• Biomolecules & Therapeutics
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• 제2권3호
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• pp.247-255
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• 1994

As a series of safety studies of DA-3030, a new rhO-CSF, its local irritancy was examined in the rabbits after the following treatment; application into the conjunctival sac of the eye(single), subcutaneous injection(single), intramuscular injection(single), and intravenous injection(8-day repeated). In addition, paravenous irritation of DA-3030 was investigated in mice. The results obtained were as follows. 1. In the result of ocular irritation test, 0.03% solution of DA-3030 could be considered as a non-irritating material. 2. The local irritation of DA-3030 by an injection of 0.5mι of its solution subcutaneously or intramuscularly was negligible and not so much different from that of saline. 3. In the vascular irritancy test, macro- and microscopic observations revealed that the irritating activity of DA-3030 in blood vessels was not different from that of saline when they were injected once a day into vein retroauricularis of rabbits for 8 days.4. The paravenous administration of DA-3030 did not induce any abnormal changes at injection sites except mild swelling in 1 mouse at 3 hours after injection which was thought to be due to slow absorption. The above-mentioned results suggest that DA-3030 has no irritating activity when injected through intravenous or subcutaneous route for clinical practice as 0.03% solution.

• Journal of the Korean Association of Oral and Maxillofacial Surgeons
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• 제34권2호
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• pp.131-134
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• 2008

Purpose: The objective of this study was to evaluate the clinical parameters in terms of the midazolam sedation in patients undergoing dental practice. Patients and Methods: Total 28 patients were included in this study. They received the dental practice in the daycare center and sedation was done with midazolam. The recorded variables were blood pressure, pulse rate, $SpO_2$, and patient's response. The differences between observations were analyzed with paired samples t-test. Results: The blood pressure was significantly decreased after the administration of midazolam and the systolic pressure was significantly increased at the start of operation (P<0.05). The pulse rate was significantly increased after lidocaine injection (P<0.001). The amnesic effect was shown 21 cases out of 28 cases (75%). Conclusions: The effect of midazolam on pulse rate was not significant. However, midazolam could decrease the blood pressure significantly. Therefore, the sedation with midazolam could be successfully used in the dental practice, particularly for the patients having the hypertension.

• 대한소아치과학회지
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• 제21권2호
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• pp.469-485
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• 1994

The present study was undertaken to examine the relationship between time required for each step in the treatment process for pedodontic patients. and age of the patients, and experience of special training for pedodontics and career of dental practitioners. Information of these matters was gained from 580 questionnaires collected from 69 practitioners (62 male and 7 female). The questionnaires included questions about the patients' sex(303 male and 207 female) and age. The patients were categorized into 5 different age groups : Group 1, age $1{\sim}3$-year ; Group 2, $4{\sim}6$-year ; Group 3, $7{\sim}9$-year ; Group 4, $10{\sim}12$-year ; Group 5, $13{\sim}15$-year. The questions about the dental practitioners were the years of experience in private dental practice(5 years or more than 5 years) and whether or not they took the special training for pedodontics in the authorized institutes. The practitioners were asked to answer the questions about Frankl scale of the patients' behavior during the treatment, and time spent for managing the patients to be subjected to local anesthetic injection (the first behavior control), time for the injection, and time for the subsequent treatment. The results obtained by analyzing the information collected from the questionnaires were as follows : 1. The younger the patients, the lower the Frankl scale was counted at the time of the first behavior control, injection, and the subsequent treatment(p<0.001). 2. The lowest Frankl scale was scored during the injection regardless of the age of the patients. 3. Time for management and treatment was decreased in the order of age Groups 1 and 2< Group 3 < Groups 4 and 5. 4. The patients showed a more positive frankl scale in response to the treatment performed by those who were more-experienced in dental practice as compared with those were less-experienced. 5. Pedodontic training experience of the practitioners did not appear to influence the patients with respect to the treatment time and Frankl scale.

• 대한약침학회지
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• 제18권4호
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• pp.38-44
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• 2015

Objectives: Radix Ginseng has been used for thousands of years to treat a wide variety of diseases. Radix ginseng has also been used as a traditional medicine for boosting Qi energy and tonifying the spleen and lungs. Traditionally, its effect could be obtained orally. Nowadays, a new method, the injection of herbal medicine, is being used. This study was performed to investigate the single-dose intravenous toxicity of water-soluble ginseng pharmacopuncture (WSGP) in Sprague-Dawley (SD) rats. Methods: All experiments were carried out at Biotoxtech, an institute authorized to perform non-clinical studies under the regulation of Good Laboratory Practice (GLP). At the age of six weeks, 40 SD rats, 20 male rats and 20 female rats, were allocated into one of 4 groups according to the dosages they would receive. The WSGP was prepared in the Korean Pharmacopuncture Institute under the regulation of Korea-Good Manufacturing Practice (K-GMP). Dosages of WSGP were 0.1, 0.5 and 1.0 mL/animal for the experimental groups, and normal saline was administered to the control group. The rat's general conditions and body weights, the results of their hematological and biochemistry tests, and their necropsy and histopathological findings were investigated to identify the toxicological effect of WSGP injected intravenously. The effect was examined for 14 days after the WSGP injection. This study was performed under the approval of the Institutional Animal Ethics Committee of Biotoxtech. Results: No deaths were found in this single-dose toxicity test on the intravenous injection of WSGP, and no significant changes in the rat's general conditions and body weights, the results on their hematological and biochemistry test, and their necropsy findings were observed during the test. The local area of the injection site showed minial change. The lethal dose was assumed to be over 1.0 mL/animal in both sexes. Conclusion: These results indicate that WSGP is safe at dosages up to 1 mL/animal.

• 대한약침학회지
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• 제18권3호
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• pp.42-48
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• 2015

Objectives: The aim of the study is to investigate both the single-dose intramuscular injection toxicity and the approximate lethal dose of water-soluble Carthami-flos and Cervi cornu parvum pharmacopuncture (WCFC) in male and female Sprague-Dawley (SD) rats. Methods: The study was conducted at Biotoxtech Co. according to the Good Laboratory Practice (GLP) regulation and the toxicity test guidelines of the Ministry of Food and Drug Safety (MFDS) after approval of the Institutional Animal Care and Use Committee. Dosages for the control, high dose, middle dose and low dose groups were 0.5 mL/animal of saline and 0.5, 0.25 and 0.125 mL/animal of WCFC, respectively. WCFC was injected into the muscle of the left femoral region by using a disposable syringe (1 mL, 26 gauge). The general symptoms and mortality were observed 30 minutes, 1, 2, 4, and 6 hours after the first injection and then daily for 14 days after the injection. The body weights of the SD rats were measured on the day of the injection (before injection) and on the third, seventh, and fourteenth days after the injection. Serum biochemical and hematologic tests, necropsy examinations, and histopathologic examinations at the injection site were performed after the observation period. Results: No deaths, abnormal clinical symptoms, or significant weight changes were observed in either male or female SD rats in the control or the test (0.125, 0.25, and 0.5 mL/animal) groups during the observation period. No significant differences in hematology and serum biochemistry and no macroscopic abnormalities at necropsy were found. No abnormal reactions at injection sites were noted on the topical tolerance tests. Conclusion: The results of this single-dose toxicity study show that WCFC is safe, its lethal doses in male and female SD rats being estimated to be higher than 0.5 mL/animal.

• 한국의료질향상학회지
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• 제25권1호
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• pp.52-65
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• 2019

Purpose: Outbreaks resulting from medication injections have recently been on the rise in Korea despite various established guidelines. The objective of this study was to assess the degree to which healthcare professionals are aware of safe injection practice guidelines and to account for the adherence to and the deviation from safe injection guidelines formulated by healthcare providers. Methods: In November 2016, a cross-sectional anonymous questionnaire covering general characteristics of injections, patient safety culture, awareness of safe injection practices, and adherence to and barriers to safe injection guidelines was issued to healthcare providers who administer medication injections or manage and supervise these injections (N=550). Multivariate logistic regression analysis via enter method was performed to define the influencing factors of adherence of safe injection practices. Results: On average, respondents adhere to 17 of the 24 guidelines. Multivariate logistic regression found that those who were more likely to adhere to safe injection guidelines either underwent a patient safety training experience within the last year, provided care in a setting characterized by a highly developed patient safety culture, or were employed as physicians or nurses, as opposed to some other type of care provider. Barriers to safe injection guidelines were attributable to; thoughts of waste to discard leftover medicine, provisions that made adherence cumbersome, a weak culture of compliance, and insufficient amounts of injectable medicine, products, and education. Conclusions: The results of this study indicate that controllable factors like training experience of healthcare providers and patient safety culture were positively associated with adherence to safe injection practices. It was suggested that the training of healthcare providers on safe injection practices be a continuous process to promote patient safety. Additionally, there should be an increased focus on developing and implementing policies to improve patient safety culture from a prevention rather than post-management perspective.

• 대한간호학회지
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• 제29권2호
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• pp.293-303
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• 1999

The purpose of this study was to understand and to explain how were nursing students experienced and accepted the fundemental nursing practice. In addition to, the results of this study are attempted to contribute for offer of basic data in projecting and accomplishing to promote quality practice education. The participants were 79 freshmen of S College of Nursing in kyungi-do. They presented record of feeling and thinking on their the fundemental nursing practice experience. The data were collected from 29, J une to 10, July in 1998. Collected data was analyzed by means of Van Kaam's phenomenological method. The results of this study was founded 423 descriptive expression and they were grouped under 42 common factors and they were grouped under 9 categories. By means of the frequency on the categories. the higher category is Anxiety. next Solemn. Flutter. Pride. Usefulness, Recognition of reality in nursing-system. Lack of practice environment. Self-accusation. Comprehension of nursing spirit were founded. 5 common factors. Tension. Difficulty, Dread. Apprehension, Burden were grouped under Anxiety. 7 common factors, Pledge, Memory, Importance of practice, Sincerity, Restriction of dress, Acceptance, Active attitude were grouped under solemn. 5 common factors, Interest, Strange, Beanimated, Waiting, Curiosity were grouped under Flutter. 5 common factors, Conceit, Self-confidence, Skilled, Worth, Accomplishment were grouped under Pride. 6 common factors, Acknowledge of nursing affairs, Expectation of furture, Fascination of nursing. Acquirement of disposition of nurse, Association of injection, Actual feeling of dept. of nursing were grouped under Recognition of reality in nursing-system. 4 common factors, Lack of practice time, Many persons of practice, Lack of practice instrument, Lack of reality were grouped under Lack of practice envirnment. 5 common factors, Inconvenient, Reflection, Loss of pride, Shyness, Feeling sorry were grouped under Self-accusation. 3 common factors, Utility, Connection of practice and theory, Various experience were grouped under Usefulness. 2 common factors, Comprehension on the dignity of human, Comprehension on a point of view of patient were grouped under Comprehension of nursing spirit. In conclusion, the following recommendation should be necessary a supplementary study to approach on the type of students that has a firm view and care about client prior to clinical nursing practice.

• 기본간호학회지
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• 제24권4호
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• pp.277-285
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• 2017

Purpose: The purpose of this study was to identify occurrence of needle stick and sharp injuries(NSI) among students, level of faculty stress, and necessity of informed consent when students practice injection skills in fundamentals of nursing practice (FNP). Methods: Data were collected using self-reporting questionnaires and 74 faculty members who teach FNP responded it. Questionnaires included general characteristics, experiences of NSI, stress level, and informed consent. Data were analyzed using frequency, percent and paired t-test. Results: Of 74 faculty members, 51.4% experienced NSI 3~4 times or more during their FNP classes. Major procedures causing NSI during FNP were 'breaking the neck of ampules', 'disposing of used items', and 'inserting needles'. The stress level of faculty was higher and more than doubled when training with human beings compared to manikins. Most faculties (86.5%) agreed to the necessity of informed consent so that the safety of faculty and students could be protected and to provide enough information even though only 10.8% of faculty in this study got informed consent. Conclusion: Because there is high risk in every procedure of NSI, faculty has a high level of stress during injection practice in FNS. Therefore, it is necessary to develop a standard NSI precaution program for junior nursing students and discuss informed consent.

• 대한약침학회지
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• 제21권2호
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• pp.104-111
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• 2018

Objective:This study is to evaluate both the single-dose intravenous injection toxicity and the approximate lethal dose of Water-soluble Danggui Pharmacopuncture (WDP) in Sprague-Dawley (SD) rats. Methods: Toxicity experiments were conducted at Good Laboratory Practice (GLP) laboratory in Biotoxtech Co., according to the regulations of GLP. WDP injection of dose 0.125, 0.25, and 0.5 mL/animal were experimental groups and normal saline injection group was control group. WDP and normal saline were injected once to 6- week old 5 male and 5 female SD rats at the tail veins at approximately 2 mL/min. During 14 days after the injection, general symptoms were observed and weight were measured. After the observation period, hematological and blood biochemical examination, macroscopic autopsy, topical resistance test at the injection area were performed. Results: RThe WDP 0.5 mL/animal injection group in 4 cases of male rats and all cases of female rats showed hematuria 30 minutes after the administration. However, after 1 hour, no more abnormal general symptoms were observed. The WDP did not affect weight, hematological and blood biochemical examination, macroscopic autopsy, and topical resistance test at the injection area. Conclusion: WDP single dose intravenous injection results showed that WDP have no toxic effects and a lethal dose of WDP should be over 0.5 mL/animal in male and female rats under the study condition. So WDP may be safe.

• Biomolecules & Therapeutics
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• 제3권1호
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• pp.63-71
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• 1995

The local irritation studies of DA-3002, an authentic recombinant human growth hormone (rhGH), were carried out in rabbits after the following treatment ; application into the conjunctival sac of the eye (single), single subcutaneous and intramuscular injection, 7-day repeated subcutaneous and intramuscular injection. The results obtained were as follows. In the result of ocular irritation test, 0.16% solution of DA-3002 could be considered as a non-irritating material. In single subcutaneous and intramuscular irritation test, the irritancy of 0.16% DA-3002 solution was not so much different from that of saline. The local irritation of DA-3002 by 7-day repeated injection was negligible and similar to that of saline by both subcutaneous and intramuscular routes. These results suggest that DA-3002 has no irritating activity when injected through subcutaneous or intramuscular route for clinical practice as 0.16% solution.