林瑞生Rey-hsen,Lin張祥成Hsiang-Chen, ChangChangHsiang-Chen醫學研究所2026-10-289999-12-311999https://handle.ncl.edu.tw/11296/h42578https://scholars.csmu.edu.tw/handle/123456789/34853中文摘要 精神分裂症是一種嚴重精神異常的疾病，其成因眾說紛紜，一般認為與遺傳因素或腦部缺損有關。精神分裂症的發病率佔全球的成年人口約1%左右，而精神科住院病患中則有近四成的病人是屬於精神分裂症。精神分裂症不僅造成病患個人的痛苦，也對其家庭及社會帶來沉重的負擔。 精神分裂症通常好發於青少年或年輕的成人，其症狀常出現妄想、幻覺、思考錯亂、社交畏縮、不合宜的感情及行為等，進而影響其自我及社會功能。上述這些精神分裂症的症狀，更進一步地被分類為「正性症狀」(如妄想及幻覺)和「負性症狀」(如社交畏縮及失語症)。 精神分裂症的治療重心一般還是針對其症狀加以控制及緩解，因此目前對於精神分裂症的治療仍以藥物治療為最主要的治療方式。雖然傳統抗精神病藥物已經能夠有效控制精神分裂症的正性症狀，但是其仍有諸多的使用限制。最嚴重的是它們具有潛在性的神經性副作用。以現今使用最為廣泛的抗精神病藥物Haloperidol為例，其具有很高的錐體外徑副作用(EPS)發生率，因此影響病患的服藥順從度導致精神病的復發。並且傳統抗精神病藥物對精神分裂症常見的負性症狀缺乏明顯之療效，因此對現代以鼓勵精神病患重返社會之治療理念造成障礙。另外仍有若干比例的難治型精神分裂症病患，對於傳統抗精神病藥物沒有明顯反應。 新一代的非典型抗精神病新藥Risperidone其藥理機轉，具有同時拮抗D2及5-HT2受體之功能，可有效治療精神分裂患者之正性症狀，亦可改善部份患者之負性症狀，且少有傳統藥物惱人的EPS副作用，因此使得病患的服藥順從度提高而有效預防精神病的復發。由於其具有改善負性症狀之功效，可使病患重返家庭及社會，進而提升患者的社會功能，減輕病患家屬與社會整體之負擔。 有鑑於Risperidone為一新近引進國內市場的抗精神病新藥，故本研究以Risperidone之臨床療效暨相關副作用為主題，於中部地區重要的精神病專科醫院(財團法人台中仁愛之家附設靜和醫院)進行回溯性的Risperidone的藥物使用評估，期望結果能做為Risperidone於精神分裂症臨床使用之參考。 本研究所進行之回溯性使用評估，是先由靜和醫院電腦處方資料庫中挑選1997年6月至同年12月間曾使用Risperidone之病患共計46位，爾後再依據藥品使用評估準篩選26位患者做為期12週之評估。病歷檢閱是依藥物使用記錄所需的資料為主，追蹤評估病患於12週間使用Risperidone及相關藥物的相關記錄，評估項目包括有病患基本資料、生理生化值資料、療效記錄、用藥記錄、錐體外徑副作用及其他藥物副作用等。 本研究的結果顯示，自1997年6月1日至同年12月31日止，靜和醫院新型抗精神病藥物Risperidone的使用人數共計46人，能符合十二週評估條件者有26人(56.52%)，未符合條件則有20人(43.48%)。符合評估的病患之中包括門診病人15人(57.69%)及住院病人11人(43.31%)。病患之現年齡：門診病人平均為37.27歲，住院病人則為44.82歲。門診病人服用Risperidone之平均劑量於為每日3.87mg，住院病人則為6.57mg。門診病患服用Risperidone前正性症狀之發生率：門診病患為80%、住院病患為81.82%；負性症狀之發生率於門診病患為53.33%、住院病患則為90.91%。使用Risperidone治療十二週後，正性症狀之發生率於門診病人下降到26.67%；住院病人則下降到45.45%。在負性症狀方面門診病人的發生率降為20%；住院病人則降為63.63%。因此，服用Risperidone十二週後的臨床改善率：正性症狀於門診病患為53.33%、住院病患為36.37%；負性症狀之改善率於門診病患為33.33%、住院病患為27.28%。在EPS副作用的發生率方面，本研究的結果顯示無論門診或住院病患其發生率均低。另外，病人對其他藥物副作用之耐受性良好，但是對於年長病患之失眠及心血管等副作用仍應小心注意。病患在用藥期間亦無任何生理及生化值異常出現。 根據這些研究結果所得之結論，Risperidone為一強力的5-HT2及D2受體阻斷劑，其獨特的平衡Serotonin/Dopamine功能作用，使其具有相當於傳統藥物的控制正性症狀之效力，且能夠成功地改善負性症狀。另外，Risperidone較傳統抗精神病藥物不易發生錐體外徑症候群(EPS)，其長期使用也可避免傳統抗精神病藥物發生遲發性不自主運動(TD)的危險。Abstract Schizophrenia is a group of illness of unknown origin that occurred in 1% of the adult population in most countries in which surveys have been conducted. The economic and social cost is considerable, as approximately 40% of all hospitalized psychiatric patients suffer from schizophrenia and related disorders, and that continues to place a large social and economic burden on individual and society. Schizophrenia usually begins during adolescence or young adulthood and is characterized by spectrum of symptoms that typically include disordered thought, social withdrawal, hallucinations (both aural and visual), paranoia and bizarre behavior. These symptoms are categorized as "positive"(e.g. hallucinations and paranoia behavior) and "negative"(e.g. social withdrawal and apathy). The pharmacological management of schizophrenia had played a major role in limiting the disintegration of the personality of schizophrenic patient. Although conventional antipsychotics are very effective to alleviate positive symptoms of schizophrenia, they have several limitations. The most important is a poor safety profile, notably the occurrence of EPS at therapeutic doses. In addition, conventional agents have relatively weak activity against negative symptoms. This is particularly important because negative symptoms are more associated than positive symptoms with poor long-term vocational and social outcomes. Finally, substantial proportions of patients are refractory to treatment with the older agents, which also have the potential to cause tardive dyskinesia. The atypical antipsychotic drug, risperidone combine, the known antipsychotic effects of dopaminergic receptor antagonism (seen in classical antipsychotics such as chlorpromazine and haloperidol) and serotoninergic receptor antagonism. On the basis of its pharmacology, risperidone can be predicted to have good therapeutic efficacy and a low incidence of extrapyramidal adverse effects. Since risperidone is a novel antipsychotic drug to be present marketing in Taiwan. We hope to comprehend the clinical efficacy and related side effects of risperidone. Thus, this study was to assess risperidone on the clinical efficacy of positive and negative symptoms, EPS and other related side effects on risperidone in schizophrenic patients in a 300-bed psychiatric hospital in the middle Taiwan. A retrospective drug utilization(D.U.E.) evaluation was conducted via computer-based data and medical records. There were 46 patients (include inpatients and outpatients) who had ever been prescribed Risperidone during June 1st 1997 to December 31st 1997. According to the criteria of D.U.E., 26 patients (including 15 outpatients and 11 inpatients whose age was between twenty one to sixty three years old) were selected for a evaluation of 12 weeks period. The usage guideline for evaluation of the effects of risperidone was defined by referring to literatures and specialists'' opinions. The average dose of risperidone for outpatients was 3.87mg daily and for inpatients was 6.57mg daily. The results of this study show that clinical improvement of risperidone on positive symptoms at the study end point were shown by 53.33% of the outpatients and 36.37% of the inpatients, respectively. In addition, clinical improvement of risperidone on negative symptoms were shown by 33.33% of the outpatients and by 27.28% of the inpatients, respectively. The incidence of extrapyramidal side effects in the study was low as placebo, which referred from some earlier literatures. The other side effects of risperidone excepted EPS in this study were mild. However, the occurrence of insomnia and some cardiovascular side effects in elder patients had to be noticed. On the other hand, no abnormal results of laboratory test were recorded in any of risperidone-treated patients. According to these findings, it is concluded that risperidone is an effective drug for improving both positive and negative symptoms of schizophrenia with a low incidence of adverse effects.精神分裂症抗精神病藥物正性症狀負性症狀多巴胺血清胺拮抗劑錐體外徑副作用藥物副作用瑞斯酮schizophreniaantipsychoticspositive symptomsnegative symptomsrisperidoneserotonin-dopamine antagonistsEPS side effectsSDAthesis