The use of drugs that reflect the experiences and achievements of modern science has given human being the benefits of treating diseases and improving health conditions. However, in addition to the benefits of those, medicines have inherently inevitable adverse reactions. Many countries are taking measures such as market entry regulations or post-marketing surveillance to minimize damage caused by drug side effects, but the occurrence of side effects cannot be eliminated. Although the damage is force majeure, in some cases, the doctor who prescribed the drug or the pharmacist who administered the drug may have to compensate for the damage. The liability depends on whether the side effects were known in advance, the type of medicine, etc. On the other hand, in some cases, drug manufacturer may have to take liability for the side effect itself. As it is not easy for victims to be compensated for damages in those cases, many countries, including Korea, are setting to protect victims through the Product Liability Act. Drugs are also one of the product, so liability set by the Product Liability Act may apply. Even before the enactment and enforcement of the Product Liability Act, damage caused by drug has occurred. To resolve them, precedents have developed case law, which have many similarities with the Product Liability Act, but also have differences. Damage caused by drug manufactured prior to the enforcement of the Product Liability Act may occur in the future. In this context, the legal principles of the case laws will remain valid and be applied. This is an important reason to review the case law of precedents.
Background: New beauty soaps are always subject to evaluation. Purposes: This study performed a human application test and safety evaluation on the cleaning effect of the fine dust mimic of the test product, Daziwar soap bar, on 52 women. Methods: The quantitative change measured the cleaning effect of fine dust before and after washing immediately after spraying the fine mimetic dust on the forearm of 22 women. In addition, the safety was evaluated at 30 minutes, 24 hours, and 48 hours after 24 hours after applying the patch to the woman's back. Results: After one time washing with the soap immediately after spraying dust on the inside of the arm, the amount of the remaining mimetic was statistically significantly decreased in both the test group and the control group (p < .001). However, the washing rate was 99.96% in the experimental group and 75.58% in the control group. The questionnaire was evaluated as 'Good' or higher in terms of efficacy. In the evaluating of adverse reactions after washing fine dust by a dermatologist, there were no reports or observations of specific skin adverse reactions or abnormal findings in the subjects. The safety evaluation was judged as non-irritating in the skin reaction evaluation at 30 minutes, 24 hours, and 48 hours after instillation on the back for 24 hours. Conclusions: The test product, Daziwar soap, was found to be very helpful in cleaning fine dust on the human body and was found to be safe for the human body.
Turbid water or suspended sediment is associated with negative effects on aquatic organisms; fish, aquatic invertebrate, and periphyton. Effects of turbid water on fish differ depending on their developmental stage and a level of turbidity. Low turbid water may cause feeding and predation rates, reaction distance, and avoidance in fish, and it could make fish to die under high turbidity and long period. Therefore, it is very important to find out how turbid water or suspended sediment can affect fish in domestic watersheds. The objectives of this study were 1) to introduce international case studies and their standards to deal with suspended sediment, 2) to determine acute toxicity in 4 major freshwater fishes, and 3) to determine in relation to adverse effect of macroinvertebrates and fish. Impacts of turbid water on fish can be categorized into direct and indirect effects, and some factors such as duration and frequency of exposure, toxicity, temperature, life stage of fish, size of particle, time of occurrence, availability of and access to refugia, etc, play important role to decide magnitude of effect. A review of turbidity standard in USA, Canada, and Europe indicated that each standard varied with natural condition, and Alaska allowed liberal increase of turbidity over natural conditions in streams. Even though acute toxicity with four different species did not show any fatal effect, it should be considered to conduct a chronic test (long-term) for more detailed assessment. Compared to the control, dominance index of macroinvertebrates was greater in the turbid site, whereas biotic index, species diversity index, species richness index, and ecological score were smaller in the turbid site. According to histopathological analysis with gills of macroinvertebrate and fishes, morphological and physiological modification of gills due to suspended sediments can cause disturbance of respiration, excretion and secretion. In conclusion, in order to maintain good and healthy aquatic ecosystem, it is the best to minimize or prevent impact by occurrence of turbid water in stream and reservoir. We must make every effort to maintain and manage healthy aquatic ecosystem with additional investigation using various assessment tools and periodic biomonitoring of fish.
Journal of Physiology & Pathology in Korean Medicine
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v.16
no.1
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pp.154-159
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2002
There are several types of salts that can be classified into raw salt(Chunil salt), purified salts(NaCl reagent grade) and processed salts(Bamboo salt, Purple bamboo salt using in this study) in Korea. Salts has been utilized for the food as well as for the drug in the Oriental Medicine. Purple bamboo salt(PB-salt) was made by heating up to 1300℃ nine times after putting the raw salts in the bamboo. Since salt is generally known to cause the blood pressure to elevate, this study was conducted to investigate the effect of PB-salt on an adverse reaction of the blood pressure elevation. The experiment was performed with the 2 protocols ; 1. Effect of NaCl and PB-salt administration i.v. with the different the concentration(250, 500, 750, 1000mg/kg) on a mean artery blood pressure(MAP) change. 2. Effect of 500mg/kg NaCl and PB-salt administration p.o. for 6 days on the systolic blood pressure change. The results were as follows; The results were as follows; In a short minute change of blood pressure by direct method, PB-salt adminstration did not induced the hypertension unlike NaCl adminstration. In a date change of blood pressure by indirect method, systolic blood pressure was increased about 12-18% in the NaCl administration group, whereas within 6% in the PB-salt administration group from 2 days to 5 days. These results suggest that PB-salt might have some unidentified ingredient to be changed in the course of processing, making it superior to other salts.
This study aimed to identify the characteristics of 40 chemical accidents that occurred in Jeollabuk-do from 2004 to 2019. During this time, there were 2.5 accidents per year on average in the province; their types were classified as spill/leak, fire, explosion, adverse reaction, and complex. There were 34 leaks and six explosions, and they are categorized as follows: 12 by worker error, 16 from facility defects, and 12 by transport vehicle accidents. The substances involved in these accidents were ammonia (15%), sulfuric acid (12.5%), and silicon tetrachloride (7.5%). Notably, the rate of chemical accidents (75%) is the highest during spring and summer. In order to reduce chemical accidents, first, there should be compliance with the relevant laws. Second, the quality of safety education and training of workers should be improved. Finally, valuable government support is also necessary to improve facilities.
Objectives : The purposes of this preliminary study was to examine the feasibility of recruiting women into a clinical trial designed to examine the effects of acupuncture in treating urinary incontinence (UI) in premenopausal women with delivery history and the feasibility of performing the study procedures. We also tried to determine if there was preliminary evidence to suggest that acupuncture may be effective in reducing UI and improving disease-specific quality of life. Methods : This study was a pragmatic randomized clinical trial. Subjects between the ages of 20 and 49 years were randomly assigned to a treatment(n=11) or control group(n=11) and analyzed. Both groups were supposed to do Kegel exercise at home during 4 weeks and acupuncture was applied to the treatment group twice a week(8 sessions) additionally. Subjects performed 1 hour pad test and completed a 3-day urination diary, international consultation on incontinence modular questionnaire(ICIQ), and incontinence - quality of life(I-QOL) at base line and 5 weeks. Results : Both group showed improvement in 1 hour pad test and the reducing amount of UI was significantly larger in treatment group(p=0.0182). The significant improvements in ICIQ and I-QOL were also observed in treatment group and sustained until the follow-up measurement at 16 weeks. Any adverse reaction related to acupuncture did not happen. Conclusions : It was feasible to recruit subjects and perform the study procedures. The positive results of this study support the requirement for additional research investigating the efficacy of acupuncture in the treatment of UI in women.
Background: The primary aims of periodontal disease treatment is to remove dental plaque and calculus, the main causes of tooth loss, and restore periodontal tissue destroyed by inflammation. Periodontal disease treatment should also help maintain the alveolar bone, alleviate inflammation, and promote periodontal ligament cell proliferation, which is essential for tissue regeneration. Conventional antibiotics and anti-inflammatories have adverse side effects, especially during long-term use, so there is a need for adjunct treatment agents derived from natural products. The purpose of this study was to investigate whether the herbal flavone baicalein has the osteogenic activity under inflammatory conditions, and assess the involvement of osteoblast immediate early response 3 (IER3) expression. Methods: Human osteoblastic MG-63 cells were cultured with the pro-inflammatory cytokines tumor necrosis factor α and interleukin 1β in the presence and absence of baicalein. Proliferation was assessed using the 3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide assay, and expression of IER3 mRNA was assessed using real-time polymerase chain reaction. The expression of IER3 protein levels and activation of associated signal transduction pathways were assessed using western blotting. Results: Baicalein increased IER3 mRNA and protein expression synergistically. In addition, baicalein reversed the suppression of cell proliferation, and the downregulation of osteogenic transcription factor runt-related transcription factor 2 and osterix induced by pro-inflammatory cytokines. Baicalein also upregulated the phosphorylation of c-Jun N-terminal kinase (JNK) and extracellular signal-regulated kinase (ERK 1/2). The upregulation of IER3 by pro-inflammatory cytokines was blocked by pretreatment with inhibitors of AKT, p38, JNK, and ERK 1/2. Conclusion: Baicalein mitigates the deleterious responses of osteoblasts to pro-inflammatory cytokines. Further, IER3 enhanced the effect of baicalein via activation of AKT, p38, JNK, and ERK pathways.
Background: Smoking exerts an adverse effect on the periodontal tissue by reorganizing the ecosystem of oral microorganisms and is considered to be an important factor in the development of periodontal disease. Although cross-sectional studies on smokers and non-smokers have been attempted to investigate the microbial differences in periodontal oral cavity, only few studies have been conducted to investigate the changes in oral microorganisms during smoking cessation. The purpose of this study was to investigate the changes of bacteria in saliva and gingival crevicular fluid (GCF) over a period of one year among 11 smokers trying to quit smoking. Methods: Eleven smokers trying to quit smoking visited the clinic at baseline, two weeks, two months, four months, six months, and 12 months to give saliva and GCF samples. The amounts of 16S rRNA, Porphyromonas gingivalis, Treponema denticola, Prevotella intermedia, Fusobacterium nucleatum subsp. nucleatum, Streptococcus mutans, and Streptococcus sobrinus in saliva and GCF were quantified using real-time polymerase chain reaction TaqMan probe assay. The results were analyzed by nonparametric statistical analysis using Friedman test and Spearman correlation coefficient. Results: After cessation of smoking, the amounts of 16S rRNA corresponding to P. gingivalis, F. nucleatum, P. intermedia, and T. denticola in saliva decreased and then again increased significantly. The amount of F. nucleatum 16S rRNA in GCF decreased significantly after smoking cessation. Positive correlations were observed between 16S rRNA and F. nucleatum and between F. nucleatum and T. denticola in saliva and GCF. Conclusion: Even if the number of subjects in this study was small, we suggest that smoking cessation may reduce the total bacterial amount and F. nucleatum in GCF. However, the results regarding changes in the microbial ecosystem due to smoking or smoking cessation were inconsistent. Therefore, further in-depth studies need to be carried out.
Jo, Soo Yeon;Ryu, Soo Hyung;Kim, Mi Young;Moon, Jeong Seop;Yoon, Won Jae;Kim, Jin Nam
Journal of Yeungnam Medical Science
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v.33
no.2
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pp.155-158
/
2016
Sorafenib (Nexavar) has been regarded as a treatment for unresectable hepatocellular carcinoma (HCC), with side effects that include hand-foot skin reaction, diarrhea, rash, fatigue, hypertension, nausea, anorexia, weight loss, and alopecia. Thyroid disorder, such as endocrine side effect, has also been reported. However no case involving adrenal insufficiency has been reported. Here, we report a case of adrenal insufficiency which occurred after taking sorafenib in a patient with HCC. A 56-year-old man visited our hospital due to right upper quadrant abdominal pain and he was diagnosed as multiple disseminated and unresectable HCCs with portal vein invasion; therefore transarterial chemoembolization was performed and sorafenib administration was started. Two months later, he was admitted to the hospital complaining of severe fatigue. The laboratory results showed cortisol of <$0.2{\mu}g/dL$ and adrenocorticotropic hormone of <1.00 pg/mL. The patient had no history of taking steroids or herbal medications. Secondary adrenal insufficiency was diagnosed and prednisolone 10 mg per day was started immediately; as a result, fatigue remarkably improved. This may be the first report indicating a possible association between sorafenib and adrenal insufficiency and it implies that the possibility of adrenal insufficiency should be considered in patients taking sorafenib who complain of severe fatigue.
The purpose of this study is to evaluate histologic result of bone substituting material on defects followed tooth extraction. We compare the histologic findings control, DFDBA, Bio-Oss(R), and $Regenafil^{TM}$, Briefly, mandibular premolar teeth were extracted available for bone filling. All alveolar sites were checked after extraction and thoroughly debrided with a dental curet to remove the periodontal ligament. Extraction sites were prepared dehiscence on buccal side 7mm height from alveolar crest. The graft materials were filled into the extraction socket and dehiscenc defects. The animals were sacrificed 12 weeks after implantation. Both treated and control mandibular sites were histologically evaluated with light microscopy. Histologic observation at 12 weeks revealed that control and experimental sites were healed uneventfully and directly apposed to new bone without any adverse tissue reaction. DFDBA and Bio-Ossn(R)sites maintain width of alveolar crest but were not fully resorbed. $Regenafil^{TM}$ sites also maintain width and particles were resorbed more than other graft materials. From this results, it was suggested that $Regenafil^{TM}$ is promising boen substituting materials maintaining the width of alveolar crest and height follewed tooth extraction.
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