Abstract
The clinical effect and side effect of micronomicin sulfate were studied in collaboration of 14 univer sities and one public hospital in accordance with the method and evaluation criteria recommended by the Association for Research in Infectious Diseases of the Eye, Japan.
The results were as follows.Among the 397 cases accepted for evaluation the clinical effect was excellent in 166 (47.8%), good in 212 (53.4%), fair or poor in 18 (4.5%), and unidentified due to adverse effect in the last one;thus the effective rate was 95.2%.By the evaluation criteria of the above Association, the drug is judged as ‘excellent’ when the effective rate is over 90% where the excellent clinical effect is 45%.The evaluation criteria of the Association also provides that the treated cases should contain more than 15 cases of infections with 3 kinds of specific bacteria, such as KOCH-WEEKS, MORAX-AXENFELD, Streptococcus pneumoniae and Pseudomonas aeruginosa.The present study contains 78 cases of 4 kinds of specific bacterial infections;excellent clinical effect was seen in 35 (44.9%) of the 78, good effect in 41 (52.6%), and the effective rate was 97.4% in these cases.As they correspond to the over-all results, the said evaluation was applicable.
The safety of micronomicin sulfate eye drops was calculated on the 451 cases including 397 adopted cases and 54 excluded cases from efficacy evaluation due to negative bacteria though continuously treated.No serious side effect was seen in these cases and the safety coefficient was found to be 1.94 (full mark: 2).The drug showing safety coefficient over 1.90 is judged as ‘excellent’ in safety.
Micronomicin sulfate was applied as the aseptic procedure of preoperative conjunctival sac according to the regulatory method, and the aseptizing rate obtained was 77% (admitting line: 70% in more than 30 cases), and the effective coefficient calculated according to the regulatory method was 13.5 (admitting line: 10).In addition, this drug prevented the manifestation of infection after an intensive in oculation with potent Pseudomonas aeruginosa into the rabbit cornea.Thus, micronomicin sulfate was judged ‘passed’ as a drug for prophylaxis of postoperative infections including those due to Pseudomonas aeruginosa.
From the above results, it was concluded that micronomicin sulfate eye drop is one of the first choice eye drops for the treatment of the external bacterial infections of the eye.
