• Biomaterials and Biomechanics in Bioengineering
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• 제1권3호
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• pp.131-150
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• 2014

Vascular stenting has a great attention as a treatment for coronary arteries diseases as compared with percutaneous balloon angioplasty. In-stent restenosis and thrombosis are side effects resulting from using bare metal stent (BMS). Employing platelet therapy allowed to reduce the rate of thrombosis, however, the rate of restenosis remains a major problem. In 2002, drug-eluting stents (DESs) were introduced as an effort to reduce the restenosis. The commercially available DESs continue to suffer from coating defects that might lead to a series of adverse effects. Most importantly, multiple concerns remain regarding the polymer coating integrity on metal surfaces or the relation of polymer irregularities to longterm adverse events.

• Clinical and Experimental Pediatrics
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• 제49권7호
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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.

• Communications for Statistical Applications and Methods
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• 제26권2호
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• pp.163-173
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• 2019

Simon's two-stage designs are frequently used in phase II single-arm trials for efficacy studies. A concern of safety studies is too many patients who experience an adverse event. We show that Simon's two-stage designs for efficacy studies can be similarly used to design a two-stage safety study by modifying some of the design parameters. Given the type I and II error rates and the proportion of adverse events experienced in the first stage cohort, we prescribe a procedure whether to terminate the trial or proceed with a stage 2 trial by recruiting additional patients. We study the relationship between a two-stage design with a safety endpoint and an efficacy endpoint as well as use simulation studies to ascertain their properties. We provide a real-life application and a free R package gen2stage to facilitate direct use of two-stage designs in a safety study.

• Journal of Korean Neurosurgical Society
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• 제62권4호
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• pp.487-491
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• 2019

Conservative therapy with appropriate antibiotics is essential for most patients with infectious spondylitis. Although most antibiotics do not cause problems if it used properly and serious side effects are rare, side effects can occur with any class of drugs and adverse reactions of antibiotics can range from mild allergic reactions to serious and fulminant adverse events. These side effects are also extremely variable from patient to patient and from antibiotic to antibiotic. A side effect of antibiotics may paradoxically increase inflammatory marker levels. Here, the author presents two cases of antibiotic-induced increase in inflammatory markers in cured infectious spondylitis. The patients were successfully treated after stopping the antibiotic therapy. The differential diagnosis between antibiotic side effects and infection should be considered very carefully because the treatment is completely different. Although the exact mechanisms underlying successful treatment without antibiotics are unclear, we should consider the side effects of antibiotics when following inflammatory markers during treatment of infectious spondylitis.

• Korean Journal of Acupuncture
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• 제40권3호
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• pp.55-61
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• 2023

Objectives : To review the needling depth, therapeutic and adverse effects of intraperitoneal acupuncture and related acupoints. Methods : Studies and reports from the literature, Korean medical health insurance data and databases were searched and selected. Results : The depth of needle insertion for acupoints related to intraperitoneal acupuncture has been documented to range from 0.9 to 10.5 cm depending on the acupoints and literature. In studies of safe needling depth, the justice of safe needling depth varied from study to study, but was generally based on the peritoneum, and the depth varies by patient age, sex, body type, and weight. Clinical studies in China have shown good efficacy and no side effects of abdominal long needle acupuncture, but there have been case reports of adverse events following abdominal acupuncture. Conclusions : To ensure both therapeutic effectiveness and safety of intraperitoneal acupuncture, It is necessary to utilize the ultrasound in clinical practice and conduct related research.

• Journal of Yeungnam Medical Science
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• 제39권1호
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• pp.62-66
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• 2022

Immune checkpoint inhibitor (ICI)-associated adrenal insufficiency is rare but may become a serious adverse event in patients treated with ICIs. The present case report documents two cases of adrenal insufficiency developed during chemotherapy plus tislelizumab (百泽安, Baize'an; BeiGene Ltd.) therapy in patients with advanced gastric cancer. Adrenal insufficiency developed after 6 and 13 cycles of treatment and was well controlled with hydrocortisone. The patients also developed hypothyroidism, which was managed with levothyroxine. Two patients showed a partial response, and one patient out of two achieved a near-complete response, sustaining over 11 months. Increased awareness of ICI-related adrenal insufficiency is crucial for early detection and prompt management of patients treated with ICIs.

• 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.

• 한방비만학회지
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• 제7권1호
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• pp.1-7
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• 2007

Background : Use of Ma Huang is controversial. Multiple reports of adverse effects led the U.S. Federal Drug Administration (FDA) to announce about prohibiting dietary supplements containing ephedrine alkaloids/Ma Huang. Objective : The objective of the study was to review the evidence from literature and rigorous clinical trials on the dosage, effectiveness, and adverse effects. Methods : Literature searches were conducted in U.S. FDA database after 2003 and digital Uibujeonok(醫部全錄). Hand searches of medical journal and bibliographies of identified articles were conducted. Results : Ma Huang has been used in Korean Oriental Medicine to treatment asthma and other ailments. Recently, Ephedrine/Ma Huang are used for weight loss or to enhance athletic performance in Europe and America, Korea. Ephedrine/Ma Huang are associated with increased risk of psychiatric, autonomic, or gastrointestinal symptoms, and heart palpitations. In addition to that, a risk of serious adverse events, including heart attack, stroke, epilepsy and psychiatric problem are also have been reported. Therefore, max dose of total alkaloids of ephedrine is studied in need of a specialist's part. Conclusion : In most reports, Ma Huang effectively promoted short-term weight loss and enhancement of athletic performance, But, safety with long-term use requires further investigation.

• Clinical and Experimental Pediatrics
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• 제57권4호
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• pp.164-170
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• 2014

Influenza causes acute respiratory infections and various complications. Children in the high-risk group have higher complication and hospitalization rates than high-risk elderly individuals. Influenza prevention in children is important, as they can be a source infection spread in their communities. Influenza vaccination is strongly recommended for high-risk children with chronic underlying circulatory and respiratory disease, immature infants, and children receiving long-term immunosuppressant treatment or aspirin. However, vaccination rates in these children are low because of concerns regarding the exacerbation of underlying diseases and vaccine efficacy. To address these concerns, many clinical studies on children with underlying respiratory diseases have been conducted since the 1970s. Most of these reported no differences in immunogenicity or adverse reactions between healthy children and those with underlying respiratory diseases and no adverse effects of the influenza vaccine on the disease course. Further to these studies, the inactivated split-virus influenza vaccine is recommended for children with underlying respiratory disease, in many countries. However, the live-attenuated influenza vaccine (LAIV) is not recommended for children younger than 5 years with asthma or recurrent wheezing. Influenza vaccination is contraindicated in patients with severe allergies to egg, chicken, or feathers, because egg-cultivated influenza vaccines may contain ovalbumin. There has been no recent report of serious adverse events after influenza vaccination in children with egg allergy. However, many experts recommend the trivalent influenza vaccine for patients with severe egg allergy, with close observation for 30 minutes after vaccination. LAIV is still not recommended for patients with asthma or egg allergy.

• 한국임상약학회지
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• 제30권1호
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• pp.11-18
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• 2020

Background: Nivolumab and pembrolizumab are antagonists of the programmed death-ligand 1 (PD-L1) receptor that function as immuno-oncological agents. This study aimed to evaluate the safety and efficacy of nivolumab and pembrolizumab in elderly patients in outpatient settings. Methods: The safety and efficacy of nivolumab and pembrolizumab were compared retrospectively among patients at the Veterans Health Service (VHS) Medical Center in Seoul, South Korea, from September 1, 2017 to August 25, 2018. Results: Eighty-seven patients were selected for the study. The median progression-free survival was 63 days for nivolumab (95% confidence interval (CI), [14 to 282]) vs. 243 days for pembrolizumab (95% CI, [22 to 348]) (p =0.04). The objective response rate (ORR) was 0% in the nivolumab group vs 5.6% in the pembrolizumab group (p =0.310). All the patients exhibited treatment-related adverse effects. More than 89% of the patients exhibited diseases of the gastrointestinal (GI) tract. Pneumonia, of grades three or higher, was the most common adverse effect, followed by weakness and anorexia. Conclusions: There was no statistically significant difference between the nivolumab group and the pembrolizumab group with respect to the ORR. The incidence and severity of the adverse effects in this study were higher than those of previous studies; however, these adverse effects are generally manageable in a real-world clinical setting. Further randomized controlled studies will be necessary to confirm these results in elderly patients.