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An Open Trial of Risperidone Shifting from Oral Form to Long-acting Injection form in Patients with Schizophrenia
口服Risperidone轉換成Risperidone長效注射針劑用於治療精神分裂症患者的臨床試驗
摘要
目的：評估口服risperidone轉換成risperidone長效注射針劑對於治療精神分裂症病人之有效性和安全性。方法：本試驗共計收納21位已接受口服risperidone最少9週，症狀穩定之精神分裂症或分裂情感性障礙病人（平均PANSS分數=51.10±12.05），在為期12週之開放性研究中，轉換為Risperidone長效針劑。於開始時、第二週、第四週、第八週及第十二週，以Positive and Negative Syndrome Schedules (PANSS)，Clinical Global Impression (CGI) and Extrapyramidal Syndrome Rating Schedules (ESRS)量表評估受試者之的臨床療效及安全性。結果：試驗結果顯示，由口服risperidone轉換至risperidone長效注射針劑後，病人在RANSS total，positive，general psychopathology subscale得分及CGI得分並無顯著差異，而negative subscale總分則有顯著降低。若以PANSS總分降低程度大於20%做為顯著改善的定義，則有14.3%的受試者之臨床症狀有顯著改善。若以PANSS總分增加大於20%或CGI變異超過2分以上做為顯著惡化的定義，試驗前後並無受試者顯示出顯著的惡化。錐體外徑路副作用則於試驗前後有顯著地減輕。受試者主觀報告之副作用，與先前使用口服risperidone時並無顯著改變。諸副作用多為一過性，程度均屬輕微。病人心已電圖上的QTc與平均體重於試驗前後並未有明顯變化。結論：本研究顯示，risperidone長效注射針劑在治療精神分裂症或分裂情感性障礙症狀穩定的病人身上，療效上至少與口服risperidone相當，負性症狀則有顯著減輕。其副作用亦與口服risperidone相當。
並列摘要
Objectives: To evaluate the clinical efficacy and safety of shifting from the oral to the long-acting depot form of risperidone. Methods: We recruited 21 schizophrenic patients who were stable on oral risperidone for at least 9 weeks for participation in this 12-week, non-randomized, single arm, open study. Clinical efficacy and safety were evaluated with the Positive and Negative Syndrome Scale (PANSS), the Clinical Global Impression scale (CGI) and the Extrapyramidal Syndrome Rating Scale (ESRS) a the start of trial and at the 2nd, 4(superscript th), 8(superscript th) and 12(superscript th) weeks. Results: Switching from oral to depot risperidone did not result in significant changes in PANSS total score, positive subscale, general psychopathology sub- scale and CGI scores, while the PANSS negative subscale score showed significant reduction. Significant clinical global improvement, as defined by a reduction in PANSS total score of greater than 20%, was found in 14.3% of patients. None of the patients showed significant deterioration in clinical condition defined by a worsening of PANS S total score ＞ 20% or a change in CGI of more than 2 points. The severity of EPS decreased significantly, especially for parkinsonism symptoms. Although various side effects were reported, most were nonspecific subjective complaints carried over from the previous period of oral risperidone treatment. No significant change in QTc or mean body weight was from baseline to the study endpoint. Conclusion: This study showed that depot risperidone was as effective as oral Risperidone in maintenance therapy for schizophrenia, and had a comparable side effect profile. A controlled prospective study with a larger sample size, however, is needed to confirm these findings.
參考文獻
延伸閱讀
- 張淑玲、吳信昇、許斐凱、李炳鈺、溫燕霞（2010）。以Risperidone或Olanzapine分別治療精神分裂症之評估。南臺灣醫學雜誌，6(2)，109-116。https://doi.org/10.6726/MJST.201012_6(2).0006
- Tsai, J. H., Tang, T. C., Yang, P. C., Yen, C. F., Yang, M. J., Yen, J. Y., & Chen, C. C. (2005). 比較risperidone與典型抗精神病藥作為躁症發作治療佐劑之效果：一個回溯性研究. The Kaohsiung Journal of Medical Sciences, 21(11), 539-544. https://www.airitilibrary.com/Article/Detail?DocID=02575655-200511-21-11-539-544-a
- Yeh, M. L. (2019). 慢性B型與C型肝炎合併感染應用長效干擾素合併雷巴威林或全口服直接作用抗病毒藥物治療之世代性研究 [doctoral dissertation, Kaohsiung Medical University]. Airiti Library. https://www.airitilibrary.com/Article/Detail?DocID=U0011-0507201914532600
- Yeh, J. Z., Chin, C. Y., & Yeh, M. K. (2012). Esomeprazole錠劑經管灌給藥之有效劑量探討. 臺灣臨床藥學雜誌, 20(2), 127-139. https://www.airitilibrary.com/Article/Detail?DocID=10275096-201206-201211290010-201211290010-127-139
- Chan, H. Y. (2009). 精神分裂症患者由第一代轉換為第二代抗精神病藥物隨機分配有對照組之研究:針對療效、短期錐體外路徑副作用以及長期錐體外路徑副作用之系列研究 [doctoral dissertation, National Taiwan University]. Airiti Library. https://doi.org/10.6342/NTU.2009.01535