Lai Ching-Lung, Yuen Man-Fung, Hui Chee-Kin, Garrido-Lestache Silvia, Cheng Charles Tze-Kin, Lai Yim-Ping
Department of Medicine, Queen Mary Hospital, Hong Kong.
J Med Virol. 2002 Jul;67(3):334-8. doi: 10.1002/jmv.10075.
Lamivudine therapy improves hepatic necro-inflammatory activity, decreases progression of fibrosis, and suppresses hepatitis B virus (HBV) replication. Famciclovir has also been shown to have some effect in the suppression of HBV replication. The aim of the study was to compare the effect of treatment with lamivudine and famciclovir on serum HBV DNA levels in patients with chronic hepatitis B and to assess safety. A prospective randomised clinical study was carried out on 100 patients with chronic hepatitis B infection (50 patients received lamivudine 100 mg daily and 50 patients received famciclovir 500 mg three times a day for 12 weeks. From the twelfth week onwards, patients were offered lamivudine 100 mg daily up to 48 weeks). Significantly more patients treated by lamivudine than by famciclovir had undetectable HBV DNA levels after 12 weeks of therapy (P < 0.001). The median HBV DNA levels were significantly lower in the lamivudine-treated patients from the second week of treatment onwards (P < 0.001 for all time points up to 12 weeks). At week 16, 4 weeks after the famciclovir treated patients were put on lamivudine, there was no longer any difference in HBV DNA levels between the two groups of patients. Both treatments were well tolerated and no serious adverse events were reported. It was concluded that in Chinese patients with chronic hepatitis B infection, lamivudine achieved effective suppression of HBV DNA levels within 4 weeks of therapy whereas famciclovir had a significantly weaker action.
拉米夫定治疗可改善肝脏坏死性炎症活动,减少纤维化进展,并抑制乙型肝炎病毒(HBV)复制。泛昔洛韦也已显示出在抑制HBV复制方面有一定作用。本研究的目的是比较拉米夫定和泛昔洛韦治疗对慢性乙型肝炎患者血清HBV DNA水平的影响并评估安全性。对100例慢性乙型肝炎感染患者进行了一项前瞻性随机临床研究(50例患者每天接受100 mg拉米夫定治疗,50例患者每天3次、每次500 mg泛昔洛韦治疗,疗程为12周。从第12周起,为患者提供每天100 mg拉米夫定,直至48周)。治疗12周后,接受拉米夫定治疗的患者中HBV DNA水平检测不到的人数显著多于接受泛昔洛韦治疗的患者(P<0.001)。从治疗第2周起,拉米夫定治疗组患者的HBV DNA水平中位数显著更低(直至12周的所有时间点P<0.001)。在第16周,即泛昔洛韦治疗的患者改用拉米夫定4周后,两组患者的HBV DNA水平不再有差异。两种治疗耐受性均良好,未报告严重不良事件。结论是,对于中国慢性乙型肝炎感染患者,拉米夫定在治疗4周内即可有效抑制HBV DNA水平,而泛昔洛韦的作用明显较弱。