• Title/Summary/Keyword: Clinical safety

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Effects of low-dose topiramate on language function in children with migraine

  • Han, Seung-A;Yang, Eu Jeen;Kong, Younghwa;Joo, Chan-Uhng;Kim, Sun Jun
    • Clinical and Experimental Pediatrics
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    • v.60 no.7
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    • pp.227-231
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    • 2017
  • Purpose: This study aimed to verify the safety of low-dose topiramate on language development in pediatric patients with migraine. Methods: Thirty newly diagnosed pediatric patients with migraine who needed topiramate were enrolled and assessed twice with standard language tests, including the Test of Language Problem Solving Abilities (TOPs), Receptive and Expressive Vocabulary Test, Urimal Test of Articulation and Phonology, and computerized speech laboratory analysis. Data were collected before treatment, and topiramate as monotherapy was sustained for at least 3 months. The mean follow-up period was $4.3{\pm}2.7months$. The mean topiramate dosage was 0.9 mg/kg/day. Results: The patient's mean age was $144.1{\pm}42.3months$ (male-to-female ratio, 9:21). The values of all the language parameters of the TOPs were not changed significantly after the topiramate treatment as follows: Determine cause, from $15.0{\pm}4.4$ to $15.4{\pm}4.8$ (P>0.05); making inference, from $17.6{\pm}5.6$ to $17.5{\pm}6.6$ (P>0.05); predicting, from $11.5{\pm}4.5$ to $12.3{\pm}4.0$ (P>0.05); and total TOPs score, from $44.1{\pm}13.4$ to $45.3{\pm}13.6$ (P>0.05). The total mean length of utterance in words during the test decreased from $44.1{\pm}13.4$ to $45.3{\pm}13.6$ (P<0.05). The Receptive and Expressive Vocabulary Test results decreased from $97.7{\pm}22.1$ to $96.3{\pm}19.9months$, and from $81.8{\pm}23.4$ to $82.3{\pm}25.4months$, respectively (P>0.05). In the articulation and phonology validation in both groups, speech pitch and energy were not significant, and all the vowel test results showed no other significant values. Conclusion: No significant difference was found in the language-speaking ability between the patients; however, the number of vocabularies used decreased. Therefore, topiramate should be used cautiously for children with migraine.

The Effect of Traditional Korean Medical Treatment on Low Back Pain during Pregnancy: a Report on Three Cases (한방 복합치료를 시행한 임신 중 요통 환자 치험 3례)

  • Lee, Su Yeon;Ryu, Soo Hyeong;Kim, Hong Guk;Ryoo, Dek Woo;Kim, Sung Jin;Jeong, Seong Mok;Goo, Bon Hyuk;Kim, Min Jeong;Park, Yeon Cheol;Baek, Yong Hyeon;Nam, Sang Soo;Seo, Byung Kwan
    • Journal of Acupuncture Research
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    • v.33 no.3
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    • pp.197-205
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    • 2016
  • Objectives : To report the clinical application and safety of Traditional Korean Medical treatment for patients with low back pain during pregnancy. Methods : Three patients who suffered from low back pain during pregnancy were treated with acupuncture, pharmacopuncture, moxibustion, and herbal medicine for 12 to 21 days. Numeric rating scale (NRS) of low back pain and Oswestry Disability Index (ODI) were checked to measure the outcome. A liver function and renal function test was carried out to identify any drug-induced liver or renal injury, and any adverse events were monitored thoroughly until delivery. Results : Low back pain reduced on NRS in all cases, and no serious adverse effects were found in the patients or infants. Conclusion : This study suggests that Traditional Korean Medical treatment is a candidate therapy for relieving low back pain during pregnancy, and also is safe for both patients and infants.

Inhibition of advanced glycation end product formation by burdock root extract (우엉 뿌리 추출물의 최종당화산물 형성 억제 효능)

  • Lee, Darye;Kim, Choon Young
    • Journal of Nutrition and Health
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    • v.49 no.4
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    • pp.233-240
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    • 2016
  • Purpose: Diabetic complications are a major concern to manage progression of diabetes. Production of advanced glycation end products (AGEs) due to high blood glucose is one of the mechanisms leading to diabetic complications. Multiple pharmacologic AGE inhibitory agents are currently under development, but clinical applications are still limited due to safety issues. Thus, it is necessary to identify a safe anti-glycation agent. It is known that burdock roots have antioxidant, anti-inflammatory, and anti-cancer activities. The objective of the present study was to investigate the inhibitory role of burdock roots on the formation of high glucose-induced glycation of bovine serum albumin (BSA). Methods: In this study, glycation of BSA by glucose, galactose, or fructose at $37^{\circ}C$ for 3 weeks was assessed based on levels of ${\alpha}$-dicarbonyl compounds (early-stage glycation products), fructosamine (intermediate products of glycation), and fluorescent AGEs (late-stage glycation products). In order to compare the inhibitory actions of burdock root extract in AGE formation, aminoguanidine (AG), a pharmacological AGE inhibitor, was used as a positive control. Results: BSA glycation by glucose, fructose, and galatose was dose- and time-dependently produced. Burdock root extract at a concentration of 4 mg/mL almost completely inhibited glucose-induced BSA glycation. The results demonstrate that burdock root extract inhibited AGE formation with an $IC_{50}$ value of 1.534 mg/mL, and inhibitory activity was found to be more effective than the standard anti-glycation agent aminoguanidine. This study identified a novel function of burdock root as a potential anti-glycation agent. Conclusion: Our findings suggest that burdock root could be beneficial for preventing diabetic complications.

A Study of Institutional Status of Risk Management for Radiotherapy in Foreign Country

  • Lee, Soon Sung;Shin, Dong Oh;Ji, Young Hoon;Kim, Dong Wook;An, Sohyoun;Park, Dong-Wook;Cho, Gyu Suk;Kim, Kum-Bae;Koo, Jihye;Oh, Yoon-Jin;Choi, Sang Hyoun
    • Progress in Medical Physics
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    • v.27 no.3
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    • pp.139-145
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    • 2016
  • With the development in field of industry and medicine, new machines and techniques are being launched. Moreover, the complexity of the techniques is associated to an increasing risk of incident. Especially, a small error in radiotherapy can lead to a serious patient-related incident, risk management is necessary in radiotherapy in order to reduce the risk of incident. However, in field of radiotherapy, there are no legally binding clauses for risk management and there is an absence of risk management systems at an institutional level. Therefore, we analyzed institutional status of risk management, reporting & classification systems, and risk assessment & analysis in 31 countries. For risk management and reporting systems, 65% of countries investigated had legislation or regulations; however, only 35% of countries used classification systems. It was found that 43% more countries had legislation for risk management in healthcare than those for radiotherapy; 19% more countries had reporting systems for healthcare than those for radiotherapy. For classification systems, 60% more countries had legislation, recommendation, and guidelines in the field of radiotherapy than those for healthcare. Recently, international institutes have published several reports for risk management and patient safety in radiotherapy, owing to which, countries adopting risk management for radiotherapy will gradually increase. Before adopting risk management in Korea, we should precisely understand the procedures and functions of risk management, in order to increase efficiency of risk management because classification & reporting system and risk assessment & analysis are connected organically, and institutional management is needed for high quality of risk management in Korea.

The anti-hypertensive effect of ginseng in patients with mild hypertension

  • Kim, Young-Suk;Jung, Woo-Sang;Park, Seong-Uk;Moon, Sang-Kwan;Park, Jung-Mi;Ko, Chang-Nam;Cho, Ki-Ho;Bae, Hyung-Sup
    • Advances in Traditional Medicine
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    • v.7 no.5
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    • pp.494-500
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    • 2008
  • Ginseng has been traditionally used to recover vital energy from Qi deficiency in oriental countries. Recent reports suggested that ginseng could regulate blood pressure (BP), but much controversy still remain. Therefore, we intended to assess the anti-hypertensive effect of some ginseng species on Koreans and Chinese. This is a randomized, double blinded controlled clinical trial. The study subjects were recruited from the mild hypertensive patients who belonged prehypertension(120/80 to 139/89 mmHg) and stage I hypertension (140/90 to 159/99 mmHg) in Korea and China. After assigning the subjects into a Korean, a Chinese, and an American ginseng group by randomization, we prescribed ginseng with the dose of 4.5 g per a day for 4 w. To assess the anti-hypertensive effect, we compared the mean of systolic and diastolic BP between before and after ginseng medication by 24 h Ambulatory Blood Pressure Monitor (24 h ABPM). We also monitored adverse effect and laboratory findings to secure the subjects' safety. There were 64 subjects treated with Korean ginseng, 58 treated with Chinese ginseng, and 64 treated with American ginseng. All of the ginseng species reduced subjects' BP. Especially, Korean and Chinese ginseng showed more excellent effects. The secondary analysis on the subjects' nationality revealed that all of the ginseng species showed more significant anti-hypertensive effect in Chinese than in Koreans. We suggest ginseng could be useful for mild hypertension regardless of its species. And it would be safe within the dosage of 4.5 g per a day.

Nurses' Knowledge and Performance for Prevention of Extravasation at Peripheral Intravenous Therapy (간호사 특성에 따른 일혈예방 지식과 간호수행)

  • Chung, Sun-A;Choi, Eun-Hee;Lee, Kyeong-Soo;Chung, Kwi-Ae
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.17 no.8
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    • pp.183-191
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    • 2016
  • This study was aimed to identify the level of knowledge and performance on nurses for the prevention of extravasation. Subjects of this study was 293 nurses working at three university hospitals, two general hospitals and one specialized hospital that frequently performed chemotherapy in D city. The highest score for the knowledge of nurses was extravasation drug related that it was $18.50{\pm}2.18$. The knowledge and performance were also higher for nurses with age greater than 50 years and married, with a clinical career of more than 10 years and high regard for extravasation. It is essential to develop other plans that promote the prevention of extravasation and to provide a continuous education for preventing extravasation. Therefore, it is necessary for medical institutes to operate patient safety management teams to develop standardized protocols and educating nurses and related persons.

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.