Arase Yasuji, Tsubota Akihito, Suzuki Yoshiyuki, Suzuki Fumitaka, Kobayashi Masahiro, Someya Takashi, Akuta Norio, Hosaka Tetsuya, Saitoh Satoshi, Ikeda Kenji, Kobayashi Mariko, Kumada Hiromitsu
Department of Gastroenterology, Toranomon Hospital, Tokyo.
Intern Med. 2003 Oct;42(10):941-6. doi: 10.2169/internalmedicine.42.941.
The efficacy of thymosin alpha 1 (Talpha1) in patients with chronic hepatitis B still requires confirmation. We, therefore, evaluated the efficacy of therapy in patients with chronic hepatitis B.
Sixteen patients were randomly assigned into one of two groups, treated with 0.8 mg of Talpha1 (low dose group; n = 8) or 1.6 mg Talpha1 (high dose group; n = 8), administered six times weekly for two weeks, followed by twice weekly for another 22 weeks. Responders were defined as patients having clearance of hepatitis B e antigen by radioimmunoassay and negativity of hepatitis B virus (HBV)-DNA by branched DNA signal amplification and normalization of serum alanine aminotransferase (ALT) 24 months after initiation of Talpha1 therapy. Transient acute exacerbation was defined as an increase of more than 300 IU/I in serum ALT level during Talpha1 therapy.
The response rate was 37.5% (6/16). Talpha1 therapy had a significant effect when, 1) transient acute exacerbation was present (p = 0.0029), 2) the serum HBV-DNA level was < 100 Meq/ml prior to the commencement of Talpha1 therapy (p = 0.0063). The difference between low and high dose groups was not statistically significant (p = 0.608).
The results of this trial show that: 1) a 24-week course of Talpha1 could be a worthwhile strategy for chronic hepatitis B patients with a serum HBV-DNA level of less than 100 Meq/ml; and 2) patients with a transient acute exacerbation during Talpha1 therapy generally often respond well.
胸腺肽α1（Tα1）对慢性乙型肝炎患者的疗效仍需确认。因此，我们评估了其对慢性乙型肝炎患者的治疗效果。
16例患者被随机分为两组，分别接受0.8mg Tα1治疗（低剂量组；n = 8）或1.6mg Tα1治疗（高剂量组；n = 8），每周给药6次，持续2周，之后每周给药2次，持续22周。应答者定义为在开始Tα1治疗24个月后，通过放射免疫分析清除乙肝e抗原、通过分支DNA信号扩增法检测乙肝病毒（HBV）-DNA呈阴性且血清丙氨酸氨基转移酶（ALT）恢复正常的患者。短暂急性加重定义为在Tα1治疗期间血清ALT水平升高超过300IU/I。
应答率为37.5%（6/16）。当出现以下情况时，Tα1治疗具有显著效果：1）存在短暂急性加重（p = 0.0029）；2）在开始Tα1治疗前血清HBV-DNA水平<100Meq/ml（p = 0.0063）。低剂量组和高剂量组之间的差异无统计学意义（p = 0.608）。
本试验结果表明：1）对于血清HBV-DNA水平低于100Meq/ml的慢性乙型肝炎患者，24周的Tα1疗程可能是一种值得采用的治疗策略；2）在Tα1治疗期间出现短暂急性加重的患者通常反应良好。
