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薬理と治療
Abstract
Background MOVICOL® for treatment for chronic constipation, is an osmotic laxative containing polyethylene glycol as its main ingredient and various electrolytes. To collect the detailed safety and efficacy data, we planned the large-scale post-marketing surveillance study of MOVICOL®. Method From May 2019 to June 2021, we performed the post-marketing surveillance study of MOVICOL® in daily medical practice. We summarized the safety and efficacy data as an interim report. Results In this study, we registered 887 patients and collected data for 571 patients. We included 544 patients in the safety analysis set of this surveillance protocol; males were 217 (39.9%)and females were 327(60.1%), and the average age was 42.2±34.1 years. The safety results showed that adverse events were reported in 20(3.7%)of 544 subjects. The efficacy results showed that the defecation frequency increased at 4 weeks after treatment. The results of the Bristol Stool Shape Scale demonstrated the improvement of the stool shape. The satisfaction with defecation also improved. Conclusion These results demonstrated that MOVICOL® improved the symptoms of constipation without any safety concerns.
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