Evaluation on COG-78 Clinical Effects for Severe Infections Complicated with Hematopoietic Diseases

A Comparative Studywith Cross-over Method

Abstract

To evaluate the clinical efficacy and safety from using reduced and alkylated intravenous immunoglobulin preparation (COG-78) with antibiotics, the clinical studies were performed to patients with severe infections complicated with hematopoietic disease by cross-over method using a dried polyethylene glycol intravenous immunoglobulin preparation (PEG-γ G) as the control. Both test drugs were administrated with a dosage of 100 mg/kg/day respectively.
The results were as follow:
1) Of 69 cases studied, the efficacy was evaluated on 54 cases: 44 received COG-78 and PEG-γ G.
2) 20 of 44 cases in COG-78 (45.5%) and 14 of 39 cases in PEG-γ G (35.9%) showed more effective than “GOOD”.
3) The effective difference between them appeared in 13 of 29 cases, in which 7 cases were preferable COG-78 and 6 cases were preferable PEG-γ G. Thus the efficacy of COG-78 and PGE-γ G resulted almost the dame level.
4) Mild rash as incidence of adverse effects was observed in only 1 of 69 cases on each COG-78 and PEG-γ G.
Both preparations appeared equally efficacious from the point of clinical trials and adverse effects, so that we deserved COG-78 as one of the effective preparations combining with antibiotics for severe infection treatment.