• Title/Summary/Keyword: drug use evaluation

Search Result 262, Processing Time 0.035 seconds

Evaluation of Toxicological Data on Food Additives and Guideline for ADI establishment - Polydimethylsiloxane as emulsifier - (식품첨가물의 독성자료 고찰과 ADI 평가지침 - 소포제 Polydimethylsiloxane를 사례로 -)

  • Choi, Chan-Woong;Jeong, Ji-Yoon;Park, Hyoung-Su;Moon, Jin-Hyun;Lee, Kwang-Ho;Lee, Hyo-Min
    • Journal of Food Hygiene and Safety
    • /
    • v.24 no.4
    • /
    • pp.352-356
    • /
    • 2009
  • The purpose of this study was to introduce the toxicological study review to evaluate the safety of PDMS on the 69th JECFA meeting. Polydimethylsiloxane is a polymer and its ADI was established at 23rd JECFA meeting in 1979. The ADI was maintained although the specification was expanded at its 26th, 29 th, 37 th meetings. Recently, it was reported that PDMS with low molecular weight and viscosity has high absorption rate and different toxicity, so it was submitted at 69th meeting. Toxicological studies of PDMS were submitted from the sponsor and additional information is collected from a document searching. The toxicological studies were reviewed in accordance with the 'Guidelines for the preparation of toxicological working papers for the Joint FAO/WHO Expert Committee on Food Additives'. In the available acute, sub-chronic and chronic toxicity studies on PDMS, dose-related increases in incidence and severity of ocular lesions(corneal crystal, inflammation of the corneal epithelium etc.) were consistently observed after oral dosing. It seems to be a local irritant effect, but the mechanism by which the ocular lesions arose is unclear, although the lack of absorption of PDMS indicates that it is unlikely to be a direct systemic effect. Consequently, the relevance of the ocular lesions for food use of PDMS could not be determined. The ADI of PDMS was re-established from 0-1.5 mg/kg bw/day to 0-0.8 mg/kg bw/day by applying additional safety factor 2 based on its ocular toxicity. The result of 0-0.8 mg/kg bw/day is a temporary ADI until further data are provided to 2010.

QT-interval prolongation due to medication found in the preoperative evaluation

  • Seto, Mika;Koga, Sayo;Kita, Ryosuke;Kikuta, Toshihiro
    • Journal of Dental Anesthesia and Pain Medicine
    • /
    • v.17 no.4
    • /
    • pp.323-327
    • /
    • 2017
  • QT prolongation is an electrocardiographic change that can lead to lethal arrhythmia. Acquired QT prolongation is known to be caused by drugs and electrolyte abnormalities. We report three cases in which the prolonged QT interval was improved at the time of operation by briefly discontinuing the drugs suspected to have caused the QT prolongation observed on preoperative electrocardiography. The QTc of cases 1, 2, and 3 improved from 518 to 429 ms, 463 to 441 ms, and 473 to 443 ms on discontinuing the use of a gastrointestinal prokinetic agent, a proton pump inhibitor, and a molecular targeted drug, respectively. These cases were considered to have drug-induced QT prolongation. We reaffirmed that even drugs administered for conditions unrelated to cardiac diseases can have adverse side effect of QT prolongation. In conclusion, our cases indicate that dental surgeons should be aware of the dangerous and even potentially lethal side effects of QT prolongation. For safe oral and maxillofacial surgery, cooperation with medical departments in various fields is important.

Drug Use Evaluation of Hypoglycemic Agents in Type 2 Diabetes

  • Ban, Young-Lan;Lee, Suk-Hyang
    • Proceedings of the PSK Conference
    • /
    • 2002.10a
    • /
    • pp.429.2-430
    • /
    • 2002
  • Complications of diabetes increase morbidity and motality and decrease quality of life. Recently. UKPDS has been reported that strict regulation of blood glucose. hypertension and hyperlipidemia could decrease complications of type 2 diabetes. This study evaluated use of hypoglycemic agents, control of blood glucose. frequency of complications and preventive management at a local 2ndary hospital in Korea. (omitted)

  • PDF

Stem Cells in Drug Screening for Neurodegenerative Disease

  • Kim, Hyun-Jung;Jin, Chang-Yun
    • The Korean Journal of Physiology and Pharmacology
    • /
    • v.16 no.1
    • /
    • pp.1-9
    • /
    • 2012
  • Because the average human life span has recently increased, the number of patients who are diagnosed with neurodegenerative diseases has escalated. Recent advances in stem cell research have given us access to unlimited numbers of multi-potent or pluripotent cells for screening for new drugs for neurodegenerative diseases. Neural stem cells (NSCs) are a good model with which to screen effective drugs that increase neurogenesis. Recent technologies for human embryonic stem cells (ESCs) or induced pluripotent stem cells (iPSCs) can provide human cells that harbour specific neurodegenerative disease. This article discusses the use of NSCs, ESCs and iPSCs for neurodegenerative drug screening and toxicity evaluation. In addition, we introduce drugs or natural products that are recently identified to affect the stem cell fate to generate neurons or glia.

Phase IV Clinical Trial, the Evaluation of Efficacy and Safety of Deoxyribonuclease-Bromelain Tablet in Patients with Traumatic Edema (외상성 부종에 대한 데옥시리보뉴클레아제-브로멜라인정의 유효성 및 안전성 평가를 위한 제IV상 임상시험)

  • Choi, Hyung-Suk
    • Korean Journal of Clinical Pharmacy
    • /
    • v.14 no.1
    • /
    • pp.24-31
    • /
    • 2004
  • There was clinical study to support the efficacy that the anti-inflammatory and analgesic properties of deoxyribonuclease, bromelain helped to reduce symptoms of inflammation. The current study investigated the effects of deoxyribonuclease, bromelain on local traumatic edema. The author used a drug containing proteolytic and mucolytic enzymes, deoxyribonuclease and bromelain, into 61 patients from 16 to 89 years old. The therapeutic response and tolerance had been excellent, which was permitted to a swift resolution on local traumatic edema and a prompt functional reestablishment. These results demonstrated that the drug was effective in local edema symptoms, pains and improving general condition suffering from trauma. Consequently, the use of the proteolytic and mucolytic enzyme$(Deanase^{(R)})$ require improvement in the rehabilitation of the injured.

  • PDF

Preconceptional use of folic acid and knowledge about folic acid among low-income pregnant women in Korea

  • Kim, Jihyun;Yon, Miyong;Kim, Cho-il;Lee, Yoonna;Moon, Gui-Im;Hong, Jinhwan;Hyun, Taisun
    • Nutrition Research and Practice
    • /
    • v.11 no.3
    • /
    • pp.240-246
    • /
    • 2017
  • BACKGROUND/OBJECTIVES: Folic acid supplementation before pregnancy is known to significantly reduce the risk of having a baby with neural tube defects (NTDs). Therefore, it is important for women to be aware of the effects of folic acid supplementation before pregnancy. The purpose of this study was to investigate the awareness and preconceptional use of folic acid and to assess the current knowledge about folic acid among low-income pregnant women in Korea. SUBJECTS/METHODS: A questionnaire survey was conducted in 2012. Five hundred pregnant women were selected from the waiting list for the Nutriplus program implemented in public health centers using a multistage clustered probability sampling design. Data from 439 women were analyzed after excluding ones with incomplete answers. RESULTS: Among women who responded to the questionnaire, 65.6% had heard of folic acid before pregnancy, and 26.4% reported on the preconceptional use of folic acid. Women with a university degree or higher education were more likely to be aware of folic acid and to take folic acid in the preconception period. In a multivariate logistic regression, when age, education level, household income, employment status, gravidity, parity, and folic acid awareness were included in the model, folic acid awareness was a strong predictor of preconceptional folic acid use. As of interview, 85.4% and 77.7% of women were aware of the NTD-preventive role of folic acid and the appropriate time to take folic acid, respectively. The main sources of information on folic acid were healthcare professionals (41.2%), friends and family members (31.2%), and the media (26.5%). CONCLUSIONS: Our results suggest that public health strategies are needed to increase the preconceptional use of folic acid among Korean women.

Simultaneous Evaluation of Cellular Vitality and Drug Penetration in Multicellular Layers of Human Cancer Cells

  • Al-Abd Ahmed Mohammed;Lee Joo-Ho;Kuh Hyo-Jeong
    • Journal of Pharmaceutical Investigation
    • /
    • v.36 no.5
    • /
    • pp.309-314
    • /
    • 2006
  • The multicellular layers(MCL) of human cancer cells is a three dimensional(3D) in vitro model for human solid tumors which has been used primarily for the assessment of avascular penetration of anti-cancer drugs. For anti-cancer drugs with penetration problem, MCL represents a good experimental model that can provide clinically relevant data. Calcein-AM is a fluorescent dye that demonstrates the cellular vitality in a graded manner in cancer cell culture system. In the present study, we evaluated the use of calcein-AM for determination of anti-proliferative activity of anti-cancer agents in MCL model of DLD-1 human colorectal cancer cells. Optical sectioning of confocal imaging was compromised with photonic attenuation and penetration barrier in the deep layers of MCL. By contrast, fluorescent measurement on the cryo-sections provided a feasible alternative. Cold pre-incubation did not enhance the calcein-AM distribution to a significant degree in MCL of DLD-1 cells. However, the simultaneous determination of drug penetration and cellular vitality appeared to be possible in drug treated MCL. In conclusion, these data suggest that calcein-AM can be used for the simultaneous determination of drug-induced anti-proliferative effect and drug penetration in MCL model.

Drug Use Evaluation of Anticholinergic Drugs Prescribed to Elderly Patients in the Ambulatory Setting Based on Beers and STOPP Criteria (Beers Criteria 및 STOPP 근거에 의거한 한국 노인 환자의 항콜린성제 약물요법의 적절성 평가)

  • Cheon, Young Ju;Lim, Sung Cil
    • YAKHAK HOEJI
    • /
    • v.58 no.5
    • /
    • pp.328-336
    • /
    • 2014
  • Anticholinergic drugs are included in the efficacy group of various antidepressants, antihistamines, antispasmodics like skeletal muscle relaxants. Elderly patients are often taking anticholinergic drugs due to various diseases such as sleep disorders and dysuria. But the use of anticholinergic drugs is restricted in guidelines such as Beers Criteria or STOPP due to the anticholinergic adverse effects including dry mouth, constipation, difficult urination, delirium, hallucinations and especially cognitive impairment. In this study, we investigated the usage of anticholinergic drugs in out-of-hospital prescription of 4,442 elderly patients. Results of the study were obtained that 32% (n=1,421) of overall patients were prescribed with 1~6 products (average 1.37) of anticholinergic drugs. 70.9% of the 1,421 patients (n=1,007) were prescribed with one drug, 22.7% (n=323) were two drugs and 4.9% (n=70) were three drugs. 27.1% of the 1,421 patients (n=430) were 70~74 years old patients who were the most commonly prescribed with anticholinergic drugs. Amitriptyline, chlorpheniramine, dimenhydrinate and quetiapine were most frequent component of ACB Score 3 drugs and amantadine, baclofen, carbamazepine, cyproheptadine and oxcarbazepine were most frequent of ACB Score 2 drugs. Anticholinergic Drug Scale (ADS) of individual patients presented one point (48.5%, n=689), 2 points (15.4%, n=219), more than 3 points (36.1%, n=513), and up to maximum 12 point (n=1). More than 2 points were more than half (51.5%, n=732). Therefore, additional prospective study in the use and adverse effects of anticholinergic drugs for elderly patients will be required. And national management such as DUR program will be required for elderly drug administration from now on.

Analysis of Research Trends Related to drug Repositioning Based on Machine Learning (머신러닝 기반의 신약 재창출 관련 연구 동향 분석)

  • So Yeon Yoo;Gyoo Gun Lim
    • Information Systems Review
    • /
    • v.24 no.1
    • /
    • pp.21-37
    • /
    • 2022
  • Drug repositioning, one of the methods of developing new drugs, is a useful way to discover new indications by allowing drugs that have already been approved for use in people to be used for other purposes. Recently, with the development of machine learning technology, the case of analyzing vast amounts of biological information and using it to develop new drugs is increasing. The use of machine learning technology to drug repositioning will help quickly find effective treatments. Currently, the world is having a difficult time due to a new disease caused by coronavirus (COVID-19), a severe acute respiratory syndrome. Drug repositioning that repurposes drugsthat have already been clinically approved could be an alternative to therapeutics to treat COVID-19 patients. This study intends to examine research trends in the field of drug repositioning using machine learning techniques. In Pub Med, a total of 4,821 papers were collected with the keyword 'Drug Repositioning'using the web scraping technique. After data preprocessing, frequency analysis, LDA-based topic modeling, random forest classification analysis, and prediction performance evaluation were performed on 4,419 papers. Associated words were analyzed based on the Word2vec model, and after reducing the PCA dimension, K-Means clustered to generate labels, and then the structured organization of the literature was visualized using the t-SNE algorithm. Hierarchical clustering was applied to the LDA results and visualized as a heat map. This study identified the research topics related to drug repositioning, and presented a method to derive and visualize meaningful topics from a large amount of literature using a machine learning algorithm. It is expected that it will help to be used as basic data for establishing research or development strategies in the field of drug repositioning in the future.

Use of Economic Evaluation in the Listing and Pricing of Pharmaceuticals (의약품 보험 급여 및 가격 결정과 경제성 평가의 활용)

  • Lee, Tae-Jin
    • Journal of Preventive Medicine and Public Health
    • /
    • v.41 no.2
    • /
    • pp.69-73
    • /
    • 2008
  • To curb a rapid increase in expenditures for pharmaceuticals, the Korean government introduced a positive list system and a negotiation process for drug prices at the end of 2006. Economic evaluation of pharmaceuticals has begun to have a pivotal role in the listing and pricing of drugs for the Korean National Health Insurance. There are some points to discuss regarding the use of economic evaluation in the listing and pricing in the context of the Korean system. First, the listing and pricing processes have been fragmented, evoking complaints from pharmaceutical companies and delaying the access of new drugs to patients. Second, there is a concern that the positive list system may limit the range and availability of drugs for patients to choose for treatment. Third, the time schedule for de-listing of existing drugs may not be realistic. Fourth, it is not always easy to provide reliable evidence of cost-effectiveness due to a lack of materials. Fifth, there is no consensus on the range of the ICER (incremental cost-effectiveness ratio) acceptable to the Korean society. In conclusion, in the near future, it will be necessary to evaluate the achievements that the economic evaluation has provided to the Korean society.