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一项关于肺结核治疗中继续期采用三种6个月间歇化疗方案的临床试验的五年随访。新加坡结核病防治所/英国医学研究委员会

Five-year follow-up of a clinical trial of three 6-month regimens of chemotherapy given intermittently in the continuation phase in the treatment of pulmonary tuberculosis. Singapore Tuberculosis Service/British Medical Research Council.

出版信息

Am Rev Respir Dis. 1988 May;137(5):1147-50. doi: 10.1164/ajrccm/137.5.1147.

Abstract

In a study in Singapore, patients of Chinese, Malay, and Indian ethnic origin with sputum-smear-positive pulmonary tuberculosis were allocated at random to daily treatment with streptomycin, isoniazid, rifampin, and pyrazinamide for 2 months (2SHRZ), for 1 month (1SHRZ), or for 2 months without streptomycin (2HRZ), followed, for all patients, by 3-times-weekly isoniazid and rifampin (H3 R3) up to 6 months. As previously reported, all except 1 of 319 patients with drug-susceptible tubercle bacilli pretreatment had a favorable bacteriologic status at the end of chemotherapy, and among the 300 patients assessed up to 30 months (24 months after the end of chemotherapy), there was only 1 bacteriologic relapse in each series, giving an overall therapeutic failure rate of only 1.3%. Follow-up has been continued at 6-month intervals up to 5 yr. During the 5 yr, the total relapse rate for patients with drug-susceptible strains pretreatment was 2.4% of 297 patients (95% confidence limits, 1.0 to 4.8%). Among the 31 patients with strains resistant to isoniazid, streptomycin, or both drugs pretreatment, there were no failures during chemotherapy and 4 (13%) subsequent relapses.

摘要

在新加坡进行的一项研究中,将痰涂片阳性的华裔、马来裔和印度裔肺结核患者随机分配,分别接受链霉素、异烟肼、利福平及吡嗪酰胺每日用药治疗2个月(2SHRZ)、1个月(1SHRZ)或不用链霉素治疗2个月(2HRZ),之后所有患者均接受异烟肼和利福平每周3次用药(H3R3),持续6个月。如先前报道,319例治疗前结核杆菌药敏的患者中,除1例之外,所有患者化疗结束时细菌学状态良好,在评估至30个月(化疗结束后24个月)的300例患者中,每个治疗组仅有1例细菌学复发,总体治疗失败率仅为1.3%。随访每6个月进行1次,持续了5年。在这5年中,治疗前结核杆菌药敏菌株患者的总复发率为297例患者中的2.4%(95%置信区间,1.0至4.8%)。在31例治疗前结核杆菌对异烟肼、链霉素或两种药物耐药的患者中,化疗期间无治疗失败,后续有4例(13%)复发。

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