies/mL）（P = 0.037）。此后，两组的HBV DNA水平相当。两组血清胆红素、ALT和INR值的改善相似。第1组22例患者（71%）和第2组25例患者（62.5%）患有重度AVH-13。单独分析重度AVH-B患者的结果相似。12个月和18个月后，拉米夫定组分别有93.5%和92.5%的患者，安慰剂组分别有96.7%和97.5%的患者HBsAg消失。两组均无死亡。1年后，组I中21例（67.7%）和组2中34例（85%）患者产生保护性抗-HBs滴度（P = 0.096）。两组中所有HBeAg阳性患者均丧失e抗原，I组和2组中分别有71%和87.5%的患者出现抗-HBe（P = 0.132）。结论：虽然拉米夫定可使HBV DNA水平显著降低，但在急性B型肝炎患者中，与安慰剂相比，拉米夫定并不能显著改善生化和临床症状。
The role of antivirals in patients with acute viral hepatitis B (AVH-B) has not been evaluated in controlled trials. The aim of this study was to evaluate the efficacy of lamivudine in patients with AVH-B. AVH-B patients with serum bilirubin of more than 5 mg/dL were randomized to receive either 100 mg of lamivudine daily for 3 months (group 1, n = 31) or placebo (group 2, n = 40). Patients were considered to have severe AVH-B if they fulfilled 2 of 3 criteria: (1) hepatic encephalopathy; (2) serum bilirubin : 10.0 mg/dL; and (3) international normalized ratio (INR) >= 1.6. At week 4, HBV DNA levels were significantly lower (P = 0.037) in group 1 (median: 3.6721 log copies/mL) than group 2 (median: 4.2721 log copies/mL). Thereafter, HBV DNA levels were comparable in the 2 groups. The improvement in serum bilirubin, ALT, and INR values was similar in the 2 groups. Twenty-two patients (71%) in group 1 and 25 patients (62.5%) in group 2 had severe AVH-13. Results were similar when patients with severe AVH-B were analyzed separately. After 12 and 18 months, 93.5% and 92.5%, respectively, of patients in the lamivudine group and 96.7% and 97.5%, respectively, of patients in the placebo group lost HBsAg. There were no deaths in either group. After 1 year, 21 patients (67.7%) in group I and 34 patients (85%) in group 2 developed protective anti-HBs titers (P = 0.096). All HBeAg-positive patients in both groups lost e antigen and anti-HBe developed in 71% and 87.5% of patients in groups I and 2, respectively (P = 0.132). Conclusion: Though lamivudine causes a greater decrease in levels of HBV DNA, it does not cause significantly greater biochemical and clinical improvement as compared to placebo in patients with acute hepatitis B.