Vassiliadis T, Nikolaidis N, Giouleme O, Tziomalos K, Grammatikos N, Patsiaoura K, Zezos P, Gkisakis D, Theodoropoulos K, Katsinelos P, Orfanou-Koumerkeridou E, Eugenidis N
2nd Propaedeutic Department of Internal Medicine, Aristotle University of Thessaloniki, Hippokration General Hospital, Thessaloniki, Greece.
Aliment Pharmacol Ther. 2005 Mar 1;21(5):531-7. doi: 10.1111/j.1365-2036.2005.02388.x.
Long-term treatment with lamivudine is required to control viral replication in patients with hepatitis B e antigen-negative chronic hepatitis B, but is associated with a high rate of viral resistance. The role of adefovir dipivoxil in these patients has not been definitively evaluated.
To address the role of adefovir in the management of patients with lamivudine-resistant hepatitis B e antigen-negative chronic hepatitis B.
Patients were assigned to receive adefovir 10 mg once daily plus ongoing lamivudine 100 mg once daily for 52 weeks. The primary end point was reduction in serum hepatitis B virus DNA level (hepatitis B virus DNA response). Secondary end points included the proportion of patients with undetectable hepatitis B virus DNA at week 52 (complete virological response) and the percentage of patients with normalization of alanine transferase level at week 52 (biochemical response).
A total of 49 consecutive patients were enrolled in this study. After 52 weeks of treatment, all patients had an hepatitis B virus DNA response and 57.1% had complete virological response. Biochemical response occurred in 75.6% of patients.
Administration of adefovir in patients with lamivudine-resistant chronic hepatitis B results in significant suppression of viral replication. Nevertheless, continuous therapy will probably be needed in order to maintain remission in these patients.
对于乙肝e抗原阴性慢性乙型肝炎患者，需要长期使用拉米夫定来控制病毒复制，但这与高病毒耐药率相关。阿德福韦酯在这些患者中的作用尚未得到明确评估。
探讨阿德福韦在拉米夫定耐药的乙肝e抗原阴性慢性乙型肝炎患者治疗中的作用。
患者被分配接受每日一次10mg阿德福韦加持续每日一次100mg拉米夫定治疗，为期52周。主要终点是血清乙肝病毒DNA水平降低（乙肝病毒DNA反应）。次要终点包括第52周时乙肝病毒DNA检测不到的患者比例（完全病毒学反应）以及第52周时丙氨酸转氨酶水平正常化的患者百分比（生化反应）。
本研究共纳入49例连续患者。治疗52周后，所有患者均有乙肝病毒DNA反应，57.1%有完全病毒学反应。75.6%的患者出现生化反应。
对拉米夫定耐药的慢性乙型肝炎患者给予阿德福韦可显著抑制病毒复制。然而，可能需要持续治疗以维持这些患者的病情缓解。
