• Safety and Health at Work
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• v.10 no.4
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• pp.518-526
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• 2019

Background: Additive manufacturing (AM) is a rapidly expanding new technology involving challenges to occupational health. Here, metal exposure in an AM facility with large-scale metallic component production was investigated during two consecutive years with preventive actions in between. Methods: Gravimetric analyzes measured airborne particle concentrations, and filters were analyzed for metal content. In addition, concentrations of airborne particles <300 nm were investigated. Particles from recycled powder were characterized. Biomonitoring of urine and dermal contamination among AM operators, office personnel, and welders was performed. Results: Total and inhalable dust levels were almost all below occupational exposure limits, but inductively coupled plasma mass spectrometry showed that AM operators had a significant increase in cobalt exposure compared with welders. Airborne particle concentrations (<300 nm) showed transient peaks in the AM facility but were lower than those of the welding facility. Particle characterization of recycled powder showed fragmentation and condensates enriched in volatile metals. Biomonitoring showed a nonsignificant increase in the level of metals in urine in AM operators. Dermal cobalt and a trend for increasing urine metals during Workweek Year 1, but not in Year 2, indicated reduced exposure after preventive actions. Conclusion: Gravimetric analyses showed low total and inhalable dust exposure in AM operators. However, transient emission of smaller particles constitutes exposure risks. Preventive actions implemented by the company reduced the workers' metal exposure despite unchanged emissions of particles, indicating a need for careful design and regulation of the AM environments. It also emphasizes the need for relevant exposure markers and biomonitoring of health risks.

• Asian Pacific Journal of Cancer Prevention
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• v.15 no.14
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• pp.5945-5950
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• 2014

Objectives: To retrospectively review the safety and clinical efficacy of bevacizumab concomitant with chemotherapy in Chinese patients with advanced non-squamous non-small cell lung cancer (NSNSCLC). Methods: Clinical data for 79 patients with NSNSCLC who received bevacizumab concomitant with chemotherapy in Chinese PLA General Hospital from April 28th 2009 to May 5th 2013 were retrospectively reviewed to analyze the clinical efficacy including disease control rate (DCR), overall response rate (ORR), progression-free survival (PFS), overall survival (OS), the Eastern Cooperative Oncology Group (ECOG) score and the safety. Results: The Eastern Cooperative Oncology Group (ECOG) score was 0-2. By the final cutoff date (June 9, 2013), 54 (68.4%) patients had disease progression and 37 (46.8%) died. The ORR was 32.9% and the DCR was 83.5%. The ORR of the first-, second-, and third- or later-line treatments were 51.4%, 25.0% and 12.5%, while the DCR were 94.3%, 80.0% and 70.8%, respectively. The median OS (mOS) and PFS (mPFS) were 13.5 and 5.83 months, respectively. The mOS of patients with the first-, second-, and third- or later- line treatments were 16.2, 10.9 and 8.30 months, while the mPFS were 7.27, 5.90 and 5.17 months, respectively. Chemotherapy-related adverse events included myelosuppression, vomiting, hepatic dysfunction and renal dysfunction, while the common serious bevacizumab-related adverse events were thromboembolic problems, gastrointestinal perforation and reversible posterior leukoencephalopathy syndrome, which could be well managed. Conclusions: Bevacizumab concomitant with chemotherapy is effective and the related toxicity can be well tolerated in Chinese patients with NSNSCLC.

• Communications for Statistical Applications and Methods
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• v.16 no.1
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• pp.51-65
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• 2009

The purpose of a phase I clinical trial is to determine the maximum tolerated dose(MTD) of a new drug. This paper investigates the performance of standard method, continual reassessment method and accelerated titration designs in phase I clinical trials. Especially we study the precision and safety at the MTD of these methods. We utilize hyperbolic tangent function and power function to define dose-toxicity model. For each method, expected toxicity rate at MTD is computed and compared with target toxicity probability. We also suggest some modifications of these methods and show some improvements in performance.

• Safety and Health at Work
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• v.11 no.1
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• pp.88-96
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• 2020

Background: The current lack of the number of nurses and high nurse turnover rate leads to major problems for the health-care system in terms of cost, patient care ability, and quality of care. Theoretically, burnout may help link emotional labor with turnover intention. The purpose of this study was to investigate the mediating effect of burnout in the association between emotional labor and turnover intention in Korean clinical nurses. Methods: Using data collected from a sample of 606 nurses from six Korean hospitals, we conducted a multiple regression analysis to determine the relationships among clinical nurses' emotional labor, burnout, and turnover intention, looking at burnout as a mediator. Results: The results fully and partially support the mediating role of burnout in the relationship between the subfactors of emotional labor and turnover intention. In particular, burnout partially mediated the relationship between emotional disharmony and hurt, organizational surveillance and monitoring, and lack of a supportive and protective system in the organization. In addition, we found that burnout has a significant full mediation effect on the relationship between overload and conflicts in customer service and turnover intention. Although the mediating effect of burnout was significantly associated with the demands and regulation of emotions, no significant effects on turnover intention were found. Conclusion: To reduce nurses' turnover, we recommend developing strategies that target both burnout and emotional labor, given that burnout fully and partially mediated the effects of emotional labor on turnover intention, and emotional labor was directly associated with turnover intention.

• Korean Journal of Clinical Pharmacy
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• v.10 no.2
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• pp.51-56
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• 2000

Deflazacort, an oxazoline derivative of prednisolone, has been claimed to have anti-inflammatory effects with fewer side effects compared to prednisone. The objectives of the study were to evaluate efficacy and safety of deflazacort in children with nephrotic syndrome. Eligible Patients were the children with nephrotic syndrome who were treated with deflazacort from October. 1994 to April. 1999. Nephrotic syndrome was defined as having albumin level of less than 2.5 mg/dL and 24-hour urinary protein excretion of greater than $40\;mg/m^2/hr$. The primary parameters evaluating the efficacy of deflazacort were response rate, time to respond and relapse frequency. The safety profiles were the impact on children's growth, calcium sparing effect, glucose metabolism, lipid profile and adverse drug reactions. As results, total of 60 children were evaluated (47 boys, 13 girls). Response rate was $95\%$ (57/60) for initial and late responders. Median time to respond was 12 days (range 7-110 days) and median relapse frequency was one time (range 0-6). Weight/height ratio increased from $22.05\pm3.47\;to\23.20\pm3.44\;kg/m$ (p<0.001) and plasma calcium level, from $7.55\pm3.86\;to\;9.98\pm3.77\;mg/dL$ after treatment (p<0.001). Change of fasting glucose level was not statistically significant $(91.92\pm3.53\;vs.\;98.19\pm4.78\;mg/dL,\;p=0.072)$, while change of total cholesterol was significant $(362.3\pm12.0\;vs\;251.4\pm11.5\;mg/dL$, p<0.001). In conclusion, patients on deflazacort showed similar efficacy in treatment of nephrotic syndrome as reported for prednisone with less impact on growth inhibition and metabolic side effects of hyperglycemia and hyperlipidemia.

• CELLMED
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• v.9 no.4
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• pp.6.1-6.4
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• 2019

Background: Hypertension is one of the major risk factors for stroke, heart attack, heart failure and kidney failure, thereby causing deaths and disability world-wide. The most predominant type of HTN is essential hypertension (HTN). Unani scholars have mentioned about the clinical manifestations and management of the hypertension and documented it in the context of 'Imtila'. The drug Sankhaholi (Evolvulus alsinoides Linn.) is one of the widely prescribed medicines for the management of essential hypertension in Unani medicine. Material and Methods: The present clinical study was carried out to evaluate the safety of Sankhaholi (Evolvulus alsinoides Linn.) in the management of stage-1 essential hypertension. Newly diagnosed 41 patients of Essential Hypertension (22 patients were in the test group and 19 patients in the control group) were enrolled for the study. All the patients in the test group were given with the test drug 3 g powder of Sankhaholi twice a day for 6 weeks orally. Patients in the control group were given standard drug Ramipril 5 mg once a day for the same duration. Clinical as well as hematological parameters were recorded before and after the treatment. Results: No significant changes are recorded in safety parameters viz. CBC, Haemogram, LFT and KFT. Clinically no adverse effect of the drug has been reported during the course of treatment. Also, significant effect on the systolic blood pressure (p<0.001) were recorded in test group. The drug Sankhaholi was also found effective on the symptoms associated with hypertension. Conclusion: The finding of the study revealed that the test drug Sankhaholi (Evolvulus alsinoides Linn.) is safe and has substantial efficacy as an antihypertensive drug.

• Korea Journal of Hospital Management
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• v.23 no.4
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• pp.15-25
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• 2018

Purposes: The objectives of this study present the direction of the criteria for the separately reimbursement of therapeutic medical device. Methodology: We summarized experts' opinion using Delphi survey and Analytic Hierarchy Process(AHP). 48 experts were gathered from Medical Insurance Review Nurses Association, medical device industry, academy and association, Medical Device Expert Evaluation Committee. Descriptive statistics, consistency index, content validity ratio were analyzed. Findings: Clinical utility, patient safety, infection control, cost-homogeneity, cost-effectiveness showed high feasibility and importance, but market contribution and functional utility showed low feasibility and importance in a relative sense. The results of functional utility differed between clinical and non-clinical experts. Measurability was low across the whole area. Among the criteria for the separately reimbursement of therapeutic medical device. Patient safety/infection control and clinical utility showed the highest relative importance values, analyzed using AHP. Practical Implications: Patient safety and infection control are needed to be considered as one of Value Assessment Criteria. It is important to find out how to improve the measurability of therapeutic medical device.

• The Korea Journal of Herbology
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• v.34 no.1
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• pp.13-21
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• 2019

Objectives : This clinical trial is performed to investigate the effect of improving the hypersensitivity reaction and the safety of powdered ethanol extract Codonopsis lanceolata (S. et Z.) Trautv. for allergic patients. Methods : This study was randomized, double blinded, placebo-controlled clinical trial. 60 allergic rhinitis subjects were randomly assigned to Treatment group(n=30) and Control group(n=30). They were received the test substance or placebo in their $1^{st}$ and $2^{nd}$ visit, and took it once a day, 1 powder bag per 1 time, for 8 weeks. The freeze dried powder of Codonopsis lanceolata (S. et Z.) Trautv. was mixed with 30% ethanol and the filtrate was collected thrice with constant stirring of the mixture. The placebo was prepared in the same form as the test substance by replacing with corn starch. Total Nasal Symptom Score(TNSS) questionnaires and laboratory tests were performed at the screening and last visit to evaluate the efficacy. And to assess safety, vital signs and adverse events were confirmed at every visit. Statistical analysis about the result was performed using SAS 9.4. Results : In treatment group, there was a significant decrease in B cell after taking the test substance(p<0.005). And there was a statistically significant difference between groups(p<0.005). Changes in nasal symptoms were not statistically significant between groups, and both groups showed statistically significant differences before and after the test(p<0.0001). Also there were no adverse events associated with the clinical trial product. Conclusions : This clinical trial showed that Codonopsis lanceolata (S. et Z.) Trautv. extract was helpful in improving the hypersensitivity reaction in allergic patients without significant side effects.

• Journal of Society of Preventive Korean Medicine
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• v.26 no.3
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• pp.97-108
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• 2022

Objectives : The purpose of this study is to confirm the efficacy and safety of Gongjin-dan and Ssanghwatang for chronic fatigue. Methods : A total of 90 people, between 19 and 65 years old, will be recruited to participate in a randomized, double-blind, and placebo-controlled a clinical trial. Participants in the Gongjin-dan group will take one pill of Gongjin-dan along with three packs of placebo oral liquid Ssanghwa-tang per day for 4 weeks. Participants in the Ssanghwa-tang group will take three packages of liquid Ssanghwa-tang and one placebo Gongjindan pill per day for 4 weeks. In the placebo group, participants will take one pill of placebo Gongjin-dan and three packs of placebo liquid Ssanghwa-tang per day, for 4 weeks. Outcomes will be measured at the baseline, 4^th week, and 6^th week. The primary outcome is the change in the Fatigue Severity Scale (FSS). Secondary outcomes are the change of Multidimensional Fatigue Inventory-20 (MFI-20), Chalder Fatigue Scale (CFQ), Short-Form 36 Health Survey (SF-36), Korean Version of Schedule of Fatigue and Anergy/General Physician (SOFA/GP), Glucose, Lactate, Ammonia, Free Fatty Acid (FAA), d-ROMs&BAP, Selenium, and Cortisol. Results : This trial was approved by the institutional review board of Pusan National University Korean Medicine Hospital (registry number: PNUKHIRB 2021-10-005). Recruitment opened in November 2021 and is supposed to be completed by December 2022. Conclusions : This trial will provide clinical information to determine the efficacy and safety of Gongjindan and Ssanghwa-tang for chronic fatigue.

• The Journal of Korean Medicine
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• v.43 no.4
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• pp.33-51
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• 2022

Objectives: This study aimed to understand the current status of clinical practice patterns of Korean medicine in the treatment of degenerative arthritis of the hip and finger joints using web-based survey. Methods: An e-mail questionnaire survey was conducted with the Korean Medicine Doctor(K.M.D) registered in the Korean Medicine Association. The survey data were analyzed using Microsoft Excel. Results: Although the response rate of the survey was low, the characteristics of the respondents generally reflected the characteristics of the study population. A total of 35.2% of the respondents had heard of the guidelines; however, they did not use them for medical treatment. The reason as answered by 32.8% of the respondents was "not enough treatment time to check the manual and apply it." More than half (78.80%) answered that they were treating patients with both degenerative hip and finger arthritis; however, the average monthly number of first-time patients was ≤5. A total of 379 (60.9%) respondents answered that "acupuncture is very important," which was the only one that exceeded the majority compared to other treatments. As a result of the safety investigation, "Acupuncture, herbal medicine, cupping" were considered high in safety, while "Pharmacopuncture and Bee venom acupuncture" were considered low in safety. Conclusions: This survey helped to determine the current clinical practice patterns of Korean medicine treatments, further providing basic data for CPGs for degenerative arthritis of the hip and finger joints.