NEJM:初始抗逆转录病毒治疗早期无临床症状的HIV感染

2015-07-22 崔倩 译 MedSci原创

来自无症状人类免疫缺陷病毒(HIV)感染的患者(他们的CD4+计数超过了350个细胞/mm3)的随机试验数据缺乏初始抗逆转录病毒治疗的益处和风险。      研究人员随机分配的HIV阳性且CD4+计数超过500细胞/mm3的成人患者立即(立即治疗组),或推迟治疗(直到CD4+计数下降到350细胞/mm3,或直到获得性免疫缺陷综合症(AIDS)或其他状态的发展),即

来自无症状人类免疫缺陷病毒(HIV)感染的患者(他们的CD4+计数超过了350个细胞/mm3)的随机试验数据缺乏初始抗逆转录病毒治疗的益处和风险。
    
研究人员随机分配的HIV阳性且CD4+计数超过500细胞/mm3的成人患者立即(立即治疗组),或推迟治疗(直到CD4+计数下降到350细胞/mm3,或直到获得性免疫缺陷综合症(AIDS)或其他状态的发展),即开始使用抗逆转录病毒疗法(延迟治疗组)。主要复合终点是任何严重的艾滋病相关事件,严重的非艾滋病相关的事件,或任何原因的死亡。
    
本研究共包括4685例患者,平均随访3.0年。在研究开始时,HIV病毒载量的中位数为12759个拷贝/mL,并且平均CD4+计数为651细胞/mm3。在2015年5月15日,在中期分析的基础上,数据和安全监测委员会确定研究的问题得到了解答,并建议延迟治疗组中的患者被提供抗逆转录病毒治疗。立即治疗组有42例患者发生了主要终点事件(1.8%;每100人年有0.60例事件),延迟治疗组有96例患者发生(4.1%;每100人年有1.38事件),危险比为0.43(95%置信区间[Cl],0.30-0.62;P <0.001)。严重艾滋病相关事件和严重的非艾滋病相关的事件的风险比分别为0.28(95%Cl,0.15-0.50;P<0.001)和0.61(95%Cl,0.38-0.97;P=0.04)。CD4+计数每mm3超过500个细胞的的患者发生了三分之二以上的主要终点(68%)事件。 4级事件的风险以及计划外住院的风险是在两组相似。
    
HIV阳性且CD4+计数多于500细胞/mm3的成人患者进行抗逆转录病毒治疗后得到了益处,开始这种治疗的患者CD4+计数已下降到350细胞/mm3

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    2016-06-30 mjldent
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    2015-12-03 hxj0117
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