:Multi-center Adequate Well-controlled Study

概要

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Clinical effects of disopyramide phosphate injectable (DP) 100 mg were examinedby comparing with intravenous injection of procainamide (PA) 500 mg, using"adequate well -controlled study", which means that the drugs were allocated atrandom to the patients and physicians know the used drug but the effect wasevaluated by the evaluation committee without information about the drug. Theregular double blind method was not employed, because intravenous antiarrhythmicdrugs, in general, are used in the emergency situation and severe risk can notbe avoided. In 126 cases of tachycardic arrhythmias (paroxismal atrial and ventriculartachycardia, and transient atrial fibrillation and flutter), DP was moreeffective (60.9%) than PA (46.8%) with a statistically significant difference, althoughno difference was observed in the effectiveness in 90 cases of extrasystolesbetween both drugs (95.6% and 88.9%). The incidence of side effects was 12.8%with DP and 12.1% with PA, showing no significant difference. These resultsindicate the usefulness of DP.
一般社団法人日本臨床薬理学会の論文