急性膀胱炎の自然治癒率と薬剤効果の判定 --Cephalexinに関連して--

Abstract

There have been numerous clinical reports on chemotherapeutics, but the methods of judging their effects are varied. In the clinical studies of a drug, we have to minimize the disadvantage of the patients who do not respond it. From this point, "effectiveness rate" seems to be more adequate than "cure rate", because the former may be obtained in a rather short period. Cases for clinical trial must be also limited to a small number. In order to compare the clinical results from different institutions, method of the study and criterion of judging drug effects must be standardized. We studied clinical effect of cephalexin on acute cystitis based on our criterion and method. Urinalysis was done always in the same manner. A double blind method with use of placebo was also adopted in this series. Cephalexin was effective in 8 of 9 cases, while placebo was so in 3 of 9. A statistical analysis proved the effectiveness of cephalexin (p=0.02418 by Fisher's exact method). Three cases in the placebo group shows that spontaneous cure of acute cystitis exists. Rate of spontaneous cure of this time is similar to 5 of 20 (Nishiura, 1965) or 14 of 65 (21.5 %) by Nishimura (1969). Acute cystitis seems to be one of the most suitable diseases for drug trial because it shows uniform symptoms. In clinical evaluation of a drug, however, possible presence of spontaneous cure must be kept in mind.