McComsey G A, Whalen C C, Mawhorter S D, Asaad R, Valdez H, Patki A H, Klaumunzner J, Gopalakrishna K V, Calabrese L H, Lederman M M
Case Western Reserve University and University Hospitals of Cleveland, Ohio, USA.
AIDS. 2001 Feb 16;15(3):321-7. doi: 10.1097/00002030-200102160-00004.
To examine the safety and the immunologic and virologic consequences of corticosteroid use in HIV-1 infection.
A randomized, double-blinded, placebo-controlled trial of corticosteroid administration in 41 patients with advanced HIV-1 infection. Patients had a baseline median CD4 cell count of 131 x 10(6) cells/l at enrollment and 85% had a history of opportunistic infection. All but one of the patients had been taking stable antiretroviral regimen, including a protease inhibitor in 36, for a median duration of 158 days. Patients were randomized to 8 weeks of prednisone 0.5 mg/kg daily or placebo.
No AIDS-defining events occurred; two patients in each group developed oral candidiasis, and two patients on prednisone developed mild herpes simplex flares. None who developed oral candidiasis or herpes simplex was receiving prophylaxis and each responded promptly to therapy. In the prednisone group, two patients developed hyperglycemia and one diabetic increased insulin requirements. CD4 cell counts and plasma HIV-1 RNA levels did not change, but plasma tumor necrosis factor alpha levels and CD38+ CD8+ cells decreased significantly in those taking prednisone.
Short-term prednisone administration is well tolerated and reasonably safe in advanced HIV-1 disease and decreases immune activation without effects on HIV-1 RNA levels or CD4 cell counts. These results suggest that, in stable HIV-1 disease, these immune activation markers are more likely consequences of but not inducers of HIV-1 replication.
研究皮质类固醇用于HIV-1感染的安全性以及免疫学和病毒学后果。
对41例晚期HIV-1感染患者进行皮质类固醇给药的随机、双盲、安慰剂对照试验。患者入组时CD4细胞计数中位数为131×10⁶个/升，85%有机会性感染史。除1例患者外，所有患者均接受稳定的抗逆转录病毒治疗方案，其中36例使用蛋白酶抑制剂，治疗时间中位数为158天。患者被随机分为两组，分别接受为期8周的每日0.5mg/kg泼尼松或安慰剂治疗。
未发生艾滋病定义事件；每组有2例患者发生口腔念珠菌病，泼尼松组有2例患者出现轻度单纯疱疹发作。发生口腔念珠菌病或单纯疱疹的患者均未接受预防治疗，且对治疗反应迅速。泼尼松组有2例患者出现高血糖，1例糖尿病患者胰岛素需求量增加。CD4细胞计数和血浆HIV-1 RNA水平未发生变化，但服用泼尼松的患者血浆肿瘤坏死因子α水平和CD38⁺CD8⁺细胞显著下降。
在晚期HIV-1疾病中，短期给予泼尼松耐受性良好且相当安全，可降低免疫激活，而不影响HIV-1 RNA水平或CD4细胞计数。这些结果表明，在稳定的HIV-1疾病中，这些免疫激活标志物更可能是HIV-1复制的后果而非诱导因素。
