KISEP Original Articles 8 1 1997 Korean J Psychopharmacol Vol 8, No 1 치료저항만성정신분열증환자의 Risperidone 효과 이홍식 * 전지용 * 김찬형 * 송동호 * 육기환 * 김병천 * 손석한 * 구민성 * Efficacy of Risperidone in Treatment-Resistant Patients with Chronic Schizophrenia Hong-Shick Lee, M.D.,* Ji-Yong Jeon, M.D.,* Chan-Hyung Kim, M.D.,* Dong-Ho Song, M.D.,* Ki-Whan Yook, M.D.,* Byung-Cheon Kim, M.D.,* Seok-Han Sohn, M.D.,* Min-Sung Koo, M.D.* ObjectsThis open study was designed to investigate the efficacy and safety of risperidone in the treatmentresistant patients with chronic schizophrenia. 24 patients were entered on the 8-week open trial. A total of 3 patients discontinued risperidone treatment before the end of the study. MethodsWe investigated risperidone s efficacy and its side effects in 21 patients with treatment-resistant chronic schizophrenia, who had previously been treated with different kinds of classical antipsychotic drugs but with insufficient clinical effect or distressing extrapyramidal side effects, over a 8-week period. After 37 days of placebo wash-out period, patients were assigned to receive risperidone. The overall clinical efficacy was assessed at the 1st, 2nd, 4th, and 8th week of the treatment using the PANSS and the CGI. Safety and tolerability were assessed by the ESRS, the UKU side effect rating scale, the vital signs, and the laboratory tests including CBC, urinalysis, liver function test, and ECG. Results Clinically PANSS total score and CGI severity score on the end study point showed a significant improvement compared with baseline state. Significant improvements in both PANSS positive and negative subscale scores was as early as week 1 through week 8. Nine43% among of the 21 patients showed at least a 20% decrease in total PANSS scores. The tolerability of risperidone was geneally found to be good. Insomnia52%, fatigue52%, and sedation52% were the most common side effects. ConclusionThese results suggest that risperidone may be a effective antipsychotic agent in the treatment of refractory schizophrenia. However, double-blind comparative trial between risperidone and clozapine should be performed to further clarify the efficacy of risperidone in treatment-resistant patients with chronic schizophrenia. Key wordsrisperidone Treatment-resistant schizophrenia Clinical efficacy Side effects. 서 론 Department of Psychiatry, Yongdong Severance Hospital, Yonsei University College of Medicine, Seoul, Korea 60
1. 연구대상 대상및방법 2. 연구방법 1) 치료약물투여 61
2) 평가방법 3) 자료분석 결 1. 대상환자의인구학적특징 과 62
2. 항정신병효과 Table 1. Patient characteristicsn21 Characteristics Ageyears 28.05.8 Sex malefemale 1110 Age at first onset of illnessyears 21.63.5 Duration of illnessyears 6.34.6 Number of previous hospitalization 2.71.8 DiagnosisDSM-IV schizophrenia subtypes Undifferentiated 7 Residual 1 Paranoid 13 Disorganized Values represent meansd or frequency% 3. 부작용 Table 3. Clinical improvement, defined as a reduction of the total PANSS score by 20% or more 20% or more decrease Time N % of subjects N21 % of improvers N9 Week 1 2 10 22.2 Week 2 3 14 33.3 Week 4 9 43 100 Week 8 9 43 Table 2. Efficacy of risperidone on psychopathology over a 8week period*n21 Scale scores Baseline Week 1 Week 2 Week 4 Week 8 PANSS Positive 23.8 6.0 21.2 5.5 19.6 5.1 18.6 4.6 18.5 4.6 Negative 23.7 6.5 21.7 5.6 21.1 7.2 19.6 6.1 18.9 6.2 Total 91.316.6 84.016.3 80.117.6 76.417.4 75.819.0 CGI severity 3.2 0.8 4.1 0.9 4.0 0.8 3.9 0.8 3.9 0.9 *Repeated measure one-way ANOVA p0.05all rating scale scores significantly decreased compared to baseline for week 1 through week 8 by Bonferroni s t-testp0.05. Values represent meansd. 63
Table 4. Extrapyramidal symptom rating scaleesrs Cluster Score per clustermean scorerange Baseline 1W 2W 4W 8W Questionnaire total score 0 0,0 0.90, 6 1.00, 4 0.60,4 0.30,2 Parkinsonism total score 0.10,1 0 0, 0 1.60,10 0.80,3 0.50,3 Dystonia total score 0 0,0 0 0, 0 0 0, 0 0.10,2 0.10,3 Dyskinesia total score 0 0,0 0 0, 0 0 0, 0 0.10,1 0 0,0 Total+++ 0.10,1 2.00,11 2.60,12 1.50,5 1.00,6 CGI of severity of dyskinesia 0 0,0 0.30, 3 0.30, 5 0.10,1 0.10,2 CGI of severity of parkisonism 0.10,1 1.00, 5 1.20, 4 1.10,3 0.70,4 Table 5. Side effects profilen21 Side effect profile Frequency% Insomnia 1152.3 Fatigue 1152.3 Sedation 1152.3 Increased dream activity 942.8 Restlessness 838.1 Concentration difficulties 838.1 Amenorrhea 330.3* Hypersalivation 733.3 Headache 628.6 Constipation 523.4 Falling memory 523.4 Dizziness 419.0 Tremor 419.0 Rigidity 314.3 Dystonia 314.3 Accomodation difficulty 314.3 Nausea/vomiting 314.3 Polyuria/polydipsia 314.3 *Nfemale10 고찰 64
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