• Korean Journal of Clinical Laboratory Science
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• v.42 no.1
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• pp.16-21
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• 2010

It has been well known that organic industrial solvents such as toluene, xylene and styrene are environmental health hazards causing occupational diseases to workers. The detection of biological metabolites of toluene, xylene and styrene in blood, urine, breast milk, saliva, and hair of workers exposed to these organic industrial solvents is a useful tool for assessing the amount of organic industrial solvents. Therefor, the external analytical quality assurance program is extremely important work for increasing reliability of the data analyzed in the special health examination laboratory. We evaluated the results of analysis by Korean analytical quality assurance program from the second half 2007 to the first half 2009. The number of participants for analytical quality assurance program for both mandatory item and one of optional items, hippuric acid and methylhippuric acid were 116-122, 116-122 and 105-115 laboratories, respectively. The proficient rate of the special health examination laboratories analyzed both mandatory item and optional item, hippuric acid and methylhippuric acid were 92-98%, 92-98% and 96-98%, respectively. We can conclude from our data that the analytical quality assurance program is a essential tool for improvement of reliability on the data analyzed in the special health examination laboratories.

• Journal of Pharmacopuncture
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• v.11 no.4
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• pp.25-37
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• 2008

Purpose The purpose of this study was to investigate sub-chronic toxicity of scolopendrid pharmacopuncture in mouse and method of increasing output of scolopendrid pharmacopuncture. Methods In order to prove the clinical safety of scolopendrid pharmacopuncture during 90 days, We have observed the physical reaction(side effect) and clinical pathology test after scolopendrid pharmacopuncture treatment and investigated method of increasing Output of scolopendrid pharmacopuncture for 90%, 80%, 70% ethanol. Results In subchronic toxicity test, there was no significant sign in clinical sign, opthalmological values, body weights, hematological values and urinalysis values. And we could see that food consumptions and water consumptions increased significantly, albumin, triglycerides, GPT in blood chemical values and Liver, Testis(right) in organ weights changed significantly in some groups, compared with those in the S1 group. But these changes were observed within the scope of physiology. So there was no sign of toxication in subchronic toxicity test, and we can tell that NOAEL(No Observed Adverse Effect Level) is above 0.286mg/kg/day. And 70% ethanol solution of scolopendrid was yielded the most amount of substance. Conclusions This study demonstrates that scolopendrid pharmacopuncture is to treatment of safety for a long time and we can obtain much amount from 70% ethanol solution of scolopendrid.

• Journal of Acupuncture Research
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• v.39 no.1
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• pp.29-35
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• 2022

Background: Electronic moxibustion has the advantage of temperature control and maintenance, and overcomes the limitations of the existing moxibustion process without the use of the combustion process. However, as the application of electronic moxibustion in clinical practice has increased, safety issues are emerging. Methods: Clinical cases of electronic moxibustion treatment for knee osteoarthritis where burns occurred were collected. In addition, adverse events reported in clinical studies using electronic moxibustion for patients with knee osteoarthritis were collected from studies retrieved from Korean and international databases. Results: There were 3 cases of superficial 2^nd degree burns retrospectively collected through chart reviews. Among the selected 5 studies for literature review, 2 studies reported adverse events which were burns milder than those reported in these 3 cases in this retrospective case review. Conclusion: Since the risk of superficial 2^nd degree burn was discovered in the cases reviewed, further research on safe electronic moxibustion treatment is required without compromising the effectiveness of moxibustion.

• Journal of Pharmacopuncture
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• v.25 no.3
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• pp.268-275
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• 2022

Objectives: This toxicological study was performed to assess for potential toxicity and to determine the approximate lethal dose of SU-Eohyeol pharmacopuncture (SUEP) following a single intramuscular injection of SUEP into male and female Sprague-Dawley (SD) rats. Methods: The groups in our experiment consisted of an experimental group treated with SUEP at a dose of 1.0 mL/animal and a control group injected with a normal saline solution, and five male and female rats were placed in each group. Each animal was administered a single intramuscular injection. We monitored all rats for clinical signs and body weight changes for 14 days after administration. At the end of the observation period, the rats were euthanized and autopsied, and localized tolerance examinations were conducted at the site of administration of the test substance. Results: There were no deaths in either sex in the SUEP-treated group. There was no significant difference between the SUEP-treated group and the control group in the clinical signs and weight changes among the rats. In addition, no significant SUEP-related changes were observed on autopsy findings or local tolerance examinations at the injection site by histopathological examination. Conclusion: Our results suggest that the approximate lethal dose of a single intramuscular administration of SUEP in female and male rats under the conditions of this study is greater than 1.0 mL/animal. To determine the safety of the use of SUEP in Korean medical clinical practice, additional toxicity studies will be needed.

• Korean Journal of Clinical Pharmacy
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• v.32 no.3
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• pp.226-237
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• 2022

Background: Monoclonal antibodies for the treatment of patients with different types of cancer, such as cetuximab, have been widely used for the past 10 years in oncology. Although drug information package insert contains some representative adverse events which were observed in the clinical trials for drug approval, the overall adverse event patterns on the real-world cetuximab use were less investigated. Also, there have been no published papers that deal with the full spectrums of adverse drug events of cetuximab using national-wide drug safety surveillance systems. Methods: In this study, we detected new adverse event signals of cetuximab in the Korea Adverse Event Reporting System (KAERS) by utilizing proportional reporting ratios, reporting odds ratios, and information components indices. Results: The KAERS database included 869,819 spontaneous adverse event reports, among which 2,116 reports contained cetuximab. We compared the labels of cetuximab among the United States, European Union, Australia, Japan, and Korea to compare the current labeling information and newly detected signals of our study. Some of the signals including hyperkeratosis, tenesmus, folliculitis, esophagitis, neuralgia, disseminated intravascular coagulopathy, and skin/throat tightness were not labeled in the five countries. Conclusion: We identified new signals that were not known at the time of market approval.

• Journal of Marine Bioscience and Biotechnology
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• v.14 no.1
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• pp.43-50
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• 2022

Squid is a sustainable source of long-chain omega 3 fatty acids. This study aims to assess the safety and triglyceride-lowering efficacy of refined oil derived from the squid(Todarodes pacificus) viscera. Male and female participants with elevated fasting serum lipids (i.e., total cholesterol of ≥5.2 mmol/L or fasting serum triglyceride of ≥1.65 mmol/L) were randomly allocated to the control (n = 52) or squid oil group (n = 52), and participants in the latter group were instructed to consume 3 g of squid oil daily for 60 days. None of the subjects reported adverse events associated with the consumption of squid oil. Baseline clinical chemistry and hematological parameter values and those toward the end of the treatment period were similar, and all values were within the normal range. Fasting cholesterol and triglyceride levels in the control and squid oil groups were similar; however, toward the end of the 60 day study period, these levels significantly reduced in the squid oil group relative to those in the control group (P< 0.01). However, high-density lipoprotein-cholesterol remained unchanged in both groups. Thus, it can be inferred that squid oil is a safe source of long-chain omega-3 fatty acids and has beneficial effects on the blood lipid levels. This is the first clinical study on squid oil usage, and suggests that it could be a sustainable source of omega 3 fatty acids.

• Korean Journal of Pharmacognosy
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• v.42 no.1
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• pp.76-81
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• 2011

The study of irritation and toxicity of honeybee(Apis mellifera. L) venom collected by a bee venom collector applied topically to the skin and mucous membrane were carried out to prove the safety of honeybee venom in clinical use. Animal for the research was the rabbit and the solution for the test was made from honeybee venom. Six animals were used for the skin test and nine animals were used for the eye mucous membrane test. In results, both tests proved that honeybee venom makes no irritable reaction on skin and eye mucous membrane of rabbit. We consider that this result is helpful for saying about the safety of honeybee venom in clinical use.

• Journal of Acupuncture Research
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• v.25 no.4
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• pp.117-125
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• 2008

Objectives : Analyze according to types of event causing the adverse outcome due to acupotomy, and discuss problems and safety reqirements to using this therapy in Korea. Methods : Based upon the indication, contraindication, treatment procedures, clinical obsevations, acupotomy-related adverse outcome case reports, the factors of damaging event were classified. Results : The main factors of adverse outcome by acupotomy were anatomical ignorance, contamination of device or hospital staff, failure to notice preexisting disease(cardiovascular disease, hypertension, renal failure, hemophilia, chronic Liver Disease, etc.), unskilled treatment procedures(massive bleeding) and techniques(nerve injury, hepatic and splenic injury, Pneumothorax). Conclusions : It is mandatory to prepare adequate sterilie aseptic technique. The clinician should ensure understand genernal health state of patient and anatomical direction.

• Korean Journal of Acupuncture
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• v.40 no.3
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• pp.55-61
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• 2023

Objectives : To review the needling depth, therapeutic and adverse effects of intraperitoneal acupuncture and related acupoints. Methods : Studies and reports from the literature, Korean medical health insurance data and databases were searched and selected. Results : The depth of needle insertion for acupoints related to intraperitoneal acupuncture has been documented to range from 0.9 to 10.5 cm depending on the acupoints and literature. In studies of safe needling depth, the justice of safe needling depth varied from study to study, but was generally based on the peritoneum, and the depth varies by patient age, sex, body type, and weight. Clinical studies in China have shown good efficacy and no side effects of abdominal long needle acupuncture, but there have been case reports of adverse events following abdominal acupuncture. Conclusions : To ensure both therapeutic effectiveness and safety of intraperitoneal acupuncture, It is necessary to utilize the ultrasound in clinical practice and conduct related research.

• The Journal of Internal Korean Medicine
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• v.39 no.1
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• pp.9-21
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• 2018

Objective: Graves' disease, the most common cause of primary hyperthyroidism, is a thyroid specific autoimmune disorder. When resistance to medication is shown in spite of long term therapy with anti-thyroid drugs, radioactive iodine therapy would be chosen in Western medicine. However, this therapy has often been reported to cause patients have hypothyroidism, thus requiring them to take levothyroxine for the rest of their lives. In this study, we evaluate the clinical efficacy and safety of Ahnjeonbaekho-tang (AJBHT) on patients with Graves' disease. Methods: We prescribed AJBHT for 3 months to two groups: patients who had been taking antithyroid drugs were administered AJBHT after discontinuing the antithyroid drugs ($Com-Tx{\rightarrow}Single-Tx$), and patients who had not been taking antithyroid drugs were started with AJBHT (Single-Tx) immediately. We evaluated the thyroidal function test (TFT) and visual analogue scale (VAS) for clinical symptoms for 3 months. Results: Serum T3 and fT4 were significantly decreased in both groups and remission rate of thyroidal hormones were significantly improved in the Single-Tx group. The clinical symptoms of palpitation, fatigue, and heat intolerance were significantly improved in both groups. In the safety analysis, all patients were in normal range of liver, renal function blood test and common blood count. Conclusion: From these results, we suggested that AJBHT was effective on TFT and clinical symptoms of Graves' disease. The study supports that AJBHT may be a useful agent for patients with Graves' disease who are resistant to antithyroid medication or radioactive iodine therapy, and for patients at first diagnosis.