A controlled trial on the clinical effects of Rifampicin (RFP). Ethambutol (EB). Isoniazid (INH) tripple combination and that of Streptomycin (SM) . Paraaminosalcyclic acid (PAS). INH tripple combination was conducted on 122 previously untreated pulmonary tuberculosis (TB)patients admitted to 29 prefectural and municipal TB hospitals all over Japan.
Newly diagnosed, previously untreated pulmonary TB patients with p o sitive tubercle bacilli in sputa were allocated at random to one of the above two regimens: 62 patients in RFP⋅EB⋅INH group and 60 patients in SM⋅PAS⋅INH group at the beginning of treatment.
The background factors of patients in each group were almost similar except for a slight advantage of SM⋅PAS⋅INH group in regard to younger age and less extensive lesions.
Dose of drugs used was as follows: 450 mg of RFP once daily before br e akfast or in 3divided dose after each meal, 750 mg of EB once daily or in 3 divided dose after each meal, 400 mg of INH once daily, 10 gram of PAS in 3 divided dose daily, orally, and 1 gram of SM twice weekly or daily, intramuscularly.
The clinical effects a nd side effects of both groups were compared. Sputum negative conversion rate on culture was 67.8, 94.7 and 98.1% at 2, 4, and 6 months in RFP⋅EB⋅INH group, while the rate was 60.3, 86.8 and 96.1% in SM⋅PAS⋅INH group, respectively.
The improvement of basic lesions on chest radiograms was observed in 44.1, 80.7 and 98.1%of patients at 2, 4 and 6 months in RFP⋅EB⋅INH group, while in 45.8, 83.6 and 94.3% in SM⋅PAS⋅INH group, respectively. The improvement of cavities was seen in 37.8, 61.6 an d 82.7% at 2, 4 and 6 months in RFP⋅EB⋅INH group, while in 44.9, 72, 6 and 82.9% in SM. PAS. INH group, respectively.
The frequency of major side effects in each group was almost similar, but minor side effects were seen slightly more frequently in SM⋅PAS⋅INH group. Five patients in RFP⋅EB⋅INH group were dropped out through allergic reactions (2 patients), elevation of S-GOT and S-GPT values (2 patients) and optic neuropathy (1 patient), while 4 patients in SM⋅PAS⋅INH group through allergic reactions (1 patient), hearing impairment (1 patient), headache (1patient) and gastrointestinal symptoms (1 patient).
It is concluded that RFP⋅EB⋅INH tripple combination is as good as SM⋅PAS⋅INH tripple combination in the original treatment of pulmonary tuberculosis.
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