CONTROLLED TRIAL OF SHORT-COURSE REGIMENS OF CHEMOTHERAPY IN THE AMBULATORY TREATMENT OF SPINAL TUBERCULOSIS - RESULTS AT 3 YEARS OF A STUDY IN KOREA

After exclusions, 265 patients with tuberculosis of the thoracic and/or lumbar spine were followed for three years from the start of treatment. They were randomly allocated to four daily regimens of chemotherapy: 1) isoniazid plus rifampicin for 6 months (6HR, 65); 2) the same drugs as in 1) but for 9 months (9HR, 71); 3) isoniazid plus para-aminosalicylic acid (PAS) or ethambutol for 9 months (9P/EH, 62); or 4) the same drugs as in 3) but for 18 months (18P/EH, 67). All patients were ambulatory from the start of chemotherapy and no form of splintage or support or operation was used in any case. Over half (55%) the patients were children and one-third had sinuses or clinically evident abscesses. At three years a favourable status, defined as no sinus nor clinically evident abscess, no myelopathy with functional impairment, no surgery nor additional chemotherapy, full physical activity with disease quiescent clinically and radiographically, was achieved in 203 patients (77%) and in another 41 (15%) in all respects except radiographically. Only 20 patients (8%) had an unfavourable status the proportion being highest (19%) in the 9P/EH series. Thirteen of these were classified as unfavourable solely because they had needed additional chemotherapy; only seven still had an unfavourable status at three years. The clinical results at three years were thus excellent in all series except the 9P/EH, in which more patients had required additional chemotherapy. In the 88 patients with sinuses or abscesses on admission, the rate of resolution was similar in all the series; most lesions (83%) had resolved by 12 months. There was an apparent recurrence, however, in 14% of 42 patients in the two P/EH series but in none of the 46 in the two HR series. Abscesses or sinuses were reported for the first time after starting chemotherapy in 33 patients; 27 resolved within 12 months. Myelopathy was present on admission (or developed in the first two months) in 30 patients, 19 having functional impairment. There was complete resolution in 23 patients by three years, one having had additional chemotherapy. A further three patients developed myelopathy after two months (two with functional impairment); two had resolved by three years. Thus at three years, eight had persisting myelopathy, two with functional impairment. These results show that isoniazid plus rifampicin for six or nine months was effective and as successful as the 18-month regimen of isoniazid plus para-aminosalicylic acid or ethambutol. The 9-month regimen of isoniazid plus PAS or ethambutol, however, was clearly inferior.