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社会不安障害患者におけるParoxetine 塩酸塩水和物(パキシル(R) 錠)の長期使用における安全性および有効性の評価-特定使用成績調査結果-
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JPY
Abstract
We conducted a special drug use investigation to evaluate the safety and effectiveness in long-term treatment of paroxetine in patients with social anxiety disorder(SAD)in clinical practice. The incidence of adverse drug reactions (ADRs)was 27.4%(252/920)in the safety analysis set with 378 ADRs reported. The common ADRs of“nausea”,“ somnolence”,“ constipation”, “insomnia”,“ malaise”,“ headache”and“dizziness”were known. No new safety issue in long-term treatment was observed based on the time to onset of the ADRs and analysis of specific AE groupings of interest. The efficacy rate(“very much improved”or“much improved”in global improvement)was 62.3%(497/798)in the efficacy analysis set. Continuous improvement trend was confirmed until 12 months later in comparison with the point of start, in other effective scales /evaluation items, the Japanese version of the Liebowitz Social Anxiety Scale(including sub-score analysis), severity of illness, SAD-related somatic symptoms(“trembling of hands, feet and voice”“, palpitation or breathing difficulty”and“perspiration”)and disturbance of daily activities. From this investigation, paroxetine appears to be efficacious and generally well tolerated for the long-term treatment of SAD.
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