[Clinical evaluation of sustained release preparations of cefaclor in dental infections. Comparative double blind clinical studies of sustained release preparations with a regular preparation of cefaclor].

In vitro viable cell count studies of sustained release preparations of cefaclor (CCL) conclude that the mixture of nonenteric and enteric coated granules of CCL in the ratio of 4 to 6 is the most appropriate form (4:6 form) for the sustained release preparation of CCL. In order to clinically confirm the above conclusion, comparative double blind clinical studies of 3 mixtures forms (2:8, 4:6 and 6:4 forms) with a regular preparation (CCL form) were conducted in dental infections regarding efficacy, safety, and usefulness of the 4 forms. Evaluable cases for efficacy and usefulness were 364 in total (96 cases for the 2:8 form group, 89 cases for the 4:6 form group, 89 cases for the 6:4 form group, and 90 cases for the CCL form group). Evaluable cases for safety were 404 cases in total (102 for the 2:8 form, 100 for the 4:6 form, 102 for the 6:4 form, and 100 for the CCL form). Daily dose of the 3 forms of sustained release preparations was 375 mg b.i.d. after breakfast and dinner and that of the CCL form 250 mg t.i.d. after breakfast, lunch and dinner. Following are the results of the clinical studies: There were no significant differences among the 4 patient-groups (2:8 form, 4:6 form, 6:4 form, and CCL form) regarding background factors of the patients and findings of their subjective and objective symptoms before the initiation of the administration, and it was therefore confirmed that there were no problems in conducting the comparative double blind clinical studies. Overall clinical effective rate determined by the efficacy evaluation criteria of the Japanese society of oral surgery (JSOS) were 89.5% at day 3 and 94.8% at day 5 in the 2:8 form group, 87.4% at day 3 and 95.5% at day 5 in the 4:6 form group, 86.4% at day 3 and 91.0% at day 5 in the 6:4 form group, and 93.3% at day 3 and 96.7% at day 5 in the CCL form group. The effective rate determined by the physicians who actually treated the patients were 84.4% in the 2:8 form group, 87.6% in the 4:6 form group, 84.1% in the 6:4 form group, and 87.8% in the CCL form group. In both judgments by the efficacy evaluation criteria of JSOS and the physicians, there were no significant differences among the 4 forms regarding overall clinical efficacy.(ABSTRACT TRUNCATED AT 400 WORDS)

[A double-blind comparison between cefaclor and cephalexin in the treatment of dental infections].

A comparative clinical study of cefaclor (CCL) with cephalexin (CEX) was carried out by randomized double-blind techniques in order to contemplate the clinical efficacy, side effects and usefulness in treatment of 243 patients with dental infections. In the CEX group, CEX was orally administered 4 times a day at a daily dosage of 1,000 mg for 3 to 5 days. In the CCL group, CCL was orally administered 3 times a day at a daily dosage of 750 mg for 3 to 5 days and 1 capsule of placebo was also given every evening in order to keep the blindness of the administration. Evaluable cases for efficacy of athe drugs were 213 consisting of 108 for CCL and 105 for CEX. There were no significant differences in background of the patients and severity of the disease between 2 treatment groups. Clinical effectiveness on the 3rd day was 89.7% in CCL group and 78.6% in CEX group, showing significant difference between 2 treatment groups. Clinical effectiveness on the final day of administration was 94.4% in CCL group and 92.4% in CEX group, showing no significant difference between 2 treatment groups. Side effects were found in 10.5% of 114 patients receiving CCL and in 4.5% of 112 patients with CEX, and there was no significant difference between 2 treatment groups. The side effects were mostly gastrointestinal origin. According to the judgement by physicians in charge, no significant difference was seen in clinical usefulness between the 2 drugs.

[Double-blind comparison of L-keflex and cephalexin (Keflex) in dental infections (author's transl)].

In order to evaluate efficacy and safety of L-Keflex (granule form of sustained release cephalexin), a double blind study comparing it with Keflex (capsule of regular cephalexin) was conducted in dental infections. Evaluable cases in adults for efficacy of the drugs were 196 consisting of 97 for L-Keflex and 99 for Keflex. Those in children were 19 (8 for L-Keflex and 11 for Keflex). There were no significant differences in background of the patients and severity of the diseases between both groups (L-Keflex and Keflex groups). The daily doses used in both groups were 1,000 mg in adults and 500 mg in children, respectively. The dose was given in two divided doses for L-Keflex group and in four divided doses for Keflex group. Following are evaluation by the committee members for the study: Adults 1. Clinical response rate at final therapy day was 93.8% in L-Keflex group and 92.9% in Keflex group, showing no significant difference between both groups. 2. No significant difference in severity of subjective and objective symptoms between both groups was observed at each therapy day. 3. Side effects were found in 6.7% of 105 patients receiving L-Keflex and in 5.6% of 107 patients with Keflex, and there was no significant difference between both groups. As the side effects, gastrointestinal symptoms, rash and itching were observed, but no any other side effects were found in both groups. Children 1. As shown in the above, number of the cases enough to evaluate statistically was not obtained, but all of both groups clinically responded to the drugs. 2. As for side effects diarrhea was observed in only one patient of Keflex group consisting of 12 patients. In the patient, however, discontinuation of the drug was not required and the side effect disappeared during the therapy. From the above results, L-Keflex (granule) is judged to have more convenience than Keflex (capsule) in that (1) it can be administered with b.i.d. regimen and (2) it can be easily taken in dental patients such as patients having difficulty in opening mouth of swallowing pain.