Cheer Susan M, Goa Karen L
Adis International Limited, Mairangi Bay, Auckland, New Zealand.
Drugs. 2002;62(18):2667-74; discussion 2675-6. doi: 10.2165/00003495-200262180-00013.
Stavudine administered once daily is a nucleoside analogue reverse transcriptase inhibitor. The efficacy (reduction in viral load and increase in CD4+ lymphocyte counts from baseline) of stavudine once daily-containing triple therapy was similar to that of stavudine immediate release (IR)-containing triple therapy in the treatment of antiretroviral-naive patients with HIV infection in two 48-week, randomised, double-blind trials. In the largest trial (n = 783), 80% of patients receiving stavudine 75 or 100mg once daily in combination with lamivudine 150mg twice daily and efavirenz 600mg once daily, and 75% of patients receiving stavudine IR 30 or 40mg twice daily-containing combination therapy, had HIV RNA levels reduced to below the limit of quantification at 48 weeks (<400 copies/ml; intent-to-treat analysis). These findings are supported by those from the smaller trial in 150 patients. Stavudine once daily triple therapy was well tolerated, with the incidence of adverse events being similar to that with stavudine IR. Grades 2-4 treatment related adverse events occurring in > or =3% of patients in either group were dizziness, rash, abnormal dream, headache, insomnia, fatigue and peripheral neurological symptoms. Peripheral neurological symptoms occurred in 3% of patients receiving long-term treatment with stavudine once daily and 6% of patients receiving stavudine IR in a combined analysis.
司他夫定每日一次给药是一种核苷类似物逆转录酶抑制剂。在两项为期48周的随机双盲试验中,对于初治的HIV感染患者,含司他夫定每日一次的三联疗法的疗效(病毒载量降低以及CD4 +淋巴细胞计数相对于基线水平增加)与含司他夫定速释制剂(IR)的三联疗法相似。在规模最大的试验(n = 783)中,80%接受司他夫定每日75或100mg联合拉米夫定每日两次150mg以及依非韦伦每日一次600mg治疗的患者,和75%接受含司他夫定IR每日两次30或40mg联合治疗的患者,在48周时HIV RNA水平降至定量下限以下(<400拷贝/ml;意向性分析)。这些发现得到了150例患者的较小规模试验结果的支持。司他夫定每日一次三联疗法耐受性良好,不良事件发生率与司他夫定IR相似。两组中≥3%的患者发生的2 - 4级治疗相关不良事件为头晕、皮疹、异常梦境、头痛、失眠、疲劳和周围神经症状。在一项综合分析中,3%接受司他夫定每日一次长期治疗的患者以及6%接受司他夫定IR治疗的患者出现了周围神经症状。