Clinical Evaluation on SM-4300 for Severe Infections Complicated in Hematological Disorders

A Comparative Study with Cross-Over Method

Abstract

Clinical efficacy and safety of SM-4300, a newly developed human immunoglobulin preparation torintravenous use, were prospectively compared by the cross-over method with those of Venoglobulin^®-I (PEG.γ·γ G) in patients with severe infections complicated in hematological disorders. Both drugs wereadministered to the patients in whom the antibiotics alone had not been effective, at a dosage of 5.0g/day with the same antibiotics being continued.
The results obtained were as follows:
1. The difference of effectiveness in cross-over trials was observed in 12 of the 26 cases. In 7 casesof the 12 SM-4300 was favorable and in 5 cases PEG-γ G was favorable. The difference, however, wasnot statistically significant. Thus the efficacy of SM-4300 and PEG.γG was almost the same.
2. Of 77 cases studied, the clinical effectiveness was evaluable in 70 cases: 34 received SM-4300and 36 PEG.γG. Clinical effectiveness was excellent in 5 cases, good in 7, fair in 5 and poor in 17 in the SM-4300 group, and excellent in 3 cases, good in 9, fair in 7 and poor in 17 in the PEG.γG group. Theefficacy rate was 35.3% in the former and 33.3% in the lateer. There was no significant differencebetween two groups.
3. No subjective and objective clinical side effect was observed in all but 1 case in the SM-4300group, in which mild dizziness and cold sweat was observed probably due to high administration speed.
4. In conclusion, clinical efficacy and safety of SM-4300 was evaluated as being equal to those of PEG.γG. Thus, combination therapy with SM-4300 and antibiotics was considered to be useful in thesevere infections complicated in hematological disorders.