Saruc Murat, Ozden Nuri, Turkel Nurten, Ayhan Semin, Hock Lynette M, Tuzcuoglu Isil, Yuceyar Hakan
University of Nebraska Medical Center, Eppley Cancer Research Institute, Omaha, NE, USA.
J Pharm Sci. 2003 Jul;92(7):1386-95. doi: 10.1002/jps.10401.
Hepatitis B e antibody (HbeAb) and hepatitis B virus (HBV) DNA positive chronic hepatitis is a clinical entity, distinct from classical hepatitis B e antigen (HbeAg) positive chronic hepatitis B. Our aim was to evaluate the long-term therapeutic efficacy of the combination of interferon alpha-2b and thymosin-alpha1 compared with lamivudine plus interferon alpha-2b and interferon alpha-2b alone. Fifty-two patients with HbeAg-negative chronic hepatitis B were assigned to three different groups in a nonrandomized manner. Group 1 (n = 27) received thymosin-alpha1 [1.6 mg subcutaneously (sc), twice a week] and interferon alpha-2b (10 MIU sc, three times per week) for 26 weeks, subsequently followed by interferon alpha-2b monotherapy at the same dosage for an additional 26 weeks. Group 2 (n = 10) received interferon alpha-2b (10 MIU sc, three times per week) for 52 weeks. Group 3 (n = 15) received interferon alpha-2b (10 MIU sc, three times per week) and lamivudine [100 mg orally (po), q.d.] for 52 weeks, followed by continuous lamivudine (100 mg po, q.d.) therapy. By the end of 78 weeks, a sustained response (SR-6 mo) was seen in 74% (20/27) of the patients within Group 1. On the contrary, Groups 2 and 3 had sustained response rates of 40 (4/10) and 53.3% (8/15), respectively (p = 0.13). At the end of 12 months post-treatment in Group 1, a virological and biochemical response rate was seen in 70.3% of patients (19/27); in contrast, Groups 2 and 3 had response rates of 20 (2/10) and 26.6% (4/15), respectively (p = 0036). At the end of the 18-month post-treatment follow-up period, 71.4% (19/27) of patients in Group 1, 10% of patients in Group 2 (1/10), and 20% of patients in Group 3(3/15) preserved their sustained response (p = 0.0003). Interferon alpha-2b and thymosin-alpha1 combination therapy results in significant virological and biochemical response rates compared with standard therapeutic regimens and is well tolerated.
乙肝e抗体（HbeAb）和乙肝病毒（HBV）DNA阳性的慢性肝炎是一种临床实体，有别于典型的乙肝e抗原（HbeAg）阳性慢性乙型肝炎。我们的目的是评估α-2b干扰素与胸腺肽α-1联合使用、拉米夫定加α-2b干扰素以及单独使用α-2b干扰素的长期治疗效果。52例HbeAg阴性慢性乙型肝炎患者以非随机方式被分为三组。第1组（n = 27）接受胸腺肽α-1[皮下注射（sc）1.6mg，每周两次]和α-2b干扰素（sc10MIU，每周三次）治疗26周，随后以相同剂量继续接受α-2b干扰素单药治疗26周。第2组（n = 10）接受α-2b干扰素（sc10MIU，每周三次）治疗52周。第3组（n = 15）接受α-2b干扰素（sc10MIU，每周三次）和拉米夫定[口服（po）100mg，每日一次]治疗52周，随后继续拉米夫定（po100mg，每日一次）治疗。到78周结束时，第1组74%（20/27）的患者出现持续应答（SR - 6个月）。相反，第2组和第3组的持续应答率分别为40%（4/10）和53.3%（8/15）（p = 0.13）。在第1组治疗后12个月结束时，70.3%的患者（19/27）出现病毒学和生化应答；相比之下，第2组和第3组的应答率分别为20%（2/10）和26.6%（4/15）（p = 0.036）。在治疗后18个月的随访期结束时，第1组71.4%（(19/27）的患者、第2组10%的患者（1/10）和第3组20%的患者（3/15）保持持续应答（p = 0.0003）。与标准治疗方案相比，α-2b干扰素和胸腺肽α-1联合治疗可产生显著的病毒学和生化应答率，且耐受性良好。
