Therapeutic effects of SM-4300 and antibiotic combinations against severe bacterial infections in the field of internal medicine

Abstract

A newly developed human immunoglobulin preparation for intravenous use, SM-4300, purified by cold ethanol precipitation and ion-exchange adsorption, has been studied in the field of internal medicine.SM-4300 has been evaluated clinically in Japan since 1982 in patients with severe bacterial and/or fungal infections in the combined use with the antibiotics which are resistant to antibiotic therapy.1. Total number of 199 patients affected with various severe infections were treated with SM-4300 and evaluated by doctors in charge. Clinical effects of SM-4300 were excellent in 15 cases, good in 56, fair in 36, poor in 48 and unknown in 44. The efficacy rate was summarized as 45.8%.2. Out of 199 cases 117 cases were accepted as the evaluable cases by the committee. The evaluable cases consisted of respiratory infections (62.4%), septicemia including suspicion of septicemia (20.5%), renal and urinary tract infections (8.5%), hepato-biliary tract infections (3.4%) and others. The majority of patients had one or more underlying diseases, mainly including malignant tumor (19.7%), chronic pulmonary disease (10.5%), cerebro-vascular disorder (17.1%), leukemia (10.3%), other diseases (17.9%). The patients without underlying diseases was 10.3%.3. Clinical effects of SM-4300 were excellent in 15 cases, good in 45, fair in 27 and poor in 30 cases. The efficacy rate was summarized as 51.3%.71 strains of clinical isolates were obtained from 54 cases. Fifty-nine strains out of them were evaluable for bacteriological effects which were eradicated in 26 strains, decreased in 6 and persisted in 27 strains. The eradication rate was 44.1%.4. The analysis of the relation between clinical efficacy and underlying diseases, backgroundf actors, isolated organisms or dosage of SM-4300 was done and there was no significant relationship.5. The rate of appearance of subjective and objective clinical side effects was 1.0%(2 cases). Abnormal laboratory findings because of SM-4300 administration were observed in 3 cases of 199 adopted cases. None of the side effects and abnormal laboratory findings was considered practically important.In conclusion, combination therapy with SM-4300 and antibiotics was considered to be safe and effective against severe bacterial and/or fungal infections in the field of internal medicine.