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目的考核利福喷丁(L)的疗效;缩短疗程或全程间歇以减少用药次数;观察全程应用吡嗪酰胺(Z)对疗效及毒副反应的影响。方法以利福平(R)为对照,采用5个月疗程方案(Ⅰ组2SHRZ/3R2H2Z2,Ⅱ组2SHRZ/3L1H2Z2)、6个月全间歇方案(Ⅲ组2S3H3R3Z3/4L1H2Z2,Ⅳ组2S3H3R3Z3/4L1H2E2),观察Z的全程应用结果,巩固期以乙胺丁醇(E)为对照。366例初治菌阳肺结核随机分入以上4组。结果(1)339例完成疗程者中329例治疗成功,满疗程时痰菌阴转率Ⅰ~Ⅳ组分别为970%、941%、1000%、972%。X线病灶有效率依序为960%、976%、1000%和944%。5个月组与6个月组空洞关闭率分别为77%及76%。各组相互比较均无显著性差异(P>0.05),未见严重副作用。(2)305例完成3年随访,Ⅰ、Ⅱ、Ⅲ、Ⅳ组细菌学加X线复发分别为2、3、6和3例。结论本研究结果进一步证明L是长效、高效、安全、便于督导的新药;巩固期用Z无必要;现有基本药物合理联用有可能缩短疗程为5个月,值得进一步研究。
Objective To assess the efficacy of rifapentine (L); shorten the course of treatment or intermittent to reduce the number of medication; observe the full application of pyrazinamide (Z) on the efficacy and side effects. Methods Rifampicin (R) was used as a control and a 5-month regimen (group 2SHRZ / 3R2H2Z2, group ⅡSHRZ / 3L1H2Z2) and a 6-month full-dose regimen (groupⅢS3H3R3Z3 / 4L1H2Z2 and groupⅣS3H3R3Z3 / 4L1H2E2) , Observed the full application of Z results, the consolidation period to ethambutol (E) as a control. 366 cases of newly diagnosed bacillary positive pulmonary tuberculosis were randomly divided into the above 4 groups. Results (1) Of the 339 patients who completed the treatment, 329 patients were successfully treated. The rates of sputum negative conversion rate Ⅰ ~ Ⅳ were 970%, 941%, 1000% and 972% respectively at the full course of treatment. The effective rate of X-ray lesion was 960%, 976%, 1000% and 944%. The void closure rates in the 5-month and 6-month groups were 77% and 76%, respectively. There was no significant difference between each group (P> 0.05), no serious side effects. (2) 305 cases completed 3 years follow-up. The bacteriological and X-ray recurrent rates of group Ⅰ, Ⅱ, Ⅲ and Ⅳ were 2, 3, 6 and 3 respectively. Conclusion The results of this study further prove that L is a new drug with long-lasting, high-efficiency, safe and easy-to-supervise. It is not necessary to use Z in the consolidation period. It is worth further research that the existing combination of essential drugs may shorten the course of treatment for 5 months.