• Environmental Analysis Health and Toxicology
• /
• v.24 no.2
• /
• pp.127-136
• /
• 2009

We have investigated the genotoxicity of 3 chemicals, aluminum oxide, calcium oxide, sodium tetraborate using mammalian erythrocyte with micronucleus induction. It was performed using 9 week male ICR mice. At 24 hours after treatment with 3 chemicals with oral route, mice were sacrificed and bone marrow cells were prepared for smear slides. As a result of counting the micronucleated polychromatic erythrocyte (MNPCE) of 2,000 polychromatic erythrocytes (PCE), all treatment groups did not show statistically significant increase than negative control group. And there was no clinical sign related with injection of the 3 chemicals. It was concluded that the 3 chemicals did not induce micronucleus in the bone marrow cells of ICR mice, and these results indicate that the 3 chemicals have no mutagenic potential under the condition in each studies.

• The Journal of KAIRB
• /
• v.1 no.2
• /
• pp.30-42
• /
• 2019

In pharmaceutical clinical trials as human material research, the collection, use, storage and provision of human materials must be in accordance with the criteria stipulated in 「Bioethics and Safety Act」, except in the case that some criteria about it is in the law related to clinical trials such as 「Pharmaceutical Affairs Act」 and 「Enforcement Rule on Safety of Drugs, etc.」 so these take precedence over. Under 「Bioethics and Safety Act」, the core aspect of the legal standard for obtaining informed consent is the use of statutory form . The use of statutory form ensure that both those who obtain informed consent and those who give it can know the contents contained this form as well as recognize its importance. Thus, the person who has the right to informed consent can sign the statutory form after correct understanding of the contents. In reality, however, some researchers and IRB members determine that only the main informed consent form is to be used because most of contents on statutory from are included in the main informed consent form. Some other researchers and IRB members judge that the use of statutory form is not needed if human materials may only be used for laboratory testing and the rest will not be stored and provided for future use. Most of these determination and judgement is based on the interpretation of the Korea National Institute for Bioethics Policy(hereafter, KoNIBP) on IRB Information Portal Site. But, it is questionable whether the KoNIBP's interpretation is legally valid and the KoNIBP is the legal entity having authority to interpret existing statute. In some cased not only using the main informed consent form including enough information about the collection, use, storage and provision of human materials but also collecting necessary minimum human materials, and discarding the rest, unusing the statutory form may not cause the problem to respect and protect the research participant's rights. Therefore, the provision stipulating the criteria about the use of statutory form as the legal standard of obtaining informed consent that applies all human material research without exception should review to revise. At least, straighten out the confusion surrounding whether or not the statutory form is to be used, before the revision of related provision, considering the logical opinions of some researchers and IRB Members, the Ministry of Health and Welfare as the legal entity having authority to interpret existing statute should represent its opinion about permission of the acceptable exceptions.

• Korean Journal of Veterinary Research
• /
• v.42 no.2
• /
• pp.241-251
• /
• 2002

Modified-live (ML) infectious laryngotracheitis (ILT) vaccines have been widely used as a preventive measure in Korea since the first outbreak of ITL. Recently, it has been observed that chickens vaccinated with the commercially available ML ILT vaccine have sometimes exhibited adverse clinical signs. In this study, we evaluated the quality of the vaccines by comparing titer of each vaccine batch and testing the stability of ILT virus (ILTV) in vaccine diluents and compared the safety and efficacy of vaccines in specific pathogen free (SPF) chickens. The ratio of maximum titer to minimum titer of vaccine produced by most manufacturers was 2 to 15. However, 2 out of 11 manufacturers produced vaccines of which the ratio was 74 to 478. Most vaccines examined were maintained vaccine titers suitable for national regulations within expiry date. However, some vaccines did not keep the titer required for the national regulations. In the test for stability of ILTV in various diluents, ILTV was highly stable in lactose-phosphate-glutamine-gelatin solution, sucrose-phophate-glutamine-albumin solution and some vaccine diluents produced by manufacturers. The safety of ML ILT vaccines was assessed in 10-day-old SPF chicks. Mortality in SPF chicks inoculated intratracheally with one dose of vaccine varied depending on vaccines and some vaccines produced 50-85% mortality. Seven-week-old SPF chickens were vaccinated intraocularly with ML ILT vaccines and then challenged intratracheally with ILT challenge virus 14 days after vaccination. The protection rate was assessed by clinical signs and reisolation of the ILT challenge virus from tracheas taken at day 4 after challenge. There were slight respiratory reactions in some vaccinated chickens after vaccination but these reactions disappeared within 5 days after vaccination. No further clinical signs and death were observed. Protection rate determined by clinical signs and mortality was 100% in all vaccinated groups. However, the challenge virus was isolated from all tracheas of chickens vaccinated with vaccine B or control groups. The challenge virus was also isolated in the trachea of one in five chickens vaccinated with either vaccine F or K, but not in tracheas of chickens vaccinated with other vaccines. In the present study, the stability of vaccine diluents, pathogenicity and protection rate based on reisolation test of the challenge virus were different depending on vaccines produced by eleven manufacturers.

• Journal of Life Science
• /
• v.15 no.1 s.68
• /
• pp.1-8
• /
• 2005

The purpose of this study was to investigate the potential subacute toxicity of dimethyl disulfide by 3 weeks inhalation in F344 rats. The test article, dimethyl disulfide was exposed by inhalation to male and female rats at dose levels of 0, 5, 25, or 125 ppm/6 hrs/ day for 3 weeks. Five rats/ sex/ group were sacrificed on day 4 after the initiation of treatment, while 5 rats/ sex/ group were sacrificed at the end of treatment period. During the test period, clinical signs, mortality, body weights, food consumption, hematology, serum biochemistry, and gross findings were examined. Slight decreases in body weight gain were noted in both sexes of the highest dose group in a dose dependent manner but were only statistically different from the control animals in males of the group. A slight non-significant reduction in food consumption were also noted in the both sexes of the highest dose group. There were no adverse effects on mortality, clinical signs, hematology, serum biochemistry, and necropsy findings at any dose tested. Based on these results, it was concluded that the 3 weeks repeated dose of dimethyl disulfide by inhalation resulted in suppressed body weight gain and decreased food consumption at 125 ppm of both sexes. In the present experimental conditions, the target organ was not determined in rats. The no­observed-adverse-effect level (NOAEL) was considered to be 25 ppm/6 hrs/day for both sexes.

• Toxicological Research
• /
• v.17
• /
• pp.173-183
• /
• 2001

Although there are still many technical difficulties to be overcome, recent advances in the molecular and cellular biology of gene transfer have made it likely that gene therapy will soon start to play an increasing role in clinical practice. However. safety issues are raised from vector system. It is not clear whether it is safe to incorporate genes into nuclear DNA. Little is known about the antigenicity of gene product which the immune system is encountering. In this review, some safety-related topics are introduced and discussed.

• Proceedings of the Korea Institute of Fire Science and Engineering Conference
• /
• 2011.11a
• /
• pp.529-532
• /
• 2011

• Journal of The Korean Society of Integrative Medicine
• /
• v.10 no.1
• /
• pp.27-38
• /
• 2022

Purpose : This study is aimed to develop and validate the clinical practice education program and clinical competence scale of occupational therapy student. Methods : The development of the clinical practice education program used the delphi technique method, which had a total of five steps. Based on the occupational therapist's job analysis, the first stage assessed the importance of 21 experts, and the second stage examined the importance of 19 new specialists to derive constitutive factors. In the third stage, in-depth interviews were conducted with three experts based on the derived factors, and in the fourth stage, the final clinical practice education program was derived. In the final stage, the details of the clinical training program were drawn up based on the themes and were reviewed by two experts. Structured and unstructured interviews were conducted with 43 job experts. Results : The expert survey through the delphi technique was conducted three times, and content analysis and descriptive statistics were conducted to examine the distribution of responses. The final 11 educational program topics and contents were derived. Topics are confirmation of client information, evaluation and intervention, cognitive therapy, spinal cord injury, brain injury, musculoskeletal disorders, pediatric occupational therapy, interventions in activities of daily living, driving rehabilitation, vocational rehabilitation, occupational therapy assessment tool, safety training and management. Conclusion : The clinical practice education program reduce the difference between school education and clinical education of occupational therapy student. Occupational therapy helps college student understand occupational therapy practices and improve the quality of clinical education. Through more research and supplementation of clinical practice education programs in the future, it is suggested that clinical practice education be successfully operated in various practice institutions and used as basic data for designing and evaluating useful educational models.

• Journal of Oriental Medical Thermology
• /
• v.7 no.1
• /
• pp.1-13
• /
• 2009

Purpose: To evaluate the hot flush relief efficacy of Yiseontang-gami in climacteric women with hot flushes, a vasomotor symptom. Methods: The 20 subjects who signing on the clinical trial written consent by self-will is registered this clinical trial after decided suitable by selection and exception standard, after take a medical experiment and checkup according to clinical trial plan. Registered subject should valuated by settled schedule after take the testing medicine(Yiseontang-gami)during thirty-day. The evaluating indexes of this trial are hot flush VAS, hot flush frequency, hot flush consistence time, sweating VAS, palpitation VAS, sleep disturbance VAS, MRS, MENQOL, PGA. Results: The results were as follows 1. 4 subjects dropped out of the clinical trial and 16 subjects completed it. 2. After Yiseontang-gami treatment, hot flush VAS, hot flush frequent, sweating VAS, Palpitation VAS, sleep disturbance VAS improved significantly. 3. After Yiseontang-gami treatment, hot flush consistence time was not improved significantly. 4. After Yiseontang-gami treatment, blood test value were not different significantly. Conclusion: In this clinical trial we consider that Yiseontang-gami is suitable treatment for the hot flushes and related symptoms.

• Journal of Korean Traditional Oncology
• /
• v.20 no.1
• /
• pp.11-21
• /
• 2015

Objectives : The cancer incidence and cancer burden is increasing. In addition, the use of botanical agents in cancer care is increasing. This article aims to review a research strategy for botanical agents. Methods : The clinical studies of anticancer botanical agents and the papers about clinical research methodology of botanical agents were reviewed. Results : In phase I study, safety confirmation, optimal dose determination and drug interaction study are important. Most botanical agents have low toxicity and some have non-monotone dose response. Therefore, dose-response curve must be evaluated separately from the dose-toxicity curve to determine optimal dose. Although anticancer botanical agents can't shrink tumor size rapidly, they do extend survival. So, in phase II study, response should be evaluated by the survival. Conclusions : Clinical research of botanical agents in cancer is different from traditional methods and strategies. Considering the characteristics of botanical agents and experimental mechanism is necessary in conducting botanical based clinical trials.

• The Journal of Korean Medicine
• /
• v.41 no.3
• /
• pp.247-259
• /
• 2020

Objectives: This review aims to investigate clinical studies related to bee venom pharmacopuncture for cancer patients and to analyze the research trend for further study. Methods: We searched for clinical studies using bee venom pharmacopuncture therapy on patients with cancer through the electronic databases including Pubmed, Cochrane library, OASIS, KISS, NDSL, and KMBASE. There was no restriction on language and publication date, and after selection/exclusion process, the study design, target disease, intervention details including acupoints, treatment frequency and period, outcomes, study results and adverse events were extracted. Results: Thirteen clinical studies were finally selected. There were a randomized controlled trial RCT about the effect of sweet bee venom pharmacopuncture on cancer-related pain, and three case series about chemotherapy-induced peripheral neuropathy. In case reports, there were nine studies about oligodendroglioma, plexiform neurofibroma, breast cancer, prostate cancer, lung cancer, urachal adenocarcinoma, malignant melanoma, and atypical squamous cells of undetermined significance. The bee venom therapy affected the improvement of outcomes such as symptoms, quality of life, tumor response, and lab findings. Conclusions: The present study found that bee venom therapy is applicable to the treatment of cancer patients, and showed some effect on various symptoms. However, due to insufficient number and quality of studies, well designed and high-quality clinical trials are necessary to confirm the effectiveness and safety of bee venom pharmacopuncture therapy in patients with cancer.