Wada Masako, Mizoguchi Kunihiro, Okumura Masao, Mitarai Satoshi, Hoshino Hitoshi, Ohmori Masako, Uchimura Kazuhiro, Yoshiyama Takashi, Ogata Hideo
Research Institute of Tuberculosis, JATA, 3-1-24, Matsuyama, Kiyose-shi, Tokyo 204-8533 Japan.
Kekkaku. 2006 May;81(5):363-9.
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.
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).
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.
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.
在全球范围内，多种类型的间歇化疗方案已应用于结核病治疗，但在日本，目前尚未采用任何类型的间歇治疗作为结核病治疗的标准方案。间歇方案在促进直接观察治疗（DOT）方面具有很大优势。为了在日本更广泛地引入DOT，我们开展了本项临床试验以评估间歇化疗的有效性和安全性。
这是一项非随机试验，旨在比较DOT下的每周两次间歇治疗与自我给药的每日治疗。纳入完成了为期2个月的4种药物初始强化期治疗的新诊断肺结核患者。药物给药监督由参与本研究的药剂师进行（药房DOT）。
本试验共纳入385例患者，其中135例患者在药剂师监督下接受每周两次的间歇维持化疗，其余250例患者接受无监督的每日维持化疗（自我给药）。间歇治疗组的治疗成功率为97.6%，每日治疗组为95.6%。疗程结束后的复发率分别为3.73/100人年和1.76/100人年。两组之间的差异无统计学意义。需要修改治疗方案的不良事件仅发生在0.2%的间歇治疗患者中。
在成功完成结核病化疗的初始强化期后，在药剂师监督下维持期每周两次的间歇化疗与每日治疗一样有效且安全，并且患者易于接受。本试验采用的维持期间歇治疗的药房DOT应在日本广泛推广。
