• The Journal of the Korea Contents Association
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• v.16 no.9
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• pp.473-481
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• 2016

Adverse drug reactions(ADRs) were caused by dexran 40 in patient with ischemic stroke and related 22 patients reported to formal ADRs at Jesus Hospital in Jeonju. This study was aimed to search ADRs related factors, type and the degree associated with dextran 40. Adverse Effects of Dextran 40 is including marked hypotension, nausea, dyspnea, generalized urticaria, fever and pulmonary edema. The average hospitalization period was 20 days and it was extended 26.8%. ADRs of Dextran 40 to incidence is 12.4%, and 9 persons(28.1%), itching, rash was 7 people (21.9%). Dextran induced ADRs reaction may be reported on early injection period and first time shot, but adverse drug reactions occurred after 4 days in 4 patients(18.2%). US FDA has recommanded that Dextran 1 significantly reduces the incidence of severe ADRs in USA. Because low molecular weighted dextran 1 prevented dextran molecules from combined Ig G completely. In Korea. Generally not yet introduced dextran 1, active use dextran 1 is able to be a good way in order to reduce ADRs of dextran 40.

• Korean Journal of Clinical Pharmacy
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• v.26 no.2
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• pp.172-180
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• 2016

Background: Ischemic heart disease is the most common type of heart disease and an important cause of death in Korea. Among marketed anti-anginal medications, molsidomine, nicorandil, and trimetazidine are approved in Korea with unique mechanism of actions. As these drugs are not approved by the US Food and Drug Administration, the access to the up-to-dated and comprehensive safety-related information has been less than optimal from drug information resources used by Korean pharmacists. Methods: A systematic review was conducted using Embase and Korean manuscripts to compile safety updates for these medications. Out of 418 articles from keyword searches, 52 studies were reviewed in full to compare adverse effects (AEs) with the approved package inserts (PI). Results: Molsidomine related adverse effects were mostly mild or moderate, but anxiety, palpitation, epigastric pain, and sexual potency reduction were additional AEs found from the review not listed in PI. Although PI has included ulceration in oral cavity and gastrointestinal tracts including anus by nicorandil, the Korea FDA recently recommended adding corneal, genital, and skin ulcers to the approved PI. Trimetazidine induced Parkinsonism, worsening of the symptoms for patients diagnosed with Parkinson's disease, gastrointestinal burning, and muscle cramps were additionally identified AEs not listed in PI for trimetazidine. Conclusion: Continuous evaluations of the safety profile of these agents are needed to balance the risks and benefits to provide evidence-based safety counseling to the patients. In addition, more focused efforts on spontaneous reporting are warranted by healthcare professionals to safeguard patients against AEs.

• Journal of Environmental Health Sciences
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• v.32 no.5 s.92
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• pp.462-468
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• 2006

Antibiotics are manufactured and used for specific physiological functions, hence they may exert adverse ecological consequences when they are in contact with nontarget organisms. In the last decade, many reports have been made on the occurrences of various antibiotic compounds in surface water, and their potential impact to the environment has become an increasing concern. This study was conducted to prioritize antibiotic substances with potential environment risk in Korea. Human use antibiotics with an EIC (Expected Introduction Concentration) value greater than $1{\mu}g/l$, US FDA's action limit criteria, were selected. In order to calculate a worst-case EIC for each substance, annual production volume (in kg) of each antibiotic substance was derived using the Korea Pharmaceutical Manufacturers Association (KPMA)'s monetary database. Sixteen substances were preliminarily selected. The EICs of the 16 antibiotic substances were refined with the excretion rate of the parent substances. Ten antibiotic substances were identified to have EIC-corrected greater than $1{\mu}g/l$, which include Amoxicillin ($15.8{\mu}g/l$), Cefaclor ($10.1{\mu}/l$), Roxithromycin ($4.2{\mu}g/l$), Cephradine ($4.5{\mu}g/l$), Cefatrizine ($2.6{\mu}g/l$), Cefadroxil ($3.3{\mu}g/l$), Aztreonam ($2.3{\mu}g/l$), Ceftazidime ($2.8{\mu}g/l$), Ribostamycin ($1.3{\mu}g/l$), and Ceftezole ($1.3{\mu}g/l$). Additional risk assessments for these antibiotic substances are suggested.

• Asian Pacific Journal of Cancer Prevention
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• v.15 no.2
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• pp.517-535
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• 2014

Poly (lactic-co-glycolic acid) (PLGA) is one of the most effective biodegradable polymeric nanoparticles (NPs). It has been approved by the US FDA to use in drug delivery systems due to controlled and sustained-release properties, low toxicity, and biocompatibility with tissue and cells. In the present review, the structure and properties of PLGA copolymers synthesized by ring-opening polymerization of DL-lactide and glicolide were characterized using 1H nuclear magnetic resonance spectroscopy, gel permeation chromatography, Fourier transform infrared spectroscopy and differential scanning calorimetry. Methods of preparation and characterization, various surface modifications, encapsulation of diverse anticancer drugs, active or passive tumor targeting and different release mechanisms of PLGA nanoparticles are discussed. Increasing experience in the application of PLGA nanoparticles has provided a promising future for use of these nanoparticles in cancer treatment, with high efficacy and few side effects.

• BMB Reports
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• v.44 no.1
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• pp.34-39
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• 2011

Resistance to PAI-1 is a factor which confers clinical benefits in thrombolytic therapy. The only US FDA approved PAI-1 resistant drug is Tenecteplase$^{(R)}$. Deletion variants of t-PA have the advantage of fewer disulfide bonds in addition to higher plasma half lives. A new variant was developed by deletion of the first three domains in t-PA in addition to substitution of KHRR 128-131 amino acids with AAAA in truncated t-PA. The specific activity of this new variant, $570\;IU/{\mu}g$, was found to be similar to those found in full length t-PA (Alteplase$^{(R)}$), $580\;IU/{\mu}g$. A 65% and 85% residual activity after inhibition by rPAI-1 was observed for full length and truncated-mutant form, respectively. This new variant as the first PAI-1 resistant truncated t-PA may offer more advantages in clinical conditions in which high PAI-1 levels makes the thrombolytic system prone to re-occlusion.

• Korean Journal of Clinical Pharmacy
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• v.28 no.2
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• pp.88-94
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• 2018

Background: We strived to evaluate the status of nivolumab use and associated factors on the clinical efficacy of the drug. Methods: The study was retrospectively conducted in patients who had been administered nivolumab at least once at the cancer center of Seoul National University Hospital from June 2015 to April 2017. Data were collected from electronic medical records. A medication-use evaluation was performed based on the American Society of Health-System Pharmacists mediation-use guidelines. Results: Sixty-six of the 74 patients (89.2%) showed indications approved for nivolumab use by the Korean Ministry of Food and Drug Safety (MFDS; n=55) or the US Food and Drug Administration (FDA; n=11). Approximately 73.0% of the patients were administered the approved dose of 3 mg/kg but 25.7% were administered an unapproved fixed dose of 100 mg. The overall response rate was 21.7%, and the response rate of non-small cell lung cancer patients, who accounted for the largest number of indications, was 18.8%. Adverse reactions were found in 90.1% of the patients and were mostly mild (86%). The expression of programmed death-ligand 1 (PD-L1) was analyzed as a factor affecting treatment response (p=0.028, odds ratio [OR]=11.331). Conclusion: PD-L1 expression was found to affect treatment response. However, caution is required while using an unapproved dosage and in the absence of monitoring for effectiveness and safety. Therefore, an effective protocol or instruction manual for the proper use of nivolumab should be considered.

• The Journal of the Korean dental association
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• v.48 no.4
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• pp.256-262
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• 2010

bone grafting is indicated in the case of bony defects and is classified into autograft, allograft, and xenograft. Synthetic bone graft is contrasted with these three categories in that it has a different donor source. Autograft is most prominent as it is known as a gold standard of all grafting procedures. Its principles and practices are well established via accumulated informations and clinical experiences, which imposes no regulations or restrictions in its clinical use. On the other hand, other bone graft procedures are under tight control for the safety and effectiveness of each product. Food and Drug Administration of the United States has a system in which the information on the approvals and clearances of bone graft materials on their internet homepage. All the bone graft materials that are under the regulations of the United States are classified into the category of medical devices, which includes allogenic bone, xenogenic bone, and synthetic bone graft materials. Each bone graft material has its own indication and the FDA approvals and clearances of medical devices contain the item of "intended use" to specify the indications of each bone graft materials. US dentists, as users of the specific bone graft materials, are provided with adequate information on the approved materials they are to utilize. As an user of these materials, Korean dentists are less provided with the information on the bone graft materials they want to use. Medical providers of the bone graft materials have to be able to provide their users with the essential information such as the intended use of the regulatory approval. Dentists must also be active in gathering informations on the material of their interest, and the system must be built in which both of the medical providers and users of bone graft materials can be satisfied in providing and getting the information, respectively.

• Korean Journal of Clinical Pharmacy
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• v.28 no.4
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• pp.263-272
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• 2018

Nonprescription drugs have become increasingly important in Korean healthcare. By leveraging lower-cost drugs and reducing expenditure associated with fewer physician visits, the nonprescription segment can deliver tremendous value to individual consumers and the Korean healthcare system. Many countries have provided simpler and more rapid routes to market entry for qualifying nonprescription drug products, using the established data on drug safety and efficacy, as well as public and professional opinion. In US, the FDA waived the pre-approval process for over-the-counter (OTC) drugs marketed through the OTC Monograph Process. In Australia and Canada, different OTC product application levels are defined, with a reduced level of assessment required when the risks to consumers are considered low. Japan established a new OTC evaluation system in 2014 to facilitate the Rx-to-OTC switch process. The legislative framework for medicinal products in the European Union allows for drugs to be approved with reference to appropriate bibliographic data for old active substances with well-established uses. Through a comparison of the regulatory framework and the requirements for nonprescription approval process in different countries, several ways to improve regulatory practice for the evaluation of nonprescription drugs in Korea have been suggested.

• Fisheries and Aquatic Sciences
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• v.26 no.2
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• pp.133-144
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• 2023

Auranofin is a US Food and Drug Administration (FDA)-approved anti-arthritis medication that functions as a thioredoxin reductase inhibitor. Spermidine, a polyamine present in marine algae, can exert various physiological functions. Herein, we examined the synergistic anticancer activity of auranofin and spermidine in hepatocellular carcinoma (HCC). Combined treatment with auranofin and spermidine suppressed cell viability more efficiently than either treatment alone in HCC Hep3B cells. The isobologram plotted by calculating the half maximal inhibitory concentration (IC₅₀) values of each drug indicated that the two drugs exhibited a synergistic effect. Based on the analysis of annexin V and cell cycle distribution, auranofin and spermidine markedly induced apoptosis in Hep3B cells. Moreover, auranofin and spermidine increased mitochondria-mediated apoptosis by promoting mitochondrial membrane potential (Δψm) loss. Auranofin and spermidine significantly increased reactive oxygen species (ROS) production in Hep3B cells, and the blocking ROS suppressed apoptosis induced by spermidine and auranofin. In addition, auranofin and spermidine reduced the expression of phosphorylated phosphatidylinositol-3 kinase (PI3K) and protein kinase B (Akt), and PI3K inhibitor accelerated auranofin- and spermidine-induced apoptosis. Using ROS scavenger and PI3K inhibitor, we revealed that ROS acts upstream of auranofin- and spermidine-induced apoptosis. Collectively, our study suggests that combination treatment with auranofin and spermidine could afford synergistic anticancer activity via ROS overproduction and reduced PI3K/Akt signaling pathway.

• Medical Lasers
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• v.8 no.1
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• pp.19-23
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• 2019

Background and Objectives The picosecond 755 nm alexandrite laser was first approved by the US FDA in 2012. A previous study described the use of a 1,064 nm picosecond laser with a micro-lens array (MLA) in peri-areolar scarring from breast reconstruction surgery and reported significant improvement in the texture and aesthetic appearance of the scar without other wound complications. The purpose of this study was to evaluate the improvement of overall scarring, not just pigmentation, in the picosecond laser treatment of patients with pigmentations. Materials and Methods Sixteen patients who underwent 1,064 nm picosecond laser treatment from June 2016 to December 2018 were enrolled in this study. Patients received two to six sessions of picosecond laser treatment at intervals of 4 weeks. Before and after the laser treatment, the patients evaluated their own satisfaction score and a physician evaluated the Vancouver Scar Scale. To evaluate the satisfaction score and complication rate, a retrospective chart review was done. Results Seven were female and nine were male. The mean of the patients' satisfaction score before the treatment was 1.44 (interquartile range [IQR], 1-2) and 3.00 (IQR 2.25-3.75) six months after treatment. The mean of the Vancouver Scar Scale before the treatment was 9.69 (IQR 8-11), and 6.25 (IQR 5-7.75) six months after treatment. All the results were statistically significant (p<0.01). Conclusion This study provides evidence that the use of a 1,064 nm picosecond laser treatment for pigmented scars can be effective in improving the pigmentation and overall scar status, including vascularity, height, and pliability, with the results of a decrease in the VSS scores between treatments.