KISEP Original Articles 12 3 2001 우울장애환자에서 Nefazodone의항우울효과, 항불안효과및수면 성기능 삶의질등에미치는영향에관한다기관연구 민성길 1 강병조 2 정인과 3 조맹제 4 윤진상 5 김동기 6 강민희 7 김도관 8 김명정 9 김석현 10 김용구 11 김정기 12 박민철 13 방계원 14 손봉기 15 신지용 16 오강섭 17 윤보현 18 이경규 19 정상근 20 정영기 21 정인원 22 정희연 23 제영묘 24 지익성 25 최병무 26 한선호 27 한오수 28 ABSTRACT A Multicenter Study on Effects of NefazodoneSerzone TM on Depression, Anxiety, Sleep, Sexual Functions, and Quality of Life in Patients with Depression Sung Kil Min, MD, PhD, 1 Byung Jo Kang, MD, PhD, 2 In Kwa Jung, MD, PhD, 3 Maeng Je Cho, MD, PhD, 4 Jin Sang Yoon, MD, PhD, 5 Dong Kee Kim, PhD, 6 Min Hee Kang, MD, PhD, 7 Doh Kwan Kim, MD, PhD, 8 Myung Jung Kim, MD, PhD, 9 Suk Hyung Kim, MD, PhD, 10 Yong Ku Kim, MD, PhD, 11 Jung Ki Kim, MD, PhD, 12 Min Cheol Park, MD, PhD, 13 Gae Won Bang, MD, PhD, 14 Bong Ki Sohn, MD, PhD, 15 Ji Yong Shin, MD, PhD, 16 Kang Seob Oh, MD, PhD, 17 Bo Hyun Yoon, MD, PhD, 18 Kyung Kyu Lee, MD, PhD, 19 Sang Keun Chung, MD, PhD, 20 Young Ki Jung, MD, PhD, 21 In Won Jung, MD, PhD, 22 Hee Yeon Jung, MD, PhD, 23 Young Moe Je, MD, PhD, 24 Ik Seung Chee, MD, PhD, 25 Byung Moo Choi, MD, PhD, 26 Sun Ho Han, MD, PhD 27 and Oh Su Han, MD, PhD 28 1 Department of Psychiatry, Yonsei University, College of Medicine, Seoul, 2 Department of Psychiatry, Kyungpook University College of Medicine, Daegu, 3 Department of Psychiatry, Korea University, College of Medicine, Seoul, 4 Department of Psychiatry, Seoul National University, College of Medicine, Seoul, 211
5 Department of Psychiatry, Chonnam University Medical School, Kwangju, 6 Department of Biostatistics, Yonsei University, College of Medicine, Seoul, 7 Department of Psychiatry, Inha University, College of Medicine, Inchon, 8 Department of Psychiatry, Samsung Seoul Hospital, Sungkyunkwan University, College of Medicine, Seoul, 9 Department of Psychiatry, Pusan University, College of Medicine, Pusan, 10 Department of Psychiatry, Guri Hospital, Hanyang University, College of Medicine, Guri, 11 Department of Psychiatry, Ahnsan Hospital, Korea University, College of Medicine, Ahnsan, 12 Maryknoll Hospital, Pusan, 13 Department of Psychiatry, Wonkwang University, College of Medicine, Iri, 14 St. John of God Hospital, Kwangju, 15 Department of Psychiatry, Choonchun Sungsim Hospital, Hallym University, College of Medicine, Choonchun, 16 Department of Psychiatry, Kangdong Sungsim Hospital, Hallym University, College of Medicine, Seoul, 17 Department of Psychiatry, Kangbuk Samsung Hospital, Sungkyunkwan University, School of Medicine, Seoul, 18 Naju Psychiatry Hospital, Naju, 19 Department of Psychiatry, Dankook University, College of Medicine, Chonahan, 20 Department of Psychiatry, Chonbuk National University Medical School, Chonju, 21 Department of Psychiatry, Ajou University, College of Medicine, Soowon, 22 Department of Psychiatry, Chungbuk University, College of Medicine, Chungju, 23 Department of Psychiatry, Chonahn Hospital, Soonchunhyang University, College of Medicine, Chonahn, 24 Chwachon Bongseng Hospital, Pusan, 25 Department of Psychiatry, Chungnam University, College of Medicine, Kwangju, 26 Department of Psychiatry, Donga University, College of Medicine, Pusan, 27 Department of Psychiatry, Soonchunhyang University, College of Medicine, Seoul, 28 Department of Psychiatry, Seoul Chungang Hospital, University of Ulsan, College of Medicine, Asan Medical Center, Seoul, Korea ObjectiveThe aim of this study is to determine effects of nefazodone on depression, anxiety, sleep and sexual function in depressive patients. Subjects and MethodsThis is an open, non-comparative, multi-center study. Antidepressant and other clinical effects of nefazodone were evaluated in 230 patients of 26 centers, aged 14 years or more, who met DSM-IV criteria to major depressive disorder or dysthymic disorder and didn t have other psychiatric disorders and were physically healthy. The clinical efficacy was assessed at week 1, 2, 4 and 8 using Clinical Global Improvement CGI, Hamilton Depression Scale HAM-D, Beck Depression Inventory BDI, State and Trait Anxiety Inventory-State Anxiety STAI-SA. Other clinical effects were assessed with Weekly Sleep Questionnaire, Sexual Functioning Questionnaire and GHQ-QOL-12, a scale for quality of life. Adverse drug reactions were checked with a questionnaire. Post-treatment effects of drug were compared with pre-treatment baseline condition. ResultsThe response rates by Clincal Grobal Improvement and HAM-D after 8 weeks treatment were 62.4% and 75.2% respectively. Comparing to baseline, nefazodone was proved to have significantly higher antidepressant and antianxiety effects in depressive patients and it improved also sleep, sexual functions and quality of life. Both patients and physicians satisfied with the effects of drug. Adverse drug reactions were a few and not serious, and most of them disappeared as treatment continued. ConclusionThese results suggest that not only nefazodone has antidepressant effects and antianxiety effects, but also it improves sleep disturbance, sexual dysfunction and the quality of life in depressive patients. Adverse drug reactions were a few and not serious. Korean J Psychopharmacol 2001;123:211-221 KEY WORDSNefazodone Antidepressant effect Anxiety Sleep disturbance Sexual dysfunction. 서론 212 Korean J Psychopharmacol 2001;123:211-221
1. 연구대상 연구대상및방법 2. 약물투여 213
3. 임상효과및평가 1) 항우울효과 2) 불안증상, 수면, 성기능및삶의질에미치는영향 4. 안전성 5. 통계처리 1) 유효성분석 214 Korean J Psychopharmacol 2001;123:211-221
2) 안전성분석 1. 연구대상환자 결 과 2. 항우울효과 215
Table 1. Patients rated as much improved in Clinical Global Improvement CGI and patients under 10 point in Hamilton Depression Scale HAM-D at 2 weeks, 4 weeks, and 8 weeks treatment period with nefazodone Week Clinical Global Improvement number of patients* % HAM-D number of patients % Week 2 59/200 29.5% 57/199 28.6% Week 4 90/187 48.1% 106/188 56.4% Week 8 103/165 62.4% 124/165 75.2% *responder/total 3. 항불안효과 4. 수면에미치는영향 5. 병용약제인진정수면제가항불안효과및수면에미치는영향 216 Korean J Psychopharmacol 2001;123:211-221
6. 성기능에미치는영향 Table 2. Changes in depression, anxiety, sleep, sexual function, and quality of life in depressive patients with nefazodone treatment* Variable** Baseline Week of study week 1 week 2 week 4 week 8 HAM-D 1) N230 N199 N188 N165 24.025.88 15.906.82 12.226.55 8.985.51 BDI 1) N208 N179 N168 N149 28.2210.12 20.869.66 16.989.98 13.649.21 STAI-SA 1) N208 N188 N179 N168 N150 63.1410.28 57.1111.13 54.0010.82 50.8511.39 47.2711.46 HAM-D N230 N199 N188 N165 91011 1) 5.591.82 3.601.77 2.881.78 2.091.46 Weekly Sleep Q 1) N207 N189 N180 N168 N151 20.104.76 16.325.29 14.765.74 13.255.43 11.875.71 HAM-D 456 1) N230 N199 N188 N165 3.681.65 2.251.84 1.621.55 1.101.32 Weekly Sleep Q 2) N207 N189 N180 N168 N151 15 14.834.28 11.504.62 10.184.87 8.964.50 7.914.44 Weekly Sleep Q 3) N207 N189 N180 N168 N151 67 5.271.61 4.821.74 4.581.80 4.291.83 3.952.06 Sexual Functioning Q N179 N130 17.244.48 14.854.50 GHQ-QOL-12 N206 N150 27.516.95 20.917.46 *Values represent MeanSD **HAM-DHamilton Depression Scale, BDIBeck Depression Inventory, STAI-SASpielberger Trait Anxiety Inventory, HAM-D 91011Items 9, 10, 11 of HAM-D, Weekly Sleep QWeekly Sleep Questionnaire, HAM-D 456 Items 4, 5, 6 of HAM-D, Weekly Sleep Q 15Items 1, 2, 3, 4, 5 of Weekly Sleep Questionnaire, Weekly Sleep Q 6 7Items 6, 7 of Weekly Sleep Questionnaire, Sexual Functioning QSexual Functioning Questionnaire, GHQ- QOL-1212 items for quality of life in General Health Questionnaire The values are significantly different compared to baseline p0.0001 The values are significantly different compared to baseline p0.0002 1 Significant difference p0.0001 between week 2 & 4, 2 & 8 and 4 & 8 2 Significant difference p0.009 between week 4 & 8, Significant difference p0.0001 between week 2 & 1, 4 & 1, 8 & 1, 2 & 4, 2 & 8 and 4 & 8 3 Significant difference p0.01 between week 4 & 1, 8 & 1, 8 & 2 and 8 & 4, No significant difference p0.05 between week 2 & 1 and 2 & 4 217
Table 3. Post-treatment satisfaction with nefazodone Post-treatment satisfaction 7. 삶의질에미치는영향 Patient N % Investigator N % Very much dissatisfied 0 0 2 1.1 Very dissatisfied 4 2.8 3 1.7 Dissatisfied 8 5.5 8 4.6 Neither dissatisfied nor satisfied 26 17.9 33 19.0 Satisfied 43 29.7 45 25.9 Very satisfied 51 35.2 64 36.8 Very much satisfied 13 9.0 19 10.9 8. 환자및의사만족도 9. 이상반응 고찰 218 Korean J Psychopharmacol 2001;123:211-221
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