PDF(Pubmed)
Abstract：
BACKGROUND: Children with human immunodeficiency virus (HIV, CWH) are at high risk of tuberculosis (TB) and face poor outcomes, despite antiretroviral therapy (ART). We evaluated outcomes in CWH and children not living with HIV treated for nonsevere TB in the SHINE trial.
METHODS: SHINE was a randomized trial that enrolled children aged <16 years with smear-negative, nonsevere TB who were randomized to receive 4 versus 6 months of TB treatment and followed for 72 weeks. We assessed TB relapse/recurrence, mortality, hospitalizations, grade ≥3 adverse events by HIV status, and HIV virological suppression in CWH.
RESULTS: Of 1204 children enrolled, 127 (11%) were CWH, of similar age (median, 3.6 years; interquartile range, 1.2, 10.3 versus 3.5 years; 1.5, 6.9; P = .07) but more underweight (weight-for-age z score, -2.3; (3.3, -0.8 versus -1.0; -1.8, -0.2; P < .01) and anemic (hemoglobin, 9.5 g/dL; 8.7, 10.9 versus 11.5 g/dL; 10.4, 12.3; P < .01) compared with children without HIV. A total of 68 (54%) CWH were ART-naive; baseline median CD4 count was 719 cells/mm3 (241-1134), and CD4% was 16% (10-26). CWH were more likely to be hospitalized (adjusted odds ratio, 2.4; 1.3-4.6) and to die (adjusted hazard ratio [aHR], 2.6; 95% confidence interval [CI], 1.2 to 5.8). HIV status, age <3 years (aHR, 6.3; 1.5, 27.3), malnutrition (aHR, 6.2; 2.4, 15.9), and hemoglobin <7 g/dL (aHR, 3.8; 1.3,11.5) independently predicted mortality. Among children with available viral load (VL), 45% and 61% CWH had VL <1000 copies/mL at weeks 24 and 48, respectively. There was no difference in the effect of randomized treatment duration (4 versus 6 months) on TB treatment outcomes by HIV status (P for interaction = 0.42).
CONCLUSIONS: We found no evidence of a difference in TB outcomes between 4 and 6 months of treatment for CWH treated for nonsevere TB. Irrespective of TB treatment duration, CWH had higher rates of mortality and hospitalization than their counterparts without HIV. Clinical Trials Registration. ISRCTN63579542.
METHODS: SHINE was a randomized trial that enrolled children aged <16 years with smear-negative, nonsevere TB who were randomized to receive 4 versus 6 months of TB treatment and followed for 72 weeks. We assessed TB relapse/recurrence, mortality, hospitalizations, grade ≥3 adverse events by HIV status, and HIV virological suppression in CWH.
RESULTS: Of 1204 children enrolled, 127 (11%) were CWH, of similar age (median, 3.6 years; interquartile range, 1.2, 10.3 versus 3.5 years; 1.5, 6.9; P = .07) but more underweight (weight-for-age z score, -2.3; (3.3, -0.8 versus -1.0; -1.8, -0.2; P < .01) and anemic (hemoglobin, 9.5 g/dL; 8.7, 10.9 versus 11.5 g/dL; 10.4, 12.3; P < .01) compared with children without HIV. A total of 68 (54%) CWH were ART-naive; baseline median CD4 count was 719 cells/mm3 (241-1134), and CD4% was 16% (10-26). CWH were more likely to be hospitalized (adjusted odds ratio, 2.4; 1.3-4.6) and to die (adjusted hazard ratio [aHR], 2.6; 95% confidence interval [CI], 1.2 to 5.8). HIV status, age <3 years (aHR, 6.3; 1.5, 27.3), malnutrition (aHR, 6.2; 2.4, 15.9), and hemoglobin <7 g/dL (aHR, 3.8; 1.3,11.5) independently predicted mortality. Among children with available viral load (VL), 45% and 61% CWH had VL <1000 copies/mL at weeks 24 and 48, respectively. There was no difference in the effect of randomized treatment duration (4 versus 6 months) on TB treatment outcomes by HIV status (P for interaction = 0.42).
CONCLUSIONS: We found no evidence of a difference in TB outcomes between 4 and 6 months of treatment for CWH treated for nonsevere TB. Irrespective of TB treatment duration, CWH had higher rates of mortality and hospitalization than their counterparts without HIV. Clinical Trials Registration. ISRCTN63579542.
摘要：
背景：感染艾滋病毒（CLWH）的儿童患结核病（TB）的风险很高，预后较差，尽管抗逆转录病毒治疗（ART）。我们在SHINE试验中评估了CLWH和未感染HIV的儿童治疗非严重TB的结果。
方法：SHINE是一项随机试验，招募了16岁以下涂片阴性的儿童，非重度TB患者随机接受4个月和6个月的TB治疗,随访72周.我们评估了结核病复发/复发，死亡率,住院治疗,按艾滋病毒状况划分的≥3级不良事件，和CLWH中的HIV病毒学抑制。
结果：在已注册的1204人中，127（11%）为CLWH，相似年龄（中位数（IQR）3.6（1.2，10.3）与3.5(1.5,6.9)年,p=0.07),但体重不足（WAZ；-2.3（-3.3，-0.8）vs-1.0（-1.8，-0.2），p<0.01）和贫血（血红蛋白9.5（8.7，10.9）vs11.5（10.4，12.3）g/dl，p<0.01）与未感染HIV的儿童相比。68（54％）CLWH为未接受ART治疗；基线中位数CD4计数719（241-1134）细胞/mm3，CD4％16（10-26）％）。CLWH更有可能住院(aOR=2.4(1.3-4.6))和死亡(aHR(95CI)2.6(1.2,5.8))。艾滋病毒状况，年龄<3岁(AHR6.3(1.5,27.3))，营养不良(aHR6.2(2.4,15.9))和血红蛋白<7g/dl(aHR3.8(1.3,11.5)独立预测死亡率.在有VL的儿童中，45%和61%的CLWH在第24周和第48周分别具有<1000拷贝/ml的VL。随机治疗持续时间（4个月比6个月）对HIV状态的TB治疗结果的影响没有差异（相互作用p=0.42）。
结论：我们没有发现CLWH治疗非重度TB4-6个月的TB结局有差异的证据。无论结核病治疗持续时间如何，CLWH的死亡率和住院率高于未感染HIV的同行。
我们比较了患有和未患有艾滋病毒的儿童治疗非严重结核病的结果。无论治疗时间如何（4或6个月），HIV感染儿童的结核病结局相似,但死亡率和住院率高于未感染HIV的儿童.
方法：SHINE是一项随机试验，招募了16岁以下涂片阴性的儿童，非重度TB患者随机接受4个月和6个月的TB治疗,随访72周.我们评估了结核病复发/复发，死亡率,住院治疗,按艾滋病毒状况划分的≥3级不良事件，和CLWH中的HIV病毒学抑制。
结果：在已注册的1204人中，127（11%）为CLWH，相似年龄（中位数（IQR）3.6（1.2，10.3）与3.5(1.5,6.9)年,p=0.07),但体重不足（WAZ；-2.3（-3.3，-0.8）vs-1.0（-1.8，-0.2），p<0.01）和贫血（血红蛋白9.5（8.7，10.9）vs11.5（10.4，12.3）g/dl，p<0.01）与未感染HIV的儿童相比。68（54％）CLWH为未接受ART治疗；基线中位数CD4计数719（241-1134）细胞/mm3，CD4％16（10-26）％）。CLWH更有可能住院(aOR=2.4(1.3-4.6))和死亡(aHR(95CI)2.6(1.2,5.8))。艾滋病毒状况，年龄<3岁(AHR6.3(1.5,27.3))，营养不良(aHR6.2(2.4,15.9))和血红蛋白<7g/dl(aHR3.8(1.3,11.5)独立预测死亡率.在有VL的儿童中，45%和61%的CLWH在第24周和第48周分别具有<1000拷贝/ml的VL。随机治疗持续时间（4个月比6个月）对HIV状态的TB治疗结果的影响没有差异（相互作用p=0.42）。
结论：我们没有发现CLWH治疗非重度TB4-6个月的TB结局有差异的证据。无论结核病治疗持续时间如何，CLWH的死亡率和住院率高于未感染HIV的同行。
我们比较了患有和未患有艾滋病毒的儿童治疗非严重结核病的结果。无论治疗时间如何（4或6个月），HIV感染儿童的结核病结局相似,但死亡率和住院率高于未感染HIV的儿童.
