• Title/Summary/Keyword: adverse drug reactions

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A Clinical Case Report of Contrast-induced drug eruption patient Treated with Traditional Oriental Medicine (조영제로 유발된 약진(藥疹)환자 치험 1례)

  • Jerng, Ui-Min;Jeong, Jong-Soo;Yoon, Seong-Woo;Park, Jae-Woo
    • Journal of Korean Traditional Oncology
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    • v.12 no.1
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    • pp.75-82
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    • 2007
  • Drug eruption is a cutaneous reaction caused by various drugs. It is a very common drug induced adverse reaction. Contrast media induced drug eruption is rare. But approximately 10% of people injected with contrast media experience adverse reaction, and drug eruption accounts for more than 40% of all adverse reactions. We report a case of mild drug eruption and its treatment process based on korean traditional medicine. The patient is a 50 years old female diagnosed with functional dyspepsia. The patient had gastric discomfort and alternation between diarrhea and constipation. All symptoms showed nearly complete remission with continued korean traditional medical treatment. The patient had been injected with contrast media for Computed tomography(CT) evaluation of her breast cancer history. Rashes appeared on back and abdomen, and urticaria and pruritus appeared on the patient's finger 1 day after injection. We prescribed Goreisan(TSUMURA CO &, TJ-17) and acupuncture on Quchi(LI11), Zusanli(ST36), Yangxi(LI5), Yanggu(SI5). Consequently, the drug eruption showed remarkable improvement. So the author reports korean traditional medicine is effective complementary treatment for drug eruption.

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A Case Report of Extensive Limb Swelling in Newborn After Vaccination: Unusual Thigh Swelling After Hepatitis B vaccination (신생아 B형 간염 예방 접종 후 하지 부종이 발생한 환아 치험 1례)

  • Han, Ju Hui;Kim, Deog Gon;Lee, Jin Yong
    • The Journal of Pediatrics of Korean Medicine
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    • v.28 no.1
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    • pp.52-60
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    • 2014
  • Objectives The purpose of this study is to report the clinical effects of oriental medical treatment on Extensive limb swelling which is rare adverse reaction of vaccination. Methods A 11 months old infant who appealed unilateral thigh swelling after immunization and signs of local inflammation was administered a complex herbal medicine consisting of five decoctions; Gwakhyangjunggisan, Binsosan, Danggwisusan, Samchulgunbitang and Gwibitang. The length of the constant regions of the thigh circumference was measured every visit. Each process was recorded by photograph. After one year from the first visit, phone call was conducted to follow-up. Results The length of the thigh after administration of herbal medicine did not change much, but the part where swelled hard became little bit softer. A year later, patient's growth and walking was normal but the swollen part not changed. Since then the similar adverse effects did not recur on booster doses vaccines. Conclusions The adverse reactions of vaccination are rarely reported and there is no specific treatment for swelling from Hepatitis B vaccine. It will be more helpful to study if more cases reported about any adverse drug reactions or any side effects from the immunization.

Effects of SULT1A1 Copy Number Variation on Estrogen Concentration and Tamoxifen-Associated Adverse Drug Reactions in Premenopausal Thai Breast Cancer Patients: A Preliminary Study

  • Charoenchokthavee, Wanaporn;Ayudhya, Duangchit Panomvana Na;Sriuranpong, Virote;Areepium, Nutthada
    • Asian Pacific Journal of Cancer Prevention
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    • v.17 no.4
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    • pp.1851-1855
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    • 2016
  • Tamoxifen is a pharmacological estrogen inhibitor that binds to the estrogen receptor (ER) in breast cells. However, it shows an estrogenic effect in other organs, which causes adverse drug reactions (ADRs). The sulfotransferase 1A1 (SULT1A1) enzyme encoded by the SULT1A1 gene is involved in estrogen metabolism. Previous research has suggested that the SULT1A1 copy number is linked with the plasma estradiol (E2) concentration. Here, a total of 34 premenopausal breast cancer patients, selected from the Thai Tamoxifen (TTAM) Project, were screened for their SULT1A1 copy number, plasma E2 concentration and ADRs. The mean age was $44.3{\pm}11.1years$, and they were subtyped as ER+/progesterone receptor (PR)+ (28 patients), ER+/PR- (5 patients) and ER-/PR- (1 patient). Three patients reported ADRs, which were irregular menstruation (2 patients) and vaginal discharge (1 patient). Most (33) patients had two SULT1A1 copies, with one patient having three copies. The median plasma E2 concentration was 1,575.6 (IQR 865.4) pg/ml. Patients with ADRs had significantly higher plasma E2 concentrations than those patients without ADRs (p = 0.014). The plasma E2 concentration was numerically higher in the patient with three SULT1A1 copies, but this lacked statistical significance.

Serum Biochemical Analysis of Rats Administered with Two Types of Yugmijihwangtang Obtained in Different Ways (구입경로가 다른 두 종류의 육미지황탕을 투여한 흰쥐의 혈액분석연구)

  • Jeon, Seong-Jin;Lee, Sun-Dong;Park, Hae-Mo;Choi, Jong-Hhan;Lee, Hyean-Woo
    • Journal of Society of Preventive Korean Medicine
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    • v.9 no.2
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    • pp.107-123
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    • 2005
  • Traditional herbal medicine is widely used among the Korean people, and other eastern Asian countries employ similar therapies as well. In recent years, due to increasing interest in herbal medicine, many researches have been made on the toxicity and adverse drug reactions of herbal medications. Through private and public media, there have been many opinions that taking herbal medicine is very harmful, especially, to liver and kidney. We face upon evaluation of herbal medication, safe, and efficacy. Furthermore, we need to control quality of herbs. This study aims to verify the evidence that taking herbal medicine will yield equal reaction in 2 lab animal groups (A and B). One frequently prescribed herbal medication, Yugmijihwangtang, was used to test the evaluation of quality on lab animals (SD-Rat). There were no significant differences in body, visceral weight, and serum analysis test results after herbal medication for 1 month. But, AST and ALT scores were raised in 2 subjects in group A (over reference range). It seems to be an adverse drug reaction, and this finding was restricted in group A herbal medicine. These results suggest that we need to qualify herbal plants in Korea, and study which herbs would cause specific reactions in human.

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Investigation on Adhesion Control Standards and Skin Adverse Effects of Skin Attached Formulations (파스제의 점착력 관리기준 및 피부 부작용 조사연구)

  • Kim, Ji Yeon;Kim, Kwang Joon;Park, Sang-Wook;Bang, Joon Seok;Lee, Wonjae
    • Korean Journal of Clinical Pharmacy
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    • v.24 no.3
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    • pp.219-228
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    • 2014
  • Objectives: This paper was aimed to investigate the adhesion control standards of pain relieving patch (PRP) drugs and to survey it's adverse effects on the skin of patients for safe use of PRP drugs. Methods: In this study, the related documents of PRP drugs of Korea pharmacopoeia (KP), United States pharmacopoeia (USP), Japanese Pharmacopoeia (JP), European pharmacopoeia (EP), and information web sites of the Ministry of Food and Drug Safety (MFDS) were surveyed. Also, the past and current labeling of PRP drugs marketed in the pharmacy was investigated and compared. Results: In KP and JP, the lower limit standard for PRP's adhesion control is established, but the upper limit standard is not designated. In USP and EP, neither the lower nor upper limit standard is established. The main reasons of skin adverse effects are considered as inherent adverse reactions of the applied drugs for PRP. Another reason is involved in patient's medication mistakes related to PRP's adhesion control, respiratory depression of skin according to physical skin closure, and microbial growth, etc. Conclusion: For safe use of PRP drugs, we proposed ensured guidelines like additional instructions of pharmacist's prescription and detailed labeling systems for usage of PRP drugs applied on skin.

PHARMACOGENOMICS IN RELATION TO TAILOR-MADE DRUGS -INTRODUCTION-

  • Satoh, Tetsuo
    • Proceedings of the Korean Society of Applied Pharmacology
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    • 2006.11a
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    • pp.51-66
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    • 2006
  • The field of cytochrome P450 pharmacogenomics has progressed rapidly during the past 25 years. Recently, conjugating enzymes including sulfotransferase, acetyltransferase, glucuronosyltransferase and glutathione transferase have been also extensively studied. All the major human drug-metabolizing P450 enzymes and some conjugating enzymes have been identified and cloned, and the major gene variants that cause inter-individual variability in drug response and are related to adverse drug reactions have been identified. This information now provides the basis for the use of predictive pharmacogenomics to yield drug therapies that are more efficient and safer. Today, we understand which drugs warrant dosing based on pharmacogenomics to improve drug treatment. It is anticipated that genotyping could be used to personalize drug treatment for vast numbers of subjects, decreasing the cost of drug treatment and increasing the efficacy of drugs and health in general. It is assumed that such personalized P450 gene-based treatment which is so-called tailor(order)-made drug therapy would be relevant for 10-20% of all drug therapy in the future.

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PHARMACOGENOMICS IN RELATION TO TAILOR-MADE DRUGS -INTRODUCTION-

  • Satoh, Tetsuo
    • 한국약용작물학회:학술대회논문집
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    • 2006.11a
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    • pp.51-66
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    • 2006
  • The field of cytochrome P450 pharmacogenomics has progressed rapidly during the past 25 years. Recently, conjugating enzymes including sulfotransferase, acetyltransferase, glucuronosyltransferase and glutathione transferase have been also extensively studied. All the major human drug-metabolizing P450 enzymes and some conjugating enzymes have been identified and cloned, and the major gene variants that cause inter-individual variability in drug response and are related to adverse drug reactions have been identified. This information now provides the basis for the use of predictive pharmacogenomics to yield drug therapies that are more efficient and safer. Today, we understand which drugs warrant dosing based on pharmacogenomics to improve drug treatment. It is anticipated that genotyping could be used to personalize drug treatment for vast numbers of subjects, decreasing the cost of drug treatment and increasing the efficacy of drugs and health in general. It is assumed that such personalized P450 gene-based treatment which is so-called tailor(order)-made drug therapy would be relevant for 10-20% of all drug therapy in the future.

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Characteristics of Cardiovascular Adverse Drug Reactions Reported to KFDA (식품의약품안전청에 보고된 심혈관계 약물유해반응의 특성 분석)

  • Rhew, Ki-Yon;Cho, Hea-Kyoung;Lee, Suk-Hyang
    • Korean Journal of Clinical Pharmacy
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    • v.22 no.1
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    • pp.41-46
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    • 2012
  • Adverse drug reaction (ADR) is a global problem of major concern in health care. ADRs can be accrued in any organs or systems. However, cardiovascular ADRs could be a more serious problem if they are irreversible or severe. For this reason, this study was conducted to analyze pattern and severity of cardiovascular ADRs, and suspicious medication. Total 646 reports including cardiovascular ADRs reported to the KFDA between January and June 2010 were analyzed. Amlodipine besylate (36 reports, 3.3%), iopromide (29 reports, 2.7%), tramadol HCl (28 reports, 2.6%) were most suspicious drugs that occurred cardiovascular ADRs. The most common cardiovascular ADRs were hypotension( 236 reports, 33.1%), palpitation (134 reports, 18.8%), and hypertension (89 reports, 12.5%). The most frequent ADRs were occurred in the age group of more than 60. This result could be of help to prescribers and other healthcare providers to predict and prevent cardiovascular ADRs. Also this study suggested that patients with cardiovascular ADR risk factors should be intensively monitored during the medications.

Analysis of Important Medical Adverse Events and Signals Related with Cyclosporine and Tacrolimus Using the FDA Adverse Event Reporting System (FAERS) Database (FDA 부작용 보고 시스템 데이터베이스를 이용한 Cyclosporine과 Tacrolimus의 주요 약물이상사례 및 실마리 정보 분석)

  • Seung Hyeon Cha;Ji Hyeon Im;Yun-Kyoung Song
    • Korean Journal of Clinical Pharmacy
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    • v.32 no.4
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    • pp.352-361
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    • 2022
  • Objective: This study aimed to analyze the important medical adverse events (IMEs) of cyclosporine and tacrolimus using the reports in US FDA adverse event reporting system (FAERS) and to detect related signals. Methods: The FAERS database was used to analyze the IMEs reported for cyclosporine or tacrolimus during 2017-2021. Reporting odds ratio (ROR) and information component were used to analyze signals for adverse events of both drugs. It was investigated whether the detected signals were present on drug labels in Korea and the United States. Results: Among the total 24,688 reports, the reports on tacrolimus accounted 75.8%. Mean age of the patients was 47.9 years old and median number of adverse events was 2.0 per report. The number of patients hospitalized for adverse events was 7,979 (25.3%). Among the adverse reactions reported on the cyclosporine and tacrolimus, 576 and 1,363 events were detected as signals for cyclosporine and tacrolimus, respectively, and of these, IMEs accounted for 44.8 and 59.2%, respectively. The IMEs related with infections/infestations, renal/urinary disorders, and blood and lymphatic system disorders were reported frequently for both drugs. The most frequently detected IMEs were renal impairment for cyclosporine and acute kidney injury for tacrolimus. Among the top 3 IMEs for each reported SOC for cyclosporine and tacrolimus, 9 and 2 unexpected adverse events were identified, respectively. Conclusion: This study identified the IMEs and signals of cyclosporine and tacrolimus, and detected unidentified adverse events in a drug information database.

Continuous Ilioinguinal-iliohypogastric Nerve Block for Groin Pain in a Breast-feeding Patient after Cesarean Delivery

  • Kim, Eun Soo;Kim, Hae Kyu;Baik, Ji Seok;Ji, Young Tae
    • The Korean Journal of Pain
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    • v.29 no.3
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    • pp.193-196
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    • 2016
  • Ilioinguinal and iliohypogastric (II/IH) nerve injury is one of the most common nerve injuries following pelvic surgery, especially with the Pfannenstiel incision. We present a case of intractable groin pain, successfully treated with a continuous II/IH nerve block. A 33-year-old woman, following emergency cesarean section due to cephalopelvic disproportion, presented numbness in left inguinal area and severe pain on the labia on the second postoperative day. The pain was burning, lancinating, and exacerbated by standing or movement. However, she didn't want to take additional medicine because of breast-feeding. A diagnostic II/IH nerve block produced a substantial decrease in pain. She underwent a continuous II/IH nerve block with a complete resolution of pain within 3 days. A continuous II/IH nerve block might be a goodoption for II/IH neuropathy with intractable groin pain in breast-feeding mothers without adverse drug reactions in their infants.