• Journal of Korean Medicine Rehabilitation
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• v.28 no.3
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• pp.119-124
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• 2018

Three cases of simple exanthematous eruption were suspected during Sumsu (Bufonis Venenum) pharmacopuncture (SP) topical anesthesia for acupotomy. Patients had skin rash with pruritus on both ankle, posterior neck, and left shoulder after 11, 12, and 7 times of SP treatment, respectively. There were no cases of systemic manifestations or changes in vital signs. As a result of using the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) causality assessment, all the cases were evaluated as 'unlikely'. However, the results of using the Korean algorithm for assessing the causality of drug adverse reactions version 2.0 were evaluated as 'possible'. This report is the first case report on adverse events suspected of occurring after SP treatment. Although the causal relationship between suspected intervention and the adverse event is not clear, there was a difficulty in completely excluding the possibility. Additional safety studies will be required to make SP more widely available.

• Tuberculosis and Respiratory Diseases
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• v.60 no.1
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• pp.44-48
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• 2006

Background : Isoniazid (INH) is one of the most effective anti-tuberculosis (TB) drugs. In Korea, the dose of INH normally used in patients over 50 kg is 400 mg/day, which differs from the dose recommended by other countries. Indeed, the metabolism of INH shows ethnic variations, and Koreans are predominantly rapid acetylators. However, two reports suggested 300 mg of INH might be sufficient to reach an ideal peak level in Korean patients over 50 kg. Therefore, the aim of this study was to compare the effectiveness and adverse reactions between INH 300 mg and 400 mg in Korean TB patients. Method : Patients who were culture-positive, susceptible to all 1st-line drugs, initially on HREZ, and weighed over 50 kg were selected from patients with pulmonary TB between April 2003 and March 2005. The treatment results and adverse reactions in the INH 300 mg and 400 mg group were compared. Since April 2004, most TB patients at Asan Medical Center were administered INH 300 mg irrespective of the body weight. Results : The study included 123 patients in the 300 mg INH group and 128 in the 400 mg INH group. There were no significant differences between the groups in terms of age, gender, weight, history of TB treatment, initial smear strength, and frequency of cavitary lesions. There was no difference in the treatment duration between the groups. One hundred eleven (90%) patients in the INH 300 mg group and 102 (80%) in the INH 400 mg group completed treatment (p>0.05). There were no differences in the frequency of modification of the initial regimen between groups due to any adverse reactions (300 mg : 9.0%, 400 mg : 13.7%) and hepatotoxicity (300 mg : 2.7% ; 400 mg : 7.8%). Conclusion : Considering treatment results and adverse reactions of two groups, 300mg of INH may be sufficient for treating Korean TB patients. Further studies comparing the frequency of relapse will be needed.

• Korean Journal of Clinical Pharmacy
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• v.21 no.3
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• pp.237-242
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• 2011

This study measures seriousness of adverse drug reactions (ADRs) among Korean physicians and pharmacists using two times surveys based on Delphi technique. Each participant scored 20 ADR terms on a scale of one to ten (10 being the most serious). We repeated the exercise for the 49 first survey respondents and 32 re-evaluated score. We compared the results of our survey with those of WHO CIOMS (Council for International Organization of Medical Sciences) working groups members conducted in 1995. The overall mean ADR seriousness score was 6.49 for Koreans and 5.12 for WHO CIOMS members, presenting Korean experts perceived more seriously for each ADR. Mean score changes for the same respondents showed similar trends regardless of access to the first survey results. There were no statistically significant score differences between the physicians and the pharmacists. The high consensus of seriousness for each ADR between the Korean experts and the WHO CIOMS members implies that the similar results are reproducible, suggesting the possibility of developing standardized tools for measuring the seriousness of individual ADRs in the future.

• Korean Journal of Clinical Pharmacy
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• v.13 no.2
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• pp.72-81
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• 2003

Adverse drug reaction (ADR) may increase hospital admission, morbidity and mortality and adding extra cost to healthcare expenditures. AIMS: This study was performed to identify the types of ADR being reported in a tertiary hospital, and to find out the ways to improve current ADR monitoring system. To investigate the attitudes of hospital pharmacists towards, and their understanding of ADR reporting. METHODS: Of 117 reports submitted to the pharmacy department during 3 months survey period, A questionnaire survey of 75 randomly selected hospital pharmacists was conducted. RESULT: Of the report was from patients aged between 60 and 70. The medical department with the high frequency in ADR reporting was Internal Medicines $(60\%)$. The most common ADR manifestations were gastrointestinal complaints $(47.8\%)\;and\;80\%$ of the reported cases were mild in their severity. The most common drugs suspected of causing ADR were CNS drugs which accounted for $38.4\%.\;55.5\%$ of respondent were aware of the need to education and information about ADR monitoring. The important reasons for unreporting ADR were unknown of how to report ADRs $(94.6\%)$. CONCLUSIONS: An ADR reporting system based on reporting by staff pharmacists has been effective increasing the number of reported reactions and pharmacist involvement in monitoring patients for ADRs. Pharmacists have the knowledge and responsibility to contribute to ADR reporting program. A great opportunity exists for pharmacists to contribute in this area of patient care.

• Parasites, Hosts and Diseases
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• v.49 no.2
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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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• 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.

• 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.

• The Korean Journal of Pain
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• v.30 no.2
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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.

• Journal of Sasang Constitutional Medicine
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• v.26 no.2
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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.

• Asian Pacific Journal of Cancer Prevention
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• v.14 no.4
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• pp.2591-2594
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• 2013

Aim: To compare the efficacy and safety of paclitaxel liposome (Lipusu$^{(R)}$) with paclitaxel in combination with tegafur and oxaliplatin in treating patients with advanced gastric cancer. Materials and Methods: Patients with advanced gastric cancer receiving chemotherapy were retrospectively collected, and divided into two groups. Patients in group A received paclitaxel liposomes at a dose of 135 $mg/m^2$ on day 1 of each cycle, and patients in group B were given paclitaxel at the same dose with the same timing. All patients received tegafur at a dose of 500 $mg/m^2$ on days 1-5, and oxaliplatin at a dose of 80-100 $mg/m^2$ on day 1 for 2 cycles (each cycle was 21 d in total). Results: Fifty-eight patients could be evaluated for efficacy. The overall response rate was 47% in group A (14/30), and 46% in group B (13/28). Disease control rate was 73% in group A (22/30), and 71% in group B (20/28) (P>0.05). No significant differences were detected in hematologic and neurologic toxicities between the two groups (P>0.05). However, nausea, vomiting and hypersensitive reactions were significantly lower in group A than in group B (P<0.05). Conclusion: Paclitaxel liposomes are as effective as paclitaxel when combined with tegafur and oxaliplation in treating patients with advanced gastric cancer, but adverse reactions with paclitaxel liposomes are less common.