• 한국임상약학회:학술대회논문집
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• 한국임상약학회 2004년도 The 4th Conference on Clinical Pharmacy
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• pp.37-44
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• 2004

• Clinical and Experimental Pediatrics
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• 제53권7호
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• pp.741-744
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• 2010

Purpose: To evaluate the long-term safety of polyethylene glycol (PEG) 4000 in children with constipation, particularly the biochemical aspects of safety. Methods: Medical records were evaluated, and 100 children, who had been taking PEG 4000 for more than 6 months, and who had been under clinical and biochemical monitoring, were enrolled. Ages; $6.11{\pm}3.12$ years, Duration of therapy; $16.93{\pm}7.02$ months, dose of PEG 4000; $0.72{\pm}0.21g/kg/d$. Results: None of the children complained of clinical adverse effect. The first biochemical test was performed at 8.05 months after beginning of PEG 4000. Serum phosphate (SP) value was high in 10 children, and leucopenia was noted in one child. The second test was performed in 44 children at 7.57 months after the first test. The SP value was high in four children, including the three children whose initial SP value was high and one new child. Six out of 10 children with high initial SP value became normal and one was lost. Hypernatremia was noted in one child. The third test was done in 15 children at 7.5 months after the second test. The SP value of the new child from the second test was high, but became normal after finishing treatment. Two out of 3 children with high SP value at the second test became normal and one was lost. The fourth test was done in 2 children few months after the third test. All of the results were normal. There were no relation between duration of therapy and hyperphosphatemia, or between dose of PEG 4000 and hyperphosphatemia. Conclusions: PEG 4000 is safe for long-term therapy in children with constipation with respect to biochemical parameters.

• 한국임상약학회지
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• 제5권2호
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• pp.51-60
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• 1995

Obesity is defined as excessive storage of energy in the form of fat resulting in adverse effect on healthy and longevity. Some data have shown increased incidence of hypertension, diabetes, hypercholesterolemia in overweight individuals and other disorders such as joint disease, cancer have been also associated with obesity. Recently, various commercial diet programs have been introduced for weight reduction without scientific evaluation for clinical effect and safety. The diet program must be based on a sound and scientific rationale and also be safe and nutritionally adequate. Pulmuone $diet^{(R)}$ is a calorie-restricted commercial diet-food, which contains adequate nutritients. The efficacy and safety of Pulmuone diet were evaluated in 28 normal healthy obese females in a prospective study. Each volunteer was placed in 3-week diet program. To observe weight reduction effect, body weight, TSF and AMC were measured every week. To account for safety of this program, blood chemistry test, blood pressure and side effects were monitored every week. Mean body weight was reduced by 3.24kg following diet program, which is statistically significant(P < 0.05) and this weight reduction was related to reduction in fat weight and not muscle weight as shown by the results of TSF and AMC Blood chemistry was not influenced by this program, but blood pressure was significantly reduced following this program. Thought diet program was generally well tolerated in most volunteers, the most frequent side effects are constipation, dizzness and headache. In conclusion, Pulmuone $diet^{(R)}$ program seems to be safe and effective for weight reduction in normal healthy obese females.

• Archives of Plastic Surgery
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• 제42권6호
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• pp.721-728
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• 2015

Background We conducted this clinical study to compare the efficacy and safety between Neuramis Deep and Restylane in the correction of nasolabial folds. Methods In this phase III, randomized, multi-center, double-masked, matched-pairs, active-controlled trial (ClinicalTrials.gov Identifier: NCT01585220), we evaluated a total of 67 subjects (n=67). All the subjects underwent Neuramis Deep treatment on one side and Restylane on the contralateral side of the bilateral nasolabial folds at a ratio of 1:1. To compare the efficacy of Neuramis Deep and Restylane, we evaluated the Wrinkle Severity Rating Scale scores and those of the Global Aesthetic Improvement Scale. In addition, we compared the safety of Neuramis Deep and Restylane based on adverse events, physical examination, and clinical laboratory tests. Results Neuramis Deep was not inferior in improving the nasolabial folds as compared with Restylane. In addition, there was no significant difference in the efficacy between Neuramis Deep and Restylane. There were no significant differences in safety parameters between Neuramis Deep and Restylane. Conclusions In conclusion, our results indicate that Neuramis Deep may be a safe, effective material for improving the nasolabial folds. However, further studies are warranted to compare the tolerability of Neuramis Deep and Restylane based on histopathologic findings.

• 대한한의학회지
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• 제31권3호
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• pp.1-7
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• 2010

Objectives: To introduce to TKM scientific dose conversion methods of human to animal or animal to human for new drug investigations. Methods: We searched guidelines of the FDA and KFDA, and compared them with references for drug-dose conversion from various databases such as PubMed and Google. Then, we analyzed the potential issues and problems related to dose conversion in safety documentation of new herbal drugs based on our experiences during Investigational New Drug (IND) applications of TKM. Results: Dose conversion from human to animal or animal to human must be appropriately translated during new drug development. From time to time, investigators have some difficulty in determining the appropriate dose, because of misunderstandings of dose conversion, especially when they estimate starting dose in clinical or animal studies to investigate efficacy, toxicology and mechanisms. Therefore, education of appropriate dose calculation is crucial for investigators. The animal dose should not be extrapolated to humans by a simple conversion method based only on body weight, because many studies suggest the normalization method is based mainly on body surface area (BSA). In general, the body surface area seems to have good correlation among species with several parameters including oxygen utilization, caloric expenditure, basal metabolism, blood volume and circulating plasma protein. Likewise, a safety factor should be taken into consideration when deciding high dose in animal toxicology study. Conclusion: Herein, we explain the significance of dose conversion based on body surface area and starting dose estimation for clinical trials with safety factor.

• 동의생리병리학회지
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• 제25권2호
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• pp.242-245
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• 2011

Socheongryong-tang has been used for the treatment of inflammatory allergic diseases such as allergic rhinitis and bronchial asthma in Asian countries. This study was conducted to investigate the safety of Socheongryong-tang in rats. The safety of this tang on acute toxicity was evaluated by single dose toxicity study. Rats were orally administrated in a single dose of 0 and 2000 mg/kg (limited dose) Socheongryong-tang. There were 7 rats in each groups. All animals were sacrificed after 14 days of treatment. After single administration, mortality, clinlcal signs, body weight changes and gross pathological findings were observed for 14 days. Three parameters were tested: organ weight measurement, clinical chemistry, and hematology. In this study with rats, Socheongryong-tang treatment did not show any acute toxicity. No mortality was noted for 14 days of treatment. There were no adverse effects on clinical signs, body weight, organ eight and gross pathological findings at all treatment groups. The clinical chemistry parameters attesting to liver and kidney functions as well as the hematological parameters were within the normal ranges. From single dose toxicity study with rats, it is considered that $LD_{50}$ of Socheongryong-tang is over 2000 mg/kg in oral administration. This finding of the safety on single dose toxicity study of Socheongryong-tang are expected to strengthen the position of Socheongryong-tang as nontoxic medicine.

• Clinical Endoscopy
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• 제56권3호
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• pp.333-339
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• 2023

Background/Aims: Intragastric balloon (IGB) is the only available endoscopic bariatric and metabolic therapy in Korea. End-ball (Endalis) has the longest history of clinical use among the IGBs available in Korea. However, little clinical data on this system have been reported. In this study, we aimed to evaluate the efficacy and safety of End-ball in Korea. Methods: We performed a retrospective cohort study of patients who underwent IGB insertion (End-ball) from 2013 to 2019. Demographic and anthropometric data were collected. The efficacy and safety of IGB treatment were analyzed. Results: In total, 80 patients were included. Mean age was 33.7 years and 83.8% were female. Initial body mass index was 34.48±4.69 kg/m². Body mass index reduction was 3.72±2.63 kg/m² at the time of IGB removal. Percent of total body weight loss (%TBWL) was 10.76%±6.76%. Percentage excess body weight loss was 43.67%±27.59%. Most adverse events were minor, and 71.4% of participants showed nausea, vomiting, or abdominal pain. Conclusions: IGB treatment showed good efficacy and safety profile in Korean patients with obesity. In terms of %TBWL and percentage excess body weight loss, the efficacy was similar to that in the Western population.

• 대한임상전기생리학회지
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• 제10권2호
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• pp.43-49
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• 2012

Purpose : This study is to supply basal data need to development of First-Aid education program for female college students of non-health department that we surveyed safety awareness practice, First-Aid knowledge, educational requirement and necessity of the female college students of health and non-health department. Methods : This date was collected from September 1th in 2012 until October 5th by 5 person selected of which explain to purpose and method of the writing. We distributed the subject questionnaire of total 410 and analyzed questionnaire 385 only. Results : The results of this study are follows. First, the health group was higher than non-health group in conductive score of safety awareness and score of First-Aid knowledge in female students and there was statistically significant difference. Second, There was significant difference in Economical state, Educational state of the Safety awareness Practice score and First-Aid knowledge score about the general characteristic of the female college students of health department. Third, there wasn't significant difference in most of all item of the Safety awareness Practice score and First-Aid knowledge score about the general characteristic of the female college students of non-health department. Conclusion : Finally, We found that the female college students of health department lower than the female college students of non-health department in First-Aid knowledge level and surveyed that they felt the needs of First-Aid education. Therefore, there are able to need the opening of a course in order to raise the quality of safety awareness and First-Aid knowledge or to needs construction of educational system in continuously.

• International Journal of Safety
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• 제10권1호
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• pp.5-9
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• 2011

Two popular activity coefficient models, Wilson and NRTL equations have been used to correlate the published flash point data on the n-propanol + propionic acid and n-butanol + propionic acid systems through the optimization method. The results of these correlation were compared with the results calculated by Raoult's law. The optimization method were found to be better than those based on the Raoult's law. The optimization method based on the Wilson equation described the published data more effectively than was the case when the optimization method was based upon the NRTL equation.

• International Journal of Safety
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• 제8권2호
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• pp.15-19
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• 2009

The flash point is the most widely used flammability property for the evaluation of the flammability hazard of combustible liquid mixtures. In this paper, the reported flash points for the the binary systems, ethylbenzene+n-butanol and ethylbenzene+n-hexanol were correlated by the optimization method. The optimization method based on the van Laar and Wilson equations were compared with the Raoult's law. The calculated values based on the optimization method were found to be better than those based on the Raoult's law.