[Study on effects of cefminox sodium on blood coagulation system]

Effects of cefminox (CMNX) on hemostasis and blood coagulation system were studied. Adult in-patients admitted to 237 centers (310 clinics) nationwide in Japan during the period from April 1988 to March 1989 were followed up using a newly designed uniformed protocol. Case cards recovered were inspected by an evaluation committee and patients to be included in analysis were determined according to the protocol. Presence or absence of abnormalities in the hemostasis and blood coagulation system was examined objectively using criteria for evaluation prepared by the committee. Out of 1,374 patients included in analysis, 10 patients were judged as having abnormalities which were suspected to have causal relationships with CMNX. Prolongation in prothrombin time was observed in 4 cases (0.29%), prolongation in activated partial thromboplastin time in 4 cases (0.29%), and decrease in fibrinogen in 2 cases (0.15%). Decrease in platelet count was not detected in any of the cases. Cross-sectional analysis according to background factors in these 10 cases revealed that abnormalities of the hemostasis and blood coagulation systems were significantly higher (P less than 0.01) for the group positive for underlying disease or complications ("positive" group) than the "negative" group. Five out of 9 patients of the positive group had malignant neoplasm. Other than this factor, no items showed statistically significant differences. From these results it is considered that the administration of CMNX is nearly free of effects on the hemostasis and blood coagulation system and development of laboratory abnormalities is chiefly due to the patients' condition.