Post-marketing Survey of Risperidone in the Treatment of Outpatients with Behavioral and Psychological Symptoms of Dementia

　　目的：評估risperidone用於治療台灣失智症伴隨行為精神症狀個案之劑量及副作用。方法：這是一個上市後監測調查，對象為110個醫師門診之558位失智症伴隨行為精神症狀個案。個案接受12週的口服risperidone治療。Risperidone劑量之調整完全依照精神科醫師之臨床判斷。個案需回診5次。每次回診紀錄risperidone劑量及副作用。結果：Risperidone初始劑量為日劑量0.5至1.0 mg，平均0.65 + 0.31 mg.治療期間risperidone平均日劑量為1.31 + 0.89 mg.絕大多數個案的日劑量在0.5至4.0 mg之間。年紀輕者服用的劑量教高，年紀越大日劑量越低。副作用中最多的為錐體外徑症候群(9.2%)。結論：台灣失智症伴隨行為精神症狀個案服用的劑量略高於西方人，整體上安全且耐受性佳。
　　Objective: The aims of this study were to evaluate the optimal dosing and possible adverse effects of risperidone in Taiwanese outpatients with behavioral and psychological symptoms of dementia (BPSD). Methods: This was a phase IV, multi-center, 12-week, post-marketing surveillance study. We enrolled 558 patients with BPSD from an outpatient drugs surveillance system (risperidone postmarketing surveillance, RPMS) in Taiwan. The study patients were scheduled to return to the clinic five times during the 12-week course of the study. Dosage of risperidone was titrated according to the patient's clinical condition at each visit. We evaluated the safety and tolerability of risperidone on the basis of adverse events reported in response to a questionnaire. Results: The initial dose of risperidone was from 0.5 to 1.0 mg daily, with a mean + standard deviation (0.65+ 0.31 mg). The mean dose + SD during the 12 weeks was 1.31 + 0.89 mg. Most patients received a final dosage from 0.5 to 4.0 mg daily. Only three patients were prescribed more than 4 mg daily. Younger patients needed higher dose of rispeirdone than older patients, and the dosage was decreased with age. The most common adverse event was extrapyramidal symptoms (9.2%). Conclusion: The mean dose of riperidone prescribed for BPSD dementic outpatients in Taiwan was slightly higher than that for Caucasians. Risperidone is safe and well-tolerated by Taiwanese BPSD outpatients.