Latent tuberculosis infection treatment for prison inmates: a randomised controlled trial
Latent tuberculosis infection treatment for prison inmates: a randomised controlled trial
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DOI：
10.5588/ijtld.11.0504
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发表时间：
2012-05-01
影响因子：
4
通讯作者：
Huang, L-M.
中科院分区：
文献类型：
--
作者：
Chan, P-C.;Yang, C-H.;Huang, L-M.
环境：北方台湾的一所监狱。目的：比较4个月的每日利福平方案（4 R）与标准的6个月的每日异烟肼方案（6 H）的安全性和完成率为潜伏性结核病感染（LTBI）在监狱囚犯。设计：这是一个开放标签的随机试验，人类免疫缺陷病毒阴性的男性囚犯。没有活动性结核病（TB）且结核菌素皮试和QuantiFERON（R）-TB Gold In-Tube检测均呈阳性的囚犯符合条件，但基线谷丙转氨酶（GPT）水平≥ 120 U/l、胆红素水平≥ 2.4 U/l或血小板计数< 150 k/mm（3）的囚犯被排除在外。主要终点是任何不良事件，导致停止LTBI treatment.RESULTS：参与者（n = 373; 14%的乙型肝炎B表面抗原阳性，21%的抗丙型肝炎病毒[HCV]阳性）被随机（分层的乙型肝炎B病毒，HCV状态和2年的监禁），直接观察治疗下接受4 R或6 H。4 R组（n = 190）发生导致治疗中止的不良事件的可能性较小（2% vs. 1.2%，所有不良事件P < 0.001; 0% vs. 8%，肝毒性P < 0.001），更有可能完成LTBI治疗（86%vs.78%，P = 0.041），与6 H组（n = 183）相比。结论：4 R治疗男性服刑人员LTBI较6 H安全，完成率较高。
SETTING: A prison in northern Taiwan.OBJECTIVE: To compare safety and the completion rate of the 4-month daily rifampicin regimen (4R) vs. the standard 6-month daily isoniazid regimen (6H) for latent tuberculosis infection (LTBI) in prison inmates.DESIGN: This was an open-label randomised trial among human immunodeficiency virus negative male inmates. Inmates without active tuberculosis (TB) who tested positive for both the tuberculin skin test and QuantiFERON (R)-TB Gold In-Tube were eligible, but those with baseline glutamic pyruvic transaminase (GPT) levels >= 120 U/l, bilirubin levels >= 2.4 U/l or a platelet count < 150 k/mm(3) were excluded. The primary endpoint was any adverse event that resulted in discontinuation of LTBI treatment.RESULTS: Participants (n = 373; 14% hepatitis B surface antigen positive, 21% anti-hepatitis C virus [HCV] positive) were randomised (stratified by hepatitis B virus, HCV status and 2-year prison term) to receive either 4R or 6H under directly observed treatment. The 4R group (n = 190) was less likely to experience an adverse event leading to discontinuation of treatment (2% vs. 1.2%, P < 0.001 for all adverse events; 0% vs. 8%, P < 0.001 for hepatotoxicity), and more likely to complete LTBI treatment (86% vs. 78%, P = 0.041), compared with the 6H group (n = 183).CONCLUSIONS: 4R is safer and has a higher completion rate than 6H as treatment for LTBI among male prison inmates.