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Tolerability, Safety and Effectiveness of Paliperidone ER in Patients with Schizophrenia : A 24-Week Interim Analysis of the 48-Week Open-Label, Prospective, Switch Study (조현병 환자에서 Paliperidone Extended Release의 효능, 안전성 및 내약성 : 48주 개방형, 전향적 연구의 24주 중간 분석)

  • 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 Jin;Lee, Sang Hyuk;Chung, Young Chul;Kim, Yong Sik;Ahn, Yong Min
    • Korean Journal of Biological Psychiatry
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    • v.20 no.1
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    • pp.12-20
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    • 2013
  • 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.

A Study on Pain, Discomfort, Depression and Coping Patterns in Chronic Arthritis Patients (만성관절염 환자의 동통, 불편감, 우울과 대응양상의 관계)

  • Mun, Mi-Suk
    • Journal of muscle and joint health
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    • v.1 no.1
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    • pp.71-87
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    • 1994
  • The purpose of this study was to assess pain, discomfort, depression and coping patterns and the relations between these in chronic arthritis patients. The sampling method was a purposive sampling technique. 1) Who have been diagnosed as having chronic arthritis and. 2) Who were at the out patients clinic of rheumatoid arthritis departments of one University hospital in seoul between september, 11, 1993 to september, 18, 1993. The instruments used for this study were Graphic Rating Scales of pain, discomfort level of the activities of daily living(ADL) developed by Lee, Eun Ok and The Beck Depression inventory. The research used to measure coping patterns was a tool developed by the present study researcher. Analysis of data was done frequency, Pearson correlation coefficients, ANOVA, regression and ANCOVA. The results were summerlized as follows ; 1. Female exceed male patients in number and onset of joint pain were more prevalent in the age groups of the 40s and the 50s. The average duration of suffering from the pain were seven years six mounths. 2. The mean pain score : The mean sensory score was 119mm and the affective score was 109mm. 3. The discomfort level of ADL, the mean score was 2.95 out of a possible score of 5.0 and depression syndrome subjects were 62.2%. 4. The coping responses for each pattern were as follows : 1) "Active coping" mean score was 2.28. 2) "Wishful coping" mean score was 2.89. 3) "Receptive coping" mean score was 3.31. 4) "Negative coping" mean score was 1.82. 5. Significant differences were found in age, religion, marriage status and the coping patterns of patients. 1) In the coping pattern of "receptive coping", the score of the age groups of the 50s were higher than that of 20s, and in the coping pattern of "negative coping", the score of the age groups of the 20s were higher than other age groups. 2) In the coping pattern of "wishful coping", the score of the christian were higher than other religion groups. 3) In the coping pattern of "negative coping", the score of the marrieds were lower than other groups. 6. Patients who scored low on factor 2, wishful coping, were much more likely to report having pain sensory than patioets scoring high on this factor. 7. Patients who scored high on factor 4, negative coping, were significantly more likely to report having pain sensory than patients scoring high on this factor. Consider overall, chronic arthritis patients report using a wide varity of strategies, certain strategies such as receptive, wishful and active coping are used frequently, whereas other strategies such as negative coping are rarely used. One of the most important finding of present study is that the reported use of coping strategies is related to adjustment to a chronic pain problem. The present study suggests that negative coping is related to poor emotional adjustment as assessed by depression, but not pain ratings. Considered overall, this pattern of findings suggests that counseling patients to decreased their use of negative coping may be useful. The present study has a number of limitations. First, the sample is restricted to chronic arthritis patients. Weather chronic pain patients suffering from other types of pain syndromes use similar coping strategies needs to be determined in subsequent research. Second, the tool of coping pattern must be studied further to obtain reliability.

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A Case Report on a Patient with Cervical Vertigo Who Improved with a Combination of Korean Medicine Treatments (한방 복합치료로 호전된 경추성 현훈 환자의 증례보고 1례)

  • Hwang, Dong-gyu;Kim, Eun-ji;Choi, Ki-hoon;Heo, Seung-jin;Youn, Deok-won
    • The Journal of Internal Korean Medicine
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    • v.38 no.3
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    • pp.392-400
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    • 2017
  • Objective: To report the case of a patient suffering from cervical vertigo who was treated with a combination of Korean medicine treatments (including acupuncture, pharmaco-acupuncture, and Chuna manual therapy). Method: An outpatient with cervical vertigo was given a combination of Korean medicine treatments five times, from December 5 to 16, 2016. All of the treatments, acupuncture with electric stimulation and pharmaco-acupuncture, were applied on the trigger points (TP) of the cervical muscles and the upper trapezoid muscles. Chuna manual therapy was then applied on the cervical area. The Numeric Rating Scale (NRS) - according to outpatient's statement on vertigo, neck pain and headache - and the Korean Dizziness Handicap Inventory (DHI), which is a self-evaluating scale of dizziness in daily life, were used to evaluate the effects of this treatment. Results: At the end of the treatment, the vertigo and the headache disappeared. The NRS decreased from 9 to 0 for vertigo and from 5 to 0 for headache. Although the neck pain also decreased, it did not disappear; this NRS decreased from 7 to 1. The DHI score also decreased significantly, from 64 to 4. Conclusion: Since the symptoms of the patient with cervical vertigo improved after the very first treatment and the improvement of the symptoms was observed as the treatment progressed, this case report is worth supporting the efficacy of combined Korean medical treatments. However, because there was only one subject, it is hard to say that this efficacy can be generalized. Moreover, this report cannot prove the individual efficacy since various treatments were combined. While there are many researches related to cervical vertigo in Western medicine, the studies in Korean medicine are comparably insufficient; therefore, follow-up research on more subjects is needed.

Effects of Humor Intervention Program on Anxiety, Depression and Coping of Humor in Hemodialysis Patients (유머중재 프로그램이 혈액투석환자의 불안, 우울과 유머대처에 미치는 효과)

  • Kim, Kyung-Hee;Lee, Myung-Hwa
    • The Korean Journal of Rehabilitation Nursing
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    • v.2 no.1
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    • pp.95-108
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    • 1999
  • The purpose of this study was to identify the effect of the humor intervention program, administred to the hemodialysis patient as an adaptive coping mechanism. The research design was non-equivalent control group non-synchronized design. The study method had been done by investigating the experimental group and control group through the questionnaire on 36 patients who had been out patient hemodialysis room at B hospital in Pusan from August 18 to September 15, 1998. The humor intervention program consisted of 1 TV comedy, 1 home video and 1 comedy film. The humor intervention program was provided to the experimental group for 20-30 minute 3 times every other day at hemodialysis room. Dependent variables were measured by Spielberger's State Anxiety Inventory, Zung's Self Rating Depression Scale, Lefcourt & s Humor Coping Scale. The analysis of the collected data had been done for the hemogeneity test in which general characteristics of the experimental group and the control group had been tested by $X^2$-test and the hemogeneity test had been tested by t-test before using the humor intervention program which is for anxiety, depression and coping of humor. To test the hypothesis the t-test had been given for the difference of anxiety, depression and coping of humor between the two groups. The result were summarized as follows : 1. Anxiety score in the experimental group and control group was not significant difference. 2. Depression score in the experimental group and control group was not significant difference. 3. Coping of humor score in the experimental group and control group was not significant difference. In conclusion, even though humor intervention program did not have any efficient effect on hemodialysis patients in reacting to anxiety, depression and coping humor, it caused very positive reactions from patients, and it also reducted anxiety of patients among the experimental group a little bit. If this program could be sufficiently applied ac cording to the character of every patients with a little bit different appliences such as selection of humor intervention program, frequency and period, it will be used as an efficient the humor intervention program.

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Temperament and Character Dimensions in Female Patients with Fibromyalgia (여성 섬유근육통 환자의 기질 및 성격 특질)

  • Kim, Tae-Suk;Kim, Kyung-Tae;Jung, Young-Eun;Park, Sung-Hwan;Lee, Chul
    • Korean Journal of Psychosomatic Medicine
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    • v.15 no.1
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    • pp.44-50
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    • 2007
  • Objectives: previous studies have suggested the possible predisposing personality in fibromyalgia(FM). The aim of this study is to investigate the personality traits in female patients with FM compared to healthy female controls using the Temperament and Character Inventory(TCI) and furthermore, to evaluate the personality traits affecting the severity of the symptoms of FM. Methods Forty female patients with FM and 40 healthy female controls were examined using the TCI and the Hamilton depression rating scale. The FM patients were also evaluated the severity of the symptoms of FM using the fibromyalgia impact questionnaire(FIQ). Results : ANCOVA with age and depression levels as covariates showed that the FM patients scored significantly higher on the harm avoidance(F=2.187, p=0.047) and lower on the self-directedness(F=4.551, p=0.036) than the healthy controls. The FIQ scores showed positive correlation with the harm avoidance scores in the FM patients when adjusting for age and depression level(R=0.399, p=0.013) Multiple linear regression models revealed that the harm avoidance scores would affect the FIQ scores in FM patients(95% Cl=0.004-1.942, p=0.049). Conclusions : These results suggest that the female FM patients have distinctive temperament and character dimensions compared to the healthy female controls. Moreover, the harm avoidance may be the predictive personality to affect the severity of the symptoms of female FM patients.

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Moxibustion for Knee Osteoarthritis : A Protocol for a Pilot Randomized Controlled Trial (슬관절염에 대한 뜸 치료의 유효성 및 안전성 연구 : 무작위 대조 예비 임상연구 프로토콜)

  • Lee, Seung-Hoon;Kim, Kun-Hyung;Kim, Tae-Hun;Kim, Jung-Eun;Kim, Joo-Hee;Kang, Kyung-Won;Jung, So-Young;Kim, Ae-Ran;Park, Hyo-Ju;Shin, Mi-Suk;Hong, Kwon-Eui;Choi, Sun-Mi
    • Korean Journal of Acupuncture
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    • v.28 no.4
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    • pp.1-15
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    • 2011
  • Objectives : The purpose of this study is to evaluate the feasibility of massive clinical research and to make a basic analysis on the effectiveness and safety of moxibustion treatment on knee osteoarthritis compared to usual care. Methods and Results : This study is a protocol for a pilot randomized controlled trial. Forty participants are assigned to the moxibustion group (n=20) and usual care group (n=20). Participants assigned to the moxibustion group receive moxibustion treatment on the affected knee(s) at six standard acupuncture points (ST36, ST35, ST34, SP9, Ex-LE04 and SP10) three times per week for four weeks (total of 12 sessions). Participants in the usual care group don't receive moxibustion treatment during the study period and follow-up are made on the 5th, 9th and 13th weeks after random allocation. Both groups are allowed to use any kind of treatment, including surgery, conventional medication, physical treatment, acupuncture, herbal medicine, over-the-counter drugs and other active treatments. Education material that explains knee osteoarthritis and current management options and self-exercise is provided for each group. The pain scale of the Korean Western Ontario and McMaster Universities Questionnaire (K-WOMAC) is the primary outcome measurement used in this study. Other subscales of the K-WOMAC, the Short-Form 36 Health Survey (SF-36), Beck Depression Inventory (BDI), Physical Function test, Patient Global Assessment, and Pain Numeric Rating Scale (NRS) are used as outcome variables to evaluate the effectiveness of acupuncture. Safety is assessed at every visit. Conclusions : The result of this trial will provide a basis for the effectiveness and safety of acupuncture treatment for knee osteoarthritis.

Cognitive Impairment in the Patients with Mildly Active Systemic Lupus Erythematosus (경증 전신성 홍반성 루프스 환자의 인지기능장애)

  • Kim, Jin-Hee;Lee, Chul;Lee, Chang-Uk;Paik, In-Ho
    • Korean Journal of Psychosomatic Medicine
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    • v.5 no.1
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    • pp.89-96
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    • 1997
  • This study was designed to determine whether cognitive impairment was evident in patients with SLE. Also, it aimed to examine the association of cognitive impairment with other clinical variables. The subjects consisted of 20 patients with mildly active SLE and 20 healthy controls. Methods : A total of 20 SLE patients and 20 normal controls completed a computerized neuropsychological test battery using Vienna Test System. These included Cognitrone test, Continuous attention test, Corsi block tapping test, Standard progressive matrices. Also, neuro-behavioral cognitive status examination was done. The symptom severity of depression was measured with Beck Depression Inventory, Hamilton Depression Rating Scale, and current medications were documented. Disease activity was rated using the SLE diasease activity index (SLEDAI). Results : SLE patients had poorer performance than normal controls on the tests of Cognitrone, attention, nonverbal IQ and memory, independent of age, education, disease activity, steroid use and depression status. Conclusion : Cognitive dysfunction was not uncommon in ambulatory SLE patients as measured by standardized neuropsychological tests. It seemed to occur independently of various clinical variables. These findings would suggest that cognitive dysfunction in SLE may be explained by reflecting subclinical central nervous system(CNS) involvement, rather than coexisting psychological distress due to chronic illness or side effect of medication.

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The Efficacy and Safety of Moclobemide Twice Daily : An Open Trial in Patients with Major Depressive Disorder (1회 2회 분복 투여하는 Moclobemide의 효과와 안전성 : 주요우울장애 환자에서 개방 시험)

  • Yoon, Jin-Sang;Lee, Hyung-Young;Kook, Seung-Hee;Choi, Young
    • Korean Journal of Biological Psychiatry
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    • v.3 no.1
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    • pp.102-108
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    • 1996
  • This was an open trial to evaluate the efficacy and safety of moclobemide twice daily for treatment of Korean patients with major depressive disorder(DSM-III-R). The duration of the trial was 6 weeks with the initial dose of moclobemide being fixed lor the first two weeks at 300mg/day(150mg twice daily, each token after morning and evening meals). Thereafter, when necessary, the dose was allowed to increase to 600mg/day or decrease to 150mg/day according to the seventy of the depression and/or the tolerability of the drug. Hypnotics and/or sedatives from a benzodiazepine group could be concomitantly administered at usual dosage. Patients were assessed at baseline and at days 14, 28 and 42. Efficacy was primarily judged on the Hamilton Rating Scale for Depression(HAM-D) and Beck Depression Inventory(BDI). Patients had to score at least 17 respectively an both scales to enter the trial. Secondary efficacy parameters included Clinical Global Impression(CGI) for severity of illness and improvement. Safety and tolerability were judged on reported adverse events, vital signs and laboratory parameters. In addition, there was a series of questions and assessments for the psychiatrists and patients to complete at the end of the trial Twenty nine patients completing trial were included in the analysis of efficacy : of thirty one patients participating in the safety and tolerability analysis, those who withdraw voluntarily without particular reasons or violated the treatment schedule were not included. The efficacies as determined by HAM-D, BDI or CGI were found to be significant compared to baseline. The number of responders defined as patients with a total score of 10 or less or with a total score of 50% or less of the baseline score on HAM-D and BDI were 17(59%) and 18(62%) respectively. Regarding safety and tolerability, nine patients(29%) reported mild adverse events probably related to moclobemide : of these one patient dropped out because of poor tolerability : however, there were no appreciable changes in blood pressure, pulse rate, body weight or laboratory parameters for all patients over the trial period. Furthermore, the physicians' and patients' opinions at final evaluation showed that moclabemide has a good antidepressant effect as well as a favorable tolerability. In conclusion, a twice-daily dosage schedule with maclobemide is recommendable for the treatment of Korean patients with major depressive disorder since its efficacy and safety were demonstrated in this study.

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The Clinical and Psychological Characteristics of the Patients with Temporomandibular Disorders according to Its Diagnostic Subgroups (진단분류에 따른 측두하악장애 환자의 임상적 및 심리적 특징)

  • 김정호;기우천;최재갑
    • Journal of Oral Medicine and Pain
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    • v.22 no.1
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    • pp.45-63
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    • 1997
  • A Study was conducted to examine the nature and extent of psychological differences among diagnostic subgroups of temporomandibular disorders(TMD) patients and to whether psychological distress acts as a precipitator for TMD or is only an incidental consequence of the discomfort and frustrations presented by the disorder. Ninty six TMD patients and ninty seven non-TMD dental patients were included for the study as an experimental group and control group. TMD patients were classified into subgroups according to their primary pain sites and labeled as: 1) Myogenous TMD group; 2) Arthrogenous TMD group; 3) Mixed TMD group. After Hilkimo indices were rated from patient history and clinical examination, levels of psychological distress were measured using SRRS (Social Readjustment Rating Scale) and MMPI (Minnesota Multiphasic Personality Inventory). Outcomes from Helkimo indices, SRRS, and MMPI were assessed in terms of diagnostic subgroups and pain chronicity. The relationship between SRRS and MMPI scores were also assessed. The results were as follows : 1. The TMD patients showed higher frequencies of AiII, DiII, and DiIII of Helkimo indices than those in the control subjects. 2. The chronic TMD patients showed lower frequencies of DiII and DiIII of Helkimo indices than those in the acute group. 3. The arthrogenous TMD group showed higher frequencies of DiII and DiIII of Helkimo indices than those in the myogenous TMD group. 4. The TMD patients showed higher SRRS mean score than that in the non-TMD patients. 5. The SRRS mean score was highest in the myogenous TMD group and lowest in the arthrogenous TMD group. 6. The chronic TMD patients showed higher SRRS mean score than the acute TMD group. 7. The TMD patients showed higher MMPI mean scores on the Hs, D, Hy, and Pt scales than those in the non-TMD patients. 8. The MMPI mean scores on th Hs, D, and Hy scales were higher than of other MMPI scales in the TMD patients as well as in the myogenous and the mixed TMD group and they showed 1-3-2(Hs, -Hy, -D.) profile pattern, conversion "V". 9. The MMPI mean scores on the Hs and Hy scales were higher in all subgroups of TMD patients than non-TMD patients. 10. Although there were no significant differences in the MMPI mean scores on all the scales between the acute and the chronic groups of all TMD patients, the chronic myogenous TMD group showed higher MMPI mean scores on the Hs, Hy, Pa, and Pt scales than the acute myogenous TMD group. 11. There were positive correlationships between SRRS score and each MMPI scores on the Hs and Hy scales.Hy scales.

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Association between Cognitive Function, Behavioral and Psychological Symptoms of Dementia and White Matter Hyperintensities in Patients with Alzheimer's Disease and Mild Cognitive Impairment (알츠하이머병 및 경도인지장애 환자에서 인지기능 및 행동심리증상과 백질고강도신호와의 연관성)

  • Kwon, Ji Woong;Kim, Hyun;Lee, Kang Joon
    • Korean Journal of Psychosomatic Medicine
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    • v.26 no.2
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    • pp.119-126
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    • 2018
  • Objectives : The aim of this study is to investigate correlation between degree of white matter hyperintensities (WMH) and neurocognitive function along with behavioral and psychological symptoms of dementia (BPSD) in Korean patients with Alzheimer's disease (AD) and mild cognitive impairment (MCI). Methods : Participants were 115 elderly subjects diagnosed with Alzheimer's disease or mild cognitive impairment in this retrospective study. WMH in brain MRI were rated with standardized visual rating scales (Fazekas scales) and the subjects were divided into two groups according to Fazekas scale. Cognitive function was evaluated with Korean version of the consortium to establish a registry for Alzheimer's Disease (CERAD-K), and BPSD was evaluated with Korean neuropsychiatric inventory (K-NPI). Independent t-test was performed to analyze the relationship between the degree of WMH and neurocognitive functions & BPSD. Results : Especially, the group with high severity of WMH showed significantly lower language fluency (p<0.05). In addition, the group with high severity of WMH showed significantly higher score in K-NPI. Conclusions : There was a significant association between WMH and neurocognitive test related with executive function. Moreover, WMH seems to affect BPSD severity. Evaluation of WMH would provide useful information in clinical settings.