RFPを含む3方式による肺結核6ヵ月化療の対照試験 (第1報)

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This investigation was designed to find out the 6 months regimen of chemotherapy which is expected to be most effective with less adverse reactions and least relapse rate. The patients were chosen from those admitted to the National Nakano Chest Hospital in October 1975 and thereafter. Smear positive cases of pulmonary tuberculosis with cavity less than 4cm in diameter or without cavity, who were previously untreated or had been treated for less than 15 days were subjected to the study. They were allocated at random to the following 3 regimens; A) RHS daily 3m.→RH daily S2 3m., B) RHZS daily 2m.→RHZ daily 4m., C) RHZE daily 2m.→RHZ daily 4m. Drug sensitivity tests were done by Canettis proportion method. Criteria for sensitivity was less than 50% to 10 mcg or 1% to 50 mcg RFP, less than 1% to SM 10mcg, INH 0.2mcg and EB 3mcg. By the end of February 1977, 113 cases have completed the 6 months chemotherapy, and 7 cases were excluded due to reasons cited in Tab. 1. The remaining 106 cases were divided into 2 categories, one completed the fixed regimen and the other in which the regimen was changed, but in all cases, the duration of chemotherapy was fixed to 6 months. All 106 cases became culture negative by the end of the 4 th month of chemotherapy, and the negative conversion took place much faster in regimen B than in regimen A (Fig. 2), and it was similar even in the aged patients and cases complicated with diabetes. The negative conversion occured much faster in this study subject than any other previous cases treated with regimens without RFP. Adverse reactions were seen most frequently in regimen B, then in C and least in A (Tab. 3) Among them, those attributable to SM and PZA were found to be most frequent. Those due to SM were allergic reactions, tinnitus and dizziness, and those due to PZA were liver dysfunction and gastrointestinal disturbances. They occured especially frequently during the first 3 months. Even though the X-ray shadow and cavity were still unstable at the end of 6 months chemotherapy, they continued to improve after stopping the chemotherapy as if they were treated continuously (Tab.2 and 6). No bacteriological relapse was seen up to the end of February, 1977, but as the observation period after stopping the chemotherapy was still short, we are following up these cases carefully. It is our regret that there are some doctors who started again an additional chemotherapy for cases who completed the 6 months chemotherapy in our hospital. The reason for restarting chemotherapy was unstable X-ray findings, and the result of bacteriological findings were disregarded by these doctors.
日本結核病学会の論文

RFPを含む3方式による肺結核6ヵ月化療の対照試験 (第1報)

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