Rivero Antonio, López-Cortés Luis, Castillo Rafael, Verdejo José, García Miguel Angel, Martínez-Marcos Francisco Javier, Díez Felipe, Escribano José Carlos, Canueto Jesús, Lozano Fernando, Pasquau Juan, Hernández Juan José, Márquez Manuel, Kindelán José María
Sección de Enfermedades Infecciosas, Hospital Universitario Reina Sofía, Córdoba, España.
Enferm Infecc Microbiol Clin. 2007 May;25(5):305-10. doi: 10.1157/13102265.
To evaluate the adherence to, and safety of three chemoprophylaxis regimens for latent tuberculosis (TB) infection in HIV-infected patients with a positive tuberculin skin test.
A randomized, comparative, open clinical assay was carried out in 316 HIV-infected patients in 12 Spanish hospitals. Patients were randomly assigned to one of three regimens, 108 to isoniazid for six months (6H), 103 to rifampin and isoniazid for three months (3RH), and 105 to rifampin and pyrazinamide for two months (2RZ). After completion of treatment, patients were followed-up for two years.
The period of observation following completion of treatment was 115, 108 and 101 person-years for 6H, 3RH and 2RZ, respectively. Twenty-seven percent of patients voluntarily abandoned chemoprophylaxis and 9.7% were withdrawn due to adverse side-effects or interactions. Seven patients were withdrawn due to hepatotoxicity (5 in 6H, 2 in 3RH and 0 in 2RZ). No appreciable differences were found among the three regimens. There were 11 cases of tuberculosis during follow-up. The TB rates (cases per 100 person-years) in the three treatment groups were 3.48 in 6H, 4.63 in 3RH and 1.98 in 2RZ. With respect to 2RZ, the relative risk for TB in the 6H and 3RH regimens was 1.76 and 2.34, respectively.
The safety of the 2RZ regimen for prophylaxis of latent TB infection in HIV patients was similar to that of the 6H and 3RH regimens. The incidence of hepatotoxicity was not higher in patients who received 2RZ.
评估三种化学预防方案对结核菌素皮肤试验呈阳性的HIV感染患者潜伏性结核（TB）感染的依从性及安全性。
在西班牙12家医院的316例HIV感染患者中开展了一项随机、对照、开放的临床分析。患者被随机分配至三种方案之一，108例接受异烟肼治疗6个月（6H），103例接受利福平和异烟肼治疗3个月（3RH），105例接受利福平和吡嗪酰胺治疗2个月（2RZ）。治疗结束后，对患者进行了两年的随访。
治疗结束后的观察期，6H组、3RH组和2RZ组分别为115、108和101人年。27%的患者自愿放弃化学预防，9.7%因不良反应或相互作用而退出。7例患者因肝毒性退出（6H组5例，3RH组2例，2RZ组0例）。三种方案之间未发现明显差异。随访期间有11例结核病病例。三个治疗组的结核病发病率（每100人年的病例数），6H组为3.48，3RH组为4.63，2RZ组为1.98。相对于2RZ组，6H组和3RH组结核病的相对风险分别为1.76和2.34。
2RZ方案预防HIV患者潜伏性结核感染的安全性与6H和3RH方案相似。接受2RZ治疗的患者肝毒性发生率并不更高。
