• 제목/요약/키워드: Adverse drug reaction

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어린이의 일차성 단일 증상성 야뇨증에서 Imipramine과 Desmopressin 복합 약물치료의 효과 및 안전성 (Efficacy and Safety during the Combination Therapy of Imipramine and Desmopressin in Primary Monosymptomatic Nocturnal Enuresis)

  • 여지현;최정연;정효석;이경수;고철우;김교순;김기혁;김정수;남궁미경;박영서;배기수;유기환;박용훈
    • Childhood Kidney Diseases
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    • 제8권2호
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    • pp.129-137
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    • 2004
  • 목적: 일차성 야뇨증에 여러 가지 치료법이 시도되고 있는데 이 중 일반적으로 사용되는 imipramine와 desmopressin 등의 약물요법은 치료효과가 빠르고 비교적 양호하기 때문에 선호하는 치료 방법이다. 그러나 효과가 매우 다양하고 때로는 약물에 의한 부작용으로 인해 사용이 어렵게 되는 경우도 있다. 본 연구에서는 이들 약물을 단독으로 투여한 경우에 비하여 복합투여 할 경우에 치료 효과와 안정성을 비교 평가하여 보다 나은 야뇨증 치료 방법을 제시하고자 하였다. 방법: 2002년 4월부터 2002년 12월까지 내원한 5-l5세 사이의 환자로서 1) 일차성 단일성 야뇨증, 2) 주 2회 이상의 야뇨증, 3) 5세 이상의 연령, 4) 비뇨기과적 이상이 없고, 5) 정신적 또는 신경학적인 증상이 없으며, 6) 내분비 질환이 없고, 7) 최근 2개월 동안 야뇨증 약물치료를 받지 않은 환아로서, 8) 부모의 동의를 받은 경우를 대상으로 하였으며 조건을 만족하는 환자들을 무작위로 선택하여 imipramine 단독투여군, desmopressin 단독투여군과 imipramine과 desmopressin 복합투여군의 3군으로 나누어 야뇨횟수, 부작용과 약물 중단 후 1개월 후 야뇨증 빈도를 확인하였다. 결과: 대상 환아들은 남, 녀 각각 78명과 90명이며, 5-10세가 119명이었고 11-16세는 49명이었다. 치료 시작 4주 이후에서부터 모든 군에서 유의하게 야뇨 횟수가 감소하였다. 치료 종료 시의 imipramine 단독투여군, desmopressin 단독투여군과 imipramine과 desmopressin 복합투여군의 치료율은 각각 68.6%, 74.4%와 86.1%로서 imipramine와 desmopressin 복합투여군의 치료율이 가장 높았으나 통계학적인 차이는 없었다. 치료 종료 후 4주의 야뇨 빈도는 imipramine 단독투여군은 주당 1.9회, desmopressin 단독투여군은 1.3회이고 imipramine와 desmopressin 복합투여군은 1.0회로 세군 사이에는 유의한 차이가 없었다. 약물에 의한 부작용은 imipramine 단독투여군은 20명, desmopressin 단독투여군은 12명, imipramine와 desmopressin 복합투여군13명에서 총 45례에서 나타났는데 이중 imipramine 투여로 인한 식욕 감퇴가 가장 많았다. 결론: 일차성 단일 증상성 야뇨증 치료를 위한 imipramine 단독용법, desmopressin 단독요법, imipramine과 desmopressin 복합요법의 치료효과와 단기간 동안 관찰한 재발 빈도에서는 의미있는 차이는 없어서, 두 약제의 복합요법이 desmopressin 단독 요법에 비해 치료효과, 재발정도와 부작용 빈도에서 차이가 없어 치료 효율성의 우월성을 발견하지 못하였다. 다만 약물 부작용 발생은 imipramine 단독요법이 다른 치료 방법에 비해 발생 빈도가 유의하게 높은 것으로 나타나서 imipramine 단독요법을 할 때에는 부작용 발생유무를 유의해서 관찰하여야 할 것으로 생각된다.

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독성 한약재의 법적 규제에 관한 연구 (Study on The Regulation on Poisonous Medicinal Herbs)

  • 권기태
    • 의료법학
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    • 제11권1호
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    • pp.271-296
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    • 2010
  • Objective: Poisonous Medicinal herbs can be considered as a risk factor to public health unless they are prescribed by Doctor of traditional Korean medicine. The proper method to manage them should be prepared to prevent risk factors caused by misuse and abuse of the poisonous medicinal herbs and enhance public health. Methods: In this dissertation (paper), the definition, scope, management status, data about pharmacology and toxicity and media release regarding adverse reaction were understood after organizing documents, laws and regulations concerning poisonous medicinal herbs. Also, management methods are suggested by analyzing related examples and regulations in China, Japan and Hong Kong, where the use of herbal medicine is general. Results: Methods for items for poisonous medicinal herbs, safety information management, management based on standardization of traditional processing methodology and reorganization and revision of related laws and regulations are established. Conclusion: Proper laws and regulations are not yet established to manage poisonous medicinal herbs in Korea. In this regard, it is urgent to establish laws and regulations which can apply independently. The purpose of the laws and regulations should be to enhance management of poisonous medicinal herbs and prevent incidence of addiction and death, improving the public health.

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SIRAS (ALBIZIA LEBBECK (L.) BENTH.) AND ITS MEDICINAL USES IN UNANI MEDICINE- A REVIEW

  • Waseem, Azma;Jamal, Anwar;Ahmad, Waseem;Fazil, Mohammad
    • 셀메드
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    • 제10권2호
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    • pp.12.1-12.5
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    • 2020
  • Higher incidences of adverse reaction associated with the prolonged use of synthetic drugs has once again increased the faith of humans in the traditional systems of medicine and motivated them to return back towards the clinical proven remedies for the treatment. It is also true that number of modern medications used in the present scenario, were developed from various plants. In Unani System of medicine, numerous herbal drugs are mentioned for medicinal purpose. Siras (Albizia lebbeck (L.) Benth.) is one of them. It is found all over India. Almost all parts of this plant are used for the treatment of ailments such as migraine, conjunctivitis, diarrhea, jaundice, skin problems, asthma etc. Many chemical constituents have been isolated from Albizia lebbeck such as lebbekannin, echinocystic acid, flavonoids, Linoleic acid, saponins etc. This review highlights the medicinal properties and therapeutic uses of Albizia lebbeck and scientific studies conducted on the drug in human and animal models that will provide the further research direction.

Dapson 증후군 1례 (A case of dapsone syndrome)

  • 원유종;김옥란;유승택;윤영욱;최두영
    • Clinical and Experimental Pediatrics
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    • 제50권5호
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    • pp.493-496
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    • 2007
  • Dapsone은 나병과 여러 수포성 피부 질환의 치료에 널리 사용되고 있다. 일반적인 투여 용량의 dapsone은 부작용이 드물지만, 피부, 신경계, 위장관, 간, 신장과 혈액학적 합병증을 일으킬 수 있다. 이들 부작용 중 하나인 dapsone 증후군은 약물 투여 수주 후에 발생하여, 예측 불가능하게 진행하며 치명적인 경과를 취할 수 있는 중증 약물 과민 반응이다. 저자들은 dapsone 투여 4주 후에 열, 박탈성 피부염, 황달, 용혈성 빈혈, 늑막 삼출 등의 특징적인 임상 소견을 보인 dapsone 증후군 1례를 경험하였기에 보고하는 바이다.

대동맥 박리증 수술 후 발생한 혈전증을 동반한 헤파린 기인성 혈소판 감소증의 치료 (The Management of Heparin-induced Thrombocytopenia with Thrombosis That Developed after Aortic Dissection Surgery)

  • 김재범;박남희;최세영
    • Journal of Chest Surgery
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    • 제43권5호
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    • pp.538-541
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    • 2010
  • 헤파린 기인성 혈소판 감소증은 헤파린과 혈소판 제4인자 사이의 복합체에 대항하여 만들어진 면역글로불린-G 항체에 의해 발생한 약물 부작용이라고 할 수 있다. 혈전증을 동반한 헤파린 기인성 혈소판 감소증은 사지 절단이나 뇌졸증, 심근경색과 같은 병을 일으켜 사망에 이르게 할 수 있다. 저자들은 혈전증을 동반한 혈소판 감소증을 agatroban을 사용하여 성공적으로 치료하여 보고하는 바이다.

The Introduction of Adverse Drug Reaction (ADR) Monitoring System

  • Jung, Sun-Hoi;Park, Kyoung-Ho;Soh, Ok-Kyoung;Lee, Byung-Gu;Park, Kaung-Jun;Bae, Guen-Shub;Jang, In-Jin;Kim, Youn-Gun;Kim, Ju-Sung;Chae, In-Ho;Kim, Yeun-Su;Ha, Jong-Won;Song, Yong-Sung;Choung, Jon-Ho;Kyun, Jin-Soo;Kim, Sang-Yeun;Go, Zae-Sung;Park, Jun-Dong;Song, Kyeng-Ja;Park, Byung-Joo
    • 대한약학회:학술대회논문집
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    • 대한약학회 2001년도 Proceedings of International Convention of the Pharmaceutical Society of Korea
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    • pp.323-323
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    • 2001
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Antiviral Potential of the Silkworm Deoxynojirimycin against Hepatitis B Virus

  • You, Jung-Eun;Seong, Su-Il;Kim, Young-Ho
    • International Journal of Industrial Entomology and Biomaterials
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    • 제7권2호
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    • pp.139-144
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    • 2003
  • Over 350 million people worldwide are chronic carriers of hepatitis B virus (HBV). Chronic viral infections of the liver can progress to cirrhosis, which may ultimately lead to hepatic failure or the development of hepatocellular carcinoma. There are two antiviral drugs on the market approved for clinical management of chronic HBV infections; interferon-alpha and the nucleoside analog lamivudine. However, they showed adverse side-effects. In the rational drug design for such therapies we would like to utilize antiviral drugs that inhibit the HBV replication in the liver. Investigation of natural extracts of silkworm exhibiting antiviral potential was held in the functional HBV polymerase activity and the release of virion particle in the HepG2.2.15 cell lines. HBV-producing transgenic mouse fed with silkworm DNJ molecule was shown as an inhibitor of serum HBV particles. We could represent this DNJ molecule as an antiviral potential complementing conventional therapies after preclinical tests against WHBV-infected animal model, woodchuck.

Interrelation between Expression of ADAM 10 and MMP 9 and Synthesis of Peroxynitrite in Doxorubicin Induced Cardiomyopathy

  • Lim, Sung Cil
    • Biomolecules & Therapeutics
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    • 제21권5호
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    • pp.371-380
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    • 2013
  • Doxorubicin is still main drug in chemotherapy with limitation of use due to adverse drug reaction. Increased oxidative stress and alteration of nitric oxide control have been involved in cardiotoxicity of doxorubicin (DOX). A Disintegrin And Metalloproteinase (ADAMs) are transmembrane ectoproteases to regulate cell-cell and cell-matrix interactions, but role in cardiac disease is unclear. The aim of this study was to determine whether DOX activates peroxynitrite and ADAM 10 and thus ADAM and matrix metalloproteinase (MMP) induce cardiac remodeling in DOX-induced cardiomyopathy. Adult male Sprague-Dawley rats were subjected to cardiomyopathy by DOX (6 times of 2.5 mg/kg DOX over 2-weeks), and were randomized as four groups. Then followed by 3, 5, 7, and 14 days after cessation of DOX injection. DOX-injected animals significantly decreased left ventricular fractional shortening compared with control by M-mode echocardiography. The expressions of cardiac nitrotyrosine by immunohistochemistry were significant increased, and persisted for 2 weeks following the last injection. The expression of eNOS was increased by 1.9 times (p<0.05), and iNOS was marked increased in DOX-heart compared with control (p<0.001). Compared to control rats, cardiac ADAM10- and MMP 9- protein expressions increased by 20 times, and active/total MMP 9 proteolytic activity showed increase tendency at day 14 after cessation of DOX injection (n=10, each group). DOX-treated $H_9C_2$ cell showed increased ADAM10 protein expression with dose-dependency (p<0.01) and morphometric changes showed the increase of ventricular interstitial, nonvascular collagen deposition. These data suggest that activation of cardiac peroxynitrite with increased iNOS expression and ADAM 10-dependent MMP 9 expression may be a molecular mechanism that contributes to left ventricular remodeling in DOXinduced cardiomyopathy.

임상시험 지정병원의 "의약품 임상시험 관리기준(KGCP)" 수행 가능성 평가에 관한 연구 (Evaluation of Good Clinical Practice(GCP) Implementability at the Designated Clinical Trial Hospitals)

  • 장선미;이의경;박병주;허순임
    • 한국의료질향상학회지
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    • 제2권1호
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    • pp.86-109
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    • 1995
  • Clinical trials of drugs on humans is the final and most important stage in evaluating the safety and efficacy of the drugs. Good Clinical Practice(GCP) standards were announced in 1987 to protect testees' rights as well as to ensure validity of the clinical trial results, but its implementation has been delayed until now. The purpose of this study is to evaluate the preparedness of the designated institutions to abide by GCP standards during clinical trials, and thereby to determine GCP implementability at the institutions. Survey on the status of clinical trials was conducted for the designated 83 clinical trial hospitals. Response rate was 95.2%. Donabedian's quality assessment model was applied as the basic framework for the study. And the relative - weights for the evaluation items were determined by expert's evaluation. Among the designated 83 hospitals, 39 conducted clinical trials to obtain drug manufacturing approval from 1990 to 1994. Only 19 institutions are found to be able to meet the requirements of KGCP. Structure variables - manpower, organization, and facility -, which are the basic elements for GCP, are evaluated as unsatisfied in many hospitals. Institutions which established IRB accounted for 41 or 51.9%, but those who have a protocol evaluation guideline, or Adverse Drug Reaction(ADR) reporting system were only 12 and 21 institutions, respectively. Also, the institutions providing educational programs on conducting clinical trials are few - 20. The study results indicates that the level of conducting KGCP is unsatisfactory. However, more institutions are expected to be able to meet the standards soon because GCP standards does not require so much regulation on facilities, but stress importance on research methodology and human right. At present as the institutions for clinical trials are primarily training hospitals with residency programs, such efforts as education will accelerate the implementability of GCP in Korea. Institutions must build the appropriate infrastructure and government must prepare to strongly enforce KGCP before it can successfully take place.

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Free-standing Three Dimensional Graphene Incorporated with Gold Nanoparticles as Novel Binder-free Electrochemical Sensor for Enhanced Glucose Detection

  • Bui, Quoc Bao;Nguyen, Dang Mao;Nguyen, Thi Mai Loan;Lee, Ku Kwac;Kim, Hong Gun;Ko, Sang Cheol;Jeong, Hun
    • Journal of Electrochemical Science and Technology
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    • 제9권3호
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    • pp.229-237
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    • 2018
  • The electrochemical sensing performance of metal-graphene hybrid based sensor may be significantly decreased due to the dissolution and aggregation of metal catalyst during operation. For the first time, we developed a novel large-area high quality three dimensional graphene foam-incorporated gold nanoparticles (3D-GF@Au) via chemical vapor deposition method and employed as free-standing electrocatalysis for non-enzymatic electrochemical glucose detection. 3D-GF@Au based sensor is capable to detect glucose with a wide linear detection range of $2.5{\mu}M$ to 11.6 mM, remarkable low detection limit of $1{\mu}M$, high selectivity, and good stability. This was resulted from enhanced electrochemical active sites and charge transfer possibility due to the stable and uniform distribution of Au NPs along with the enhanced interactions between Au and GF. The obtained results indicated that 3D-GF@Au hybrid can be expected as a high quality candidate for non-enzymatic glucose sensor application.