조현병 환자에서 Paliperidone Extended Release의 효능, 안전성 및 내약성 : 48주 개방형, 전향적 연구의 24주 중간 분석

최유라,정동청,김은영,김세현,이현정,이남영,장성만,심주철,주은정,김재진,이상혁,정영철,김용식,안용민,Choi, You Ra,Jung, Dong Chung,Kim, Eun Young,Kim, Se Hyun,Lee, Hyun Jeong,Lee, Nam Young,Chang, Sung Man,Shim, Joo Cheol,Joo, Eun Jeong,Kim, Jae 대한생물정신의학회 2013 생물정신의학 Vol.20 No.1

Objectives We investigated the tolerability, safety, and treatment response to flexible-dose paliperidone ER in patients with non-acute schizophrenia in whom previous antipsychotic drugs were ineffective. Methods This 24-week interim analysis of the 48-week multicenter, prospective, open-label study assessed effectiveness using the Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression-Schizophrenia-Severity (CGI-SCH-S) Scale, Personal and Social Performance (PSP) and Drug Attitude Inventory (DAI). Safety and tolerability were assessed using the Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) and Liverpool University Neuroleptic Side Effect Rating Scale (LUNSERS). Results Effectiveness was assessed in 169 patients. Significant improvement in the PANSS total score was observed by week-1 and continued until week-24. The response rate was 33%. The CGI-SCH-S and PSP total scores significantly improved during 24 weeks ; however, no change occurred in the total DAI. Fifty-nine percent of patients reported adverse events, of which extrapyramidal symptoms were the most frequent (19.0%). The DIEPSS and LUNSERS scores were improved after 24 week. Conclusions Switching to the flexible-dose paliperidone ER from an ineffective antipsychotic drug was safe, tolerable, and showed a good treatment response in Korean patients with schizophrenia.

정신건강의학과 자문 의뢰된 암 환자의 항우울제 내약성 비교 연구

고은미,박진성,하주원,임세원,김태석,하지현,백종우,이병철,최병무,이강준,김성완,양종철,고영훈,오강섭,Ko, Eunmi,Park, Jin-Seong,Ha, Juwon,Lim, Sewon,Kim, Tae-Suk,Ha, Jee Hyun,Paik, Jong-Woo,Lee, Boung Chul,Choe, Byeong Moo,Lee, Kang-Joon,Kim, Sun 한국정신신체의학회 2013 정신신체의학 Vol.21 No.1

연구목적 암환자들은 다양한 정신건강의학과적 증상을 겪으며 약물 부작용에 취약하다. 본 연구는 정신건강의학과 자문 의뢰된 암환자에서 항우울제의 내약성을 비교하고자 한다. 방 법 9개 대학병원 및 종합병원 정신건강의학과에 자문 의뢰된 암 환자들을 후향적으로 검토하여 자료를 분석하였다. 가장 빈번하게 처방된 세가지 항우울제(Escitalopram, Mirtazapine, Paroxetine)의 6개월 동안 치료 중단율을 비교하였다. 결 과 처방 빈도는 Escitalopram 150(47.2%), Mirtazapine 92(28.9%), Paroxetine 76(23.9%) 순서로 항우울제 투여 중단 비율은 세군 간 유의한 차이가 없었다. 입원 환자에 비해 외래 환자에서 유의하게 약물 중단 위험도가 높았다(p<0.0001). 결 론 임상 현장에서 암환자의 항우울제 치료 중단율은 약물 종류에 따라 차이가 없었다. 치료 순응도 향상을 위하여 암환자의 특성을 고려한 개별 접근이 필요할 것이다. Objectives : Many patients diagnosed with cancer suffer from various psychiatric symptoms such as depression, anxiety and insomnia as well as cancer itself. Patients with cancer are more vulnerable to possible adverse events of psychotropic medications. Although antidepressants are widely used among cancer patients, there is little information about tolerability of antidepressants. This study was conducted to compare tolerability of antidepressants in cancer patients referred for psychiatric consultation. Methods : The participants were cancer patients who had been referred to psychiatrist for their psychiatric symptoms. We retrospectively analyzed the data of patients diagnosed with cancer from 9 general hospitals in Korea. The discontinuation rate for a 6 months period after treatment initiation for three antidepressants(Escitalopram, Mirtazapine, Paroxetine) were compared. Results : Antidepressants were prescribed for 96.3% of subjects and Escitalopram 150(47.2%), Mirtazapine 92(28.9%) and Paroxetine 76(23.9%) were prescribed frequently in order There were no significant differences in discontinuation rates among the three antidepressants during the 6 month period after initiation of pharmacotherapy. But there was a difference in discontinuation rates between inpatients versus outpatients(p<0.0001). Conclusions : In a naturalistic setting for the antidepressant treatment for cancer patients, it seems that there are no differences in discontinuation rates among these three antidepressants. It is therefore essential that such interactions are carefully considered when treating patients of antidepressants who already have cancer.

기분부전장애에서 Moclobemide와 Amitriptyline의 치료 효과와 내약성 비교 연구

이민수,남종원,유승호,차지현,김용구,Lee, Min Soo,Nam, Jong Won,Ryu, Seung Ho,Cha, Ji Hyun,Kim, Yong Ku 대한생물정신의학회 1999 생물정신의학 Vol.6 No.1

Background : Since dysthymia begins in late childhood or adolescence and has a chronic course, long-term pharmacotherapy may be required. New generation antidepressant, moclobemide, with more acceptable side effect profiles, is effective in the treatment of dysthymia. The main objective of this study was to determine whether they exhibit comparable efficacy and tolerability in dysthymia to amitriptyline. Method and Materials : The efficacy and tolerability of the moclobemide and amitriptyline, were compared in a eight-week single-centre double-blind study in patients(n=37) with dysthymia using he HAMD-17, the Clinical Global Impression Scale(CGI), the Montgomery-Asberg Depression Rating Scale (MADRS), Efficacy Index-Therapeutic Index(EITE), 4-point Index Side Effect Scale(4-PISES), and Efficacy Index- Side Effect Scale(EISE). Results : A total of 37 patients entered the study, 19 were randomly assigned to the moclobemide group and 18 to be amitriptyline group. Demo-graphic and illness characteristics were similar in both groups. There were no significant difference between two groups at the total 17-HDRS score, the HAMD-17% improvement, the total MADRS score, CGI response, and the EITE. In the comparison of EISE between two groups, the scores of the moclobemide group were relatively lower than the amitriptylinen group in full treatment. And the differences were significant(moclobemide group $1.39{\pm}0.61$ ; amitriptyline group $2.00{\pm}0.85$, p<.001). At the 4-PISE, There was no serious or treatment threatening side effects. And there was no specific difference in side effects between two groups. The moclobemide group reported higher EIR scores than the amitriptyline group at every follow up day, but the differences were not significant. And, there was no significant differences in the scores of five HRQOL subcategories which is compared between two groups at every follow up days. Conclusions : In terms of 17-HDRS and MADRS, moclobemide and amitriptyline are equally effective at least in allevating dysthymic symptoms. But moclobemide tended to be less troubling and better tolerated than amitriptyline. Therefore, moclobemide treatment can be used as a safe, and higher satisfactory treatment strategy for the dysthymia.

주의력결핍 과잉행동장애에서 오로스 메칠페니데이트의 내약성과 안전성

김효원(Hyo-Won Kim),고복자(Bock Ja Ko),박태원(Tae Won Park),신윤오(Yun O Shin),이정섭(Jeong-Seop Lee),정운선(Un-Sun Chung),조인희(In Hee Cho),최태영(Tae Young Choi),반건호(Geon Ho Bahn) 대한소아청소년정신의학회 2012 소아청소년정신의학 Vol.23 No.S

We review the effect of methylphenidate, focusing on Osmotic-controlled Release Oral delivery System (OROS) methylphenidate, on cardiovascular system, appetite and growth, sleep, tic, epilepsy, psychiatric and rare adverse events. Although OROS methylphenidate has side effects including increased heart rate or blood pressure, decreased appetite, delayed sleep onset, emergence or aggravation of tics, withdrawal or changes in mood, these effects appeared to be minimal in impact or difficult to distinguish from risk to untreated population and tended to be improved by dose adjustment or drug discontinuation. However, in subjects with underlying cardiac problems, uncontrolled epilepsy, previous psychotic episode, clinicians should pay attention and balance the risk and benefit.

가정의학과 외래 고혈압환자의 특성 및 항고혈압제 단독요법후 추적조사

김영식,김병성,김경수,박훈기,정유석,여에스더,전태희,정승필,최지호,이상엽,김윤진,박영규 대한가정의학회 2001 Korean Journal of Family Medicine Vol.22 No.6

노년기 우울증에서의 항우울제 치료에 대한 고찰

윤지호(Jee-Ho Yoon),박상진(Sang-Jin Park) 대한노인정신의학회 2013 노인정신의학 Vol.17 No.1

Late-life depression (LLD) refers to depressive syndromes defined in the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) and in the International Classification of Diseases-10 (ICD-10) that arise in adults older than age 65 years. LLD often affects people with chronic medical diseases, cognitive impairment, or other forms of disability. The phenomenology of LLD differs in part from that of early-life depression. Antidepressants appear to have a neutral or protective effect against suicidal ideation or behavior in the elderly despite having the risk of opposite effect in children, adolescents, and young adults. The treatment of depression may be divided into acute, continuation, and maintenance phases. Currently available antidepressant medications represent several classes of agents with similar antidepressant efficacy. Differences in side effect profile, interactions, and out-of-pocket cost are important determinants in the choice of medication for an elderly patient. To minimize side effects, starting doses for older adults may be lower than those for younger adults, but older adults often require full adults doses for an adequate response. Antidepressants are as effective when given to elderly individuals as they are when given to younger adults. Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) the antidepressants of choice, followed by bupropion, and mirtazapine. Tricyclic antidepressants (TCAs) are effective but are no longer considered to be first-line treatments because of their side effects.

급성 조증에서 기분안정제와 리스페리돈의 병합 투여 효과 : 다기관 개방연구

김광수,배치운,윤진상,김영훈,이양현,지익성,이철,송혜경,최성구,박원명 大韓神經精神醫學會 2005 신경정신의학 Vol.44 No.2

Ohjective : The primary purpose of this study was a replication of the effectiveness and tolerability of rispehdone in the treatment of patients with acute mania in very larger cohon in naturalistic treatment setting to extend the data on the effect and tolerability of risperidone in the treatment of patients with acute mania to Asian population. Methods : A total of 909 patients with DSM-TV criteria of bipolar disorder current manic and hypomanic episode, entered this large, open, multicentre study. The Young Mania Rating Scale (YMRS), Clinical Global Impression (CGI) and Simpson-Angus Rating Scale (SARS) were measured at baseline and weeks 1, 3 and 6, for the assessment of effectiveness and extra-pyramidal symptom (EPS). Results : This study showed statistically significant reduction of scores on the YMRS and CGI-s (mean change=-23.5±11.8, p<0.0001 ; mean change=-2.7±1.5, p<0.0001, respectively) from the baseline to the endpoint (week 6). Number of patients with 50% reduction or more in the YMRS and CGI-s scores was 693 (77.8%) and 630 (70.7%) at endpoint, respec-tively. There were no statistically significant increments of scores on SARS. Risperidone was generally well tolerated. Conclusion : The present larger open study demonstrates that hsperidone add-on therapy is effective and tolerable in treat-ment of bipolar disorder, replicating results in various controlled and uncontrolled studies from Western countries.

소아청소년 자폐성 스펙트럼 장애에서 SSRI 장기 사용에 대한 후향적 분석

구애진,박진박,이종일,진혜경,김예니,Goo, Ae-Jin,Park, Jin-Park,Lee, Jong-Il,Jhin, Hye-Kyung,Kim, Yeni 대한생물정신의학회 2012 생물정신의학 Vol.19 No.4

Objectives The purpose of this study was to investigate clinical profile, efficacy, and safety of long-term treatment with selective serotonin reuptake inhibitors (SSRIs) in Korean autism spectrum disorders (ASDs) patients. Methods Effectiveness was assessed through a retrospective review of self-reported target symptom improvement at the last follow-up visit. Changes in illness severity and improvement were measured using the Clinical Global Impression-Severity (CGI-S) of illness and Clinical Global Impression-Improvement (CGI-I) Scales. Tolerability was assessed through a review of the reason for discontinuation of SSRI and documented adverse events. Results A total of 21 ASDs patients (aged 9 to 19 years) treated with SSRI during July 2010 to July 2011 in department of child and adolescent psychiatry of Seoul National Hospital were identified. The mean duration of SSRI treatment was 47.9 (standard deviation = 36.9) months (range 0.7-114.5), and the mean fluoxetine equivalent dosage of SSRIs was $27.1{\pm}10.8$ mg. Nineteen (90.5%) patients were using concomitant medication. We found that SSRIs were prescribed for symptoms of agitation, stereotyped behavior, aggression, depression, impulsivity and self-injury in ASDs. Ten patients (47.6%) reported improvement in their target symptom after SSRI treatment based on CGI-I scores (CGI-I ${\leq}$ 2). The side effects were reported in 5 patients (23.8%) ; vomiting (n = 2, 9.5%), excessive mood elevation (n = 1, 4.8%), insomnia (n = 1, 4.8%), somnolence (n = 1, 4.8%) and decreased appetite (n = 1, 4.8%). Self-injurious behavior was reported in one patient (4.8%). Conclusions The results of this study suggest that SSRIs may be used effectively in children and adolescents diagnosed with ASDs. However, safety issues need to be considered carefully when choosing SSRIs for treatment. Future controlled trials are needed to confirm these findings.

약물 교체가 필요한 조현병 환자에서 Paliperidone Extended Release로의 교체 후 유효성과 안전성에 관한 분석

문영선,나경세,김철응,김용식,윤진상,안용민,정희연,유범희,전양환,이상규,석정호,함병주,박두병,김현,이병욱,홍창형,김종우,한진희 대한정신약물학회 2012 대한정신약물학회지 Vol.23 No.3

ObjectivezzThis study aimed to evaluate the clinical efficacy, safety, and tolerability of paliperidone extended release (ER) in patients with schizophrenia by switching previous antipsychotics to paliperidone ER. MethodszzAn open-label, 24 weeks, prospective, non-comparative, multi-center study evaluated total 387 patients with schizophrenia requiring a switch in antipsychotic medication due to suboptimal efficacy, intolerability, and non-compliance. Patients were switched to flexible-dose trial of paliperidone ER (3-12 mg/day). Efficacy was measured by Krawiecka Scale, Clinical Global Impression-Schizophrenia-Severity (CGI-SCH-S), Clinical Global Impression-Schizophrenia-Improvement (CGI-SCH-I), sleep visual analog scale (VAS), and Personal and Social Performance Scale (PSP). Safety assessments included adverse events (AEs), evaluation of extrapyramidal symptoms (EPS) using the Drug Induced Extrapyramidal Symptoms Scale (DIEPSS), and laboratory tests. ResultszzData from a total of 321 subjects who took the paliperidone ER and had at least one follow-up assessment without a major protocol violation were analyzed. Switching to paliperidone ER led to a significant improvement in the Krawiecka, CGI-SCH-S, CGI-SCH-I, PSP, and DIEPSS scales. However, serum prolactin levels and metabolic parameters including body weight and waist circumference were significantly increased. Insomnia was the most common adverse event. ConclusionzzThis study suggested that patients with schizophrenia who showed insufficient response or intolerance to other previous antipsychotics can be switched to paliperidone ER, with efficacy, safety, and tolerability.

주의력결핍 과잉행동장애 아동에서 공존질환에 따른 OROS-Methylphenidate의 효과와 안전성

윤형준,육기환,전덕인,석정호,홍나래,조성식,홍현주 대한소아청소년 정신의학회 2008 소아청소년정신의학 Vol.19 No.3

Objectives : The purpose of this study is to evaluate the efficacy and tolerability of OROS-Methylphenidate(MPH) in children with Attention Deficit Hyperactivity Disorder(ADHD) according to comorbid psychiatric disorders. Methods : This is an 8-week open label study of OROS-MPH monotherapy. Subjects were 6-12 years of aged 113 children with ADHD. Outcome measures were Korean version parent ADHD rating scale(K-ARS), Korean version Conners parent rating scale(K-CPRS), Clinical Global Impression-Severity and Clinical Global Impression -Improvement. Side effects were monitored with the Barkley’s side effect rating scale. We compared change-over-time of mean scores of outcome measure according to comorbidity of disruptive behavior disorder, depressive disorder, anxiety disorder, and tic disorder. Results : Mean scores of K-ARS and K-CPRS were significantly decreased regardless of comorbidity. Mean doses of OROS-MPH and dropout rate were not different significantly according to comorbidity. For side effects, overall OROS-MPH was well tolerated despite comorbidity. However, children with tic disorder reported higher tics or nervous movements item than those without tic disorder from 2nd week to 8th week. Conclusion: OROS-MPH is efficacious for decreasing the symptoms of ADHD and well tolerated regardless of comorbid psychiatric disorders.