• Korean Journal of Clinical Pharmacy
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• v.27 no.3
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• pp.143-149
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• 2017

Background: L-asparaginase (L-ASP) is a critical agent for the treatment of acute lymphoblastic leukemia and lymphoma, which is associated with serious toxicities including hypersensitivity, pancreatitis and thrombosis. Methods: To evaluate the toxicity of L-ASP in real clinical settings, we included the patients with L-ASP adverse drug reactions (ADRs) reported in a regional pharmacovigilance center of Seoul St. Mary's hospital from January 2014 to December 2015. Results: A total of 83 cases of L-ASP related ADRs were reported in 54 patients. Of these 83 cases, 65 cases (78.3%, 65/83) were spontaneously reported and 18 cases (21.7%, 18/83) were detected by further medical records review. Of the patients with ADRs, pediatric patients accounted for 83.3% of the cases (45/54) and median age was 9 years. The most common clinical manifestations of ADRs were hematology manifestations (31.3%, 26/83), followed by hepatobiliary manifestations (18.1%, 15/83). Thirty-four serious ADRs were reported in 19 patients. The sserious ADR group showed significantly longer hospitalization and higher rate of discontinuation of L-ASP than the non-serious ADR group (p = 0.005, 0.03). The most common clinical manifestations of serious ADRs were hepatobiliary manifestations (41.2%, 14/34). In total, 8 cases (9.6%, 8/83) of unlabeled ADRs were identified. They were serious ADRs. Conclusion: We identified unlabeled serious ADRs of L-ASP. Also, correlations were observed between serious ADRs and length of hospitalization, discontinuation rate respectively. Further investigations and developed spontaneous ADR reporting systems are needed to evaluate these correlations.

• The Journal of Pediatrics of Korean Medicine
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• v.35 no.3
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• pp.67-88
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• 2021

Objectives The purpose of this study is to analyze randomized clinical trials (RCTs) on traditional Chinese medicine to summarize its efficacy and safety for the treatment of functional gastrointestinal disorders (FGIDs) in children. Methods We searched literatures published up to March 19, 2021 using two Chinese electronic databases. Data regarding patients, interventions, results, and adverse events were extracted from RCTs of herbal medicine for children with FGIDs. Results A total of 34 RCTs were included: 16 trials on functional dyspepsia, 7 trials on functional constipation, 6 trials on functional abdominal pain, 4 trials on irritable bowel syndrome, and 1 trial on functional diarrhea. 26 of 29 trials that reported total effective rate, the treatment group showed a significant improvement compared to the control group. Most of other evaluation indicators, such as symptom score, symptom disappearance time, and recurrence rate also demonstrated statistically significant improvement. Of the 16 studies which reported safety, 5 studies reported no adverse reactions in either group, and 4 studies reported no statistically significant differences in the incidence of adverse events between two groups. Also, reported adverse events were mostly mild. Conclusions Herbal medicine may help improve symptoms of FGIDs in children. However, due to limited types of studies on sub-diseases of FGIDs and small sample sizes in each study, additional large scale clinical studies on various other FGIDs are necessary.

• Korean Journal of Clinical Pharmacy
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• v.28 no.4
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• pp.293-299
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• 2018

Background: 3-Hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) effectively reduce serum levels of low-density lipoprotein (LDL) and total cholesterol. High-intensity statins are recommended for all patients aged ${\leq}75$ with clinical atherosclerotic cardiovascular disease (ASCVD), diabetes mellitus aged 40-75 with ${\geq}7.5%$ estimated 10-year ASCVD risk and LDL-C ${\geq}190mg/dL$. High-intensity statins associated with more frequent adverse events (AEs) compared to moderate- to low-intensity statins. The aim of this study was to compare AEs between high-intensity and moderate- to low-intensity statin group using the Korea Adverse Event Reporting System (KAERS) database. Methods: Adults (${\geq}18years$) with statin-associated AEs from July 2009-June 2014 were included. Only AEs classified as "certain", "probable" and "possible" based on the WHO-Uppsala Monitoring Center criteria were analyzed. Results: In total, 247 AEs from 196 patients [high-intensity statin group (HG), n = 25 (13%); moderate- to low-intensity statin group (MLG), n = 171 (87%)] were included. Mean age was higher in HG compared with MLG ($67{\pm}14$ vs $62{\pm}12$). The HG showed a significant higher frequency of liver/biliary system disorders (37% vs 14%, p = 0.001). Hepatic function abnormal was reported more frequently in HG compared to MLG (26% vs 9%, p = 0.006). Conclusion: According to KAERS data, liver/biliary system disorders were more frequently reported in HG compared to MLG.

• Clinical and Experimental Pediatrics
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• v.51 no.11
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• pp.1185-1190
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• 2008

Purpose : This study was undertaken to evaluate the immunogenicity and reactogenicity of Td booster immunization in early preadolescents of Korea. Methods : Healthy preadolescents, who had been vaccinated with 4 or 5 doses of DTaP vaccines until 6 years old age, were enrolled in this study from August 2006 to April 2007. Diphtheria and tetanus anti-toxoid antibodies in sera were measured by ELISA just before vaccination and 4 weeks after vaccination to evaluate immunogenicity. Local and systemic adverse reactions observed for 4 weeks after vaccination to access reactogenicity. Results : 183 preadolescents were enrolled and mean age was $11.40{\pm}0.51$ years old. All subjects achieved seroprotective diphtheria and tetanus anti-toxoid antibodies (titers ${\geq}0.1IU/mL$) after Td booster vaccination. Among 183 vaccinees, 73.8% showed local adverse reactions and 37.2% systemic adverse reactions. Pain at injection site (66.1%) was the most common local reaction, and the most commonly shown systemic reaction was myalgia (17.5%). The adverse reactions were spontaneously relieved within three days after vaccination. Conclusion : Td vaccine in this study was high immunogenic and showed an acceptable tolerance in Korean preadolescents. Td booster vaccination at 11-12 years old is the most effective method to increase compliance of the vaccination and to decrease the incidence of diphtheria and tetanus.

• Childhood Kidney Diseases
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• v.8 no.2
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• pp.129-137
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• 2004

Purpose : Nocternal enuresis is a common disorder. Tricyclic antidepressant and desmopressin have been accepted pharmacological treatment for this disorder We conducted a cooperative study to investigate the efficacy and adverse reactions of imipramine, desmopressin and combination treatment in children with primary monosymptomatic nocturnal enuresis(PMNE). Methods: Data from a large multicenter study were analysed. In the period of 8 months in 2002, the study comprised of 168 children(78 boys and 90 girls, 5 to 15 years old) with PMNE for imipramine, desmopressin or combination treatment. Before treatment a history, physical examination and laboratory tests were performed and the children were observed for 2 weeks. Response rate, adverse reactions and enuresis episodes after stopping drug administration were evaluated after 12-weeks of imipramine, desmopressin or combination of both. Results: After 4 weeks, the frequency of bed wetting in all treated patients decreased during treatment significantly Even though a 30-50%, reduction in the number of wet nights were 68.6%, 74.4% and 86.1% during 12 weeks treatment by imipramine, desmopressin and both of them respectively, there was no significant difference between them. The most common adverse reaction was decreased appetite from imipramine administration. But no serious drug-related adverse events were reported. Conclusion: Efficacy of the combination therapy of imipramine and desmopressin in PMNE appears not to be better than either drug alone. It is necessary to pay attention on account of adverse reactions during imipramine treatment even though imipramine and desmopressin were generally well tolerated.

• Journal of Sasang Constitutional Medicine
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• v.19 no.3
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• pp.277-282
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• 2007

1. Objectives This paper reports a case of cervical cancer patient who showed positive results to Sasang Constitutional Medicine. The target symptoms were urinary disorder due to unilateral hydronephrosis and urticaria due to adverse drug reactions. 2. Methods We measured urinary output and interval. We evaluated skin urticaria by severity and size of itchy site. The patient treated using Sasang Constitutional Medicine. 3. Results and Conclusions Significant improvement was observed in urinary output and interval.

• The Journal of Internal Korean Medicine
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• v.38 no.4
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• pp.501-508
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• 2017

Objective: This study evaluated the effects of traditional Korean medicine on a patient with hyperthyroidism, who could not use antithyroid medication due to an adverse reaction to methimazole. Methods: Herbal medicine was administered and acupuncture was carried out. A thyroid function test was used to evaluate the effects of the treatment. Results: After treatment with traditional Korean medicine and therapy, the patient showed significant improvements in symptoms and FT4 levels. Conclusion: This case proved that traditional Korean medicine can be used for patients who have adverse reactions to antithyroid medication; however, studies of larger populations are required in the future.

• Journal of Veterinary Clinics
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• v.34 no.3
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• pp.197-199
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• 2017

A 14-year-old castrated male ShihTzu diagnosed with chronic kidney disease (CKD) 6 months prior was referred to our clinic. The patient had been experiencing symptoms such as vomiting, poor appetite and hind limbs weakness. Hematology tests showed that he had a non-regenerative anemia. With aggressive treatment, the patient's state had gotten worse. He showed ragged breath, vomiting blood and loss of consciousness temporarily. Hematocrit maintained low level. Gastric hemorrhage was strongly suspected by hematemesis. Whole blood transfusion was performed and heparin was used as an anticoagulant. Prior to transfusion, the blood cross matching between donor and patient was performed and the result was compatible. After the transfusion was stabilized, 1 mg of protamine sulfate for each 100 units of heparin was prepared and given intravenously over 3 minutes to reverse the effects of heparin. Immediately after protamine injection, the patient conducted severe anaphylactic shock. Protamine sulfate is used to reverse the anticoagulant action of heparin in dogs and humans. The adverse reaction of protamine sulfate range from mild reaction to fetal cardiac arrest. When using protamine sulfate as heparin neutralization, it can lead to the death of a patient cause of anaphylactic shock. For this reason, the protamine sulfate should be injected slowly with antihistamine and the clinician should carefully monitor patients.

• Journal of Korean Medicine Rehabilitation
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• v.30 no.4
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• pp.133-142
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• 2020

Objectives Studies on Chinese herbal injections are increasing. But, its safety are still not well reported. We have reviewed the literature related to the safety of Chinese herbal injection, especially those related to anaphylaxis. Methods The PubMed database was used to select the literatures related to anaphylaxis in China and to study the quality control and safety of Chinese herbal injection. Results Chinese herbal injection is a major traditional medical treatment in China, but it is the cause of adverse drug reactions including anaphylaxis. In order to solve this problem, various proposals have been made to identify the pharmacological and chemical causes of major side effects and to use them safely clinically. In addition, various researches have been conducted from preclinical to postmarketing surveillance to secure the safety of Chinese herbal injection. Based on this, it was found that various efforts are needed to secure the safety of bee sting needles. Conclusion In order to secure the safety of chinese herbal injections, it is necessary to identify the main mechanism of action and the pharmacological components contributing to it, and to develop a standardized formulation based on this. In addition, institutional pharmacovigilance is required.

• The Korean Journal of Pain
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• v.27 no.2
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• pp.103-111
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• 2014

Nefopam (NFP) is a non-opioid, non-steroidal, centrally acting analgesic drug that is derivative of the nonsedative benzoxazocine, developed and known in 1960s as fenazocine. Although the mechanisms of analgesic action of NFP are not well understood, they are similar to those of triple neurotransmitter (serotonin, norepinephrine, and dopamine) reuptake inhibitors and anticonvulsants. It has been used mainly as an analgesic drug for nociceptive pain, as well as a treatment for the prevention of postoperative shivering and hiccups. Based on NFP's mechanisms of analgesic action, it is more suitable for the treatment of neuropathic pain. Intravenous administration of NFP should be given in single doses of 20 mg slowly over 15-20 min or with continuous infusion of 60-120 mg/d to minimize adverse effects, such as nausea, cold sweating, dizziness, tachycardia, or drowsiness. The usual dose of oral administration is three to six times per day totaling 90-180 mg. The ceiling effect of its analgesia is uncertain depending on the mechanism of pain relief. In conclusion, the recently discovered dual analgesic mechanisms of action, namely, a) descending pain modulation by triple neurotransmitter reuptake inhibition similar to antidepressants, and b) inhibition of long-term potentiation mediated by NMDA from the inhibition of calcium influx like gabapentinoid anticonvulsants or blockade of voltage-sensitive sodium channels like carbamazepine, enable NFP to be used as a therapeutic agent to treat neuropathic pain.