[A double blind comparative study on the efficacy of S6472, cefaclor and amoxicillin, in the treatment of bacterial pneumonia].

The S6472 is a 4:6 mixture of 2 types of granules of cefaclor (CCL) coated with different films; one type of granules is soluble at low pH's and absorbed in the stomach while the other type is soluble at high pH's and absorbed in the intestine. The difference in absorption sites makes it possible to maintain blood concentrations of the drug at clinically efficient levels for a longer period of time compared with ordinary CCL. The efficacy, safety and usefulness of S6472 in the treatment of bacterial pneumonia was compared with those of ordinary CCL and of amoxicillin (AMPC) by the blind method. The patients entered in this trial were those who had bacterial pneumonia or lung abscess and were 16 years or above of age. The S6472 was given orally for 14 days at a daily dose of 1,500 mg (750 mg each after breakfast and supper), CCL was given at a daily dose of 1,500 mg (500 mg each after every meal), and AMPC at 2,000 mg (500 mg each after every meal and at the bedtime). To make the study blind, placeboes were matched with the test drug so that patients in every treatment group took 4 doses per day. Out of a total of 195 patients thus treated, 179 patients (55 in S6472 group, 62 in CCL group and 62 in AMPC group) were adopted for the evaluation by committee members while 185 patients (58 in S6472 group, 63 in CCL group and 64 in AMPC group) by controllers. When clinical results of the 3 treatment groups were compared, no statistically significant differences were observed in efficacy rates (cure rates), incidences of side effects nor abnormal findings of laboratory tests. From these results of this trial, it is concluded that oral administration of 750 mg of S6472 twice a day (1,500 mg per day) is as effective and useful as that of 500 mg of ordinary CCL 3 times a day (1,500 mg per day) or 500 mg of AMPC 4 times a day (2,000 mg per day) in the treatment of bacterial pneumonia or lung abscess.