Randomized placebo-controlled trial of prednisone for paradoxical tuberculosis-associated immune reconstitution inflammatory syndrome

被引：270

作者：

Meintjes, Graeme ^{[1
,2
,3
]}

Wilkinson, Robert J. ^{[2
,3
,4
,5
]}

Morroni, Chelsea ^{[6
]}

Pepper, Dominique J. ^{[2
,3
]}

Rebe, Kevin ^{[2
,3
]}

Rangaka, Molebogeng X.

Oni, Tolu ^{[4
]}

Maartens, Gary ^{[7
]}

机构：

[1] Univ Cape Town, Fac Hlth Sci, Inst Infect Dis & Mol Med, ZA-7925 Cape Town, South Africa

[2] Univ Cape Town, Dept Med, ZA-7925 Cape Town, South Africa

[3] GF Jooste Hosp, Infect Dis Unit, Cape Town, South Africa

[4] Univ London Imperial Coll Sci Technol & Med, Wright Fleming Inst, Div Med, London, England

[5] Natl Inst Med Res, London NW7 1AA, England

[6] Univ Cape Town, Sch Publ Hlth & Family Med, Womens Hlth Res Unit, ZA-7925 Cape Town, South Africa

[7] Univ Cape Town, Dept Med, Div Clin Pharmacol, ZA-7925 Cape Town, South Africa

来源：

AIDS | 2010年 / 24卷 / 15期

基金：

英国医学研究理事会; 英国惠康基金;

关键词：

antiretroviral therapy; glucocorticoids; HIV; immune reconstitution inflammatory syndrome; IRIS; prednisone; tuberculosis; ANTIRETROVIRAL THERAPY; INFECTED PATIENTS; DRUG-RESISTANCE; RISK-FACTORS; DOUBLE-BLIND; HIV; INITIATION; DISEASE; TYPE-1;

D O I：

10.1097/QAD.0b013e32833dfc68

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

Objective: Paradoxical tuberculosis-associated immune reconstitution inflammatory syndrome (TB-IRIS) is a frequent complication of antiretroviral therapy in resource-limited countries. We aimed to assess whether a 4-week course of prednisone would reduce morbidity in patients with paradoxical TB-IRIS without excess adverse events. Design: A randomized, double-blind, placebo-controlled trial of prednisone (1.5 mg/kg per day for 2 weeks then 0.75 mg/kg per day for 2 weeks). Patients with immediately life-threatening TB-IRIS manifestations were excluded. Methods: The primary combined endpoint was days of hospitalization and outpatient therapeutic procedures, which were counted as one hospital day. Results: One hundred and ten participants were enrolled (55 to each arm). The primary combined endpoint was more frequent in the placebo than the prednisone arm {median hospital days 3 [interquartile range (IQR) 0-9] and 0 (IQR 0-3), respectively; P = 0.04}. There were significantly greater improvements in symptoms, Karnofsky score, and quality of life (MOS-HIV) in the prednisone vs. the placebo arm at 2 and 4 weeks, but not at later time points. Chest radiographs improved significantly more in the prednisone arm at weeks 2 (P = 0.002) and 4 (P = 0.02). Infections on study medication occurred in more participants in prednisone than in placebo arm (27 vs. 17, respectively; P = 0.05), but there was no difference in severe infections (2 vs. 4, respectively; P = 0.40). Isolates from 10 participants were found to be resistant to rifampicin after enrolment. Conclusion: Prednisone reduced the need for hospitalization and therapeutic procedures and hastened improvements in symptoms, performance, and quality of life. It is important to investigate for drug-resistant tuberculosis and other causes for deterioration before administering glucocorticoids. (C) 2010 Wolters Kluwer Health vertical bar Lippincott Williams & Wilkins

引用

页码：2381 / 2390

页数：10

共 31 条

[11] Tuberculosis Immune Reconstitution Inflammatory Syndrome: Drug Resistance and the Critical Need for Better Diagnostics [J].