Bellman P C
St Vincent's Hospital and Medical Center, Lenox Hill Hospital, New York, New York, USA.
AIDS. 1998 Jul 30;12(11):1333-40. doi: 10.1097/00002030-199811000-00015.
To determine the effectiveness and safety of adding delavirdine mesylate to a treatment regimen that included indinavir and nucleoside analog reverse transcriptase inhibitors in patients in whom combination therapy had failed.
Observational study.
Private practice.
HIV-1-positive patients with peripheral blood CD4+ lymphocyte counts < 300 x 10(6)/l in whom antiretroviral therapy had failed or whose condition was deteriorating. Of the 53 patients who were eligible for the study, 47 took part; for the majority of these patients indinavir combination therapy had been unsuccessful. the majority of the patients were male (98%), white (92%) and homo/bisexuals (96%).
Delavirdine added to current therapy (usually zidovudine, indinavir and lamivudine); in approximately half of the patients zidovudine was replaced with stavudine.
Plasma HIV-1 RNA levels; peripheral blood CD4+ and CD8+ lymphocyte counts. Safety of the therapy was assessed by monitoring side-effects.
Mean baseline CD4+ lymphocyte count was 127 x 10(6)/l and mean baseline HIV-1 plasma RNA was 5 log10 copies/ml. Adding delavirdine to the therapeutic regimen produced a rapid and sustained decrease in the mean plasma HIV-1 RNA of 1.1 log10 copies/ml over 6 months; 18-21% of patients showed decreases of 2-3 log10 copies/ml. Viral burden in 33% of subjects declined below the assay's limit of detection (2.6 log10 copies/ml) after 6 months. CD4+ lymphocyte counts increased by 66-90% in each group between 1 and 9 months (mean increase approximately 60 x 10(6)/l after 6 months). Adding delavirdine to current therapy was well tolerated. Side-effects reported were: skin rash, 28%; nausea, 9%; kidney stones, 9%; diarrhea, 6%; flank pain, 2%; proteinuria, 2%. Three patients reported serious medical events all of which resolved and none of which were attributed to delavirdine.
Adding delavirdine to the combination regimen of patients in whom protease inhibitor therapy had failed often resulted in a rapid and remarkable decrease in viral load, sustained improvement in CD4+ lymphocyte counts and viral load, and clinical improvement with minimal toxicity.
确定在联合治疗失败的患者中，将甲磺酸地拉韦啶添加到包含茚地那韦和核苷类似物逆转录酶抑制剂的治疗方案中的有效性和安全性。
观察性研究。
私人诊所。
外周血CD4+淋巴细胞计数<300×10⁶/l的HIV-1阳性患者，这些患者抗逆转录病毒治疗失败或病情正在恶化。在符合研究条件的53名患者中，47名参与了研究；这些患者中的大多数接受茚地那韦联合治疗未成功。大多数患者为男性（98%）、白人（92%）以及同性恋者/双性恋者（96%）。
在当前治疗（通常为齐多夫定、茚地那韦和拉米夫定）基础上加用甲磺酸地拉韦啶；大约一半患者的齐多夫定被司他夫定替代。
血浆HIV-1 RNA水平；外周血CD4+和CD8+淋巴细胞计数。通过监测副作用评估治疗的安全性。
基线时CD4+淋巴细胞计数的平均值为127×10⁶/l，基线时血浆HIV-1 RNA的平均值为5 log₁₀拷贝/ml。在治疗方案中加用甲磺酸地拉韦啶后，6个月内血浆HIV-1 RNA平均值迅速且持续下降1.1 log₁₀拷贝/ml；18 - 21%的患者下降了2 - 3 log₁₀拷贝/ml。6个月后，33%受试者的病毒载量降至检测下限（2.6 log₁₀拷贝/ml）以下。1至9个月期间，每组CD4+淋巴细胞计数增加了66%至9%(6个月后平均增加约60×10⁶/l)。在当前治疗基础上加用甲磺酸地拉韦啶耐受性良好。报告的副作用有：皮疹，28%；恶心，9%；肾结石，9%；腹泻，6%；胁腹痛，2%；蛋白尿，2%。3名患者报告了严重医疗事件，所有事件均得到解决，且无一归因于甲磺酸地拉韦啶。
在蛋白酶抑制剂治疗失败的患者联合治疗方案中加用甲磺酸地拉韦啶，通常会使病毒载量迅速显著下降，CD4+淋巴细胞计数和病毒载量持续改善，且临床症状改善，毒性最小。
