CLINICAL EVALUATION OF CEPHALEXIN IN PEDIATRIC PATIENTS WITH ACUTE PHARYNGITIS AND TONSILLITIS: DISCUSSION OF DRUG EVALUATION ON ANTIBIOTICS

• Published in: Japanese journal of antibiotics 1978/02/25, Vol.31(2), pp.72-82
• Main Authors: KONNO, MASATOSHI, GOTO, MASASHI, TERANISHI, TAKASHI, ITO, MASAO, YASUDA, MASATOSHI, KIBI, MASAO, KIMURA, MOTOAKI
• Format: Article
• Language: Japanese
• Subjects: Acute Disease; Age Factors; Cephalexin - administration & dosage; Cephalexin - therapeutic use; Child; Child, Preschool; Clinical Trials as Topic; Delayed-Action Preparations; Drug Evaluation - methods; Female; Humans; Male; Pharyngitis - drug therapy; Tonsillitis - drug therapy
• ISSN: 0368-2781; 2186-5477
• DOI: 10.11553/antibiotics1968b.31.72

We reviewed and discussed comparative double blind clinical studies of sustained release cephalexin (S-6437) with regular cephalexin conducted by Dr. Fujii and G.P.'s group consisting of pediatricians in pediatric patients with acute upper respiratory tract infections who visited their clinics within 24 hours after fever appeared. The following is the summary of our findings on the studies: (1) It was found that total evaluation of the drugs by the investigators in the studies was done based upon many clinical examinations and about 64% of the total evaluation was covered by 15 examinations such as body temperature, subjective and objective symptoms, and the amount of food intake on the initial treatment day, the degree of improvement of symptoms (except objective symptoms) on the 2nd treatment day, the degree of improvement of symptoms on the 3rd treatment day, and recovery days. The total evaluation in the studies was performed based mainly upon symptoms (e.g. body temperature, objective symptoms and amount of food intake) which can objectively be observed. Especially, antipyretic time, objective symptoms and ithe degree of improvement of the symptoms on the 3rd treatment day were taken as important factors for the drug evaluation. (2) The degree of subjective symptoms on the initial treatment day, the degree of improvement of the symptoms on the 2nd and the 3rd treatment days, and recovery days of the symptoms were highly relative to body temperature. (3) The patients in the studies showed notable improvement or recovery within 48 hours after the initiation of the treatment. (4) From the above finding, the evaluation of the drugs by the investigators in the studies was considered to be made based upon objective evidences. (5) Also, it was considered to be important to examine body temperature, objective symptoms and amount of food intake at short intervals in early stage of the disease for the drug evaluation in pediatric patients with acute upper respiratory tract infections, though many examinations will be required for the evaluation.