• Title/Summary/Keyword: Clinical safety

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Studies about the bioactive component analysis and an oral glucose tolerance test of Add-Omit-Saenghyeoryunbu-eum(AO-SHU) for confirmation of diabetes therapy (가감생혈윤부음(加減生血潤膚飮)의 당뇨병 치료효과 확인을 위한 생리활성성분 분석과 경구포도당부하 연구)

  • In, Jeongdo;Im, Daisig;Kim, Won-Ill
    • Herbal Formula Science
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    • v.24 no.2
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    • pp.80-99
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    • 2016
  • Objectives : Instrumental chemical analysis was utilized to investigate the effect of Add-Omit-Saenghyeoryunbu-eum(AO-SHU) on diabetic treatment. One of the most exciting, yet also controversial, arguments is the safety and biological mechanisms of the natural medicine on human body. Therefore, the aim of this study is to provide a better understanding on bioactive chemical components, hazards of heavy metal contamination and biological mechanism of the diabetic medicine composed of 12 different natural herbs. Methods : To study bioactive compound and metallic component in the diabetic medicine in detail, LC-MS/MS (Liquid Chromatography-Mass/Mass), GC (Gas Chromatography) and ICP (Inductively Coupled Plasma) were utilized to characterize the extract of the diabetic medicine and the result was compared with 18 marker substances selected from literature survey. In addition, in vitro assay experiments including GPR 119 activity and human DGAT-1 inhibition, and OGTT (Oral Glucose Tolerance Test) were performed to verify the effectiveness of this medicine on diabetic treatment. Results : Out of 18 marker substances, 9 bioactive compounds were identified from LC-MS/MS analysis which include Citruline, Catalpol, Berberine, Ginsenoside Rb1, Ginsenoside Rg1, Oleanolic acid, β-Sitosterol, Mangiferin, and Schizandrin. ICP study on 245 residual pesticides revealed that 239 species were not detected but 6 species, Dimethomorph, Trifloxystrobin, Pyraclostrobin, Isoprocarb, Carbaryl and Flubendiamide, while the amounts are trace levels, below permitted concentrations. The biological activity was observed in vitro assay and Oral Glucose Tolerance Test(OGTT), which are consistent with a preliminary clinical test result, a drop in blood sugar level after taking this herbal medicine. Conclusions : Instrumental chemical analysis using LC-MS/MS, GC, and ICP was conducted successfully to identify bioactive compounds in AO-SHU for the treatment of diabetes, finding 9 bioactive compounds. Furthermore, in vitro assay experiments and OGTT show that AO-SHU has its biological activities, which imply that it can be a candidate for the future diabetes remedy.

The Study of Safety of Herbal Medicine Including Fuzi(附子) on High Range of LFT, RFT Patients (간, 신장수치 이상 환자에 부자(附子) 배합 처방 투여가 미치는 영향)

  • Lee, Young-Jun;Hwang, Won-Duk;Lee, Jae-Wook;Jeong, Hui-Jin;Bae, Su-Hyun;Kim, Kyu-Gon
    • Herbal Formula Science
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    • v.19 no.2
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    • pp.179-189
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    • 2011
  • Objectives : Aconiti Lateralis Preparata Radix(fuzi, 附子) and its class herbs(chaunwu, caowu etc.) are necessary for some clinical conditions, such as cold pain, chilling etc,. But, they has some poison component. And, they have been known to cause liver and kidney injury, and dangerous in the patients who has abnormal range of LFT and RFT. This study shows the consequences for aspartate aminotransferase(AST), alanine aminotransferase(ALT), blood urea nitrate(BUN), and Creatinine were analyzed using samples from patients who took the decoction containing fuzi. Methods : Blood samples for Experiment Group(E) were collected from 63 patients, who took the decoction containing fuzi, admitted into the 6th internal medicine department of Dong Eui Oriental Medical Hospital between from January 2007 to March 2011. In compared to those of experiment group, blood samples as Control Group(C) were collected from 64 patients, who took the decoction not containing fuzi, admitted into the same hospital from January 2009 to April 2011. Results and Conclusions : 1. AST No changed : E 4.17%, C 2.63%, Increased : E 12.5%, C 28.95%, Decreased : E 80.33%, C 68.42% 2. ALT No changed : E2.94%, C5.13%, Increased : E 8.82%, C 20.51%, Decreased : E 88.24%, C 74.36% 3. BUN No changed : E 0%, CG 7.14%, Increased : E 32.25%, CG 14.29% Decreased : EG 67.65%, CG 78.57% 4. Creatinine No changed : EG 5.00%, CG 0%, Increased : EG 35.00%, CG 54.55% Decreased : EG 60.00%, CG 45.45% 5. The results suggest that the decoction containing fuzi isn't harmful AST, ALT, BUN, Cr of the patients who has high range of them.

Efficacy of levetiracetam in refractory childhood epilepsy (난치성 소아 간질에서 levetiracetam의 효과)

  • Lee, Keon-Su;Kang, Joon-Won
    • Clinical and Experimental Pediatrics
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    • v.53 no.4
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    • pp.571-578
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    • 2010
  • Purpose : To evaluate the efficacy and safety of levetiracetam adjunctive therapy for reducing the rate of seizure frequency in children with intractable pediatric epilepsy. Methods : We reviewed the medical records of 86 patients with intractable pediatric epilepsy who visited our hospital between March 1989 and February 2009. Levetiracetam was included in the previous anticonvulsant regimen for at least 6 months and the reduction in the rate of seizure frequency was determined in follow-up examinations. We analyzed demographic data, seizure types, antiepileptic drug history, levetiracetam dose, adverse effects of levetiracetam therapy, treatment outcome, electroencephalogram findings, etc. Results : More than 50% reduction in the seizure frequency was observed in 62 of the 86 (72.1%) patients; 44 patients (51.1%) became seizure free, while the seizure frequency increased in 5.8% patients. The associations between seizure reduction rate and age, associated diseases, seizure types, and seizure frequency before treatment were not significant. However, the duration of disease, dose of levetiracetam, duration and frequency of anticonvulsant administration before levetiracetam therapy were significantly correlated. Electroencephalogram findings and the cause of epilepsy showed partial correlation. Forty (46%) patients showed adverse symptoms; the symptoms in the order of their frequency were somnolence, hyperactivity, irritability, aggressiveness, tiredness, etc. Conclusion : The findings of our study provide the evidence that levetiracetam adjunctive therapy is efficacious and well tolerated in various refractory childhood epilepsy cases.

A Survey for Needs and Preference of Food and Nutrition information on Mass Media for Korean Female Adults (대중매체 식품영양정보에 대한 성인 여성의 요구도 조사)

  • Kwak, Jeong-Eun;Lee, Seo-Yeon;Lee, Sang-Hoon;Ko, Kwang Suk
    • Korean Journal of Community Nutrition
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    • v.19 no.6
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    • pp.550-557
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    • 2014
  • Objectives: This study was conducted to examine the preferences and needs of typical Korean females adults for food and nutrition information provided by the mass media. Methods: A total of 343 females (77 in their 20s, 85 in their 30s, 88 in their 40s and 93 in their 50s) residing in the Seoul/Gyeonggido area was surveyed on general characteristics, main sources of food and nutrition information and needs for sources and contents of nutrition information. Results: The survey showed that typical Korean females obtained knowledge of food and nutrition mainly through the Internet (30.4%) and broadcasting (29.0%). Typical Korean females were interested in 'dietary management for weight control' (21.9%), 'the prevention and treatment of disease' (20.0%), 'food safety' (16.8%), 'proper dietary habits' (14.6%), 'cookery' (11.8%), 'functional foods' (9.6%), 'restaurant details' (3.5%) and 'life-cycle-specific dietary guideline' (1.6%). Needs for food and nutrition program forms on TV were 'educational programs' (34.3%), 'documentaries' (20.8), 'expert lecture-style' (13.0%), 'entertainment programs' (11.9%), 'expert conversation' (11.4%), 'news-style' (4.6%) and 'public campaign advertisements' (4.0%). On the Internet, 38.6% of the respondents preferred to get information provided by food and nutrition-related institutions (38.6%) while 26.1% preferred webtoons for nutritional information. The favored forms in mobile applications were 'monitoring their diets' (29.5%), 'data-based texts information' (21.4%), 'experts feedback' (20.6%), 'communities' (15.1%) and 'games' (13.1%). The rates of the preference to obtain information from experts such as nutritionists and dietitians and doctorsor dietitian turned reporters increased markedly with older ages. Conclusions: Since the mass media is a main source of food and nutrition information for the general public, the effectiveness and accuracy of the information provided should be enhanced by taking the needs of the public into account. The quality of information should be improved by involving more nutrition experts.

Development of an Automatic External Biphasic Defibrillator System (Biphasic 자동형 제세동기 시스템 개발)

  • Kim, Jung-Guk;Jung, Seok-Hoon;Kwon, Chul-Ki;Ham, Kwang-Geun;Kim, Eung-Ju;Park, Hee-Nam;Kim, Young-Hoon;Heo, Woong
    • Journal of Biomedical Engineering Research
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    • v.25 no.2
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    • pp.119-127
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    • 2004
  • In this paper, an automatic external biphasic defibrillator that removes ventricular fibrillation efficiently with a low discharging energy has been developed. The system is composed of software including a fibrillation detection algorithm and a system control algorithm, and hardware including a high voltage charging/discharging part and a signal processing part. The stability of the developed system has been confirmed through continuous charging/discharging test of 160 times and the detection capability of the real-time fibrillation detection algorithm has been estimated by applying a total of 30 various fibrillation signals. In order to verify the clinical efficiency and safety, the system has been applied to five pigs before and after fibrillation inductions. Also, we have investigated the system efficiency in removing fibrillation by applying two different discharging waveforms, which have the same energy but different voltage levels.

A Case of Naturally Acquired Cheyletiellosis in a Rabbit: Therapeutic Trial of Selamectin (애완토끼에서 발생한 Cheyletiellosis 피부염에 대한 selamectin 치료 1례)

  • Hoh Woo-pil;Oh Won-Seok;Oh Hynn-ho;Lee Kenn-woo;Eom Ki-dong;Oh Tae-ho
    • Journal of Veterinary Clinics
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    • v.22 no.1
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    • pp.56-59
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    • 2005
  • An about 5-month-old, female rabbit was presented with pruritus, alopecia and mucopurulent ocular discharge. On physical examination mild to moderate scales on whole body were observed. Dermatological lesions such as alopecia, erythema, papules, pustules and crusts were observed in the eyelids, nose, inner pinna, medial sites of four feet, metacarpal and metatarsal areas, and cranial site of left stifle joint. Also, mild conjunctivitis, blepharitis and keratitis were found. For extensive dermatologic diagnostic evaluation skin scraping, tape stripping, impression smear, combing, wood' light, bacterial culture and fungal culture were performed. Finally, Cheyletiella spp. was found by combing. Many heterophils and eosinophills were appeared in impression smear. The result of fungal culture was negative. Pasteurella spp was cultured. Definitive diagnosis of Cheyletiellosis and secondary Pasteurella spp infection were established. The rabbit was treated with 6 mg/kg of selamectin topically every two weeks and restricted in cage for one month. During one month of initial treatment, clinical signs such as pruritus, alopecia, scales, papules, pustules and crusts were remarkably improved. However, in spite of good therapeutic response of selamectin the rabbit was dead suddenly at 22 days after second administration of selamectin. This case showed that selamectin was possibly effective for cheyletiellosis in rabbit; safety of selamectin for rabbit was not identified.

Effect of Chungsangboha-tang on LPS induced Anti-inflammatory in THP-1 cells (LPS로 유발된 대식세포의 염증반응에 대한 청상보하탕(淸上補下湯)의 효과)

  • Lee, Kyung-Hee;Kim, Hong-yeoul;Jung, Hee-Jae;Lee, Hyung-Koo
    • The Journal of Internal Korean Medicine
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    • v.29 no.1
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    • pp.12-24
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    • 2008
  • Background and Objective : Chungsangboha-tang (CSBHT) has analgesic, sedative, anti-convulsive and anti-histamine effects, so it alleviates the symptoms of asthma. For the comparison of anti-inflammatory effect(s) on CSBHT, PD098059 was used as a negative control. Materials and Methods : This study emphasized THP-1 cells, which had been well characterized as a human monocytic leukemic cell line. The cells resemble monocytes with respect to several criteria and can be differentiated into macrophage-like cells by treatment with PMA. By using the MTS assay, it was possible to prove the safety of CSBHT. Results : Results shows that the CSBHT did not affected cell survival within $10^{1}$ ng/ml to $10^{5}$ ng/ml. Especially, $10^{5}$ ng/ml CSBHT treated cells show 70% deduction of $TNF-{\alpha}$ gene expression against that of LPS treated group. Furthermore, $IL-1{\beta}$, IL-6, IL-8, IL-10 and $TNF-{\alpha}$ levels are down-regulated when treated with CSBHT with concentrations up to 100 ug/ml on monocyte-derived macrophages. Interestingly, CSBHT-treated samples showed that overall transcriptional activities were down-regulated to 20% of that of PD098059 ($TNF-{\alpha}$ inhibitor). At protein level, the expression of $TNF-{\alpha}$ showed similar results as that of transcriptional activity. Results show that the protein level decreased more in the CSBHT-treated group (487 ${\pm}$ 87 pg/ml) than in the LPS-treated group (703 ${\pm}$ 103 pg/ml). In addition, the protein level of IL-8 in the CSBHT treated-group (9.84 ${\pm}$ 3.28 ng/ml) decreased similar as the expression of the control and PD098059-treated groups. Conclusion : CSBHT affects immune response, especially allergic responses and suppression of inflammatory reaction. The results provide us an alternative way to care for clinical inflammatory diseases, not only asthma but also the other possible general inflammatory and allergic diseases.

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Four-week Repeated Oral Toxicity Study of the Extract of Aralia elata in Rats (랫드에서 두릅 추출물의 4주 반복투여 독성시험)

  • Jin, Ju-Youn;Yang, Hee-Kyoung;Kim, Ji-Min;Ko, Mun-Su;Hong, Hyun-Ju;Jin, Young-Gun;Kim, Dong-Gun;Kim, Sang-Chul;Lee, Il;Hyon, Min-Kyong;Kang, Sang-Chul;Kim, Jae-Hoon;Lee, Young-Jae
    • Toxicological Research
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    • v.22 no.4
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    • pp.445-452
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    • 2006
  • Aralia elata, a common medicinal and culinary herb, has beer consumed for centuries without any reported adverse effects. However, due to its limited safety information, we decided to investigate the repeated-dose toxicity of ethanolic extract of Aralia elata. The test was administered once daily by the gavage to male and female rats at doses of 0, 250, 500 and 1,000 mg/kg/day for four weeks. Throughout the study, no treatment-related deaths or clinical signs were observed. Also, no apparent changes were detected in ophthalmoscopy, urinalysis, serum biochemistry, hematology and gross necropsy. The test result showed a significant decrease in body and heart weight of males treated with 250 mg/kg of extract of Aralia elata compared to normal control, a significant increase in relative brain weight and adrenal weight in females treated with 250 mg/kg of extract compared to normal control. However, all these changes were not considered toxicologically important due to irrelevant dose-response relationship to gross and microscopic findings. Histopathologically, abnormal changes were not observed in any target organs. On the basis of these results, the NOAEL of extract of Aralia elata was estimated to be more than 1,000 mg/kg/day under the tested conditions.

10% Pentastarch Versus 5% Albumin Solution for Volume Expansion Following Cariopulmonary Bypass in Patients Undergoing Open Heart Surgery (개심수술후 혈량 증가를 위한 10% Pentastarch와 5% Albumin 용액의 비교연구)

  • 장병철
    • Journal of Chest Surgery
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    • v.27 no.3
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    • pp.177-186
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    • 1994
  • Pentastarch is a hydroxyethyl starch similar to hetastarch, but lower average molecular weight and fewer hydroxyethyl groups which result in enhanced enzymatic hydrolysis and faster renal elimination.This report was performed to compare the clinical efficacy and safety of 10 % pentastarch[Pentaspan , group I] for plasma volume expansion after open heart surgery with that of 5% albumin[Plasmanate, group II]. There were no statistically significant differences between the group I [n=18] and group II [n:19] in the preoperative parameters [age, sex, body weight] and operative parameters[bypass time, aorta cross clamping time]. During the first 24 hours after arrival of the patient in the surgical intensive care unit, colloid solution [500--1000 ml] was infused to maintain left atrial pressure of more than 8 mmHg, or cardiac index of 2.0 L/min/M2 of more. In results, there were 3 complications of hypotension immediately after infusion of 5 % albumin solution and 2 among the 3 patients were excluded for the study. However there was no complication after infusion of 10 % pentastarch solution. Hemodynamic responses to infusion was similar for both groups, although in group I a greater increase in both left atrial pressure[mean 1.8 versus 0.7 mmHg, p< 0.05] and right atrial pressure [mean 2.2 versus 1.7 mmHg, p < 0.05] was observed during infusion of the first 500 ml. There were no significant differences in any of the measured respiratory parameters[PaO2, intrapulmonary shunt, and effective lung compliance]. Homodilution with colloid significantly reduced hemoglobin [mean 1.2 versus 0.8 gm/dl], and serum protein and albumin level[total protein;4.8$\pm$ 0.5 versus 5.2 $\pm$0.5 gm/dl, p < 0.05: albumin: 3.2 $\pm$0.4 versus 3.6 $\pm$0.6 gm/dl, p < 0.05] by 6:00 AM on 1 day postoperatively, however there were no significant differences on 7 day postoperatively. The mean serum colloid osmotic pressure and osmolarity was similar in both group.There were no abnormal findings of liver function and kidney function in all the patients. There were no significant between-group differences in bleeding time, platelets, prothrombin time, activated partial thromboplastin time and amount of chest tube output measured on 1st and 7th postoperative day. These findings demonstrated that 10% pentastarch is more effective and safe for plasma volume expension than 5 % albumin solution with no adverse effects on coagulation. Also 10 % pentastarch is less expensive than 5 % albumin and it would appeare to be a reasonable first choice for plasma volume expansion.

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The Effect of Mineral-induced Alkaline Reduced Water on the DSS-induced Acute Inflammatory Bowel Disease Mouse Model (알칼리환원수 음용이 급성 염증성장질환 생쥐 모델에 미치는 영향)

  • Jin, Dan;Kim, Dong-Heui;Teng, Yung-Chien;Xufeng, Qi;Lee, Kyu-Jae
    • Applied Microscopy
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    • v.38 no.2
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    • pp.81-87
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    • 2008
  • Alkaline reduced water (ARW) has been used for drinking widely in several countries of Asia. The safety and clinical effects of ARW has been reported including anti-oxidative effect and intestinal abnormal fermentation. To confirm the effect of ARW on DSS-induced acute inflammatory bowel disease (IBD) mouse model, we observed the length of total large intestine and the histopathological changes after supplying mineral induced-ARW (MARW) for 2 weeks and oral administration of 4% DSS (dextran sulfate sodium). As the result, the length of total large intestine and the disease scores by macro and microscopical access in the ARWsupplied group showed no significant differences compared with those in the control group. This result suggests that the supply of ARW for 2 weeks exerted no effect on amelioration in the DSS-induced acute IBD model. However, in consideration of the effect of ARW on the improvement of intestinal environment and gastrointestinal disease, this result seems that acute IBD animal model is not suitable or the period of ARW supply is not enough to prove the effect of ARW. The ameliorative effect of ARW on the intestinal abnormal fermentation has been confirmed by some researchers, but the precise mechanism also remain unclear. In conclusion, although MARW had no effect on the DSS-induced acute experimental colitis model, further studies on the verification of the effects of ARW by using other intestinal disease model and by long-term supply of ARW will be required. Also, It needs to clear the mechanism of ARW on the intestinal environment.