• 한국임상약학회지
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• 제20권2호
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• pp.128-137
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• 2010

This review summarizes gender differences in pharmacokinetics, pharmacodynamics, and adverse drug reactions. Gender differences in pharmacokinetics are categorized by four major factors: absorption/bioavailability, distribution, metabolism, and elimination. There are sex-based differences in gastric emptying time, gastric alcohol dehydrogenase activity, apparent volume of distribution, ${\alpha}1$-acid glycoprotein level, phase I (CYP) and phase II metabolizing enzymes, glomerular filtration rate, and drug transporters. This review also reports gender differences in pharmacokinetics and pharmacodynamics of cardiovascular agents, central nervous system acting agents and antiviral agents. In addition, it has been reported that females experience more adverse reactions such as coughing, tachycardia, nausea, vomiting, rash, hypersensitivity, hepatotoxicity, and metabolic disorder after taking cardiovascular, central nervous system acting and antiviral agents. Therefore, in order to provide optimal drug dosage regimens both in male and female, gender differences in pharmacokinetics, pharmacodynamics, and adverse drug reactions must be considered.

• 한국임상약학회지
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• 제24권1호
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• pp.45-52
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• 2014

Objective: To evaluate the clinical manifestations and causative drugs of the outpatient adverse drug reactions (ADRs) reported by community pharmacy. Methods: From April 2013 to September 2013, all outpatient ADRs reported by community pharmacy to Regional Pharmacovigilance Center of Korean Pharmaceutical Association were included. The causality of ADRs was assessed by the criteria of WHO-Uppsala Monitoring Centre. The clinical features and the offending drugs were analyzed using the WHO-Adverse Reaction Terminology and the classification of American Hospital Formulary Service Drug Information, respectively. Results: 2,826 (97.0%) of the total 2,912 ADRs had causal relationship. The 1,923 patients with mean age of 55.1 years and female fraction of 66.5% were included in the ADRs. Gastrointestinal (33.6%), nervous system (14.9%), and skin (13.5%) symptoms were common in ADRs. Analgesic drugs (19.7%), gastrointestinal drugs (17.7%), and central nervous system drugs (11.0%) were prevalent offending drugs. The leading causative generic drug was the complex of acetaminophen and tramadol. Among 203 ADRs by the nonprescription drugs, the most common clinical features were skin (37.4%) and gastrointestinal (23.6%) symptoms and the most prevalent offending drugs were analgesic drugs (40.0%) and mucocutaneous system drugs (16.3%). The combination of acetaminophen and chlorzoxazone was the leading causative generic in nonprescription drugs. Conclusion: In this study, gastrointestinal symptom was the most common manifestation and analgesic drug was the most common causative drug in outpatient ADRs reported by community pharmacy.

• Asian Pacific Journal of Cancer Prevention
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• 제15권20호
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• pp.8797-8800
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• 2014

Objective: To analyze cost-effectiveness of morphine, MS contin and oxycodone in the treatment of cancer pain, providing guidance for rational drug use in the clinic. Methods: Confirmed by histology, a total of 171 patients with various cancers who required analgesic treatment were selected and divided into 3 groups, 57 cases for each group, given morphine, MS contin and oxycodone, respectively. If there appeared a poor short-term effect or aggravated sudden pain during the treatment, a short-acting morphine injection was given and adverse reactions were processed by symptomatic treatment. The pain relief rate and adverse reactions of groups were observed and pharmacoeconomics evaluation was undertaken. Results: The pain relief rates with morphine, MS contin and oxycodone were 89.5%(51/57), 91.2%(52/57) and 93.0%(53/57), respectively, with no difference samong groups (${\chi}^2=4.4489$, P=0.6162). The occurrence rates of adverse reactions were 59.7%(34/57), 54.4%(31/57) and 43.9%(25/57), again with no significant variation (P>0.05). The ratios of cost-effectiveness (C/E) for the 3 groups were $14.6{\pm}7.21$, $15.0{\pm}7.44$ and $16.1{\pm}8.10$. When the price of 3 kinds of analgesics was reduced by 10%, the ratios of cost-effectiveness were $12.2{\pm}6.53$, ($13.4{\pm}6.08$ and $14.5{\pm}6.74$ but there was no differences when compared with before the price adjustment (t=1.86, P=0.0651; t=1.30, P=0.1948; t=1.17, P=0.2453). Conclusion: Morphine, MS contin and oxycodone give similar pain relief and adverse reaction rates but of all, morphine is the preferred drug for the treatment of cancer pain from the perspective of pharmacoeconomics.

• Clinical and Experimental Pediatrics
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• 제52권4호
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• pp.499-503
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• 2009

요오드성 조영제는 즉각적인 부작용과 지연성 부작용을 일으킬 수 있다. 저자들은 컴퓨터 단층 촬영을 위해 요오드성 조영제인 iopromide ($Ultravist^{(R)}$)를 사용하고 2일 뒤에 전신에 반점 구진성 반점과 발열이 반복적으로 발생한 환아를 경험하였다. 이 환아에서 피부단자시험, 피내반응검사, 첩포검사를 포함한 피부반응검사를 시행하여 $Ultravist^{(R)}$에 지연성 반응임을 확인하고 다른 조영제인 ioversol ($Optiray^{(R)}$), iohexol ($Iobrix^{(R)}$), iobitridol ($Xenetix^{(R)}$) 에도 교차반응이 있음을 확인하였기에 보고하는 바이다.

• 대한임상약리학회:학술대회논문집
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• 대한임상약리학회 2006년도 제15차 추계학술대회
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• pp.43-44
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• 2006

• Clinical and Experimental Pediatrics
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• 제62권8호
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• pp.299-300
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• 2019

• 한국임상약학회지
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• 제33권2호
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• pp.122-127
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• 2023

Background: This study was aimed to identify the safety signals of metoclopramide in Korea Adverse Event Reporting System (KAERS) database by proportionality analysis methods. Methods: The study was conducted using Korea Institute of Drug Safety and Risk Management-Korea Adverse Event Reporting System Database (KIDS-KD) reported from January 2013 to December 2017 through KAERS. Signals of metoclopramide that satisfied the data-mining indices of proportional reporting ratio (PRR), reporting odds ratio (ROR) and information component (IC) were defined. The detected signals were checked whether they included in drug labels in the Ministry of Food and Drug Safety (MFDS), U.S. Food and Drug Administration (FDA) and Micromedex^®. Results: A total number of drug AE reports associated with all drugs of data in this study was 2,665,429. Among them, the number of AE reports associated with metoclopramide was 22,583. Forty-two meaningful signals of metoclopramide were detected that satisfied with the criteria of data-mining indicies. Especially neurological signals including extrapyramidal reactions, represented in the safety letter of regulatory agencies were identified in this study. Conclusion: Neurological signals of metoclopramide including extrapyramidal reactions were detected. It is believed that this search for signals can contribute to ensuring safety in the use of metoclopramide.

• 대한방사선기술학회지:방사선기술과학
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• 제30권4호
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• pp.305-311
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• 2007

조영제는 영상검사를 위해 유용한 의약품이며 점차 그 사용량이 늘어나고 있지만, 불가항력적인 부작용이 발생한다. 부작용에 대비해서 작성하게 되는 조영제 사용 동의서는 의료기관에게는 유리하고 피검자에는 불리한 내용이 담겨져 있어, 동의서에 부작용이 발생할 수 있다는 것에 동의하였다고 하여 그에 대한 손해배상책임까지 면제된다고 볼 수는 없다. 또한 조영제를 사용하는 검사 시 검사자와 조영제제조자는 선량한 관리자의 주의의무, 예견의무, 결과회피의무를 다하여야 하며, 의무를 소홀히 하게 되면 민사상의 책임이 있다. 조영제는 생산, 제조, 유통과정에 결함이 생길 수 있기 때문에 조영제제조자는 의약품 결함으로 인해 손해가 발생된다면 제조물책임을 지게 된다. 결함은 제조물의 제조 설계 또는 표시 상의 결함이나 기타 통상적으로 기대할 수 있는 안전성이 결여되어 있는 것으로 정의하고 있다. 제조물책임이란 제조물의 결함으로 말미암아 그 제조물의 이용자 또는 제 3자가 생명 신체 또는 재산상 손해를 입었을 때 그 제조물의 제조자나 판매자에게 그 결함제조물로 인하여 입은 손해를 배상하도록 책임을 묻는 것을 말한다. 조영제 사용의 증가 추세에 따른 부작용 발생빈도가 높아질 개연성과 함께 피검자들의 건강권에 대한 권리 의식이 점차 강조되고 있는 현실을 감안한다면 이제는 그에 대한 법적 책임이 정리되어야 하고, 조영제제조자는 조영제 사고에 대비하여 자구적인 대처방안을 수립하거나, 조영제 제조단체 공동으로 제조물책임보험을 들도록 하는 방안이 마련되어야 할 것이다. 의료기관과 조영제 회사 간의 거래 계약 체결 시 조영제 부작용에 대한 내용을 포함함으로써 의료기관이나 검사 당사자의 조영제 부작용 법적 책임을 경감할 수 있을 것이다.

• 대한암한의학회지
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• 제16권1호
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• pp.55-61
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• 2011

Objectives : Epidermal growth factor receptor-inhibitors have demonstrated improved overall survival in patients with non-small cell lung cancer, but their use is associated with dermatologic adverse reactions that often require symptomatic treatment. Methods : A 44-year-old woman, who started the chemotherapy of Iressa$^{(R)}$ on August 2010, developed cutaneous symptoms such as papulopustular rash, dry skin, and pruritus on her face and scalp after taking Iressa$^{(R)}$ for four weeks. The patient visited our clinic with such symptoms on March 2011 and underwent herebal remedy targeted to alleviate the skin reactions. The severity of dermatologic symptoms was evaluated with the numeric rating scale and the Common Terminology Criteria for Adverse Events version 4.0. Results : Noticeable changes on the skin lesion were observed after the two months of treatment, without any dose modification of the Iressa$^{(R)}$. The cutaneous symptoms as papulopustular rash, dry skin and pruritus were improved and there was no adverse event induced by the treatment with herbal medicine. Conclusions : This case report suggests that the treatment with a herbal medicine, Samultang-gagambang be considered as a useful treatment to relieve EGFR-inhibitor induced dermatologic adverse reactions.

• 한국임상약학회지
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• 제30권1호
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• pp.59-64
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• 2020

The emergence of phosphodiesterase (PDE) 5 inhibitors gave rise to the solution for erectile dysfunction, starting with the development of sildenafil. Although their efficacy in treating erectile dysfunction has been shown, the side effects of PDE5 inhibitors, especially sildenafil, must be taken into consideration. A 64-year-old man received 100 mg of sildenafil and experienced blue vision in both eyes; however, after a day or so, his symptoms improved. The symptoms disappeared when he stopped administering sildenafil, but reappeared when the medication was re-administered. Therefore, he discontinued sildenafil treatment and was prescribed udenafil instead. After that, visual adverse events no longer occurred. Causality assessment showed that in this case, sildenafil-induced cyanopsia was "certain" under the World Health Organization-Uppsala Monitoring Center (WHO-UMC) criteria and Korean causality assessment algorithm (Ver.2), and was "probable" according to the Naranjo scale. In addition, sildenafil also led to abnormal visual reactions in other cases. Sildenafil can also inhibit PDE6, which is present in retinal cells, unlike other PDE5 inhibitors. Thus, visual adverse reactions, such as blue vision, are the unique results of sildenafil, and other PDE5 inhibitors may be used to prevent them.