Background and objective: Various types of intermittent chemotherapy regimens have been applied for the treatment of tuberculosis worldwide, but, in Japan, any type of intermittent treatment has not been adopted currently as the standard regimens for the treatment of tuberculosis. Intermittent regimens have a great advantage to facilitate directly observed therapy (DOT). To introduce DOT more extensively in Japan, we conducted the present clinical trial to assess the effectiveness and safety of intermittent chemotherapy.
Patients and methods: This is a non-randomized trial to compare twice-weekly intermittent therapy under DOT with daily therapy by self-administration. Newly diagnosed patients with pulmonary tuberculosis who completed the initial intensified phase of 2 months with 4 drugs were enrolled. Supervision of drug administration was carried out by the pharmacists who cooperated to the study (Pharmacy DOT).
Results: Total 385 patients were enrolled in this trial, of which 135 patients were treated by twice-weekly intermittent maintenance chemotherapy under the supervision by pharmacists and remaining 250 patients were treated by daily maintenance chemotherapy without supervision (self-administration). Treatment success-rates were 97.6% for intermittent treatment group and 95.6% for daily treatment group. Relapse rates after the completion of the treatment course were 3.73/ 100 person-year and 1.76/100 person-year, respectively. The difference between the two groups was not statistically significant. Adverse events required the modification of treatment schedule occurred only in 0.2% of the intermittently treated patients.
Conclusions: After the successful completion of the initial intensified phase of tuberculosis chemotherapy, twice-weekly intermittent chemotherapy during the maintenance phase under the supervision by pharmacist is as effective and safe as the daily therapy, and is conveniently accepted by the patients. The pharmacy DOT with the intermittent therapy during maintenance phase adopted in this trial, should be widely introduced in Japan.