| Abstract: | The clinical effectiveness, safety and usefulness of KN-7 tablet as a new oral application of the prostatic extract, on urinary dysfunction of neurogenic bladder were compared with those of Robaveron injection by the double-blind test method. In the study, 2 tablets t.i.d. and a shot of intramuscular injection 1 ml a day were given successively for 3 weeks. A total of 233 cases were reported from 37 facilities belonging to the KN-7 Clinical Research Group. Some of them were excluded or dropped out. The number of cases used for analysing the effectiveness, safety and usefulness were 214, 232 and 215, respectively. There was no bias between the two groups with a significant homogeneity in the background. In the overall clinical effectiveness, the effective rate including excellent, moderate and slightly effective was 76.9% with KN-7 and 77.4% with Robaveron. In the clinical usefulness, the rate of usefulness of slightly useful or above was 75.0% with KN-7 and 75.7% with Robaveron. There was no significant difference between the two groups in the clinical effective and useful rates at a significant level of 5%. Side effects were observed in 1 of the 114 (0.9%) patients given KN-7 and 8 of the 118 (6.8%) patients given Robaveron. The incidence of adverse reactions with KN-7 was significantly lower than that with Robaveron. Based on the results, it was concluded that KN-7 tablets, 2 tablets t.i.d., would be as effective and useful as a Robaveron injection 1 ml daily and safer than the latter in the treatment of neurogenic bladder. |
