• Title/Summary/Keyword: Four weeks repeated

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A Thirteen Week Repeated Oral Dose Toxicity Test and A Four Week Recovery Test of ACM(Added Chongmyung-tang) in Sprague-Dawley Rats (ACM의 Rat를 이용한 13주 반복 경구투여 독성시험 및 4주 회복시험)

  • Park, Dae-Myung;Lee, Sang-Ryong;Lim, Jong-Soon;Kim, Seung-Hyung;Jung, In-Chul
    • Journal of Oriental Neuropsychiatry
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    • v.23 no.3
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    • pp.143-160
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    • 2012
  • Objectives : To provide information on the safety of ACM, we carried out a 13-week repeated oral dose toxicity and a 4-week recovery test of ACM in Sprague-Dawley rats. Methods : Female and male rats were treated with ACM with oral doses of 800, 2000, and 5000 mg/kg. The ACM was administered for 13 weeks. Mortality, clinical signs, body weight changes, food consumption, ophthalmologic findings, urinalysis, hematological and biochemical parameters, gross findings, organ weights and histological markers were monitored during the study period. Moreover, the rats were monitored for 4 extra weeks to determine recovery time after the study period. Results : We found no mortality and no abnormalities in clinical signs, body weight, food consumption, ophthalmologic findings, urinalysis, hematological and biochemical parameters, gross findings, organ weights and histological markers in any of the rats tested. Conclusions : The no-observed adverse effects level (NOAEL) was considered as over 5000 mg/kg for male and female rats.

Four-week Oral Toxicity Study of DA-5018, a New non-narcotic Analgesic Agent (비 마약성 진통제 DA-5018의 랫드에 대한 4주 경구투여 아급성독성)

  • 강경구;김옥진;백남기;안병옥;김원배;양중익
    • Biomolecules & Therapeutics
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    • v.5 no.2
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    • pp.133-149
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    • 1997
  • 4-week repeated dose toxicity of DA-5018, a new capsaicin analogue analgesic agent, was examined in 5D rats at dosage levels of 0,0.4,2, 10 and 50 mg/kg/day. DA-5018 was administered orally to 17 males and 17 females per group at doses of 0, 10 and 50 mg/kg and to 12 males and 12 females per group at doses of 0.4 and 2 mg/kg. After the administration period, 5 males and 5 females at the 0, 10 and 50 mg/kg were placed on withdrawal for 2 weeks. Treatment-related clinical signs were observed at 10 and 50 mg/kg. Clinical signs observed immediately after the administration of DA-5018 were grooming, sedation or depression, lacrimation, atacia, reddening of extremities and ears, ventral or lateral recumvincy, respiratory distress, cyanosis and convulsion. Delayed-type clinical signs including focal scabbing and depilation around nose were also observed 1 or 2 weeks after the start of administration of DA-5018. Only at the 50 mg/kg group, corneal opacities, reduced body weight gain (male) and death (male 6/17, female 3/17) were noted. In blood biochemical analysis, serum levels of glucose and triglyceride decreased at 10 and 50 mg/kg. In hematological examination, there were increases in the number of red blood cell, hemoglobin content and percent of hematocrit at 10 and 50 mg/kg. Pulmonary enlargement and hemorrhagic spot, focal scabbing and depilation around nose and corneal opacities were seen at the necropsy of the animals died during the dosing of DA-5018 50 mg/kg. Focal scabbing and depilation around nose were observed in the animals terminally necropsied at doses of 10 and 50 mg/kg. Histopathological examination revealed pulmonary hemorrhage, focal necrosis in the scabbed area, corneal necrosis, fibrosis and neovasculization in the stroma. At 0.4 and 2 mg/kg, there were no significant toxic changes attributable to the administration of DA-5018. In conclusion, target organs following to 4-week repeated dose of DA-5018 in the rat were determined to be lung, skin and eyes. Definite toxic dose and no-observed-adverse-effect-level (NOAEL) were estimated to be 50 and 2 mg/kg/day, respectively.

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The Effects of Self Foot Reflexology on Depression, Sleep and Low Back Pain in Community Dwelling Elderly Women (자가 발반사마사지가 재가 여성노인의 우울, 수면, 요통에 미치는 효과)

  • Eom,, Mi-Ran;Kim, Eun-Kyun;Oh, Hee-Young;Kim, Hyun-Sook;Kwak, Kyung-Hee
    • Journal of Korean Academy of Fundamentals of Nursing
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    • v.15 no.4
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    • pp.504-512
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    • 2008
  • Purpose: The purpose of this study was to identify the effects of self foot reflexology on depression, sleep, and low back pain in elderly women. Method: The study was one group pre-posttest design. Data collection was done from December 2007 to January 2008 in D city. The participants were 47 women (65 years of age and over). After two weeks of reflexology education, the women did foot reflexology themselves for approximately 40 minutes, five times a week for four weeks. To verify the effects of foot reflexology, the scores for depression, sleep, and LBP were measured at baseline, after 4 weeks of self-treatment. Repeated measure ANOVA with the SPSS WIN 14.0 program were used to analyze the data. Results: There were significant differences in depression, sleep, and LBP between baseline, after 4 weeks of self-treatment. Conclusion: These findings suggest that self foot reflexology could be utilized as an effective nursing intervention for improving depression, sleep, and LBP in elderly women.

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Four-Week Oral Toxicity Study of CJ-50002 (Vibrio Vaccine) in Rats (CJ-50002(비브리오백신)의 랫드에 대한 4주간 경구 반복투여 독성연구)

  • 윤병일;정수연;김달현;이영수;김대용
    • Toxicological Research
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    • v.15 no.1
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    • pp.9-17
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    • 1999
  • This study was performed to evaluate the subacute toxicity of CJ-50002 (Vibrio Vaccine) in SPF Spraqur-Dawley (SD) rats. Vibrio vaccine was administered orally at a dose level of high (167mg/kg/day), medium (16.7mg/kg/day), and low (16.7mg/kg/day) once a day and repeated fro 4 weeks. Ten males and female rats were assigned to each group. After 4 week administration, no significant dose-dependent changes in body weight, water and food consumption rate or organ weight were noted dependent changes in body weight, water and food consumption rate or organ weight were noted among 4 groups. Urinanalysis, hematology, and serum chemistry, also fail to detect any dose-related change among 4 groups tested. During necropsy and histopathological examination, no specific toxicity related to treated material was found. The result of this study demonstrated that vibrio vaccine when administered orally for 4 weeks at a high dose of 167mg/kg/day, no dose-related toxicity was found in treated make and female rats.

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An empirical study on the selection of the optimal covariance pattern model for the weight loss data (체중감량자료에 대한 적정 공분산형태모형 산출에 관한 실증연구)

  • Jo, Jin-Nam
    • Journal of the Korean Data and Information Science Society
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    • v.20 no.2
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    • pp.377-385
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    • 2009
  • Twenty five female students in Seoul participated and were divided into two group in the experiment of weight loss effect of two treatments. Fourteen students(Treatment A group), randomly chosen from the students, had fed on diet foods and exercised over 8 weeks, and the remaining students(Treatment B group) had fed on diet foods only for the same periods. Weights of 25 students had been measured repeatedly four times at an interval of two weeks during 8 weeks, It resulted from mixed model analysis of repeated measurements data that separate Toeplitz pattern for each treatment group was selected as the optimal covariance pattern. Based upon the optimal covariance pattern model, the baseline effect and time effect were found to be highly significant, but the treatment-time interaction effect was found to be insignificant. Finally, the students with diet foods and exercises were more effective in losing weight than the students with only diet foods were.

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Single and Four-Week Repeated Oral Toxicity Study of CJ-11555 in Sprague-Dawely Rats (CJ-11555의 Sprague-Dawely 랫드를 이용한 단회 및 4주 반복경구투여 독성시험)

  • 김일환;이성학;최재묵;박지은;김덕열;노현정;김택로;이상호;김영훈
    • Toxicological Research
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    • v.20 no.2
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    • pp.143-151
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    • 2004
  • This study was to investigate single and repeated-dose toxicities of CJ-11555, an anticirrhotic agent, in Sprague-Dawley (SO) rats. In single-dose oral toxicity study, the test article were administered once by gavage to males and females at dose levels of 0 and 2,000 mg/kg. No dead animals and abnormal necropsy findings were found in control and CJ-11555 treated group. Therefore, the approximate lethal dose of CJ-11555 was considered to be higher than 2,000 mg/kg in rats. In the 4-week repeated oral toxicity study, the test article was administered once daily by gavage to male and female rats at dose levels of 0, 10, 50 and 200 mg/kg/day for 4-weeks. In clinical signs, yellow-colored urine and yellow hair coat were observed in the 50 and 200 mg/kg male and female groups. In hematology, erythrocyte count and hemoglobin were significantly decreased in the 200mg/kg male and female groups. In serum biochemistry, total cholesterol was significantly increased and aspartate aminotransferase (AST) was significantly decreased in the 50 or 200 mg/kg male and female groups. In histopathological examinations, centrilobular hepatocellular hypertrophy in the liver, congestion and pigmentation in the spleen, hyaline droplets in the kidney were observed in the 50 and 200 mg/kg male and female groups. In toxicokinetic study, CJ-11555 was dose-dependent in systemic exposure and showed better absorption in female with minimum accumulation after multidosing. Based on these results, it was concluded that the 4-week repeated oral dose of CJ-11555 resulted in the suppression of AST activity and centrilobular hepatocellular hypertrophy in both sexes at a dose level of 50 or 200 mg/kg/day. The target organ was estimated to be liver, spleen and male's kidney. The no-observed-adverse-effect level (NOAEL) for CJ-11555 in rats following gavage for at least 4-week is 10 mg/kg/day.

PRECLINICAL TOXICITY STUDY OF A NEW PHOSPHODIESTERASE-5 INHIBITOR (II) FOUR-WEEK SUBACUTE TOXICITY STUDY IN RATS

  • Hyeon Cho;Kim, Dong-Hwan;Kang, Kyung-Koo;Ahn, Byoung-Ok;Kim, Won-Bae
    • Proceedings of the Korean Society of Toxicology Conference
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    • 2001.05a
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    • pp.128-128
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    • 2001
  • Toxic effects of a new phosphodiesterse-5 inhibitor, DA-8159, were investigated in Sprague-Dawley rats by repeated oral administration. Four groups of 10 male and 10 female rats were treated with DA-8159 at a dose of 0, 40, 80, or 320 mg/kg/day for 4 weeks.(omitted)

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Effects of the Auricular Acupressure on Pruritus and Fatigue in Hemodialysis Patients (이혈요법이 혈액투석 환자의 소양증과 피로에 미치는 효과)

  • Chun, Youngmi;Park, Sangyoun
    • Korean Journal of Adult Nursing
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    • v.28 no.4
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    • pp.436-446
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    • 2016
  • Purpose: The purpose of this study was to identify the effect of auricular acupressure on pruritus and fatigue in hemodialysis patients. Methods: The study design was a randomized control group pre-post test. Initially, forty-four patients were randomly assigned to one of two groups. There was a loss of three participants assigned to the treatment group. The period of data collection was from December 2014 to March 2015. Both groups completed a pre-test. The treatment group received auricular acupressure once a week for ten weeks. Data were collected from the treatment group at two time periods: five weeks and ten weeks following initiation of the treatment protocol. Data were collected from the control group at week 5 and week 10. Data analysis was performed using IBM SPSS Statistics 21.0 program, specifically with the independent t-test and the Repeated Measures of ANOVA. Results: Auricular acupressure was effective in reducing pruritus (F=13.93, p<.001) and fatigue (F=18.33, p<.001). Conclusion: Auricular acupressure is a non-invasive simple method that can be used for the relief of symptoms reported by hemodialysis patients. This treatment modality could be used in several clinical areas.

Effects of Bridge Exercise with Trunk Rotation on Trunk Muscle Thickness in Healthy Adults (몸통 회전을 이용한 교각운동이 정상 성인의 몸통 근육 두께에 미치는 영향)

  • Kwang Duk Park;Yong Nam Kim
    • Journal of Korean Physical Therapy Science
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    • v.30 no.3
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    • pp.41-48
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    • 2023
  • Background: This study examined the effects of the bridge exercise with trunk rotation on the thickness of body trunk muscles, including external oblique, internal oblique, and transverse abdominis in healthy male adults. Design: Randomized controlled trial Methods: Twenty-four men were evenly divided into a trunk rotation bridge exercise group and a basic bridge exercise group by drawing lots. The two groups performed the respective exercise for thirty minutes, three times a week for six weeks. repeated measure analysis of variance (ANOVA) was used after distinguishing between three different time points before the experiment, three weeks after the experiment, and six weeks after the experiment. The significance level was set at 0.05. In case an interaction between time and group existed, the paired t-test was used to examine the within-group difference. The independent-sample t-test was used to check the between-group difference. The significance level was set at 0.05. Results: All the men showed a significant change over time in their external oblique, internal oblique, and transverse abdominis muscles. An interaction between time and group was also found (p<0.05). Conclusion: The bridge exercise with trunk rotation causes a meaningful difference in the thickness of external oblique, internal oblique, and transverse abdominis muscles. Therefore, this study proposes the use of this exercise for lower-back stabilization in future research and clinical settings.

Intravenous Single Dose and Four-week Repented Dose Toxicity Study of YHB216, a Recombinant Human Erythropoietin, in Beagle Dogs (YHB216의 비글개에서 정맥내 단회 및 4주 반복투여독성시험)

  • 노용우;장호송;지형진;정은용;신지순;강민정;안경규;최연식;이종욱
    • Biomolecules & Therapeutics
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    • v.10 no.1
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    • pp.59-69
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    • 2002
  • Recently, recombinant human erythropoietin (rHu-EPO) has been used to treat various types of anemia. YHB216 is a new rHu-EPO developed by Yuhan Research Institute. In this study, we investigated the single dose and 4-week repeated dose toxicity of YHB216 in Beagle dogs. In the single dose toxicity study, YHB216 was administered intravenously at single dose levels of 0 and 25,000 IU/kg to dogs (2 dogs/sex/group). There were no treament-related changes in survivals, clinical signs, body weight gain, hematological values, blood chemical values, and necropsy finding during experimental period. In the repeated dose toxicity study, YHB216 was administered intravenously to dogs for 4 weeks at the dose levels of 0, 100, 500, and 2,500IU/kg (3 dogs/sex/group). There were no toxicologically significant changes in clinical signs, body weights, food and water consumptions, ophthalmoscopy, urinalysis and blood chemistry. There were increased values of red blood cell, hemoglobin, and hematocrit at all treated groups. Spleen revealed increased weight and extramedullary hematopoiesis at 500 IU/kg or more. These changes are all considered to be Pharmacology-related effects and were recovered after 4-week recovery period. From these results, it is concluded that LD50 value was above 25,000 IU/kg in the single dose toxicity study of YHB216 in dogs and the no observed adverse effect level (NOAEL) was 100 IU/kg day in the repeated dose toxicity study of YHB216 in dogs.