A CONTROLLED TRIAL OF AMBULANT OUT-PATIENT TREATMENT AND IN-PATIENT REST IN BED IN THE MANAGEMENT OF TUBERCULOSIS OF THE SPINE IN YOUNG KOREAN PATIENTS ON STANDARD CHEMOTHERAPY

Abstract

1. Two hundred young Korean patients with a diagnosis of tuberculosis of the spine were allocated at random to in-patient rest in bed (IP) for six months followed by out-patient treatment, or to ambulatory out-patient treatment (OP) from the start. A second random allocation was made to chemotherapy with streptomycin for three months and PAS plus isoniazid for eighteen months (SPH), or to PAS plus isoniazid for eighteen months (PH). For various reasons twenty-nine patients had to be excluded from the study. The main analyses of this report therefore concern 171 patients, namely, forty IP/SPH, forty-six IP/PH, forty-two OP/SPH and forty three OP/PH. The comparisons made are a) of in-patient and out-patient treatment, and b) of the SPH and PH regimens. 2. The clinical and radiographic condition of the four groups on admission was similar. Many patients had extensive lesions. 3. Two in-patients died, probably from miliary tuberculosis, but neither had evidence of residual activity of the spinal lesion. 4. For the eighty-six in-patients the mean stay in hospital was 199 days and five were later readmitted. Of the eighty-five out-patients twenty-one (fourteen SPH, seven PH) were admitted to hospital in the first six months for complications of the spinal disease, for other medical conditions, or for domestic or geographical reasons; after the first six months eight more were admitted. 5. Three in-patients and five out-patients received chemotherapy beyond eighteen months for abscess or for paraparesis. 6. An abscess or sinus was either present initially or developed during treatment in 76 per cent of the in-patients and 72 per cent of the out-patients. Complete resolution occurred in most of the patients, some abscesses being aspirated. At three years 11 per cent of the in-patients and 5 per cent of the out-patients still had residual abscesses or sinuses. 7. On admission the mean total vertebral loss was 1·79 in the in-patients and 1·33 in the out-patients, and increased over the three-year period by 0·15 and 0·31 respectively. 8. The mean angulation of the spine at the start of treatment was 37 degrees for the in-patients and 27 degrees for the out-patients, the mean increase over the three-year period being 8 and 18 degrees respectively. 9. On admission six in-patients and four out-patients had incomplete motor paraplegia. This resolved completely within nine months in eight patients, as did the one cauda equina lesion. Only two patients (both out-patients) developed paraparesis during the course of the study; both recovered. 10. At eighteen months 66 per cent of the in-patients and 58 per cent of the out-patients had responded favourably. The corresponding percentages at thirty-six months were 84 and 88. 11. There was little difference in behaviour between the SPH and the PH series; at thirty-six months 82 per cent of eighty SPH and 90 per cent of eighty-eight PH patients had a favourable response. 12. A multiple regression analysis failed to identify any factor of clearly prognostic importance on admission.