[Thiamphenicol versus trimethoprim-sulfamethoxazole in bacterial exacerbations of chronic unspecific respiratory tract diseases. A controlled study].

To document the efficacy of trimethoprim-sulfamethoxazole (TMP-SMZ) in treating bacterial exacerbations of chronic bronchitis, and to evaluate the efficacy of thiamphenicol (TAP), 29 patients with chronic bronchial disease were treated for two separate bacterial exacerbations, once with 0.48 g of TMP and 2.4 g SMZ daily, and once with 1.5 g of TAP daily, for 14 days. Patients were evaluated weekly and different measurements, including graded clinical observations, ventilatory tests, sputum measurements, quantitative bacterial counts and blood studies were performed. Side effects were closely monitored. Of the 29 patients entered, 20 finished the trial and hence 40 exacerbations were evaluated. All graded clinical observations were improved by the antimicrobials, whereas no marked change in the ventilatory tests was seen. Of the sputum measurements the daily volume, purulence, numbers of neutrophils and bronchial epithelial cells decreased, as did the numbers of Haemophilus influenzae and pneumococci. Of the blood studies the red blood cell count fell by more than 20% of the pretreatment value in 2 patients on TAP and 2 on TMP-SMZ. Using the same criterion, the hemoglobin level fell in 4 patients on TAP and in the hemoglobin level fell in 4 patients on TAP and in 2 patients on TAP-SMZ, while the hematocrit fell in 4 patients on TAP and in 1 on TMP-SMZ. However, all these changes were completely reversible. Minor gastrointestinal side effects were observed in 11 patients receiving TAP, compared to 3 patients on TMP-SMZ. 1 patient on the latter drug experienced a rash at the end of therapy. From the viewpoint of overall clinical assessment, 16 patients improved and 4 remained unchanged during therapy with TAP. The corresponding figures for TMP-SMZ were 17 patients improved, 2 the same and 1 worse at the end of therapy. The average relapse time after TAP was 184 days and after TMP-SMZ 180 days. In conclusion, 80% or more of exacerbations were improved by the two drugs. For all the variables measured, no significant differences were statistically detectable between the two antimicrobials, whether given in the sequence TAP first and TMP-SMZ second, or vice versa.

RCT Entities:   Population Interventions Outcomes