• 제목/요약/키워드: 반복투여

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90-day Repeated-dose Oral Toxicity Study of 20 kGy Irradiated Cold Water Extract Powder of Mistletoe (20 kGy 감마선으로 조사된 겨우살이 냉수 추출물의 90일 반복투여 독성평가)

  • Kim, Jin-Kyung;Jeon, Young-Eun;Yin, Xing Fu;Lee, Ju-Woon;Kang, Il-Jun
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.40 no.5
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    • pp.704-711
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    • 2011
  • Traditionally, mistletoes have been used as immunostimulant for the management of certain diseases such as cancer with high profile immune depleting potentials. In order to examine the safety of the 20 kGy irradiated cold water extract powder of mistletoes, we performed a 90-day repeated-dose toxicity study with ICR mice. The mice were treated with daily doses of the 20 kGy irradiated cold water extract powder of mistletoes by gavage at 0, 20, 100, and 500 mg/kg/day for 90 consecutive days. We recorded clinical signs of toxicity, body weight, organ weights, histological changes in target organs, hematology, and clinical blood chemistry analysis data for all mice. There were no significant changes in body and organ weights during the experimental period. The hematological analysis and clinical blood chemistry data revealed no toxic effects from the 20 kGy irradiated cold water extract powder of mistletoes. Pathologically, neither gross abnormalities nor histopathological changes were observed between the control and treated mice of both sexes. Collectively, these data suggest that the 20 kGy irradiated cold water extract powder of mistletoes have a high margin of safety.

The age and dose-related hyponatremia during carbamazepine and oxcarbazepine therapy in epileptic children (소아 경련 환자에서 carbamazepine과 oxcarbazepine 치료 시 환자 연령과 약물 용량과 저나트륨혈증의 연관성에 대한 연구)

  • Lee, Kyu Ha;Song, Jun Hyuk;Cha, Sung Ho;Chung, Sa Jun
    • Clinical and Experimental Pediatrics
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    • v.51 no.4
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    • pp.409-414
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    • 2008
  • Purpose : To assess the prevalence of hyponatremia in epileptic children receiving carbamazepine or oxcarbazpine, we investigate serum sodium changes according to age, serum carbamazepine level, and daily oxcarbazepine dosage, and the prevalence of symptoms of hyponatremia. Methods : We reviewed the clinical data of the 197 children receiving carbamazepine and/or oxcarbazepine with or without antiepileptic therapy. And these were classified into the carbamazepine treated patients (group I), oxcarbazepine treated patients (group II), and carbamzepine or oxcarbazepine with other antiepileptics treated patients (group III). Potentially predictive values for development of hyponatremia were examined in each group: age, plasma level of carbamazepine and daily dosage of oxcarbazepine. We assessed the symptoms of hyponatremia. Results : The overall prevalence of hyponatremia was 20.8% (group I, II and III : 17.9%, 22.6%, and 21.8%, respectively), and the prevalence in groups II and III compared with controls (P<0.03) was significantly lower. The changes of serum sodium levels relation to age were not significantly different. The changes of serum sodium levels by increasing of serum levels of carbamazepine and dosage of oxcarbazepine were statistically significant (P<0.01). Among the 41 patients who had biochemical hyponatremia, the prevalence of hyponatremic symptoms was 17.1%. Conclusion : Hyponatremia may occur relatively more frequently with oxcarbazepine or combined other antiepileptics than carbamzepine therapy only. Age of children receiving carbamazepine or oxcarbazepine was no predictive value for occurrence of hyponatremia. The patients whose serum level were less than 125 mEq/L showed more severe clinical symptoms than any other study groups.

Effect of Repeated MSG Administration on Cognitive Ability and Anxiety of Juvenile Rats (MSG의 반복투여가 어린랫드의 인지능력과 기억력에 미치는 영향)

  • Lee, Hae-Nim;Choo, Gang-Sik;Shin, Seong-Ah;Park, Jung-Joon;Lee, Se-Geun;Kim, Se-Woon;Kim, Hyun-Sun;Lee, Song-Hee;Lim, Jeong-Min;Kim, Hyeong-Jin;Park, Young-Seok;Kim, Sang-Ki;Park, Byung-Kwon;Kim, Byeong-Soo;Jung, Ji-Youn
    • Journal of Food Hygiene and Safety
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    • v.30 no.1
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    • pp.120-125
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    • 2015
  • The objective of this study is to investigate the effect of MSG on cognitive function and anxiety by the T-maze and elevated-plus-maze test and repeated oral dose toxicity in SD rat of MSG. The rats were treated with MSG of control group, low group (3 g/kg) and high group (5 g/kg) intragastrically for 4 weeks, respectively. We examined the body weight, the clinical signs, T-maze, Elevated-plus-maze, hematological analysis and serum biochemical analysis, we also observed the histopathological changes of liver, kidney in rats. No significant differences in body weights, biochemical analysis and histopathological observations between control and MSG treatment group were found. In the elevated plus maze (EPM), MSG-treatment group has more open arm visited than controls. MSG-treatment group has been more activated in T-maze test. These data indicate the continuous high MSG intake could be increased the anxiety and could be decreased cognitive ability. In conclusion, MSG is physiologically safety, but high MSG intake could be increased the anxiety and could be decreased cognitive ability in juvenile rat.

Radiosensitization of Cis-Platimum in the Treatment of Advanced Head and Neck Squamous Cell Carcinoma (국소 진행된 두경부편평 상피암에 대한 CIS-PLATINUM과 방사선치료의 동시 병행요법)

  • Chang, Hye-Sook
    • Radiation Oncology Journal
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    • v.10 no.1
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    • pp.27-34
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    • 1992
  • Cis-Platinum (DDP) was utilized as a radiosensitizer in a pilot study for stage III and IV squamous cell carcinoma between 1984-1987, and DDP 20 $mg/M^2$/day was administered for 4 days at 3 week interval with concurrent radiotherapy. This study consisted of three phases: cytoreduction phase, eradicative treatment phase and adjuvant phase. Total 59 patients were subjected to evaluate a tumor response and its toxicity. During the eradicative phase,27 patients underwent surgery (group I ), 29 patients were treated with radiotherapy only (group II) and 3 patients did not complete the second phase of therapy. At the cytoreduction phase, $95\%$ response rate with complete response (CR) $47.5\%$ and partial response (PR) $47.5\%$ was observed. Complete tumor clearance (CTC) rate following 2nd phase of therapy was $84\%$ (47/56) with 26/27($96\%$) in group I achieved CTC with surgery and 21/29 ($72\%$) patients In group II achieved CTC following 2nd phase. $67\%$ of primary lesions and $70\%$ of nodal diseases in group I showed no tumor in the surgical specimen. $34\%$ of patiets who achieved CTC at 2nd phase developed recurrence and median time to recur was 8 months. Actuarial disease free survival at 4 years was $59\%$ and $51\%$(24/27) of patients who achieved CTC at 2nd phase were alive without any evidence of disease at median follow-up 31 months (range, 10-48 months). There was no significant difference in overall and disease free survival between group I and II between CR and PR group following 1st Phase. Only significant Prognostic factor in this study was the complete tumor clearance following 2nd phase theapy. In general, toxicity was not excessive. Author concludes that this study confirmed the significant radiosensitizing effect of DDP with the acceptable toxicity and warrant the prospective study to determine optimum scheduling for DDP and radiotherapy which maximizes the therapeutic gain.

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Single Oral Dose-increasing Toxicity Test and Four Weeks Repeated Oral Dose Determinating Test of ACM (Added Chongmyung-tang) in Beagle Dogs (ACM의 비글견을 이용한 단회 경구투여 용량증가 독성 시험 및 4주 반복 경구투여 용량 결정 시험)

  • Lim, Jung-Hwa;Lee, Sang-Ryong;Jung, In-Chul
    • Journal of Oriental Neuropsychiatry
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    • v.24 no.1
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    • pp.131-144
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    • 2013
  • Objectives : To provide information on the safety of ACM, we carried out a single oral dose-increasing toxicity and 4-weeks repeated oral dose determining test of ACM in beagle dogs. Methods : In a single oral dose-increasing toxicity test, beagles were treated with ACM orally increasing dose level (1,000, 2,000, 5,000 mg/㎏) at interval of 3 days. After administration, signs of toxicity were observed for two weeks. In 4-weeks repeated oral dose determinating test, beagles were treated with ACM with oral dose 500, 1,000, 2,000 mg/kg for 4 weeks. Mortality, clinical signs, body weight changes, food consumption, urinalysis, hematological and biochemical parameters, organ weights, necropsy findings, and histological findings were monitored during the study period. Results : In a single oral dose-increasing toxicity test, we found no mortality, abnormalities in clinical signs, body weight, and necropsy findings during the study period. In 4-weeks repeated oral dose determinating test, we found no mortality, abnormalities in clinical signs, body weight, food consumption, urinalysis, hematological and biological parameters, gross findings, organ weights, necropsy findings, and histopathological findings in any of the beagles tested. Conclusions : The results obtained in these studies suggest that maximum tolerated dose (MTD) of ACM in male and female beagle dogs was supposed to be over 5,000 mg/kg. For the future studies of toxicity, it is advisable that high dose and low dose are set at 2000 mg/kg and 500 mg/kg, respectively.

Single Oral Dose Toxicity Test and Four Weeks Repeated Oral Dose Determination Test of Crude Antifungal Compounds Produced by Bacillus subtilis SN7 in Rats (Bacillus subtilis SN7이 생성한 조항균 물질의 단회 경구투여 독성 시험 및 4주 반복 경구투여 용량 결정 시험)

  • Chang, Hae-Choon;Koh, Sang-Bum;Lee, Jae-Joon
    • The Korean Journal of Community Living Science
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    • v.27 no.3
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    • pp.437-449
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    • 2016
  • To provide information on the safety of crude antifungal compounds produced by Bacillus subtilus SN7 isolated from Meju, we carried out an acute (single) oral dose toxicity test and 4 week repeated oral dose determination test on crude antifungal compounds in male and female Sprague Dawley rats. In the acute toxicity test, rats were treated with crude antifungal compounds produced by Bacillus subtilus SN7 orally at increasing dose levels (500, 1,000, and 2,000 mg/kg) and observed for 2 weeks. In the repeated-dose 28-day oral dose determination study, rats were orally administered doses of 500, 1,000, and 2,000 mg/kg daily for 4 weeks. There were no test article-related deaths or abnormal clinical signs in the two studies. In the 4 week repeated oral dose determination test, there were also no significant differences in clinical signs, body and organ weight changes, or any other hematological and biochemical parameters between the control and treated groups. The results suggest that the crude antifungal compounds produced by Bacillus subtilus SN7 up to a dosage level of 2,000 mg/kg are not toxic in male and female rats.

Single Oral Dose Toxicity Test and Four Weeks Repeated Oral Dose Determination Test of GST in Sprague-Dawley Rats (GST의 Sprague-Dawley Rat를 이용한 단회 경구투여 독성시험 및 4주 반복 경구투여 용량결정시험)

  • Han, Jong-Min;Hong, Jee-Hee;Lee, Hye-Yeong;Jung, In-Chul;Jin, Mi-Rim;Kim, Seong-Hyeong;Park, Yang-Chun
    • The Journal of Internal Korean Medicine
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    • v.34 no.4
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    • pp.349-361
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    • 2013
  • Objectives : This study aimed to evaluate the single oral dose toxicity and four weeks repeated dose determination of Gamisasangja-tang (GST) in male and female Sprague-Dawley rats. Methods : In the single oral toxicity study, rats were orally administered a single dose of 0 and 5,000 mg/kg GST. There were 5 rats in each group. After single administration, mortality, clinical signs, body weight changes and gross pathological finding were observed for 14 days. In the 4-weeks repeated oral dose determination study, rats were orally administered a single dose of 0, 1,250, 2,500 or 5,000 mg/kg GST. There were 5 rats in each group. Mortality, clinical signs, body weight changes, food consumption and gross pathological finding were observed for 28 days. Organ weight, clinical chemistry and hematology were tested after 28 days. Results : There was no mortality in either of the two studies. There were also no significant differences in clinical sign, body weight, organ weights, hematological or serum chemical parameters between the GST and control groups. Conclusions : The results obtained in this study suggest that the 50% lethal dose of GST is over 5,000 mg/kg, so this finding would be expected to provide scientific evidence for the safety of GST.

Single Oral Dose Toxicity Test and Four Weeks Repeated Oral Dose Determination Test of Oplopanax elatus (Nakai) Nakai Hydrothermal Extract Powder in Sprague-Dawley Rats (Sprague-Dawley 랫드를 이용한 땃두릅나무 열수추출물 분말의 단회 경구투여 독성시험 및 4주 반복 경구투여 용량 결정 시험)

  • Yoo, Nam Ho;Kwon, Yongsoo;Chun, Hyeon Soo;An, Kyu Sup;Kim, Hye Jin;Ryu, Hyeon Yeol;Lee, So Min;Song, Kyung Seuk;Park, Byung Jun;Kim, Myong Jo
    • Korean Journal of Pharmacognosy
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    • v.50 no.3
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    • pp.205-218
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    • 2019
  • This study was conducted to investigate the toxicity symptoms and approximate lethal dose (ALD) of Oplopanax elatus (Nakai) Nakai hydrothermal extract powder by single oral dose toxicity and 4 weeks of repeated oral dose determination. The Sprague-Dawley (SD) male and female rats were treated with 1,250 (low- dosage group), 2,500 (medium- dosage group) and 5,000 (high- dosage group) mg/kg. In the single oral dose toxicity test, no dead animals and toxic symptoms were observed during the experiment. And there were no related with anomalies in normal weight changes and autopsy results. In the four-week repeated oral dose determination test, no death animals and toxicity symptoms were observed during the experiment, and there were no abnormal results in weight changes, feed and negative intake measurements. Results of eye examination, urinalysis, hematological values and serum biochemical values, gross findings and absolute organ were not of singularity. These result demonstrated that no toxic symptoms were observed by the test substance Oplopanax elatus (Nakai) Nakai hydrothermal extract powder under this test condition, and the non-toxic content is determined to be 5,000 mg/kg/day.

Compared the Causes of Problematic Chemo-Ports According to the Types of Chemo-Ports(Valved, vs. Non-Valved) (Valve포트와 Non-Valved포트 사용에 따른 문제점의 비교 분석)

  • You, In-Gyu;Lim, Cheong-Hwan;Han, Beom-Hee;Jung, Hong-Ryang;Joo, Yeong-Cheol
    • Journal of radiological science and technology
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    • v.34 no.1
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    • pp.35-41
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    • 2011
  • Total implanted central venous port (TIAP, Chemoport) is widely used in oncology patients because it does not require external dressing and restricts patient activity. Chemoport only requires monthly flushes of heparinized saline to keep the patency of the catheter and probably less prone to infectious complications than tunneled catheter. Despite the extensive use of permanent central venous access in oncology patients, there are only few reports about clinical experience of the Groshong catheter. The purpose of this study is to compare the complication rate between the traditional open-ended (non-valved) chemoports and valved chemoports (Groshong catheter connected to TIAP). During 5 years (Jan 2006 to May 2010), 438 patients received chemoport insertion procedure in our interventional radiology department. Among them 30 patients was referred to our department for problematic chemoports. We compared the cause of problematic chemoports between two types of chemoports (valved, vs. non-valved). Valved chemoports had higher referral rates than non-valved chemoports. When there is a need to insert valved port, different method of insertion and maintenance procedure seems to be necessary. More than 20 ml of flusing with heparinized saline after blood sampling could be a good suggestion. Adequate care of chemoport is essential for long patency. Also following the guideline from the manufacturing company is necessary.

The Toxicological Pathologic Study of Amanita muscaria in Sprague-Dawley Rat (Amanita muscaria 경구투여 시 Sprague-Dawley Rat에서의 독성병리 연구)

  • Kim, Jin;Kim, Hyeong-Jin;Kim, So-Jung;Kim, Byeong-Soo;Kim, Sang-Ki;Park, Byung-Kwon;Park, Young-Seok;Cho, Sung-Dae;Jung, Ji-Won;Nam, Jeong-Seok;Choi, Chang-Sun;Lee, Seung-Ho;Jung, Ji-Youn
    • Journal of Life Science
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    • v.19 no.8
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    • pp.1152-1158
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    • 2009
  • For the toxicological pathologic study of amanita muscaria, we have investigated single and repeated dose toxicity in Sprague-Dawley (SD) rats. Single dose toxicity study was identified as catalepsy, incline and tail pinch methods (control 0 mg/kg, low 3.3 mg/kg, middle 16.5 mg/kg, high 33.0 mg/kg). Repeated dose toxicity study was carried out in blood tests, serum tests and histopathological methods. Neurotoxicity - muscle paralysis, and convulsion and loss of movement - was observed at 33.0 mg/kg group in the single dose toxicity study. Dysfunction of liver and kidney were shown in the repeated oral administration of the amanita muscaria at 3${\sim}$4 weeks. Serum chemistry results revealed a marked increase of LDH [Lactate Dehydrogenase (3181.5 IU/L; normal 230-460 IU/l)], ALT [Alanine transaminase (124.0 IU/l; normal <40 IU/l)] but the kidney was normal. Histopathological results show interstitial edema and tubular epithelial necrosis in the kidney. These results suggest that amanita muscaria has a neurotoxic effect and causes dysfunction of liver and kidney in the SD rat.