• Parasites, Hosts and Diseases
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• 제49권2호
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• pp.153-159
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• 2011

A total of 286 individuals from 3 selected communities (Areedi-Aje, Ipakodo/Ojokodo, and Ijebu-Igbo) of Ijebu-North, southwestern Nigeria were examined for Loa loa microfilaremia using finger prick blood smear, between December 2008 and March 2009. Rapid assessment procedure for loiasis (RAPLOA) was used to obtain information, from 187 Ijebu-Igbo residents, on adverse reactions experienced from retrospective treatments with ivermectin and history of eye worm. Only 33.9% of the respondents reported having had a history of eye worm while 33.2% had microfilaremia. The demographic factor of gender was not significant determinants of the prevalence (p>0.05) while age was significant (P<0.05). The highest prevalence of eye worm history and microfilaremia were recorded in 61-70 and 15-20 years of age categories, respectively. Ijebu-Igbo had 27.3% eye worm history, 32.1% microfilaremia, and the highest intensity of 140 microfilariae (mf)/ml. Ipakodo area had the highest eye worm history of 54.4% and the highest intensity of 420 mf/ml. Areedi-Aje had the highest occurrence of 45.2% microfilaremia and the highest intensity of 460 mf/ml. Predictably, Areedi-Aje and Ipakodo areas were high risk communities. The low intensity of L. loa infection with an insignificant (2.1%; P>0.05) adverse reactions from 187 subjects involved in the retrospective ivermectin administration confirmed that ivermectin delivery may be considered safe. The community-directed treatment with ivermectin (CDTI) programme was most probably responsible for the low prevalence and intensity.

• Asian Pacific Journal of Cancer Prevention
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• 제17권4호
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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.

• The Korean Journal of Physiology and Pharmacology
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• 제20권1호
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• pp.63-67
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• 2016

Severe graft-versus-host disease (GVHD) is an often lethal complication of allogeneic hematopoietic stem cell transplantation (HSCT). The safety of clinical-grade mesenchymal stem cells (MSCs) has been validated, but mixed results have been obtained due to heterogeneity of the MSCs. In this phase I study, the safety of bone marrow-derived homogeneous clonal MSCs (cMSCs) isolated by a new subfractionation culturing method was evaluated. cMSCs were produced in a GMP facility and intravenously administered to patients who had refractory GVHD to standard treatment resulting after allogeneic HSCT for hematologic malignancies. After administration of a single dose ($1{\times}10^6cells/kg$), 11 patients were evaluated for cMSC treatment safety and efficacy. During the trial, nine patients had 85 total adverse events and the rate of serious adverse events was 27.3% (3/11 patients). The only one adverse drug reaction related to cMSC administration was grade 2 myalgia in one patient. Treatment response was observed in four patients: one with acute GVHD (partial response) and three with chronic GVHD. The other chronic patients maintained stable disease during the observation period. This study demonstrates single cMSC infusion to have an acceptable safety profile and promising efficacy, suggesting that we can proceed with the next stage of the clinical trial.

• Biomolecules & Therapeutics
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• 제14권1호
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• pp.56-65
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• 2006

Adverse drug events (ADEs) are the most common type of adverse events in medical practice. Hospital admissions related to ADEs cost high and should be monitored to prevent them. While concerns about the ADEs are increasing, the frequency and characteristics of admissions related to ADEs have not been reported in Korea. The objective of the study was to assess the rate of hospital admission related to ADEs and their characteristics through ADE signal-based retrospective reviews of medical records. As results, a total of 1,420 patients had ADE signals suggesting potential ADEs from 3,494 patients who discharged from an academic medical center over one month period. Six pharmacists independently assessed the presence of ADEs after the review of patients' medical records. Among the 3,494 discharges, 62 admissions (1.8%) were found to be realted to ADEs. Of admissions with ADEs, 83.9% were moderate (category F by the NCC MERP classification), 37.2% were preventable, and 85.5% were type A reaction. The most frequent suspected drugs causing ADEs were antineoplastics (48.9%), and the most frequent ADE signal detecting hospital admissions related to ADEs was white blood cell count (24.2%). Hospital admissions related to ADEs were found through screening the ADE signals. The ADE signal-based retrospective review could be a practical approach for identifying hospital admissions related to ADEs.

• Clinical and Experimental Reproductive Medicine
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• 제43권4호
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• pp.215-220
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• 2016

Objective: To evaluate the efficacy and safety of dienogest treatment in patients who had received dienogest for 12 months or more to treat endometriosis. Methods: We analyzed the clinical data of 188 women with endometriosis who had been treated with 2 mg of dienogest once a day for 12 months or more at a single institute. We evaluated changes in endometriosis-associated pain and endometrioma size, recurrence rate, and adverse events following dienogest administration. Bone mineral density (BMD) was measured in patients who were prescribed dienogest for more than 18 months. Results: Pain was significantly reduced at 12 months after dienogest medication. In those treated with dienogest due to recurrent endometrioma, the size of the endometrioma was significantly decreased at the 12-month and 18-month follow-ups. We found only one case of sonographic recurrence during dienogest administration among those who were treated postoperatively to prevent recurrence (1 of 114, 0.9%). The most common adverse drug reaction was uterine bleeding (3.2%), and other adverse events were generally tolerable and associated with low discontinuation rates (5.2%). Among the 50 patients in whom BMD was measured, 10 patients (20%) had a Z-score below the expected range for age. Conclusion: The administration of dienogest for a year or more seems to be highly effective in preventing recurrence after surgery, reducing endometriosis-associated pain, and decreasing the size of recurrent endometrioma, with a favorable safety and tolerability profile. However, BMD should be checked in patients on long-term medication due to possible bone loss in some women.

• The Korean Journal of Pain
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• 제30권2호
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• pp.86-92
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• 2017

Osteoblasts, originating from mesenchymal cells, make the receptor activator of the nuclear factor kappa B ligand (RANKL) and osteoprotegerin (OPG) in order to control differentiation of activated osteoclasts, originating from hematopoietic stem cells. When the RANKL binds to the RANK of the pre-osteoclasts or mature osteoclasts, bone resorption increases. On the contrary, when OPG binds to the RANK, bone resorption decreases. Denosumab (AMG 162), like OPG (a decoy receptor), binds to the RANKL, and reduces binding between the RANK and the RANKL resulting in inhibition of osteoclastogenesis and reduction of bone resorption. Bisphosphonates (BPs), which bind to the bone mineral and occupy the site of resorption performed by activated osteoclasts, are still the drugs of choice to prevent and treat osteoporosis. The merits of denosumab are reversibility targeting the RANKL, lack of adverse gastrointestinal events, improved adherence due to convenient biannual subcutaneous administration, and potential use with impaired renal function. The known adverse reactions are musculoskeletal pain, increased infections with adverse dermatologic reactions, osteonecrosis of the jaw, hypersensitivity reaction, and hypocalcemia. Treatment with 60 mg of denosumab reduces the bone resorption marker, serum type 1 C-telopeptide, by 3 days, with maximum reduction occurring by 1 month. The mean time to maximum denosumab concentration is 10 days with a mean half-life of 25.4 days. In conclusion, the convenient biannual subcutaneous administration of 60 mg of denosumab can be considered as a first-line treatment for osteoporosis in cases of low compliance with BPs due to gastrointestinal trouble and impaired renal function.

• 대한한방내과학회지
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• 제40권5호
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• pp.983-989
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• 2019

Objective: Many types of delayed adverse reactions, such as long-term numbness, occur after injecting contrast medium, but few clinical studies have reported effective treatments for these reactions. We report that herbal medicine can have a positive clinical effect in patients who have experienced long-term numbness after contrast medium injection. Method: A patient who had felt numbness in her head and whole limbs presented at Semyung University Korean Medicine hospital. Her numbness had first started 2 days after injection of contrast medium, and she had felt it constantly for almost 2 years. After admission at the hospital, she took "modified Samul-tang" herbal medicine (120 cc three times per day) from 29 January 2019 to 2 February 2019. We measured her numbness using a numeric rating scale (NRS) on 29 January and 2 February and we compared both scores to determine the degree of favorable and clinical effects of herbal medicine. Result: The NRS score for numbness was 5 for her head and limbs on the first day (29 January), but after 4 days (2 February), the NRS score decreased to 0 for her head and both arms and hands, and it decreased from 5 to 2 for both her legs and feet. Conclusion: Korean herbal medicine can have positive clinical effects on treating adverse reactions due to injection of contrast medium.

• 사상체질의학회지
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• 제26권2호
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• pp.205-212
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• 2014

Objectives Adverse reactions can becaused by contrast media used in computed tomography. The aim of this study was to report the improvement of allergic response caused by contrast media after treatment with Modified Hyeongbangpaedok-san, histamine antagonists and steroids. Methods We retrospectively reviewed the medical records. The patient's subjective symptoms such as rash and pruritus were evaluated by the range of rash and numeric rating scale(NPS). Results All symptoms showed nearly complete remission with continued Korean traditional medical treatment. Conclusions A female patient had been injected with contrast media for Computed tomography(CT) evaluation of lung cancer. Rash and pruritus appeared 1 day after injection. We prescribed Modified Hyeongbangpaedok-san. Patients were treated with both Korean medicine and Western medicine. Consequently, the symtoms were improved significantly after combination treatment of Korean medicine and Western medicine.

• 한국임상약학회지
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• 제30권1호
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• pp.19-30
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• 2020

Objective: To describe patterns of spontaneous reporting on adverse events following immunization (AEFIs) using the human papilloma virus (HPV) vaccine according to the Brighton Collaboration (BC) criteria. Methods: We used the Korea Adverse Event Reporting System (KAERS) database including vaccinations between 2008 and 2017. To apply BC criteria, we classified 58 BC AEFIs into World Health Organization Adverse Reaction Terminology (WHO-ART) codes. We applied MedDRA standard medical queries that were pre-defined as five BC AEFIs. Terminology mapping between MedDRA and WHO-ART terms was performed by three researchers. Descriptive statistics of individual case safety reports were analyzed according to BC applicability. Disproportionality analyses were performed on each BC AEFI and each preferred AEFI term according to the case-noncase approach; reporting odds ratio (ROR) and 95% confidence intervals (CI) were calculated. Results: Among the 30,266 reports of vaccinations between 2008 and 2017, 2,845 reports included the HPV vaccine. Of these reports, 1,511 (53.1%) included at least one BC AEFI. Reports from physicians or manufacturers included more BC AEFIs than from other reporters. Injection site reactions and fever were frequently reported in BC AEFIs; spontaneous abortion and ectopic pregnancy (ROR, 14.29 [95% CI, 4.30-47.49]) and vasculitic peripheral neuropathy (ROR, 8.57 [95% CI, 2.61-28.10]) showed the highest ROR. Among non-BC AEFIs, dizziness or myalgia were frequently reported; exposure during pregnancy (ROR, 23.95 [95% CI, 16.27-35.25]) and inappropriate schedule of administration (ROR, 22.89 [95% CI, 16.74-31.31]) showed the highest ROR. Conclusion: BC criteria would be applicable for labeled AEFIs, whereas analyzing non-BC AEFIs would be useful for detecting unlabeled AEFIs.

• 대한지역사회영양학회지
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• 제3권1호
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• pp.76-93
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• 1998

Three hundred sixty-two(male 131, female 231) elderly aged over 65 in Chungb- uk area were interviewed to determine the disease states and drug usage patterns. The prebalence of disease was 78% and women reported more chronic diseases(83%) than men(71%). Elderly who live with spouse and have an occupation have a lower rate of disease. Average number of diseases of the elderly was $1.8\pm{1.1}$, and women$(2.1\pm{1.3)}$ have significantly higher average number of diseases than that of men$(1.4\pm{0.7)}$. Also the elderly in urban areas$(2.1\pm{1.4)}$ have significantly higher number of diseases than that of the elderly in rural areas$(1.6\pm{0.9)}$. Arthritis, hypertension, cardiovascular and gastric diseases were the most frequently listed chronic diseases in order for both men and women. Anemia and fracture of bone were relatively higher in women than in men. Particularly, the arthritis of the urban elderly have a rate of 1.5 times higher than that of the rural elderly. Fifty-two percent of the elderly were currently using drugs ; among drug users 71.2% used prescription drugs and 20.5% used nonprescription drugs. The average number taken per person was 2.1$\pm$1.4 and there was no sex or age difference. However, the elderly in rural areas $(2.7\pm{1.7)}$ consumed a significantly higher number of drugs than those in urban areas$(1.7\pm{0.7)}$. The average number of prescripti- on drugs taken was 2.0$\pm$1.4 while the average of nonprescription drugs taken was $(1.3\pm{0.6)}$. Analgesics and antihypertensive drugs were most commonly used. Vitamin and analgesics were the most frequently used self-prescribed drugs. It was noted that potential adverse drug interaction by concominant drug consumption for arthritis and antihypensive drug, abuse of digestants and antiacid without treatment of the underlying disease, and misuse of quick-acting bowel medications were problematic for the elderly. In addition drugs used for the elderly have some adverse effect on the digestive system. The types and composition of drugs used by the elderly were identified and presented. Medication compliance was poor and 13.5% reported adverse reactions such as edema, heartburn, nausea, and difficulty with eating. Seventeen percent of the elderly obtained drugs arranged by those other than medical staff. Also, even among those elderly who obtained drugs prescribed by a doctor, 69.1% of subjects had not receive instruction about potential adverse reactions. These results suggest that nutritional problems related to drug usage might exist and so dietitians, either individually or as members of health teams, need to have a better understanding of drug-nutrient interaction and closer supervision, and drug information/education service should therefore be provided to prevent or minimize adverse drug reaction in elderly users of medication.