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背景:西班牙四个城市9 家公共卫生治疗中心。目的:比较2 个月利福平+吡嗪酰胺(2RZ)与6 个月异烟肼(6H)治疗潜伏结核感染(LTBI),评估其效益及安全性。设计:对传染性肺结核病人的HIV(-)接触者进行多中心的前瞻性随机比较研究。结果:352 例中接受6H 者199 例,2RZ 者153 例;6H 组及2RZ 组治疗完成率各为73%及71%(P=0.73)。因肝毒性反应(AST 或ALT>5 倍正常上限值(ULN))而中断治疗者,2RZ 组为10%,6H 组为2.5%(P=0.007)。2RZ 组肝毒性反应高于期望发生率,因而未到期即终止了研究。停止治疗后肝功能均恢复正常。结论是RZ 方案只应用于不适用其它治疗方案者,且需有强化观察肝功能的条件。
Background: 9 public health treatment centers in four Spanish cities. OBJECTIVE: To compare the efficacy and safety of rifampin + pyrazinamide (2RZ) and 6-month isoniazid (6H) in the treatment of latent tuberculosis infection (LTBI) at 2 months. Design: A multicenter, prospective randomized, comparative study of HIV (-) contacts in patients with infectious tuberculosis. Results: Among 352 cases, 199 cases received 6H and 153 cases had 2RZ. The completion rates of 6H group and 2RZ group were 73% and 71% respectively (P = 0.73). Treatment discontinued due to hepatotoxicity (AST or ALT> 5-fold upper limit of normal (ULN)) was 10% in the 2RZ group and 2.5% in the 6H group (P = 0.007). The 2RZ group had a higher than expected rate of hepatotoxicity and discontinued the study without expiration. After stopping treatment, liver function returned to normal. The conclusion is that the RZ regimen should be used only for those who are not eligible for other regimens and need to have an intensive observation of liver function.