• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.25 no.2
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• pp.20-37
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• 2012

Objectives : The primary purpose of present study is to evaluate the effect of a supplement of Bee Larva on tinnitus. the second is to comparatively evaluate safety of this supplement. Methods : Among those patients who visited Semyung Oriental Medical Center from January 11st, 2010 to February 20th, 2010, we screened 45 patients considered suitable for this study after some examinations and consent of the patients. they were devided into 2 groups. Group A took 5 tablets of this supplement everyday for 4 weeks, group B, placebo, in the same way. for 4 weeks, we checked changes in intensity, duration, extent of tinnitus on daily life and sleep and THI(Tinnitus Handicap Inventory) score. to evaluate safety of this supplement, adverse events, assessment of vital sign, hematologic examination were recorded. Result : Through 4 weeks of the clinical trial, we found that this supplement is effective on tinnitus and it improves intensity, duration and extent (its influence on daily life) of tinnitus, influence of tinnitus on sleep and THI score more effectively than the placebo drug. Also, in the assessment of the safety of the study the supplement of bee Larva and placebo drug, there were no adverse events and side effects over the average which need treatment for it. Moreover, there were not any abnormal findings in change of blood pressure and hematologic examination. Conclusion : According to this experiment, we confirmed that the supplement of bee Larva can be used effectively and safely on tinnitus.

• Clinical and Experimental Pediatrics
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• v.49 no.7
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• pp.703-709
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• 2006

Since the advent of growth hormone(GH), children with a wide variety of growth disorders have received GH treatment. In GH deficiency(GHD), Turner syndrome, chronic renal failure, children born small for gestational age, Prader-Willi syndrome, and idiopathic short stature, the therapeutic effects and safety profile of GH are reviewed. GH therapy has been clearly shown to improve height velocity and final adult height in a variety of pediatric conditions in which growth is compromised irrespective of GHD. Early initiation and individualization of GH treatment has the potential to normalize childhood growth. The supra-physiological doses of GH have been shown to increase height velocity during childhood and final height in non-GHD conditions. Adverse events during GH therapy are uncommon and often not drug related. However continued surveillance into adult life is crucial, especially in children receiving supra-physiological doses or whose underlying condition increases their risk of adverse effects.

• Korean Journal of Clinical Pharmacy
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• v.24 no.1
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• pp.39-44
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• 2014

Purpose: To investigate adverse drug reactions (ADR) and causative drugs in the elderly 65 years of age or older, using Korean spontaneous reporting adverse events reporting database from June 2009 to December 2010. Methods: We estimated the association between ADRs and implicated medications by calculating a proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC). We reexamined the most frequently implicated medications and ADRs, and the seriousness of ADRs. Then, we assessed reports and concordant rate of ADRs due to medications designated as "high-risk" in elderly by 2012 healthcare effectiveness data and information set (HEDIS) or "potentially inappropriate" by 2012 American Geriatrics Society updated Beers criteria for potentially inappropriate medications (PIMs). Results: Among 15,484 elderly reports, data-mining analysis by PRR, ROR and IC showed that 421 drug-ADR pairs were detected as signals (3,189). The most frequently reported ADR and causative drug were urticaria (470) and contrast media agents (647), respectively. One hundred eighty nine ADR cases were graded as serious. Twenty-two kinds of high-risk medications were shown to be implicated in only 0.9% of ADRs. Only thirty-nine cases were consistent with 2012 Beers criteria or HEDIS. Conclusion: These results suggest that management of the other medications including contrast media agents as well as close monitoring of PIMs are necessary for reducing ADRs in the elderly.

• The Korean Journal of Applied Statistics
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• v.33 no.2
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• pp.203-213
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• 2020

The self-controlled case series (SCCS) study measures the relative risk of exposure to exposure period by setting the non-exposure period of the patient as the control period without a separate control group. This method minimizes the bias that occurs when selecting a control group and is often used to measure the risk of adverse events after taking a drug. This study used SCCS to examine the increased risk of side effects when two or more drugs are used in combination. A conditional Poisson model is assumed and analyzed for drug interaction between the narcotic analgesic, tramadol and multi-frequency combination drugs. Bayesian inference is used to solve the overfitting problem of MLE and the normal or Laplace prior distributions are used to measure the sensitivity of the prior distribution.

• Journal of Yeungnam Medical Science
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• v.37 no.3
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• pp.159-168
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• 2020

The demand for drug-induced sedation for magnetic resonance imaging (MRI) scans have substantially increased in response to increases in MRI utilization and growing interest in anxiety in children. Understanding the pharmacologic options for deep sedation and general anesthesia in an MRI environment is essential to achieve immobility for the successful completion of the procedure and ensure rapid and safe discharge of children undergoing ambulatory MRI. For painless diagnostic MRI, a single sedative/anesthetic agent without analgesia is safer than a combination of multiple sedatives. The traditional drugs, such as chloral hydrate, pentobarbital, midazolam, and ketamine, are still used due to the ease of administration despite low sedation success rate, prolonged recovery, and significant adverse events. Currently, dexmedetomidine, with respiratory drive preservation, and propofol, with high effectiveness and rapid recovery, are preferred for children undergoing ambulatory MRI. General anesthesia using propofol or sevoflurane can also provide predictable rapid time to readiness and scan times in infants or children with comorbidities. The selection of appropriate drugs as well as sufficient monitoring equipment are vital for effective and safe sedation and anesthesia for ambulatory pediatric MRI.

• The Korean Journal of Physiology and Pharmacology
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• v.26 no.6
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• pp.439-446
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• 2022

The antitumoral effects of valdecoxib (Val), an United States Food and Drug Administration-approved anti-inflammatory drug that was withdrawn due to the side effects of increased risk of cardiovascular adverse events, were investigated in hypopharyngeal squamous cell carcinoma cells by performing a cell viability assay, transwell assay, immunofluorescence imaging, and Western blotting. Val markedly inhibited cell viability with an IC50 of 67.3 µM after 48 h of treatment, and also downregulated cell cycle proteins such as Cdks and their regulatory cyclin units. Cell migration and invasion were severely suppressed by inhibiting integrin α4/FAK expression. In addition, Val activated the cell cycle checkpoint CHK2 in response to excessive DNA damage, which led to the activation of caspase-3/9 and induced caspase-dependent apoptosis. Furthermore, the signaling cascades of the PI3K/AKT/mTOR and mitogen-activated protein kinase pathways were significantly inhibited by Val treatment. Taken together, our results indicate that Val can be used for the treatment of hypopharyngeal squamous cell carcinoma.

• Korean Journal of Clinical Pharmacy
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• v.23 no.3
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• pp.239-247
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• 2013

Background: Fixed drug combinations are formulations containing two or more active ingredients in a single dosage form. Such combination therapies are commonly applied to improve efficacy, reduce adverse events and replace co-administration, etc. National and international guidelines for hypertension treatment recommend addition of other classes of antihypertensive drugs rather than incremental dose of mono-therapy, when blood pressure is not adequately controlled. Thus, many dual combinations of antihypertensive drugs have been approved and pharmaceutical companies are recently interested in developing antihypertensive triple combinations. Clinical trial designs for the fixed combinations are various depending on the target patients, dosage and clinical endpoints. Thereby, further discussions for the clinical trials of antihypertensive triple therapies are required regarding the indication claimed. Conclusion: This article provides a review for the assessment of the label and medical reports of the clinical trials on antihypertensive triple therapies in advanced foreign countries.

• Tuberculosis and Respiratory Diseases
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• v.85 no.2
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• pp.111-121
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• 2022

Multidrug-resistant tuberculosis (MDR-TB) is caused by an organism that is resistant to both rifampicin and isoniazid. Extensively drug-resistant TB, a rare type of MDR-TB, is caused by an organism that is resistant to quinolone and one of group A TB drugs (i.e., linezolid and bedaquiline). In 2018, the World Health Organization revised the groupings of TB medicines and reclassified linezolid as a group A drug for the treatment of MDR-TB. Linezolid is a synthetic antimicrobial agent in the oxazolidinone class. Although linezolid has a good efficacy, it can cause substantial adverse events, especially hematologic toxicity. In both TB infection and linezolid mechanism of action, mitochondrial dysfunction plays an important role. In this concise review, characteristics of linezolid as an anti-TB drug are summarized, including its efficacy, pathogenesis of hematologic toxicity highlighting mitochondrial dysfunction, and the monitoring and management of hematologic toxicity.

• The Korean Journal of Pain
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• v.31 no.2
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• pp.73-79
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• 2018

All drugs have both favorable therapeutic and untoward adverse effects. Conventional opioid analgesics possess both analgesia and adverse reactions, such as nausea, vomiting, and respiratory depression. The opioid ligand binds to ${\mu}$ opioid receptor and non-selectively activates two intracellular signaling pathways: the G protein pathway induce analgesia, while the ${\beta}$-arrestin pathway is responsible for the opioid-related adverse reactions. An ideal opioid should activate the G protein pathway while deactivating the ${\beta}$-arrestin pathway. Oliceridine (TRV130) has a novel characteristic mechanism on the action of the ${\mu}$ receptor G protein pathway selective (${\mu}$-GPS) modulation. Even though adverse reactions (ADRs) are significantly attenuated, while the analgesic effect is augmented, the some residual ADRs persist. Consequently, a G protein biased ${\mu}$ opioid ligand, oliceridine, improves the therapeutic index owing to increased analgesia with decreased adverse events. This review article provides a brief history, mechanism of action, pharmacokinetics, pharmacodynamics, and ADRs of oliceridine.

• Tuberculosis and Respiratory Diseases
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• v.78 no.4
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• pp.321-325
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• 2015

Background: The adverse effects of the phosphodiesterase-4 inhibitor roflumilast, appear to be more frequent in clinical practice than what was observed in chronic obstructive pulmonary disease (COPD) clinical trials. Thus, we designed this study to determine whether adverse effects could be reduced by starting roflumilast at half the dose, and then increasing a few weeks later to $500{\mu}g$ daily. Methods: We retrospectively investigated 85 patients with COPD who had taken either $500{\mu}g$ roflumilast, or a starting dose of $250{\mu}g$ and then increased to $500{\mu}g$. We analyzed all adverse events and assessed differences between patients who continued taking the drug after dose escalation and those who had stopped. Results: Adverse events were reported by 22 of the 85 patients (25.9%). The most common adverse event was diarrhea (10.6%). Of the 52 patients who had increased from a starting dose of $250{\mu}g$ roflumilast to $500{\mu}g$, 43 (82.7%) successfully maintained the $500{\mu}g$ roflumilast dose. No difference in factors likely to affect the risk of adverse effects, was detected between the dose-escalated and the discontinued groups. Of the 26 patients who started with the $500{\mu}g$ roflumilast regimen, seven (26.9%) discontinued because of adverse effects. There was no statistically significant difference in discontinuation rate between the dose-escalated and the control groups (p=0.22). Conclusion: Escalating the roflumilast dose may reduce treatment-related adverse effects and improve tolerance to the full dose. This study suggests that the dose-escalated regimen reduced the rate of discontinuation. However, longer-term and larger-scale studies are needed to support the full benefit of a dose escalation strategy.