A New Method for the Clinical Evaluation of Drugs on Gastric Ulcers:An Application of Prognosis-type Method of Healing

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A "prognosis method of healing" was applied to the clinical assessment of a double blind study involving glycopyrronium bromide (A) and placebo (P) on gastric ulcers. In each case the healingtime was assessed empirically based on the initial viewing by the endoscope, supposing the treatment to be conventional therapy. Evaluation of efficacy was made by judging whether or not the ulcer of each patient had healed to the scaring stage by the prognosticated time. Only inpatients were subjected to this study and the endoscopy was carried out every other week.<BR>The efficacy rate of A was 74.5% and that of P was 56.6% (p=0.086). There was no significant difference between the two groups at a=0.05, because the P group revealed a higher efficacy rate than expected. However, the difference in the efficacy rates between both groups tended to increase as the severity of ulcers became greater.<BR>We consider this method to be useful in correcting the bias of severity in the two groups under comparison. However, the precision of the prognosis in this study was insufficient, and has to be further improved.
一般社団法人日本臨床薬理学会の論文