• Title/Summary/Keyword: adverse effect

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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.

Efficacy of Electroacupuncture with Dysphagia Caused by Stroke - Double-blind, Randomized Controlled Trial - (중풍으로 유발된 연하 장애 환자에 대한 전침 치료의 임상 효과)

  • Kim, Min-Kyung;Lu, Hsu-Yuan;Cho, Seung-Yeon;Jung, Woo-Sang;Moon, Sang-Kwan;Park, Jung-Mi;Ko, Chang-Nam;Cho, Ki-Ho;Park, Seong-Uk
    • The Journal of Korean Medicine
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    • v.35 no.1
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    • pp.26-40
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    • 2014
  • Objectives: This study investigated the effect of electroacupuncture on swallow function in stroke patients with dysphagia. The purpose was to determine whether electroacupuncture could improve swallow function and quality of life for patients with dysphagia caused by stroke. A pilot double-blind, randomized controlled trial design was used Methods: A total of 17 stroke patients with dysphagia were recruited to this study, 8 assigned to the swallowing electroacupuncture (SE) group and 9 to the control group. Swallowing electroacupuncture was assessed for 5 Hz electrical or sham stimulation for 20 min duration 3 times a week. Outcome measurements were DOSS, 14-item questionnaire from the SWAL-QOL, NIHSS and MBI. Assessment was carried out for baseline, 2 weeks and 4 weeks Results: In the 2 weeks follow up data, the study group showed significant difference in DOSS and SWAL-QOL compared with the baseline. The study group also showed significant difference in DOSS and SWAL-QOL compared with the control group. Similarly in the 4 weeks follow up data, the study group showed improvement tendency in DOSS and SWAL-QOL compared with baseline and also with the control. The NIHSS and MBI scores returned no significant differences. The swallowing electroacupuncture was well tolerated in all cases with no serious adverse effects. Conclusions: The findings from the pilot study indicated that electroacupuncture has significant effects on improvement in swallowing function and quality of life. With both inpatients and outpatients, further larger and longer-term follow-up study is needed to confirm this suggestion.

Comparisons of Adherence Level of Micro-organisms According to Contact Lens Materials and Protein Deposition and Disinfection Efficacy of Multipurpose Solution (콘택트렌즈 재질 및 침착 단백질에 따른 균 흡착 정도와 다목적용액의 살균력 비교)

  • Sung, Hyung Kyung;Kim, So Ra;Park, Mijung
    • Journal of Korean Ophthalmic Optics Society
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    • v.20 no.1
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    • pp.35-42
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    • 2015
  • Purpose: The present study was aimed to compare the difference in adherence level of microorganisms according to contact lens materials and protein deposition and to evaluate disinfection efficacy of multipurpose solution. Methods: The evaluations of micro-organisms' adherence and disinfection efficacy of multi-purpose solution were conducted by employing the Part 2. Regimen Procedure for Disinfecting Regiments in the Disinfection Efficacy Testing under the "FDA Evaluation Criteria & Method". Results: Pseudomonas aeruginosa, Serratia marcescens, Candida albicans except Staphylococcus aureus adhered more on etafilcon A lens and disinfection efficacy of total 4 products investigated was almost perfect except Candida albicans. The 3 micro-organisms except Serratia marcescens adhered more to albumin-predeposited lens. Disinfection efficacy of multi-purpose solution was higher against the micro-organisms adhered to albumin-deposited lens than against the micro-organisms adhered to the lysozyme-deposited lens. Furthermore, disinfection efficacy of multi-purpose solution was different according to types of micro-organisms. Conclusions: It was revealed that the type of micro-organisms, the lens materials and type of absorbed tear protein affected the amount of adhered micro-organisms to contact lens and that adhesion of tear protein could induce the change of disinfection efficacy of multi-purpose solution. It suggest that the hygienic condition of contact lens can vary by these factors influencing on disinfection efficacy and the occurrence of adverse effect can be affected.

The Effect of CYP2D6/3A5 Genotypes on Plasma Concentrations of Haloperidol after Adjunctive Treatment of Aripiprazole

  • Shim, Joo-Cheol;Ahn, Jung-Mi;Jung, Do-Un;Kong, Bo-Geum;Kang, Jae-Wook;Liu, Kwang-Hyeon;Shin, Jae-Gook
    • Korean Journal of Biological Psychiatry
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    • v.18 no.2
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    • pp.95-100
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    • 2011
  • Objectives To evaluate the drug interactions between aripiprazole and haloperidol, authors investigated plasma concentrations of those drugs by genotypes. Method Fifty six patients with a confirmed Diagnostic and Statistical Manual of Mental Disorders 4th edition diagnosis of schizophrenia were enrolled in this eight-week, double blind, placebo-controlled study. Twenty-eight patients received adjunctive aripiprazole treatment and twenty-eight patients received placebo while being maintained on haloperidol treatment. Aripiprazole was dosed at 15 mg/day for the first 4 weeks, and then 30 mg for the next 4 weeks. The haloperidol dose remained fixed throughout the study. Plasma concentrations of haloperidol and aripiprazole were measured by high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) at baseline, week 1, 2, 4 and 8. $^*1$, $^*5$, and $^*10$ B alleles of CYP2D6 and $^*1$ and $^*3$ alleles of CYP3A5 were determined. The Student's T-test, Pearson's Chi-square test, Wilcoxon Rank Sum test and Logistic Regression analysis were used for data analysis. All tests were two-tailed and significance was defined as an alpha < 0.05. Results In the frequency of CYP2D6 genotype, $^*1/^*10$ B type was most frequent (36.5%) and $^*1/^*1$ (30.8%), $^*10B/^*10B$ (17.3%) types followed. In the frequency of CYP3A5 genotype, $^*3/^*3$ type was found in 63.5% of subjects, and $^*1/^*3$ type and $^*1/^*1$ were 30.8% and 5.8% respectively. The plasma levels of haloperidol and its metabolites did not demonstrate significant time effects and time-group interactions after adjunctive treatment of aripiprazole. The genotypes of CYP2D6 and 3A5 did not affect the plasma concentration of haloperidol in this trial. No serious adverse event was found after adding aripiprazole to haloperidol. Conclusion No significant drug interaction was found between haloperidol and aripiprazole. Genotypes of CYP2D6 and 3A5 did not affect the concentration of haloperidol after adding aripiprazole.

A Case Report of Insomnia and Fatigue in Alcoholic Hepatitis Patients Treated with Korean Medicine and Western Medicine (알코올성 간염 환자의 불면과 피로 개선에 대한 한양방 병용치료 치험 1례)

  • Nam, Hyun seo;Han, Seung-hee;Jeong, In-chae;Sun, Seung-ho;Kim, Mikyung;Han, In-sik;Baek, Tae hyun;Jerng, Ui min
    • The Journal of Internal Korean Medicine
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    • v.41 no.2
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    • pp.186-193
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    • 2020
  • Objectives: This study aimed to report a case that showed improvements in the symptoms of patients with alcoholic hepatitis without any indication of deterioration of the disease. Methods: Western medicine with Urusa tablets and Godex capsules and Korean medicine therapeutic approaches, including Shihogayonggolmoryo-tang, acupuncture, and moxibustion, were administered to a patient during the period of treatment. Blood tests were used to determine levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT), AST/ALT ratio, alkaline phosphatase (ALP), gamma glutamyltransferase (GGT), total bilirubin, direct bilirubin, and total cholesterol. Fatigue was measured using the numeric rating scale (NRS), and the patient's total sleeping time was checked, daily. Results: After the combined treatment, the AST/ALT ratio and the AST, ALT, ALP, GGT, total cholesterol, and direct bilirubin levels were decreased. Through Oriental medicine for the purpose of improving symptoms, NRS of fatigue decreased from 10 to 5, and the amount of sleeping time increased from 2 to 5 hours. Conclusions: The herbal medicine had no effect on the hepatoprotective drugs such as Urusa tablets and Godex capsules used to treat alcoholic hepatitis, and no adverse reaction from the combined administration was observed. To reduce fatigue and insomnia in patients with alcoholic hepatitis, it might be helpful to combine Western medications with Korean medicine treatments, including acupuncture, moxibustion, and Shihogayonggolmoryo-tang.

An Implementation of Obesity Management System with Individually Adapted Complex Care (개인 맞춤형 통합 치료가 가능한 비만 관리 시스템 개발)

  • Noh, Si-Cheol;Kim, Ju-Young;Kim, Jin-Su;Kang, Sang-Sik;Choi, Heung-Ho
    • Journal of the Korean Society of Radiology
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    • v.6 no.2
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    • pp.83-91
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    • 2012
  • The obesity is a medical condition in which excess body fat has accumulated to the extent. It may have an adverse effect on health, leading to reduced life expectancy and increased health problems such as lifestyle disease, hypertension, and diabetes. Furthermore, it may cause the mental illness such as depression, bipolar disorder, anorexia, hyperphagia, and so on by shrinking psychologically. So, it is regarded as the serious worldwide social problem. Recently, although there are many general obesity care methods with various approaches, these can't be the radical obesity care because of the side effects such as surgery aftereffect, drug addiction, and so on. For these reasons, a methodical approach with a consideration of individual obesity pattern is strongly demanded. In this study, complex obesity care and management system which is overcome the weakness of non-surgical obesity treatment is proposed. And the individually adapted obesity treatment system with the far-infrared therapy module, oxygen therapy module, color therapy module, and microwave therapy module was developed. The complex obesity treatment system which is proposed in this study, could improve the efficiency of treatment by suggesting the various treatment protocols. And proposed system could be the foundation of the high quality obesity treatment system.

Effects of Licorice on Embryonic and Fetal Development in Rats (감초가 랫드의 배 · 태자 발생에 미치는 영향)

  • Shin Sunhee;Jang Ja Young;Baek In-Jeoung;Yon Jung-Min;Nam Sang-Yoon;Yun Young Won;Cho Dae-Hyun;Kim Soon-Sun;Rhee Gyu-Seek;Kwack Seung-Jun;Kim Yun-Bae
    • Toxicological Research
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    • v.21 no.4
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    • pp.325-332
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    • 2005
  • The developmental toxicity of water extract of licorice (Glycyrrhiza glabra) was evaluated in rats. Licorice extract (500, 1,000 or 2,000 mg/kg) was dissolved in drinking water and orally administered to male rats from 9 weeks before mating to the day of copulation, and to females from 2 weeks before mating to gestational day 19. On gestational day 20, the animals were sacrificed for Cesarian section, and maternal and fetal abnormalities were examined. Licorice extract neither induce clinical signs, nor affect the body weight gain, feed and water intake, estrous cycle, copulation and fertility rates, blood $17\beta-estradiol$ level and organ weights of dams. Also, the implantation and development including body weights, absorption and death of embryos and fetuses were not influenced by in utero exposure to licorice. In addition, there were no increases in external, visceral and skeletal abnormalities of fetuses. Taken together, it is suggested that no observed adverse effect level of licorice extract is higher than 2,000 mg/kg, and that long-term in utero exposure to licorice might not cause developmental toxicities of embryos and fetuses.

Factors Affecting Re-smoking in Male Workers (남성 근로자의 재흡연에 관련된 요인)

  • Yang, Jin-Hoon;Ha, Hee-Sook;Lim, Ji-Seun;Kang, Yune-Sik;Lee, Duk-Hee;Chun, Byung-Yeol;Kam, Sin
    • Journal of Preventive Medicine and Public Health
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    • v.38 no.2
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    • pp.208-214
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    • 2005
  • Objectives: This study was performed to examine the factors affecting re-smoking in male workers. Methods: A self-administrated questionnaire survey was conducted during April 2003 to examine the smoking state of 1,154 employees of a company that launched a smoking cessation campaign in1998. Five hundred and eighty seven persons, who had stopped smoking for at least one week, were selected as the final study subjects. This study collected data on smoking cessation success or failure for 6 months, and looked at the factors having an effect on re-smoking within this period. This study employed the Health Belief Model as its theoretical basis. Results: The re-smoking rate of the 587 study subjects who had stopped smoking for at least one week was 44.8% within the 6 month period. In a simple analysis, the re-smoking rates were higher in workers with a low age, on day and night shifts, blue collar, of a low rank, where this was their second attempt at smoking cessation and for those with a shorter job duration (p<0.05). Of the cues to action variables in the Heath Belief Model, re-smoking was significantly related with the perceived susceptibility factor, economic advantages of smoking cessation among the perceived benefits factor, the degree of cessation trial's barrier of the perceived barriers factor, smoking symptom experience, recognition of the degree of harmfulness of environmental tobacco smoke and the existence of chronic disease due to smoking (p<0.05). In the multiple logistic regression analysis for re-smoking, the significant variables were age, perceived susceptibility for disease, economic advantages due to smoking cessation, the perceived barrier for smoking cessation, recognition on the degree of harmfulness of environmental tobacco smoke, the existence of chronic disease due to smoking and the number of attempts at smoking cessation (p<0.05). Conclusion: From the result of this study, for an effective smoking ban policy within the work place, health education that improves the knowledge of the adverse health effects of smoking and the harmfulness of environmental tobacco smoke will be required, as well as counter plans to reduce the barriers for smoking cessation.

Effects of Dietary Pine Cone Meal on Egg Production, Egg Quality, Serum Cholesterol and Cholesterol Content and Fatty Acid Composition of Egg Yolk in Laying Hens (산란계 사료 내 잣 부산물의 첨가가 산란율, 계란 품질, 혈청 콜레스테롤 및 난황 내 총 콜레스테롤과 지방산 함량에 미치는 영향)

  • Lee, J.H.;Kim, K.S.;Shin, S.O.;Cho, J.H.;Chen, Y.J.;Kim, I.H.
    • Korean Journal of Poultry Science
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    • v.34 no.3
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    • pp.223-229
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    • 2007
  • This study was conducted to evaluate effects of dietary pine cone meal on egg production, egg quality, serum cholesterol and cholesterol content and fatty acid composition of egg yolk in laying hens. The total of 252 (51-wks) Hy-line brown commercial hens were used for 5 weeks. Dietary treatments included 1) T1 (basal diet + 1% cottonwood sawdust), 2) T2 (basal diet + 0.5% cottonwood sawdust + 0.5% pine cone meal) and 3) T3 (basal diet + 1% pine cone meal). During the overall period, there was no significant difference in egg production, egg weight and egg quality among the treatments. Lipids profile(total, HDL, LDL cholesterol and triglyceride) in serum was not affected by treatments. Egg yolk cholesterol was not significantly different among the treatments. In fatty acid contents of yolk, C18:3 was higher in T1 treatment than T3 treatment(P<0.05). Total SFA, PUFA, MUFA and UFA/SFA were not significantly different in experimental period. In conclusion, dietary supplementation of pine cone meal affected C18:3 fatty acid content of yolk in laying hens, without any adverse effect on egg production.

Assessment of Metal Pollution of Road-Deposited Sediments and Marine Sediments Around Gwangyang Bay, Korea (광양만 내 도로축적퇴적물 및 해양퇴적물의 금속 오염 평가)

  • JEONG, HYERYEONG;CHOI, JIN YOUNG;RA, KONGTAE
    • The Sea:JOURNAL OF THE KOREAN SOCIETY OF OCEANOGRAPHY
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    • v.25 no.2
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    • pp.42-53
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    • 2020
  • In this study, heavy metal in road-deposited sediments (RDS) and marine sediment around Gwangyang Bay area have been investigated to assess the pollution status of metals and to understand the environmental impact of RDS as a potential source of metal pollution. Zn concentration for <63 ㎛ size fraction was the highest (2,982 mg/kg), followed by Cr, Ni, Pb, Cu, As, Cd, and Hg. Metal concentrations in RDS increased with decreasing particle size and relatively higher concentrations were observed around the metal waste and recycling facilities. For particle size in RDS smaller than 125 ㎛, EF values indicated that Zn was very high enrichment and Cr, Cd, Pb were significant enrichment. The concentrations of metals in marine sediments were mostly below the TEL value of sediment quality guidelines of Korea. However, the Zn concentrations has increased by 30~40% compared to 2010 year. The amounts of Zn, Cd and Pb in less than 125 ㎛ fraction where heavy metals can be easily transported by stormwater runoff accounted for 54% of the total RDS. The study area was greatly affected by Zn pollution due to corrosion of Zn plating materials by traffic activity as well as artificial activities related to the container logistics at Gwangyang container terminal. The fine particles of RDS are not only easily resuspended by wind and vehicle movement, but are also transported to the surrounding environments by runoff. Therefore, further research is needed on the adverse effects on the environment and ecosystem.