Gao X F, Wang L, Liu G J, Wen J, Sun X, Xie Y, Li Y P
Chinese Evidence-Based Medicine Centre, West China Hospital, Sichuan University, Chengdu, Sichuan Province, China.
Int J Tuberc Lung Dis. 2006 Oct;10(10):1080-90.
Six trials from Haiti, Mexico, the U.S.A., Brazil, Spain, Zambia and Hong Kong.
To evaluate the efficacy and safety of rifampicin plus pyrazinamide (RZ) vs. isoniazid (INH) for the prevention of tuberculosis (TB) among persons with or without human immunodeficiency virus (HIV) infection.
Meta-analysis of randomised controlled trials (RCTs) and quasi-RCTs that compared RZ for 2-3 months with INH for 6-12 months. Endpoints were development of active TB, severe adverse effects and death. Treatment effects were summarised as risk difference (RD) with 95% confidence intervals (CI).
Three trials conducted in HIV-infected patients and three trials conducted in non-HIV-infected persons were identified. The rates of TB in the RZ group were similar to those in the INH group, whether the subjects were HIV-infected or not (HIV-infected patients: pooled RD = 0%, 95% CI -1-2, P = 0.89; non-HIV-infected persons: pooled RD = 0%, 95% CI -2-1, P = 0.55). There was no difference in mortality between the two treatment groups (HIV-infected patients: pooled RD = -1%, 95% CI -4-2, P = 0.53; non-HIV-infected persons: pooled RD = 0%, 95% CI -1-1, P = 1.00). However, both subgroup analyses showed that a higher incidence of all severe adverse events was associated with 2RZ than INH among non-HIV-infected persons (RD = 29%, 95% CI 13-46, P = 0.0005 vs. RD = 7%, 95% CI 4-10, P < 0.0001).
RZ is equivalent to INH in terms of efficacy and mortality in the treatment of latent tuberculosis infection. However, this regimen increases the risk of severe adverse effects compared with INH in non-HIV-infected persons.
来自海地、墨西哥、美国、巴西、西班牙、赞比亚和中国香港的六项试验。
评估利福平加吡嗪酰胺（RZ）与异烟肼（INH）在预防有或无人免疫缺陷病毒（HIV）感染人群中结核病（TB）的疗效和安全性。
对随机对照试验（RCT）和半随机对照试验进行荟萃分析，比较2 - 3个月的RZ与6 - 12个月的INH。终点指标为活动性结核病的发生、严重不良反应和死亡。治疗效果总结为风险差异（RD）及95%置信区间（CI）。
确定了三项在HIV感染患者中进行的试验和三项在非HIV感染人群中进行的试验。无论受试者是否感染HIV，RZ组的结核病发病率与INH组相似（HIV感染患者：合并RD = 0%，95% CI -1 - 2，P = 0.89；非HIV感染人群：合并RD = 0%，95% CI -2 - 1，P = 0.55）。两个治疗组之间的死亡率没有差异（HIV感染患者：合并RD = -1%，95% CI -4 - 2，P = 0.53；非HIV感染人群：合并RD = 0%，95% CI -1 - 1，P = 1.00）。然而，两项亚组分析均显示，在非HIV感染人群中，与INH相比，2RZ组所有严重不良事件的发生率更高（RD = 29%，95% CI 13 - 46，P = 0.0005 对比 RD = 7%，95% CI 4 - 10，P < 0.0001）。
在治疗潜伏性结核感染方面，RZ在疗效和死亡率方面与INH相当。然而，与INH相比，该方案在非HIV感染人群中增加了严重不良反应的风险。
