Smith C I, Kitchen L W, Scullard G H, Robinson W S, Gregory P B, Merigan T C
JAMA. 1982 Apr 23;247(16):2261-5.
Ten young adult patients with chronic hepatitis B virus infection and positive hepatitis B e antigen and DNA polymerase (DNAP) levels were treated with alternating courses of seven to 28 days of 5 to 7.5 mg/kg of vidarabine monophosphate (adenine arabinoside monophosphate) and 28 days of human leukocyte interferon (IFN-alpha); three different regimens were given on an outpatient basis. All patients with a fall in their DNAP level, and the DNAP remained undetectable six months after treatment was stopped in one patient. The major side effect, which most often occurred in those patients receiving 7.5 mg/kg of vidarabine monophosphate, was severe muscular pains. This study demonstrated the feasibility of administering vidarabine monophosphate and interferon to outpatients. Based on data from this and other studies, it is now possible to use a relatively nontoxic regimen that includes 28 days of 5 mg/kg of vidarabine monophosphate in a larger controlled study to answer the question of efficacy.
十名慢性乙型肝炎病毒感染、乙肝e抗原和DNA聚合酶(DNAP)水平呈阳性的年轻成年患者,接受了为期7至28天、剂量为5至7.5毫克/千克的单磷酸阿糖腺苷(阿糖腺苷单磷酸)与为期28天的人白细胞干扰素(IFN-α)交替疗程的治疗;三种不同方案在门诊进行给药。所有患者的DNAP水平均有所下降,且在一名患者停止治疗六个月后,DNAP仍检测不到。主要副作用最常发生在接受7.5毫克/千克单磷酸阿糖腺苷治疗的患者中,为严重肌肉疼痛。本研究证明了对门诊患者给予单磷酸阿糖腺苷和干扰素的可行性。基于本研究及其他研究的数据,现在有可能在一项更大规模的对照研究中使用一种相对无毒的方案,该方案包括28天、剂量为5毫克/千克的单磷酸阿糖腺苷,以回答疗效问题。