[Clinical evaluation of co-tetroxazine in acute purulent sinusitis and acute tonsillitis in a double-blind...

127 outpatients, 78 with acute purulent sinusitis and 49 with acute tonsillitis, were treated for 7 days with a benzylpyrimidine -sulphonamide combination. In this double-blind and randomized study 59 patients received co- tetroxazine (100 mg tetroxoprim and 250 mg sulphadiazine) b.i.d., whilst the reference substance, co-trimoxazole (160 mg trimethoprim and 800 mg sulphamethoxazole) was given to the remaining 68 patients b.i.d. The test criteria were the therapeutic efficacy and both subjective and objective tolerance. An improvement in clinical symptoms and signs occurred in both conditions under each therapeutic regimen. Clinical therapeutic success was rated very good or good in 96.6% treated with co- tetroxazine and in 97.1% of patients treated with co-trimoxazole. In the former group therapy failed in 1 patient with sinusitis and in 1 with acute tonsillitis . In 98.3% of patients treated with co- tetroxazine the tolerance was very good or good, whilst the respective figure for co-trimoxazole was only 91.2%. 6 patients suffered from side effects ( gastric spasm, gastralgia , nausea, vomiting, diarrhoea) which were so severe in 2 cases that treatment had to be prematurely terminated. The generally good tolerance to both preparations was confirmed by the results of the laboratory investigations.