• 제목/요약/키워드: Drug Review

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외래 호흡기계 질환에서 항생제 사용에 대한 후향적 평가방안 (Retrospective Drug Utilization Review of Antibiotics for Respiratory Tract Infection(RTI) in Ambulatory Outpatient Care)

  • 김동숙;배그린;김수경;이학선;김윤진;이숙향
    • 한국임상약학회지
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    • 제22권4호
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    • pp.291-303
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    • 2012
  • As respiratory tract infections (RTI) account for about 60% of all antibiotic prescriptions in outpatient care setting, there are significant concerns about emerging resistance that are largely due to the excessive or inappropriate use of antibacterial agents for viral respiratory infections. This study was aimed to develop retrospective drug utilization review (DUR) program of antibiotics for RTIs using Delphi methods. Retrospective DUR criteria of antibiotics for RTIs were identified based on clinical practice guidelines and opinion of experts. Expert panel members were clinical doctors and pharmacists and Delphi method was applied by survey on 16 members of panels. The claim data from Korean Health Insurance Review & Assessment (HIRA) were used to examine trends in outpatient antibiotic prescription between Janunary to December of 2008. As results, Quality index for RTI was assessed for the claim type, antibiotics use of quantity, duration, number and cost. Antibiotic prescription rate for RTIs, Defined Daily Dose (DDD), and duration of antibiotics use were more recognized as significant quality index by experts' opinion. Use of first line agents suggested by guidelines was low and duration of antibiotics use was shorter compared to the recommendations. Antibiotics were over prescribed for RITs. However, dose and duration of antibiotics were under-used.

Drug allergy in children: what should we know?

  • Park, Ji Soo;Suh, Dong In
    • Clinical and Experimental Pediatrics
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    • 제63권6호
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    • pp.203-210
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    • 2020
  • The drug allergy "label" may have a lifetime of consequences for a child. Many children with alleged drug allergies are proven to be tolerant to the culprit medication when challenged. The field of drug hypersensitivity is a recently evolving field of research, but studies on its epidemiology and diagnostic tools are lacking in children. Clinical history is significant in the diagnosis and classification of drug hypersensitivity in children. Diagnostic tools have been evaluated in a limited number of children; therefore, the guidelines are mainly in line with those for adults. Here, we review the clinical characteristics, main drugs, risk factors, and diagnosis of drug hypersensitivity to aid in its accurate diagnosis in children.

기공 운동 치료가 고혈압에 미치는 영향: 체계적 문헌 고찰 (Qigong Exercise Therapy for Hypertension: A Systematic Review)

  • 안재규;이상현;김현태;박선영;허인;정민정;황의형;장인수
    • 척추신경추나의학회지
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    • 제15권2호
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    • pp.9-18
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    • 2020
  • Objectives This study verified the clinical effectiveness of Qigong exercise therapy for individuals with hypertension. Methods Ten electronic databases were used for information retrieval. Only randomized controlled trials (RCTs) using Qigong exercise therapy as a treatment for hypertension were included in this study. Cochrane risk of bias tool was used to assess the methodological quality of each RCT. Results After a thorough review, six RCTs were deemed eligible. These studies were divided into two groups: Qigong vs. no intervention and Qigong plus anti-hypertensive drug vs. anti-hypertensive drug alone. Among the six RCTs, four studies were Qigong vs. no intervention, and two studies were Qigong plus anti-hypertensive drug vs. anti-hypertensive drug alone. The meta-analysis demonstrated that adding Qigong exercise to anti-hypertensive drug treatment lowers diastolic blood pressure more than the anti-hypertensive drug alone. Conclusions Although Qigong exercise is not widely used in the Korean medical field, the results of this study demonstrated the necessity of exercise while controlling hypertension. However, the number of included studies was small, with their high risk of bias. In conclusion, although it is difficult to determine whether Qigong exercise lowers blood pressure in hypertensive patients, exercise including Qigong must be parallel with the intake of anti-hypertensive drugs.

Genetically Engineered Mouse Models for Drug Development and Preclinical Trials

  • Lee, Ho
    • Biomolecules & Therapeutics
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    • 제22권4호
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    • pp.267-274
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    • 2014
  • Drug development and preclinical trials are challenging processes and more than 80% to 90% of drug candidates fail to gain approval from the United States Food and Drug Administration. Predictive and efficient tools are required to discover high quality targets and increase the probability of success in the process of new drug development. One such solution to the challenges faced in the development of new drugs and combination therapies is the use of low-cost and experimentally manageable in vivo animal models. Since the 1980's, scientists have been able to genetically modify the mouse genome by removing or replacing a specific gene, which has improved the identification and validation of target genes of interest. Now genetically engineered mouse models (GEMMs) are widely used and have proved to be a powerful tool in drug discovery processes. This review particularly covers recent fascinating technologies for drug discovery and preclinical trials, targeted transgenesis and RNAi mouse, including application and combination of inducible system. Improvements in technologies and the development of new GEMMs are expected to guide future applications of these models to drug discovery and preclinical trials.

외국(外國)의 의약품허가신청첨부자료(醫藥品許可申請添付資料) 및 자문기구(諮問機構)의 현황(現況) ( I ) (Status of Worldwide Regulations on Scientific Data for the Registration of Drugs for Human Uses & Advisory Committees(I))

  • 용군호
    • Journal of Pharmaceutical Investigation
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    • 제10권3호
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    • pp.51-77
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    • 1980
  • A comparison of worldwide drug registration requirements on scientific data required by the different regulatory authorities for the investigational new drug and new drug application for human uses was briefly reviewed and as one of administrative processings on review and evaluation of applications, the functions of scientific advisory committees were reviewed.

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Lipid A as a Drug Target and Therapeutic Molecule

  • Joo, Sang Hoon
    • Biomolecules & Therapeutics
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    • 제23권6호
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    • pp.510-516
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    • 2015
  • In this review, lipid A, from its discovery to recent findings, is presented as a drug target and therapeutic molecule. First, the biosynthetic pathway for lipid A, the Raetz pathway, serves as a good drug target for antibiotic development. Several assay methods used to screen for inhibitors of lipid A synthesis will be presented, and some of the promising lead compounds will be described. Second, utilization of lipid A biosynthetic pathways by various bacterial species can generate modified lipid A molecules with therapeutic value.

Transdermal Drug Delivery Devices Based on Microneedles: A Review

  • Kim, Byeong Hee;Seo, Young Ho
    • Journal of mucopolysaccharidosis and rare diseases
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    • 제1권1호
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    • pp.5-14
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    • 2015
  • This paper addresses the state of arts of microneedles for the transdermal drug delivery applications. Microneedles can be classified based on materials and shapes. For the materials, microneedles could be made of ceramics, metals and polymers. The shape of the microneedles can be classified into solid and hollow microneedles. Methods of transdermal drug delivery based on microneedle patch are discussed, and various fabrication methods of microneedle patches are introduced.

인삼이 간의 약물 대사 효소에 미치는 영향 (Effects of Ginseng on the Drug Metabolizing Enzymes)

  • 김낙두
    • 약학회지
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    • 제28권1호
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    • pp.29-33
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    • 1984
  • The paper aimed to review the influences of ginseng on the metabolism of foreign substances and on the activity of hepatic drug metabolizing enzyme system in mouse or rat liver. It has been known that ginseng components reduces the motality rates and the toxic effects induced by foreign materials. Chronic pretreatment of mouse or rat with ginseng extract fractions or saponin caused the increase in the metabolism of foreign materials and the activity of drug metabolizing enzymes, such as cytochrome $P_{450}$, NADPH cytochrome C reductase and glucuronyl S-transferase in liver. Thus, it may be concluded that decrease in toxic effect of foreign substances by ginseng pretreatment may be partly related to the induction of drug metabolizing enzymes in liver.

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International Harmonization of Regulatory Quality Control and Quality Assurance of Drug

  • Kang, Chan-Soon
    • 대한약학회:학술대회논문집
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    • 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2-1
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    • pp.28-28
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    • 2003
  • After approval, the drug should be manufactured and maintained with uniform quality. To assure the quality of drugs, the drug companies should comply with GMP guidelines and regulatory authorities should assess their compliance. In this article, I want to review the definition of drugs as well as the quality surveillance system. To be controlled as drugs, they ought to have their own specifications and test methods. (omitted)

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정보 성분과 상대위험도를 이용한 clopidogrel의 약물상호작용 시그널 검색 : 건강보험데이터베이스를 대상으로 한 데이터마이닝 연구 (Use of Information Component (IC) and Relative Risk (RR) for Signal Detection of Drug Interactions of Clopidogrel : Data-mining Study Using Health Insurance Review & Assessment Service (HIRA) Claims Database)

  • 김진형;최청암;오정미;손성호;신완균
    • 한국임상약학회지
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    • 제21권2호
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    • pp.90-99
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    • 2011
  • Health Insurance Review & Assessment Service (HIRA) claims database has a high potential to detect signals of new drug interactions. The aim of this study was to evaluate the usefulness of information component (IC) and relative risk (RR) as a tool for signal detection, and to analyze the possible drug interactions caused by clopidogrel using HIRA claims database. This study was performed in elderly patients over 65 years of age who administered clopidogrel from January 2005 to June 2006 in South Korea. Serious Adverse Events (SAEs) as drug interactions of clopidogrel were defined as any ambulatory hospitalization for ischemic diseases within comcomitant medication period of clopidogrel. Information Component (IC) and Relative Risk (RR) were calculated to compare the proportion of drug-SAE pairs in order to select drug specific SAEs. IC and RR signals of clopidogrel drug interaction were screened when IC's 95% confidence interval was greater than 0 and RR's 95% confidence interval was greater than 1 respectively. All detected signals were compared to references such as $Micromedex^{(R)}$ and 2010 Drug Interaction $Facts^{TM}$. Sensitivity, specificity, positive predicted value and negative predicted value were used to evaluate usefulness of this method. Among 13,252,930 cases of elderly patients who co-administered clopidogrel and other drugs, 47,485 cases were detected as SAE. Of these, one-hundred nine cases were detected by the IC-based data-mining approach and ninety one cases were detected by the RR-based data-mining approach. Total One-hundred sixty three unrecognized signals were detected by IC or RR. Twelve signals from IC-based data-mining (57.1%) were corresponded with drug interactions from references and eight signals from RR-based data-mining (38.1%) were corresponded with drug interactions from references. These signals include proton pump inhibitors, calcium channel blockers and HMG CoA reductase Inhibitors, which were known to affect CYP450 metabolism. Further studies using HIRA claims database are necessary to develop appropriate data-mining measure.