[Controlled clinical trial on efficacy of 5-month regimens and whole course intermittent 6-month regimens in treating bacillary pulmonary tuberculosis]

Zhonghua Jie He He Hu Xi Za Zhi. 1998 Jul;21(7):388-91.
[Article in Chinese]

Abstract

Objective: To assess the therapeutic efficacy of rifapentine (L), to reduce the duration of treatment and the frequency of drug administration, and to observe the influence on efficacy and adverse reactions of using pyrazinamide (Z) through whole-course.

Method: Two 5-month regimens respectively including rifampin (R) and L and two whole course intermittent regimens were designed as following: I: 2SHRZ/3R2H2Z2; II: 2SHRZ/3L1H2Z2; III: 2S3H3R3Z3/4L1H2Z2; IV: 2S3H3R3Z3/4L1H2E2. A total of 366 newly-diagnosed bacillary pulmonary tuberculosis patients were admitted and randomly allocated.

Results: 339 cases completed the prescribed short course chemotherapy. The sputum conversion rates at the end of the treatment of groups I, II, III and IV were 97.0%, 94.1%, 100.0% and 97.2% respectively. X-ray resolution rates were 96.0%, 97.6%, 100.0% and 94.4% respectively. Cavity-close rates of the 5-month regimens and the 6-month regimens were 77% and 76%. Comparing the results among groups, there were no statistically significant differences (P > 0.05), and no obvious side-effect was found. 305 patients have been followed up for 3 years since completion of the chemotherapy. The bacteriological relapse and bacteriological relapse with deterioration on chest X-ray in groups I, II, III and IV were seen in 2,3,6 and 3 cases respectively.

Conclusion: Domestic-made rifapentine is a long-acting, highly effective antituberculosis drug. It is unnecessary to use Z in continuation phase, and it is possible to shorten the duration to 5 months with the appropriate combination of essential drugs, which is worthwhile for further study.

Publication types

  • Clinical Trial
  • Comparative Study
  • English Abstract
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Antitubercular Agents / administration & dosage*
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Follow-Up Studies
  • Humans
  • Mycobacterium tuberculosis / isolation & purification
  • Pyrazinamide / administration & dosage*
  • Recurrence
  • Rifampin / administration & dosage*
  • Rifampin / analogs & derivatives*
  • Sputum / microbiology
  • Tuberculosis, Pulmonary / drug therapy*
  • Tuberculosis, Pulmonary / microbiology

Substances

  • Antitubercular Agents
  • Pyrazinamide
  • Rifampin
  • rifapentine