• Toxicological Research
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• v.35 no.4
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• pp.319-330
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• 2019

Adverse drug reactions (ADRs) constitute key factors in determining successful medication therapy in clinical situations. Integrative analysis of electronic medical record (EMR) data and use of proper analytical tools are requisite to conduct retrospective surveillance of clinical decisions on medications. Thus, we suggest that electronic medical recording and human genetic databases are considered together in future directions of pharmacovigilance. We analyzed EMR-based ADR studies indexed on PubMed during the period from 2005 to 2017 and retrospectively acquired 1161 (29.6%) articles describing drug-induced adverse reactions (e.g., liver, kidney, nervous system, immune system, and inflammatory responses). Of them, only 102 (8.79%) articles contained useful information to detect or predict ADRs in the context of clinical medication alerts. Since insufficiency of EMR datasets and their improper analyses may provide false warnings on clinical decision, efforts should be made to overcome possible problems on data-mining, analysis, statistics, and standardization. Thus, we address the characteristics and limitations on retrospective EMR database studies in hospital settings. Since gene expression and genetic variations among individuals impact ADRs, pharmacokinetics, and pharmacodynamics, appropriate paths for pharmacovigilance may be optimized using suitable databases available in public domain (e.g., genome-wide association studies (GWAS), non-coding RNAs, microRNAs, proteomics, and genetic variations), novel targets, and biomarkers. These efforts with new validated biomarker analyses would be of help to repurpose clinical and translational research infrastructure and ultimately future personalized therapy considering ADRs.

• 대한상한금궤의학회지
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• v.9 no.1
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• pp.47-58
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• 2017

Objective : The purpose of this paper is to report the adverse drug reactions of patient with cervical spondylotic myelopathy(CSM) treated by herb medicine, Soshiho-tang. Methods : The patient was prescribed Soshiho-tang herbal medicine for 9days. The patient complained of dizziness, difficulty of concentration and elevation of blood pressure on the 6th day. The doctor made the patient stop to take the herbal medicine and every symptoms and abnormal blood pressure are normalized after 6 days. The abnormal responses were assessed by WHO-UMC Causality Categories and LDS scale. Results : The WHO-UMC Causality is 'probable/likely' and LDS scale is 5, it means 'moderate' severity. Conclusions : The herbal medicine, Soshiho-tang is relevant to abnormal responses of the patient with CSM. This is a first case report of hypertension induced by herbal medicine, Soshiho-tang in Korea.

• The Journal of Korean Medicine
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• v.23 no.1
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• pp.183-188
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• 2002

Adverse reactions associated with acupuncture are common even in standard practice. The incidence of recorded reactions are various from mild symptoms: tiredness, itching, dizziness or nausea to serious symptoms: pneumothorax, cardiac injury or infection. Recently we experienced one patient, a 36-year-old woman, admitted to the emergency department with chest pain, dyspnea and back pain one hour after acupuncture treatment. The diagnosis was a left-sided pneumothorax by chest PA X-ray and chest HR CT. In this study, we differentiate spontaneous pneumothorax from misunderstood iatrogenic. Further evaluation between adverse effects and similar symptoms is needed.

• Journal of Ginseng Research
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• v.46 no.4
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• pp.601-608
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• 2022

Background: Various treatments are used to relieve menopausal symptoms for women. However, herbal substances are frequently used as complementary and alternative therapies as other treatments can increase ovarian and breast cancer risk. While the herbal substances' therapeutic effect is essential, the safety of their use is considered more important. This study aims to confirm the safety of red ginseng and herb extract complex (RHC), which are used to relieve menopausal symptoms. Methods: This randomized, double-blind, placebo-controlled clinical study recruited and divided 120 women experiencing menopausal symptoms into the RHC and placebo groups (60 women per group). Subjects were administered with 2 g RHC or placebo daily for 12 wk. Adverse reactions, female hormonal changes, and uterine thickness were observed and recorded on wk 0, 6, and 12. Hematologic and blood chemistry tests were also conducted. Results: The reactions of the subjects who received RHC or placebo at least once were analyzed. A total of six adverse reactions occurred in the RHC group, while nine occurred in the placebo group; common reactions observed in both groups were genital, subcutaneous tissue, and vascular disorders. However, there was no statistically significant difference between the administration groups (p = 0.5695), and no severe adverse reactions occurred in both groups.

• Proceedings of the Ginseng society Conference
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• 1980.09a
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• pp.229-236
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• 1980

Tow groups of subjects were studied before, during, and after long-term use of commercial Panax ginseng preparations. Group A (n = 10) consisted of users who also used other psychomotor stimulants including caffeine, while subjects in Group B (n = 8) used no drugs other than ginseng. During 12 weeks of regular ginseng use, users in Group A showed signs of central nervous system stimulation and reported feelings of well-being. Two subjects manifested possible allergic reactions while one developed a ginseng abuse syndrome marked by hypertension, nervousness, sleeplessness, skin eruptions, edema, and morning diarrhea. This syndrome was associated with excessive dosages, concomitant intake of caffeine, and possible allergic reactions. Subjects in Group B reported stimulation and feelings of well-being while showing some signs of nervousness. One subject developed a possible contact urticarial reaction to a ginseng cosmetic. All adverse reaction were transient and disappeared when ginseng use was discontinued. It is suggested that adverse reactions can be prevented by moderate use of standardized ginseng preparations while restricting use of other psychomotor stimulants.

• Journal of Veterinary Science
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• v.24 no.6
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• pp.77.1-77.7
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• 2023

Antibiotics are known to be able to cause hypersensitivity reactions through various mechanisms. We present a case of drug-induced immune thrombocytopenia (DITP) and anaphylactic shock occurring simultaneously in a dog after the administration of two classes of antibiotics, namely trimethoprim-sulfamethoxazole (TMP-SMX) and amoxicillin-clavulanate (AMC). The patient recovered completely from DITP on discontinuation of TMP-SMX and the anaphylactic shock caused by AMC was treated with intensive care. DITP is a rare adverse drug reaction (ADR), and anaphylactic shock is a life-threatening ADR. This is the first case report of a dog manifesting two types of hypersensitivity reactions caused by two antibiotics.

• Korean Journal of Clinical Pharmacy
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• v.31 no.4
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• pp.324-331
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• 2021

To investigate signals of adverse drug reactions of finasteride by using the Korea Adverse Events Reporting System (KAERS) database. This pharmacovigilance was based on the database of the drug-related adverse reactions reported spontaneously to the KAERS from 2013 to 2017. This study was conducted by disproportionality analysis. Data mining analysis was performed to detect signals of finasteride. The signal was defined by three criteria as proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC). The signals of finasteride were compared with those of the other drugs; dutasteride (similar mechanism of action), minoxidil (different mechanism but similar indications for alopecia), silodosin (different mechanism but similar indications for BPH). It was examined whether the detected signals exist in drug labels in Korea. The total number of adverse event-drug pairs was reported 2,665,429 from 2013 to 2017, of which 1,426 were associated with finasteride. The number of investigated signals of finasteride was 42. The signals that did not include in the drug label were 29 signals, including mouth dry, hypotension, dysuria etc. The signal of finasteride was similar to that of dutasteride and silodosin but was different to that of minoxidil. Early detection of signals through pharmacovigilance is important to patient safety. We investigated 29 signals of finasteride that do not exist in drug labels in Korea. Further pharmacoepidemiological studies should be needed to evaluate the signal causality with finasteride.

• The Journal of Internal Korean Medicine
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• v.35 no.2
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• pp.111-118
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• 2014

Drugs may cause adverse effects, and spontaneous adverse drug reaction (ADR) reports have been used as the main method of drug safety evaluation after drugs have been released. The World Health Organization (WHO) collects ADR data reported from pharmacovigilance organizations in each nations. In China, pharmacovigilance centers operate with hierarchical structure at local, provincial and national levels. Also, Japan and Korea each operate their own respective independent pharmacovigilance organizations. WHO is collecting ADR reports for herbal medicine and 15~20% of all ADRs was related to herbal medicine in China. There are status reports of ADRs for herbal medicine in Japan as well. However, in Korea, there is no ADR reporting system regarding herbal medicine. In light of these overseas cases, a spontaneous ADR reporting system for herbal medicine in Korea should be necessary as well.

• Advances in Traditional Medicine
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• v.2 no.1
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• pp.28-35
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• 2002

Toad venom, 'Chan su' in Chinese and 'somso' in Korean, is a well-known traditional oriental medicine obtained from the skin venom gland of the toad. Formulations of toad venom have been widely applied in China, Japan, Korea and other oriental countries for a long time. It is often found in traditional Chinese formulations, such as Jiuxin (or Kyushin in Japan), Yixin, Huoxin, Shexiang baoxin wan, Lu shen wan and Laryngitis pills. According to a pharmaceutical chemistry study, toad venom contains multiple biological active substances, such as bufalin, resibufogenin and cinobufagin. Modern pharmacological studies indicated that toad venom has multiple pharmacological actions, including acting as a cardiotonic, antitumor local anesthetic effects, stimulates the respiratory center, vasopressor action, anti-inflammatory and diuretic effects. Like other medications, toad venom also has certain toxicity and adverse effects, for example, inducing delayed afterdepolarization and triggered arrhythmia. The major chemical constituents, basic pharmacological actions and adverse reactions of toad venom are discussed in this article.

• Journal of Dental Anesthesia and Pain Medicine
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• v.16 no.3
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• pp.209-212
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• 2016

Lidocaine, a local anesthetic commonly used in dental treatments, is capable of causing allergies or adverse effects similar to allergic reactions. However, the frequency of such occurrences in actual clinical settings is very rare, and even clinical tests on patients with known allergies to local anesthetics may often show negative results. When adverse effects, such as allergy to lidocaine, are involved, patients can be treated by testing other local anesthetics and choosing a local anesthetic without any adverse effects, or by performing dental treatment under general anesthesia in cases in which no local anesthetic without adverse effects is available. Along with a literature review, the authors of the present study report on two cases of patients who tested positive on allergy skin tests for lidocaine and bupivacaine and subsequently underwent successful dental treatments with either general anesthesia or a different local anesthetic.