<原著>発声時の仮声帯の内転運動に関する研究 : 一側声帯麻痺例の臨床的検討

The purpose of this study is to clarify the mechanism of the adduction of ventricular folds during phonation. We assessed the type and degree of adduction of ventricular folds during phonation by fiber-stroboscopy in 277 cases of unilateral laryngeal nerve paralysis. In 169 cases of the 277 assessed, adduction of the ventricular folds occurred during phonation (61%), which was produced by the unaffected ventricular fold. Five cases (2%) exhibited adduction of the affected ventricular fold. There was no sex difference observed in the cases in which adduction of ventricular folds occured during phonation. As compared to nonadduction, the incidence of marked hyperadduction significantly increased with age in the later part of life. As for the maximum phonation time (MPT), the mean flow rate (MFR), and the SPL-range during the vocal function test, cases of marked hyperadduction of the ventricular folds showed significant reduction as compared with these with nonadduction. Regarding the pitch perturbation quotient (PPQ), the amplitude perturbation quotient (APQ) and the normalized noise energy (NNE) determined during the acoustic analysis, cases of marked hyperadduction of the ventricular folds showed significant reduction as compared with those of nonadduction. In many cases, reduction of the affected vocal fold function was observed in cases in which the fixed position of the vocal fold on the affected side was intermediate. In other words, the adduction of the ventricular folds was regarded as a compensatory reaction to glottal insufficiency. In 206 cases in which a silicon injection was performed, we compared the degree of adduction of the ventricular fold before and after the silicon injection. It is notable that following a silicon injection the degree of adduction was reduced in 106 (84%) out of the 126 cases in which adduction of ventricular folds was observed prior to injection.国立情報学研究所で電子

Challenges of clinical trial design when there is lack of clinical equipoise: use of a response-conditional crossover design

Clinical equipoise is widely accepted as the basis of ethics in clinical research and requires investigators to be uncertain of the relative therapeutic merits of trial comparators. When clinical equipoise is in question, innovative trial designs are needed to reduce ethical tension while satisfying regulators’ requirements. We report a novel response-conditional crossover study design used in a Phase 3, randomized, double-blind, placebo-controlled clinical trial of intravenous 10% caprylate-chromatography purified immunoglobulin for chronic inflammatory demyelinating polyradiculoneuropathy. During the initial 24-week period, patients crossed over to the alternative treatment at the first sign of deterioration or if they failed to improve or were unable to maintain improvement at any time after 6 weeks. This trial design addressed concerns about lack of equipoise raised by physicians interested in trial participation and proved acceptable to regulatory authorities. The trial design may be applicable to other studies where clinical equipoise is in question