• Korean Journal of Acupuncture
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• 제25권2호
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• pp.95-105
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• 2008

Objectives : This study is to establish the appropriate assessment of causalities from adverse events (AEs) which are related to acupuncture treatment. Methods : We assessed thirty AEs which were caused in the early phase trial on concomitant use of acupuncture and herbal medicines. We scored each AE on the questionnaire in Naranjo and SNU algorithm scale which are for drug causality assessment in pharmacoepidemiology. Results : In Naranjo scale, there were consistencies among the evaluators qualitatively with "Probable", "Possible" degree. In reliability test, parameters, such as, gamma and kendall's tau-b revealed the degrees of 73%, and 32%, respectively. There were disaccordant tendency in SNU algorithm scale. Conclusion : A new algorithm which reflects acupuncture properties should be developed and elucidated.

• 한국임상약학회지
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• 제15권2호
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• pp.94-99
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• 2005

The aim of this study was to evaluate the safety and efficacy of treatment of mesoglycan. This study was conducted between September 2003 and May 2004. A total of 292 patients with vascular disorders including cerebral infarction were enrolled. The patients were administered with 50-100mg of mesoglycan by an oral route everyday for eight weeks. Subjective physicians' assessments of efficacy had ratings of 'improvement', 'invariability', 'exacerbation' and 'not being able to assess'. An improvement was observed in 241 patients out of 274; 18 patients were rules out. The efficacy rate was influenced statistically significantly by the duration of therapy (p=0.0392) and daily mean drug dose (p<0.0001). The adverse events were reported in 8 patients (9 cases) out of 292 patients: skin/appendages disorders (0.7%), liver/biliary system disorders (0.7%), cardiovascular system disorders (0.7%), neurologic disorders (0.3%). respiratory disorders (0.3%) and gastrointestinal system disorders (0.3%). There showed no serious adverse events. These results indicate that mesoglycan was well tolerated and effective for the prevention of vascular disorders.

• Industrial Engineering and Management Systems
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• 제8권1호
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• pp.37-46
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• 2009

Patient safety has become a growing concern in health care. The U.S. Institute of Medicine (IOM) report "To Err Is Human: Building a Safer Health System" in 1999 included estimations that medical error is the eighth leading cause of death in the United States and results in up to 100,000 deaths annually. However, many adverse events and errors occur in surgical practice. Within all kinds of surgical adverse events, wrong-side/wrong-site, wrong-procedure, and wrong-patient adverse events are the most devastating, unacceptable, and often result in litigation. Much literature claims that systems must be put in place to render it essentially impossible or at least extremely difficult for human error to cause harm to patients. Hence, this research aims to develop a prototype system based on active RFID that detects and prevents errors in the OR. To fully comprehend the operating room (OR) process, multiple rounds of on site discussions were conducted. IDEF0 models were subsequently constructed for identifying the opportunity of improvement and performing before-after analysis. Based on the analysis, the architecture of the proposed RFID-based OR system was developed. An on-site survey conducted subsequently for better understanding the hardware requirement will then be illustrated. Finally, an RFID-enhanced system based on both the proposed architecture and test results was developed for gaining better control and improving the safety level of the surgical operations.

• Perspectives in Nursing Science
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• 제13권1호
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• pp.1-9
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• 2016

Purpose: The purpose of this study was to identify the current state of research on healthcare professionals who make medical errors, who are known as "second victims", and support systems for them. Methods: An extensive search was conducted in electronic databases, Google, and websites related to patient safety using search terms such as "second victims", "medical errors", "adverse events", and "sentinel events". Results: Research to date in Korea has rarely focused on healthcare professionals' experiences after making medical errors. Abroad, there are comprehensive and systematic reviews of the impact of medical errors on healthcare professionals, their coping responses, and support systems for these second victims. Additionally, several institutes related to patient safety provide official guidelines and accessible support systems to support second victims in the aftermath of medical errors, especially serious adverse events. Conclusion: The impact of medical errors on healthcare professionals is profound and complex. Although systematic support systems for second victims are imperative, this has been overlooked in Korea. Thus, more research about the experiences of healthcare professionals after medical errors needs to be conducted prior to developing support systems or programs. Additionally, further efforts are required to raise awareness of the necessity of supporting healthcare professionals in healthcare systems.

• The Korean Journal of Pain
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• 제26권1호
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• pp.3-13
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• 2013

Chronic noncancer pain is a significant and growing public health challenge in the United States. Lacking effective alternative interventions for effective chronic noncancer pain management, many physicians have turned to opioid pharmacotherapy. Increased opioid prescribing brings not only gains in therapeutic benefit but also a higher incidence of adverse drug events including increased medication misuse and opioid related mortality. Currently the United States must confront the dual problems of widespread undertreated chronic noncancer pain and a prescription opioid abuse crisis. Withholding pain relieving drugs from patients in need is unjustifiable, yet drug diversion, abuse and adverse drug events have become major social as well as medical problems. At the heart of this crisis is the lack of definitive evidence about the risk to benefit ratio of opioid pharmacotherapy for chronic noncancer pain both on an individual case and on a population basis. This article describes the extent and severity of the American chronic noncancer pain problem and the history of opioid pharmacotherapy for chronic noncancer pain in the United States. It then discusses the concept of evidence based practice and reviews current evidence supporting opioid pharmacotherapy for chronic noncancer pain as well as adverse drug events related to opioid pharmacotherapy including misuse and abuse. Finally, it considers the conflict of providing pain relief versus protecting society and reviews steps that governmental agencies, industry and others are taking to contain and ultimately resolve the problems of excessive prescribing and conflicting priorities.

• 대한한방내과학회지
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• 제43권1호
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• pp.79-89
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• 2022

This study examined the clinical effects of Korean medicine therapy in a patient with hypopharyngeal cancer treated with chemotherapy. A 53-year-old male patient suffering from hypopharyngeal cancer was treated with docetaxel as well as acupuncture and herbal medicine. Tumor size was measured by computed tomography (CT) and adverse events were evaluated according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. After two months of combined treatment, the size of the tumor mass was reduced at the left side of the neck, posterior to the CCA and at the lymph node in the left retropharyngeal area and medial aspect of the carotid sheath. The adverse events of chemotherapy also improved. This study indicates that Korean medicine therapy, such as acupuncture and herbal medicine, may lessen the side effects of chemotherapy and may be effective in the treatment of hypopharyngeal cancer.

• Journal of Korean Neurosurgical Society
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• 제65권6호
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• pp.853-860
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• 2022

Objective : This prospective, randomized, double-blinded trial aimed to evaluate the efficacy and safety of prophylactic ramosetron administration against postoperative nausea and vomiting (PONV) in patients undergoing microvascular decompression (MVD). Methods : In this study, 100 patients undergoing MVD were randomly allocated to the control (normal saline, 2 mL) or ramosetron (ramosetron, 0.3 mg) groups at the end of surgery. The incidence and severity of PONV, need for rescue antiemetics, patient satisfaction score, duration of hospital stay, and the occurrence of adverse events were evaluated 48 hours post-surgery. Results : Data obtained from 97 patients were included in the final analysis. The incidence of PONV was significantly lower in the ramosetron group than in the control group throughout the 48-hour postoperative period (29.2% vs. 51.0%, p=0.028). A similar trend was observed with regard to PONV severity (p=0.041). The need for rescue antiemetics, satisfaction score, duration of hospital stays, and the occurrence of adverse events did not significantly differ between the groups. Conclusion : Prophylactic ramosetron administration reduced the incidence and severity of PONV in patients undergoing MVD without causing serious adverse events. Thus, ramosetron use may improve patient recovery following MVD.

• Journal of Yeungnam Medical Science
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• 제38권4호
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• pp.366-370
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• 2021

Immune checkpoint inhibitors (ICIs) have become the main drugs for programmed cell death receptor-1 or ligand-1 expressing non-small cell lung cancer (NSCLC) combined with conventional chemotherapy. ICIs are generally more tolerable than cytotoxic chemotherapies in terms of toxicity, and ICI-related adverse events are mild and manageable. However, these drugs may lead to unexpected severe adverse events such as immune-related hematologic toxicities, which could be life-threatening. Here, a rare case of a pembrolizumab-related adverse event in a patient with NSCLC who showed early-onset hemolytic anemia and recovered by high-dose steroid and a series of plasma exchanges is reported.

• 한국컴퓨터정보학회논문지
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• 제14권3호
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• pp.183-192
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• 2009

약물부작용감시시스템 (Adverse drug event surveillance system)은 약물부작용신호를 이용하여 약물의 부작용 여부를 식별하는 시스템이다. 기존의 자발적 보고나 차트리뷰 보다 효율성이 뛰어난 시스템으로 분류할 수 있다. 본 논문에서는 약물부작용감시시스템을 구현하기 위하여 임상데이터마트(GDM)를 구축하였다. 특히, 데이터 품질관리 기법을 적용하여 구축된 CDM에 지식 탐사 기법 중 비교사학습 기법으로 적용하여 모델의 재현성을 평가하여 최적의 약물부작용 군집화 개수(n=4)를 도출하였다. 군집화 개수(n=4)를 이용하여 약물부작용 판별을 위한 K-means, Kohonen, two-step clustering model 알고리즘에 적용하여 분석함으로써 K-means 알고리즘이 가장 우수한 군집 효과를 나타냄을 확인하였다.

• 한방재활의학과학회지
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• 제21권2호
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• pp.265-278
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• 2011

Objectives : This trial were conducted to evaluate the efficacy and adverse events of Bofutsusho-san(BTS) and Boiogiot-tang(BOT) by oriental obesity pattern identification on obese subjects, as compared to placebo. Methods : 166 subjects(body mass index ${\geq}25kg/m^2$) were recruited and randomized to receive BT(n=55), FH(n=55) or placebo(n=56) for 8 weeks. Anthropometric factors, serum lipid, glucose, blood pressure(BP), pulse rate, resting metabolic rate and oriental obesity pattern identification questionnaire were measured at baseline and 8 weeks. Adverse events and safety outcome variables were also checked during trials. Results : The frequency of top-scored oriental obesity pattern was ordered by indigestion(食積) > stagnation of the liver qi(肝鬱) > yang deficiency(陽虛) > spleen deficiency(脾虛) > phlegm(痰飮) > blood stasis(瘀血) in subjects. BTS group significantly decreased body weight, body mass index(BMI), waist circumference(WC), body fat mass, total cholesterol and HDL-cholesterol in stagnation of the liver qi(肝鬱) and WC in indigestion(食積). BOT group showed significant decrease of body weight, BMI, WC, and body fat mass in indigestion(食積) not in deficiency(虛症). Adverse events were reported most frequently in yang deficiency(陽虛) by BT group and stagnation of the liver qi(肝鬱) by BOT group. Conclusions : Bofu-tsusho-san was effective in treating obesity with stagnation of the liver qi(肝鬱). Obesity pattern identification could be a useful diagnostic tool predicting treatment effects and adverse events.