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[大学生论坛]:使用强的松预防结核相关的免疫重建炎症反应综合征

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蓝色的大海 发表于 2019-1-3 22:49:59 | 显示全部楼层 |阅读模式
Prednisone for the Prevention of Paradoxical Tuberculosis-Associated IRIS
使用强的松预防结核相关的免疫重建炎症反应综合征

本文来自:https://www.nejm.org/doi/full/10.1056/NEJMoa1800762


Abstract
摘要

Background
Early initiation of antiretroviral therapy (ART) in human immunodeficiency virus (HIV)–infected patients who have tuberculosis reduces mortality among patients with low CD4 counts, but it increases the risk of paradoxical tuberculosis-associated immune reconstitution inflammatory syndrome (IRIS).
背景
当患者感染了人类免疫缺陷病毒(HIV),并伴有肺结核病,CD4细胞计数低,如果在早期开始抗逆转录病毒治疗(ART),就可以降低死亡率,但会增加患结核相关的免疫重建炎症反应综合征(IRIS)的风险。

Methods
We conducted this randomized, double-blind, placebo-controlled trial to assess whether prophylactic prednisone can safely reduce the incidence of paradoxical tuberculosis-associated IRIS in patients at high risk for the syndrome. We enrolled HIV-infected patients who were initiating ART (and had not previously received ART), had started tuberculosis treatment within 30 days before initiating ART, and had a CD4 count of 100 cells or fewer per microliter. Patients received either prednisone (at a dose of 40 mg per day for 14 days, then 20 mg per day for 14 days) or placebo. The primary end point was the development of tuberculosis-associated IRIS within 12 weeks after initiating ART, as adjudicated by an independent committee.
研究方法
我们进行了此项随机的双盲试验,以安慰剂作对照,来评估预防疾病的强的松是否可以降低高危综合征患者发生结核相关的IRIS的几率而且没有任何其他风险。我们登记了一些感染艾滋病毒的患者,他们之前30天内已经开始接受结核病治疗,并正开始接受抗逆转录病毒治疗(以前没有接受过抗逆转录病毒治疗),每微升CD4细胞计数在100及以下。有些患者摄入强的松(剂量为每天40毫克,持续14天,之后为每天20毫克,持续14天),有些患者摄入安慰剂。研究主要结果指标是患者在开始抗逆转录病毒治疗后12周内结核相关的IRIS的发展状况,由独立委员会裁定。

Results
Among the 240 patients who were enrolled, the median age was 36 (interquartile range, 30 to 42), 60% were men, and 73% had microbiologically confirmed tuberculosis; the median CD4 count was 49 cells per microliter (interquartile range, 24 to 86), and the median HIV type 1 RNA viral load was 5.5 log10 copies per milliliter (interquartile range, 5.2 to 5.9). A total of 120 patients were assigned to each group, and 18 patients were lost to follow-up or withdrew. Tuberculosis-associated IRIS was diagnosed in 39 patients (32.5%) in the prednisone group and in 56 (46.7%) in the placebo group (relative risk, 0.70; 95% confidence interval [CI], 0.51 to 0.96; P=0.03). Open-label glucocorticoids were prescribed to treat tuberculosis-associated IRIS in 16 patients (13.3%) in the prednisone group and in 34 (28.3%) in the placebo group (relative risk, 0.47; 95% CI, 0.27 to 0.81). There were five deaths in the prednisone group and four in the placebo group (P=1.00). Severe infections (acquired immunodeficiency syndrome–defining illnesses or invasive bacterial infections) occurred in 11 patients in the prednisone group and in 18 patients in the placebo group (P=0.23). One case of Kaposi’s sarcoma occurred in the placebo group.
研究结果
登记的240名患者,中位数年龄为36岁(四分位差为30至42岁),60%为男性,73%患有微生物学证实的结核病;CD4计数中位数为每微升49个细胞(四分位差为24至86),I型HIV的RNA病毒载量中位数为5.5 log10拷贝/毫升(四分位差为5.2至5.9)。每组共有120名患者,18名患者因随访或中途离开而不作记录。强的松组有39名患者诊断出患有结核相关的IRIS(占比32.5%);安慰剂组有56名患者(占比46.7%)(相对风险度0.70;95%置信区间[CI] 0.51 ~ 0.96; P = 0.03)。强的松组有16例(占比13.3%)在治疗结核相关的IRIS时开具非盲糖皮质激素;安慰剂组有34例(占比28.3%)(相对风险度0.47;95%置信区间0.27 ~ 0.81)。强的松组有5例死亡;安慰剂组有4例(P = 1.00)。强的松组有11名患者出现严重感染症状;安慰剂组有18名患者(即获得性免疫缺陷综合征,它是疾病或侵袭性细菌感染的特征)(P = 0.23)。安慰剂组还有1例卡波济氏肉瘤的发作。

Conclusions
Prednisone treatment during the first 4 weeks after the initiation of ART for HIV infection resulted in a lower incidence of tuberculosis-associated IRIS than placebo, without evidence of an increased risk of severe infections or cancers. (Funded by the European and Developing Countries Clinical Trials Partnership and others; PredART ClinicalTrials.gov number, NCT01924286.)
结论
在开始用抗逆转录病毒治疗法(ART)治疗艾滋病毒(HIV)感染后的前4周期间,相比于安慰剂治疗,强的松治疗让结核相关的IRIS发生率更低,且没有任何证据表明增加了严重感染和癌症的风险。



作者:Graeme Meintjes, M.B., Ch.B., Ph.D., Cari Stek, M.D., Lisette Blumenthal, M.B., Ch.B., Friedrich Thienemann, M.D., Charlotte Schutz, M.B., Ch.B., Jozefien Buyze, Ph.D., Raffaella Ravinetto, Pharm.D., Ph.D., Harry van Loen, M.Sc., Amy Nair, M.Sc., Amanda Jackson, B.Sc., Robert Colebunders, M.D., Ph.D., Gary Maartens, M.B., Ch.B., Robert J. Wilkinson, F.Med.Sci., and Lutgarde Lynen, M.D., Ph.D. for the PredART Trial Team
期刊名称:The New England Journal of Medicine
发表时间:2018-11-15
N Engl J Med 2018; 379:1915-1925 | DOI: 10.1056/NEJMoa1800762
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