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NEJM:白细胞介素-2对治疗HIV-AIDS无效

来源:生命经纬 2009-10-26 10:17

一个国际研究小组证实,使用白细胞介素-2(interleukin-2,  IL-2)治疗HIV-AIDS是无效的。因此研究人员建议关于IL-2的临床试验应该终止。这项研究报告发表在New England Journal of Medicine上。

IL-2是目前高活性抗逆转录病毒疗法(highly  active  antiretroviral  therapy,HAART)中常用的补体(complement),也常用于HIV-AIDS患者的治疗中。由于HAART能够控制血液中病毒的复制,医生认为IL-2有助于CD4+免疫细胞的再生。也有人认为IL-2通过帮助免疫细胞成熟,能够增强患者的免疫力。

而最近的这项研究结果表明,IL-2对AIDS患者没有任何治疗效果。更确切地说,虽然IL-2出现可是CD4+免疫细胞数量的增加,但这些因IL-2刺激新增加的CD4+细胞与患者自身免疫系统中未接受IL-2自然形成的CD4+相比,其功能远不如后者。因此,IL-2治疗对预防AIDS相关的传染病没有任何好处。

因此,研究人员强调,在评价患者的健康水平时,仅仅关注某些生物标记物的值是不够的。(生物谷Bioon.com)

相关阅读:

PLoS Pathogens:HIV可利用多种途径逃脱免疫监控

EBM:试管测试能侦测空窗期HIV的感染

Science:HIV疫苗的新靶点

J. Virol.:切中HIV要害有助疫苗开发

PEDIATRICS:艾滋病可通过父母“嚼喂”传染给婴儿

生物谷推荐原始出处:

NEJM Volume 361:1548-1559 October 15, 2009

Interleukin-2 Therapy in Patients with HIV Infection

The INSIGHT–ESPRIT Study Group and SILCAAT Scientific Committee

ABSTRACT

Background Used in combination with antiretroviral therapy, subcutaneous recombinant interleukin-2 raises CD4+ cell counts more than does antiretroviral therapy alone. The clinical implication of these increases is not known.

Methods We conducted two trials: the Subcutaneous Recombinant, Human Interleukin-2 in HIV-Infected Patients with Low CD4+ Counts under Active Antiretroviral Therapy (SILCAAT) study and the Evaluation of Subcutaneous Proleukin in a Randomized International Trial (ESPRIT). In each, patients infected with the human immunodeficiency virus (HIV) who had CD4+ cell counts of either 50 to 299 per cubic millimeter (SILCAAT) or 300 or more per cubic millimeter (ESPRIT) were randomly assigned to receive interleukin-2 plus antiretroviral therapy or antiretroviral therapy alone. The interleukin-2 regimen consisted of cycles of 5 consecutive days each, administered at 8-week intervals. The SILCAAT study involved six cycles and a dose of 4.5 million IU of interleukin-2 twice daily; ESPRIT involved three cycles and a dose of 7.5 million IU twice daily. Additional cycles were recommended to maintain the CD4+ cell count above predefined target levels. The primary end point of both studies was opportunistic disease or death from any cause.

Results In the SILCAAT study, 1695 patients (849 receiving interleukin-2 plus antiretroviral therapy and 846 receiving antiretroviral therapy alone) who had a median CD4+ cell count of 202 cells per cubic millimeter were enrolled; in ESPRIT, 4111 patients (2071 receiving interleukin-2 plus antiretroviral therapy and 2040 receiving antiretroviral therapy alone) who had a median CD4+ cell count of 457 cells per cubic millimeter were enrolled. Over a median follow-up period of 7 to 8 years, the CD4+ cell count was higher in the interleukin-2 group than in the group receiving antiretroviral therapy alone — by 53 and 159 cells per cubic millimeter, on average, in the SILCAAT study and ESPRIT, respectively. Hazard ratios for opportunistic disease or death from any cause with interleukin-2 plus antiretroviral therapy (vs. antiretroviral therapy alone) were 0.91 (95% confidence interval [CI], 0.70 to 1.18; P=0.47) in the SILCAAT study and 0.94 (95% CI, 0.75 to 1.16; P=0.55) in ESPRIT. The hazard ratios for death from any cause and for grade 4 clinical events were 1.06 (P=0.73) and 1.10 (P=0.35), respectively, in the SILCAAT study and 0.90 (P=0.42) and 1.23 (P=0.003), respectively, in ESPRIT.

Conclusions Despite a substantial and sustained increase in the CD4+ cell count, as compared with antiretroviral therapy alone, interleukin-2 plus antiretroviral therapy yielded no clinical benefit in either study.

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