Miles S A, Wang H J, Cortes E, Carden J, Marcus S, Mitsuyasu R T
UCLA AIDS Center.
Ann Intern Med. 1990 Apr 15;112(8):582-9. doi: 10.7326/0003-4819-112-8-582.
To study the efficacy of high doses of beta-ser-interferon (recombinant human 17-serine beta-interferon) in patients with human immunodeficiency virus (HIV) infection and Kaposi sarcoma.
A nonrandomized, controlled trial of two high-dose regimens of beta-ser-interferon administered until tumor progression, toxicity, or an acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection occurred.
An AIDS treatment clinic at a tertiary care center.
A sequential sample of 39 patients with biopsy-proven, AIDS-related Kaposi sarcoma were enrolled during a 2-year period. Thirty-eight patients were evaluable for response. Most patients (35 of 38) had one or more of the following clinical or laboratory predictors for a poor response to interferon therapy: HIV p24 antigenemia, low CD4 cell numbers, elevated beta 2-microglobulin levels, previous opportunistic infections, or previous systemic chemotherapy.
Beta-ser-interferon was self-administered subcutaneously at home 5 days per week. The first 21 patients used 90 million IU/d, and the remainder used 180 million IU/d.
Six patients (16%) had a major clinical response, and 15 (39%) had stable disease for prolonged periods. Toxicities were minimal; the major toxicity was a skin reaction at the injection site. The HIV p24 antigen level declined more than 50% in 8 of the 19 patients with initial values greater than 50 pg/mL. Antiretroviral activity and antitumor activity were seen only in patients with normal initial beta 2-microglobulin levels. Minimal changes were seen in CD4 and CD8 cell numbers. Only 1 patient had an opportunistic infection while on study, but five other patients developed infections after treatment was discontinued for an incidence of six opportunistic infections in 285 patient-observation months.
The high doses of interferon did not improve the major response rate in patients with poor-prognosis, AIDS-related Kaposi sarcoma. There was, however, a suggestion of antiviral activity in patients with normal beta 2-microglobulin levels and a decrease in the expected incidence of opportunistic infections.
研究高剂量β-丝氨酸干扰素（重组人17-丝氨酸β-干扰素）对人类免疫缺陷病毒（HIV）感染合并卡波西肉瘤患者的疗效。
一项非随机对照试验，采用两种高剂量β-丝氨酸干扰素方案，持续给药直至肿瘤进展、出现毒性反应或发生获得性免疫缺陷综合征（AIDS）定义的机会性感染。
一家三级医疗中心的艾滋病治疗诊所。
在两年期间，连续纳入39例经活检证实为艾滋病相关卡波西肉瘤的患者。38例患者可评估疗效。大多数患者（38例中的35例）具有以下一项或多项临床或实验室指标，提示对干扰素治疗反应不佳：HIV p24抗原血症、CD4细胞数量低、β2-微球蛋白水平升高、既往机会性感染或既往全身化疗。
β-丝氨酸干扰素由患者每周5天在家自行皮下注射。前21例患者使用9000万国际单位/天，其余患者使用1.8亿国际单位/天。
6例患者（16%）有主要临床反应，15例（39%）病情长期稳定。毒性反应轻微；主要毒性反应为注射部位皮肤反应。19例初始值大于50 pg/mL的患者中，8例患者的HIV p24抗原水平下降超过50%。仅在初始β2-微球蛋白水平正常的患者中观察到抗逆转录病毒活性和抗肿瘤活性。CD4和CD8细胞数量变化极小。研究期间仅1例患者发生机会性感染，但另外5例患者在治疗中断后发生感染，在285个患者观察月中机会性感染发生率为6例。
高剂量干扰素并未提高预后不良的艾滋病相关卡波西肉瘤患者的主要反应率。然而，对于β2-微球蛋白水平正常的患者，有抗病毒活性的迹象，且机会性感染的预期发生率有所降低。
