The effectiveness of a 9-month regimen of isoniazid alone versus 3- and 4-month regimens of isoniazid plus rifampin for treatment of latent tuberculosis infection in children: results of an 11-year randomized study.
The effectiveness of a 9-month regimen of isoniazid alone versus 3- and 4-month regimens of isoniazid plus rifampin for treatment of latent tuberculosis infection in children: results of an 11-year randomized study.
复制标题
单独使用异烟肼 9 个月方案与异烟肼加利福平 3 个月和 4 个月方案治疗儿童潜伏性结核感染的有效性：一项 11 年随机研究的结果。
DOI：
--
复制
发表时间：
2007
影响因子：
11.8
通讯作者：
M. Tsolia
中科院分区：
文献类型：
--
作者：
N. Spyridis;P. Spyridis;A. Gelesme;V. Sypsa;Mina Valianatou;Flora Metsou;D. Gourgiotis;M. Tsolia
背景
目前推荐使用9个月疗程的异烟肼单药治疗潜伏性结核感染（LTBI），并已证明对儿童和成人均有效。对该方案的依从性降低迫使医生探索更短的方案。本研究的目的是比较3个月和4个月的异烟肼加利福平联合治疗方案与9个月的异烟肼单药治疗方案治疗儿童LTBI。
方法
这项前瞻性、随机、对照研究进行了11年（1995-2005）。第一阶段（1995-1998年），232例患者接受异烟肼治疗9个月（A组），238例患者接受异烟肼和利福平治疗4个月（B组）。第二阶段（1999-2002年），236例患者接受异烟肼和利福平治疗4个月（C组），220例患者接受异烟肼和利福平治疗3个月（D组）。所有患者均观察≥ 3年。
结果
总体治疗依从性良好，但接受异烟肼单药治疗的患者依从性低于接受短程联合治疗的患者（A组与B组P= 0.011; C组与D组P= 0.510）。在随访期间，任何组中均无患者发生临床疾病。接受异烟肼单药治疗的患者（24%）比接受较短方案治疗的患者（B、C和D组分别为11.8%、13.6%和11%; A组与B组相比P= 0.001; C组与D组相比P= 0.418）更常见提示可能存在活动性疾病的新影像学结果。未发现严重的药物相关不良反应。
结论
异烟肼和利福平短期治疗3-4个月是安全的，并且似乎上级优于异烟肼单药治疗9个月。
BACKGROUND
A 9-month course of isoniazid monotherapy is currently recommended for the treatment of latent tuberculosis infection (LTBI) and has been shown to be effective in both children and adults. Reduced compliance with this regimen has forced physicians to explore shorter regimens. The aim of this study was to compare 3- and 4-month combination regimens of isoniazid plus rifampin with a 9-month regimen of isoniazid monotherapy for the treatment of LTBI in children.
METHODS
This prospective, randomized, controlled study was conducted over an 11-year period (1995-2005). In period 1 (1995-1998), 232 patients received isoniazid therapy for 9 months (group A), and 238 patients received isoniazid and rifampin for 4 months (group B). In period 2 (1999-2002), 236 patients were treated with isoniazid and rifampin for 4 months (group C), and 220 patients received the same regimen for 3 months (group D). All patients were observed for > or = 3 years.
RESULTS
Overall compliance with treatment was good, but patients who received isoniazid monotherapy were less compliant than were those who received short-course combination therapy (P=.011, for group A vs. group B; P=.510, for group C vs. group D). No patient in any group developed clinical disease during the follow-up period. New radiographic findings suggestive of possible active disease were more common in patients who received isoniazid monotherapy (24%) than in those treated with shorter regimens (11.8%, 13.6%, and 11% for groups B, C, and D, respectively; P=.001 for group A vs. group B; P=.418 for group C vs. group D). Serious drug-related adverse effects were not detected.
CONCLUSIONS
Short-course treatment with isoniazid and rifampin for 3-4 months is safe and seems to be superior to a 9-month course of isoniazid monotherapy.