Shortening Treatment in Adults with Noncavitary Tuberculosis and 2-Month Culture Conversion
Shortening Treatment in Adults with Noncavitary Tuberculosis and 2-Month Culture Conversion
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DOI：
10.1164/rccm.200904-0536oc
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发表时间：
2009-09-15
影响因子：
24.7
通讯作者：
Boom, W. Henry
中科院分区：
文献类型：
--
作者：
Johnson, John L.;Hadad, David Jamil;Boom, W. Henry
空洞性疾病和延迟的培养转化与复发有关。结合患者的特点和措施的细菌学反应可能会让治疗缩短与目前的药物在some patients.Objectives：为了评估治疗是否可以缩短6至4个月的非空洞性结核病患者的痰培养转化为阴性后2 months.Methods：本研究是一项随机，开放标签的等效性试验。未感染HIV的成人非空洞性肺结核患者每天接受异烟肼、利福平、吡嗪酰胺和乙胺丁醇治疗2个月，随后接受异烟肼和利福平治疗2个月。4个月后，对药物敏感的结核病患者，其固体培养基上的痰培养物在治疗8周后为阴性，被随机分配继续治疗2个月或停止治疗。患者随访复发30个月后开始treatment. Measures和主要结果：招募被停止后，安全性监测委员会394例患者由于明显增加复发的风险，在4个月的arm.A共370例符合方案分析。4个月组中有13名患者复发，6个月组中有3名患者复发（7.0 vs. 1.6%;风险差异，0.054; Hauck-Anderson校正的95%置信区间，0.01-0.10）。将非空洞性疾病成人患者的治疗时间从6个月缩短至4个月，并在使用当前药物2个月后进行培养转换，复发率非空洞性疾病和2个月培养转化的结合不足以识别复发风险降低的患者。
Rationale Cavitary disease and delayed culture conversion have been associated with relapse. Combining patient characteristics and measures of bacteriologic response might allow treatment shortening with current drugs in some patients.Objectives: To assess whether treatment could be shortened from 6 to 4 months in patients with noncavitary tuberculosis whose sputum cultures converted to negative after 2 months.Methods: This study was a randomized, open-label equivalence trial. HIV-uninfected adults with noncavitary tuberculosis were treated daily with isoniazid, rifampin, pyrazinamide, and ethambutol for 2 months, followed by 2 months of isoniazid and rifampin. After 4 months, patients with drug-susceptible TB whose sputum cultures on solid media were negative after 8 weeks of treatment were randomly assigned to continue treatment for 2 more months or to stop treatment. Patients were followed for relapse for 30 months after beginning treatment.Measurements and Main Results: Enrollment was stopped by the safety monitoring committee after 394 patients were enrolled due to apparent increased risk for relapse in the 4-month arm. A total of 370 patients were eligible for per protocol analysis. Thirteen patients in the 4-month arm relapsed, compared with three subjects in the 6-month arm (7.0 vs. 1.6%; risk difference, 0.054; 95% confidence interval with Hauck-Anderson correction, 0.01-0.10).Conclusion: Shortening treatment from 6 to 4 months in adults with noncavitary disease and culture conversion after 2 months using current drugs resulted in a greater relapse rate. The combination of noncavitary disease and 2-month culture conversion was insufficient to identify patients with decreased risk for relapse.