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A Study on Amendment of Approval Specifications for Traditional Korean Medicines (한약제제 허가기준 개선방안 연구(I))

  • Han Byong-Hyon;Hwang Gwi-Seo
    • Journal of Society of Preventive Korean Medicine
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    • v.5 no.1
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    • pp.57-75
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    • 2001
  • This study was conducted to improve the current regulation guidelines for developing traditional Korean medicines with effectiveness and productivity, in order to cope with the upcoming ICH on specifications on oriental herbal drugs. Also, major purposes of this study are to motivate R&D and to pioneer foreign markets for domestic herbal drug companies. First, after examining concepts of traditional Korean medicines and comparing the numbers and differentiation of herbal drugs registered on Pharmacopeia among Korea, China, and Japan, the current new drug development requirements for traditional Korean medicines were reviewed in detail, followed by comparison of foreign regulation systems including USA, EU, China, and Japan. Second, empirical cases on failure of development for new traditional Korean medicines under the current regulation system in the domestic companies including Dong-A, Kwangdong, and Samchondang, were collected and analyzed. As a result, hanbangsaengyak, the new category for traditional Korean medicines was newly developed on the basis of scientification of data between saengyak and hanyak, from the perspectives of harmonization between oriental medicine and western medicine and of balance between food and drug, in terms of industrialization, publicity, modernization, and effectiveness of administration. In addition, the new regulation requirements for the new hanbangsaengyak preparations were discussed by establishing principles of reinforcing preclinical test and of simplifying clinical trials in Korea. Finally, the further researches to articulate the complete specifications for pre-clinical and clinical requirements for traditional Korean medicines were strongly suggested.

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Case Report for Severe Hepatitis A Treated in a Korean Hospital

  • Kim, Sul-Ki;Jeon, Cheon-Hoo;Lee, Nam-Heon;Cho, Jung-Hyo;Son, Chang-Gue
    • The Journal of Korean Medicine
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    • v.41 no.4
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    • pp.100-105
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    • 2020
  • A 25-year-old male presented with influenza-like symptoms and took Western anti-inflammatory analgesic drugs for 2 days. The symptoms aggravated, so the patient decided to rely on Korean medicine (KM). Based on the highly elevated hepatic enzymes (AST 4,621 IU/L and ALT 2,763 IU/L) with a positive result of anti-HAV IgM, he was diagnosed with hepatitis A. The patient was hospitalized and given herbal drugs (Chunggan-plus extract, Innae-Tang) and acupuncture, according to symptom differentiation, the accumulation of damp heat (濕熱蘊結)". The subjective symptoms (fatigue, nausea, gastric discomfort) including jaundice and dark urine as well as laboratory abnormalities gradually improved gradually in 10 hospital days, and the patient completely recovered in 25 days as an out-patient. This case presents a classic case of severe hepatitis A in 2019 Korean outbreak, and is informative to physicians for diagnosis and treatment in the traditional Korean medicine field.

A Comparative Study of the Brainstem Auditory-Evoked Response during Medetomidine, Propofol and Propofol-Isoflurane Anesthesia in Dogs

  • Sorin Choi;Myeong-Yeon Lee;Young Joo Kim;Dong-In Jung
    • Journal of Veterinary Clinics
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    • v.40 no.4
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    • pp.260-267
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    • 2023
  • Specialized hearing tests for pets are currently in demand. A brainstem auditory evoked response (BAER) test is an objective, non-invasive, and practical electrophysiological method that records electric signals from the peripheral auditory system to the brainstem when an auditory stimulation is provided. In veterinary medicine, sedation or anesthesia is essential for a successful examination. In human medicine, research has established the indications for various sedatives, anesthetics, and drugs according to the depth of anesthesia required. However, in veterinary medicine, there are very few comparative studies on propofol or isoflurane, which are the most common anesthetics used. Therefore, the present study aimed to analyze the difference in BAER test results between sedation with medetomidine, anesthesia using propofol, and inhalation anesthesia with isoflurane after propofol administration. The test was conducted on four healthy adult dogs. There was no statistically significant difference in latency, interpeak latency, or amplitude between the various drugs. The results suggest that a sedative or anesthetic for the administration of a BAER test can be selected according to the patient's needs.

Evaluation of Therapeutic Differences of Angiotensin II Receptor Blockers and Calcium Channel Blockers Among Hypertensive Patients Classified by Oriental Traditional Way (한국적 의학 기준에 근거한 고혈압환자의 Angiotensin II Receptor Blockers와 Calcium Channel Blockers의 약물 평가)

  • Lee, Ok Sang;Cheon, Young Ju;Ye, Kyong Nam;Yoon, Hee Young;Kim, Jung Tae;Lee, Yun Jeong;Lim, Sung Cil
    • YAKHAK HOEJI
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    • v.58 no.2
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    • pp.141-149
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    • 2014
  • Background: Oriental lifestyle for treating diseases has been developed and well-accepted for a long time among Koreans. Sasang Constitution theory, originated from Korean traditional medicine, suggests that medication treatment should be differentiated by each patient's body classification (So-yang [SY], So-eum [SE], Tae-yang [TY], and Tae-eum [TE]), in contrary to western medicine's theory that medication should be applied equally by disease indication without such classification. However, the pharmacotherapeutic outcomes of these theories have not been compared to date. In this study, we aimed to compare the two theories by evaluating blood pressure (BP), which is lowered as a therapeutic outcome, among hypertensive patients taking angiotensin II receptor blockers (ARBs) or calcium channel blockers (CCBs), two most commonly used antihypertensive classes in Korea. Methods: From April 2006 to June 2012, we retrospectively collected data on hypertensive patients with Sasang Constitution classification at Kyunghee University Hospital at Gangdong, one of the East-West collaborative medical centers in Korea. We collected information on age, gender, underlying diseases, antihypertensive drugs (ARB, CCB, ARB+CCB), and BP by reviewing the electronic medical records. We excluded patients with missing blood pressure at baseline or follow-up, or those who had a change in their antihypertensive drug class during follow-up. Results: We selected a total of 573 patients (SY: 165, SE: 158, TY: 0, TE: 250). Baseline BPs were on average 139.0/82.0 mmHg for SY, 137.8/78.5 mmHg for SE, and 138.7/79.2 mmHg for TE. In all three groups, CCBs were the most prescribed, followed by combination therapy with ARB+CCB, then ARBs. BP reduction after 1 month of initial medication was significantly different among the drug classes, but not in Sasang constitutional classification (ARB [SY: -12.4/-4.7, SE: -12.3/-2.5, TE: -8.6/-1.8], CCB [SY: -12.3/-5.4, SE: -13.0/-2.3, TE: -10.8/-6.0], ARB+CCB [SY: -15.6/-6.7, SE: -18.4/-8.1, TE: -20.2/-6.7], drug [$P{\leq}0.05$/P>0.05], constitutional type [P>0.05/P>0.05]). Conclusion: We observed significant differences in reduction of blood pressure by classes of drugs (ARB+CCB>CCB>ARB) but not by Sasang constitutional classification. Therefore, current approach of antihypertensive pharmacotherapy assisted by Western medicine is appropriate for treatment of hypertension. However, further larger scale or prospective studies are required in order to confirm these results.

The Difference of Efficacy for Oral Hypoglysemic Pharmacotherapy Based on Sasang Constitutional Medicine Among Type II Diabetes Mellitus Patients in Korea (제 2형 당뇨병 환자에서 사상체질에 따른 경구 혈당강하요법의 치료 반응성 및 사용 패턴 평가)

  • Kim, Ji Yeon;Lee, Myung Koo;Kim, Jung Tae;Lim, Sung Cil
    • YAKHAK HOEJI
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    • v.58 no.1
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    • pp.71-79
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    • 2014
  • Although Korean patients with type 2 diabetes mellitus (T2DM) are generally treated by western medicine, many of them strongly believe in the traditional oriental Sasang constitutional classification and depend on it for food, health supplements, and oriental medicines decision making. Sasang constitutional classification is a part of traditional Korean medicine that divides people into four constitutional types (Tae-Yang: TY, Tae-Eum: TE, So-Yang: SY, and So-Eum: SE), which differ in inherited characteristics such as appearance, personality traits, susceptibility to diseases, and drug responses. It is recommended for T2DM patients to control their blood glucose very well from early stages with drugs and diet. However, many T2DM patients respond differently to their drugs, even though they receive the same medicine. Therefore, the present study investigated whether Sasang constitutional type can explain the therapeutic differences between oral hypoglycemic agents (OHAs) therapy (mono, dual and triple drug therapy). Patients of 618 with T2DM diagnosis and Sasang constitutional type known who received both western and oriental medicine treatment in a hospital between April 2006 and April 2013 retrospectively studied. HbA1c (%) and blood glucose (mg/dl) levels before OHAs therapy and 3 month after were collected for metformin (MET) or sulfonylurea (SU) monotherapy, MET+SU dual therapy, MET+except SU (where was either alpha-glucosidase inhibitor, dipeptidyl peptidase-4 inhibitor, meglitinide or thiazolidinedione) dual therapy, and triple therapy, according to Sasang constitutional type. For statistical analysis, ANOVA was used and paired t-test by SPSS 19.0 where P values less than 0.05 were considered statistically significant. Pattern was similar levels of HbA1c and blood glucose and which was decreased in order of mono, MET+SU dual, MET+except SU dual and triple therapy. In all patients comparison, for the So-yang (SY) constitutional type, either monotherapy was less effective; for Te-eum (TE) type, MET+SU dual therapy was less effective while MET+except SU dual therapy was more effective and the triple therapy was less effective; and for So-eum (SE) type, the triple therapy was more effective. For the management of TE type it is recommended to use drugs except SU when dual therapy is needed, restrict triple therapy and consider dual and insulin therapy; for SY type it is recommended to follow current guidelines; and for SE type it is advisable to skip dual therapy and start the triple therapy early. Finally, the therapeutic response to OHAs is different among Korean T2DM patients with different Sasang constitutional types. Taken together, the choice of effective OHAs therapy for each type is necessary in order to minimize the poor control of blood glucose level, the risk of complications, and the costs from a failure of therapy.

Enhancement of Arsenic Trioxide ($As_2O_3$)-Mediated Apoptosis Using Berberine in Human Neuroblastoma SH-SY5Y Cells

  • Kim, Dae-Won;Ahan, Song-Ho;Kim, Tae-Young
    • Journal of Korean Neurosurgical Society
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    • v.42 no.5
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    • pp.392-399
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    • 2007
  • Objective : Arsenic trioxide ($As_2O_3$) has been used as an anticancer agent in traditional Chinese medicine for thousand years and berberine is an isoquinoline alkaloid present that has indicated significant antimicrobial activity. We have examined the combined anticancer effects of $As_2O_3$ and berberine against the human neuroblastoma (HNB) SH-SY5Y cells in vitro, and to elucidate underlying molecular mechanism. Methods : HNB SH-SY5Y cells were treated with $2\;{\mu}M\;As_2O_3$ and $75\;{\mu}g/ml$ berberine, and their survival, cell death mechanism as well as synergistic cytotoxic effects were estimated by using MTT assay, DAPI staining, agarose gel electrophoresis, flow cytometric analysis, and western blot analysis. Results : The combined treatment of two drugs also markedly decreased cell viability. The cytotoxic effects of two drugs were revealed as apoptosis characterized by chromatin condensation, DNA fragmentation, and the loss of mitochondrial membrane potential. The apoptotic cytotoxicity was accompanied by activation of caspase-3 protease as well as decreased the expression of Bcl-2, Bid, and Bcl-x/L. In addition, the cells treated with combination of two drugs also showed significantly increased intracellular reactive oxygen species levels and lipid peroxidation compared to cells $As_2O_3$or berberine only. Conclusion : Combined treatment of $As_2O_3$ with berberine induced activation of apoptotic signaling pathways in HNB SH-SY5Y cells. These results suggest that the possibility of the combined treatment of two chemotherapeutic agents with low concentration improving cytotoxic effect for cancer cells with minimal side effects.

Study of Toxicity Presence Classification about Herbal Diet in Tang-aec-pyeon of Dong-ui-bo-gam (동의보감 탕액편에 기재된 식이본초의 독성유무에 대한 분류 연구)

  • Shin, Ho-Dong;Jeong, Jong-Un
    • The Journal of Korean Medicine
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    • v.32 no.1
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    • pp.12-35
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    • 2011
  • Objectives: The two criteria to clarify the toxicity of a herbal diet are well known. Although mechanical analysis of effective ingredients, a western approach, is widely used, the toxicity presence classification through the herbal analysis from a viewpoint of a theory of the herbal medicine properties has been disregarded. This study is for the safe use of a herbal diet through classification and study of toxicity presence in the herbal diet from the view of a theory of herbal medicine properties, one of the methods of Oriental Medicine. Methods: We classified and studied the toxicity presence in four kinds of herbal diets, waters and grains, animals groups, fruits and vegetables, and herbs and trees, excluding mineral natural drugs, of 1,400 kinds of medicines in 16 chapters of Tang-aec-pyeon, Dong-ui-bo-gam, for which the herbal analysis from a viewpoint of the theory of the herbal medicine properties has been used. The criteria of the toxicity presence in the herbal diet have been largely classified into the toxicant and the non-toxicant, and the toxicant is in turn classified into the insignificant, the medium and the significant. The category to clarify herbal diet has been limited to simultaneous utilization of food and natural drugs. The main text is Dong-ui-bo-gam, although diverse other references have also been used. Results: There are toxicant diets: a kind of tortoise meat of animals groups; five kinds of grains part in fruits and vegetables: aengdo, peach, oyat, small apple and gingko nut; and 12 kinds of vegetables part in fruits and vegetables: ginger, oriental cabbage, lettuce, chongbaek, onion, garlic, leek, fern, houttuynia cordata (myeol), pyeongji, geundae, and spinach, which should be prohibited from long-term use both as food and medicine. Conclusion: If herbal diet is used as health food supplements or food, the toxicity presence should be considered on the grounds of an Oriental Medicine theory of the herbal medicine properties.

Study on the Treatment of Benign Prostatic Hyperplasia(BPH) in Oriental Medicine (전립선비대증 치료의 한의학적 접근방법에 관한 연구)

  • Kim, Joong-Kil;Song, Bong-Keun;Lee, Eun-Jeong;Kim, Hyeong-Kyun
    • The Journal of Korean Medicine
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    • v.19 no.2
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    • pp.211-227
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    • 1998
  • Benign Prostatic Hyperplasia(BPH) is the most common benign tumor seen in the western male, and it is found in 50% of men over 50 years of age. It is characterized by the formation of large discrete lesions in the periurethral region. As they enlarge, these nodules tend to compress the urethra and cause partial or almost complete obstruction of .urine flow. The etiology of BPH is uncertain, but the increasing incidence with advancing age suggests the possibility of an imbalance between male and female sex hormones. In the past, most patients have had multiple indications to support the decision to initiate therapy. But both the urologic surgeon and the patient must be clearly aware of the results that can be expected and the risks involved in achieving them. The aims of this study are to investigate and summarize the current trends of treatment for BPH so as to suggest the effective and available way to treat the disease. In Oriental medicine, the BPH is recognized as uroschesis and ischuria, and the etiology is mainly in stagnated blood and insufficiency of the kidneys. The point of treatment of BPH is recovery of urination, and the treatment can be approached in two ways through herb drugs and acupuncture. Some of the herb drugs have substances which reduce BPB. Acupuncture therapy stimulates the pelvic plexus and is reported to be effective for voiding. Suppository, massotherapy, rectal injection, locus injection and attachment of herb drugs to the navel or the acupoint are announced as the effective treatments. So, this study of the approach and application of these treatments on BPH would be necessary.

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Systematic Review of the Cause of Drug-Induced Liver Injuries in Korean Literature (약인성 간손상의 원인물질에 관한 국내연구의 체계적 고찰)

  • Yun, Young-Ju;Shin, Byung-Cheul;Lee, Myeong-Soo;Cho, Sung-Il;Park, Jae-Hyeon;Lee, Hye-Jung
    • The Journal of Korean Medicine
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    • v.30 no.2
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    • pp.30-45
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    • 2009
  • Background: The safety of herbal products is an important issue in Korea. It is more complicated because of the concomitant use of conventional western drugs and herbal medicine, including prescribed medicine, folk herbs and food supplements. Although both western and traditional Korean medical doctors have studied on the safety of HMP, their results did not show relevant or consistent conclusions because of the poor quality of studies, including bias. Objectives: The aim of this study was to review the studies in Korea related to drug induced liver injury (DILI) systematically. We tried to estimate the proportion of causative materials of DILI and evaluate the clinical difference of DILIs from different materials. Methods: Systematic searches were performed on MedRIC and MEDLIS in Korea. The extraction of data as well as selective screening of the studies was carried out independently by two of the authors. There were no restrictions on the types of publication, including grey literature. Results: Twenty-one articles were included. Of them only 7 adapted prospective design and only 6 were published in peer-reviewed journals. The proportion of conventional drugs associated with hepatotoxic injuries in all DILI ranged from 15.8% to 83.3% and that of herbal medicine was from 28.9% to 44.7%. However, the criteria for herbal medicine were not clearly defined and concomitant medications were not fully investigated in most studies. There were limited objective data in the clinical differences of liver injuries from different materials and their results were conflicting. Conclusions: The causality assessments regarding DILI of herbal medicine were not performed properly and causative materials were misclassified in most of the studies published in Korea. These make the safety issue still ambiguous because of the limitations and lack of objectivity of the studies. More rigorous studies are required for clearly addressing these conflicting issues with cooperative investigation between traditional Korean and western medicine.

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A Case Study on Drug Prescription for Vascular Dementia in Western and Oriental Medicine (혈관성치매에 대한 한.양방 치료약물의 처방 사례연구)

  • Choi, Seong-Hun;Cheon, Woo-Hyun;Baek, Kyung-Min;Han, Chang-Hyun;Jeon, Won-Kyung;Gam, Cheol-Ou;Lee, Young-Joon
    • Journal of Society of Preventive Korean Medicine
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    • v.15 no.3
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    • pp.39-49
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    • 2011
  • Objectives : Vascular dementia is the second common cause of dementia after Alzheimer's disease. It assumed that the ratio of prescription drugs on vascular dementia are quite different from each hospital in Western medicine or Oriental medicine, respectively. The aim of this research is to collect and analyze the ratio of prescription drugs on vascular dementia in Western medicine or Oriental medicine in university hospitals. Methods : We collected and analyzed the data related to prescriptions on vascular dementia in the department of neurology in three university hospitals(A, B, C) and in the department of internal medicine in two Oriental medicine hospitals(Daegu Haany Oriental Hospital, Dong Eui Oriental Hospital). Results : In the department of neurology in A university hospital, donepezil(69.1%), memantine(14.0%), rivastigmine(12.3%), galantamine(4.5%) were prescribed in order. In B university hospital, galantamine(57.8%) donepezil(33.3%), rivastigmine(6.7%), donepezil with memantine(4.4%) were prescribed. In C university hospital, donepezil(62.0%), rivastigmine(25.0%), galantamine(7.0%) memantine(6.0%) were prescribed. The average frequencies of prescribed medication in the department of neurology in A, B, C university hospitals were donepezil(54.8%), galantamine(23.1%), rivastigmine(14.7%), memantine(7.4%). In Oriental medicine hospitals, various prescriptions have been used for vascular dementia. Among them, Ansincheongnoetang (安神淸腦湯) and Gamijihangeumja(加味地黃飮子) were often prescribed in Daegu Haany Oriental Hospital, and Bojungikgitang(補中益氣湯) in Dong Eui Oriental Hospital, too. Conclusions : Cholinesterase inhibitors such as donepezil, galantamine, rivastigmine and NMDA receptor inhibitor like memantine have been used as a drug of choice for vascular dementia in all surveyed university hospitals. In oriental hospitals, various prescriptions have been used for vascular dementia.