• Title/Summary/Keyword: Adverse drug reaction

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Evaluation of Using Pattern of the Topical Agents in Korean Community (한국 외래형 국소용 피부 외용제의 사용 현황에 대한 기초 평가)

  • Cheon, Young Ju;Kim, Sug Hyun;Kim, Ok Ju;Hong, Se Hwa;Yang, Jin Wook;Kim, Jung Tae;Lim, Sung Cil
    • YAKHAK HOEJI
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    • v.58 no.6
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    • pp.378-386
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    • 2014
  • Topical agents including of steroids are easily exposed to Korean patients in community setting. Those topical agents must be use cautiously because can cause adverse drug reaction unlike other oral medication. We evaluate the using pattern topical agents of Korean in community setting. We performed a questionnaire survey in three different pharmacies (general community pharmacy, dermatology clinic oriented pharmacy, general hospital oriented pharmacy) and in three university town. The survey asked necessity of topical agents, the number of applications per day, application period, site, and exist of steroids ingredient, etc. Total 330 people was participated in the survey from May 1st to July 31st, 2014. We analysed the survey by the frequency of each question and cross-analysis of the compliance between general public and pharmacy groups. In results, Korean people used topical agents for sudden skin diseases (66.9%), was gotten by dermatologist's prescription (89.1%), and did not know their diagnosis (39.2%). The people applied topical agents on face (22.3%), less one half FTU (finger tip unit) per application (61.9%), less than one week (62.9%). Though they was received drug education from pharmacist (52.2%), did not heard about adverse effects (78.4%). And compliance of applied times in pharmacy group was higher than in-non-pharmacy group (56% vs 38%, p=0.002). The highest compliance between 3 pharmacy subgroup was general community pharmacy (76.3% vs 61.6%, 61.2%, p=0.039). Compliance of applied duration was no difference between groups. Majority of respondents did not know diversity of ingredients, potency, application area of topical steroids, and replied to feel some vague reluctance and to think so dangerous about topical steroids. In conclusion, Korean people in community use topical agents well but still some exposed to risk from topical agents.

Hypersensitivity Reactions to Oxaliplatin: Clinical Features and Risk Factors in Koreans

  • Kim, Mi-Yeong;Kang, Sung-Yoon;Lee, Suh-Young;Yang, Min-Suk;Kim, Min-Hye;Song, Woo-Jung;Kim, Sae-Hoon;Kim, Yo-Jung;Lee, Keun-Wook;Cho, Sang-Heon;Min, Kyung-Up;Lee, Jong-Seok;Kim, Jee-Hyun;Chang, Yoon-Seok
    • Asian Pacific Journal of Cancer Prevention
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    • v.13 no.4
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    • pp.1209-1215
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    • 2012
  • Background and Aim: Oxaliplatin hypersensitivity is a well-known adverse reaction but the prevalence varies and data for frequency and clinical features have not been reported for Korea. Here we evaluates the prevalence and risk factors for hypersensitivity reactions to oxaliplatin after chemotherapy. Methods: Clinical information on all patients treated with oxaliplatin was retrospectively reviewed in electronic medical records between August 2009 and July 2010 in Seoul National University Bundang Hospital. Patients who experienced hypersensitivity reactions to oxaliplatin were compared with those who did not. Results: A total of 393 patients received oxaliplatin, with 42 (10.7%) experiencing hypersensitivity reactions including three cases of anaphylaxis. Median cycle of the first hypersensitivity reaction was 8. Reactions correlated with lower dexamethasone doses. Other variables were not significant. Conclusions: The prevalence of hypersensitivity reactions was 10.7%, symptoms being mostly mild and cutaneous. Lower dexamethasone doses could be a predictor for hypersensitivity reactions to oxaliplatin.

A Clinical Effect of Ofloxacin, Prothionamide, Cycloserine Streptomycin(Kanamycin or Tuberactinomycin) in Retreatment of Pulmonary Tuberculosis (폐결핵 재치료에서 Ofloxacin, Prothionamide, Cycloserine, Streptomycin(Kanamycin or Tuberactinomycin) 4제요법의 임상 효과)

  • Song, Ju-Young;Yoo, Min-Kyu;Hong, Jae-Rack;Jeong, Jae-Man;Kim, Young-Jun;Kim, Moon-Shik
    • Tuberculosis and Respiratory Diseases
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    • v.42 no.3
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    • pp.295-301
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    • 1995
  • Background: The serious problems in retreatment of pulmonary tuberculosis are a significant proportion of drug resistance. Preferably retreatment should contain the drugs which has never used before, so drug retreatment is limited in selection. A new antibacterial substance, ofloxacin(OFX) is the activity against mycobacterium tuberculosis and it has been used in the treatment of pulmonary tuberculosis. The present report concerns the result of retreatment of pulmonary tuberculosis patients containing OFX treated at National Kongju Tuberculosis Hospital. Method: A retrospective study was made through the regular follow up of 92 smear positive cases, who were treated by four drugs regimen between Mar 1991 and June 1994 at National Kongju Tuberculosis Hospital. Four drugs were, namely prothionamide, cycloserine, ofloxacin and streptomycin(kanamycin or tuberactinomycin). The duration of follow up was over one year. Results: 1) Out of 92 cases with positive sputum AFB smear, 67(73%) achieved the negative conversion. 2) Considering the negative sputum conversion in all the groups, the vast majority(85%) of sputum conversion occurred within the first 4 months. 3) The roentgenological improvement occurred in 49 percent on the whole and when the extent of disease was minimal, moderately, far advanced pulmonary tuberculosis, sputum AFB smear negative response to retreatment was 100%, 93%, 68%, respectively. 4) When the duration of patient's illness was less than 1 year, 1 to 3 years, 3 to 5 years and more than 5 years, sputum AFB smear negative response to retreatment was 87%, 76%, 65% and 55%, respectively. 5) Adverse reaction to prothionamide, with complaints of gastrointestinal troubles was common and hepatic dysfunction without jaundice was observed in 7 percent, convulsion in 1 percent, that to cycloserine occurred renal dysfunction & psycosis & convulsion, 2%, 1%, 1%, respectively. Tinnitus with KM occurred in 1% and dirrhea with OFX in 4%. Conclusion: The duration of patient's illness was shorter, sputum AFB smear negative response rate was better. Radiologic responses were not remarkable, but extent of disease by national tuberculosis association was smaller, the result of retreatment was better. Adverse reaction of the secondary antituberculosis agent was mainly observed gastrointestinal troubles, as regard to tolerance to the secondary drugs the role of the physician is of very important value and toxic effects can be overcome by the strong confidence.

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Effects of Purple Bamboo Salt(PB-salt) on the Blood Pressure in Rats (자죽염이 백서의 혈압 변동에 미치는 영향에 대한 연구(I))

  • Yun Dae Hwan;Park Hyun Chul;Cho Jae Woo;Kim Jeong Sang;Jang Kyeong Sean;Na Chang Soo
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.16 no.1
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    • pp.154-159
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    • 2002
  • There are several types of salts that can be classified into raw salt(Chunil salt), purified salts(NaCl reagent grade) and processed salts(Bamboo salt, Purple bamboo salt using in this study) in Korea. Salts has been utilized for the food as well as for the drug in the Oriental Medicine. Purple bamboo salt(PB-salt) was made by heating up to 1300℃ nine times after putting the raw salts in the bamboo. Since salt is generally known to cause the blood pressure to elevate, this study was conducted to investigate the effect of PB-salt on an adverse reaction of the blood pressure elevation. The experiment was performed with the 2 protocols ; 1. Effect of NaCl and PB-salt administration i.v. with the different the concentration(250, 500, 750, 1000mg/kg) on a mean artery blood pressure(MAP) change. 2. Effect of 500mg/kg NaCl and PB-salt administration p.o. for 6 days on the systolic blood pressure change. The results were as follows; The results were as follows; In a short minute change of blood pressure by direct method, PB-salt adminstration did not induced the hypertension unlike NaCl adminstration. In a date change of blood pressure by indirect method, systolic blood pressure was increased about 12-18% in the NaCl administration group, whereas within 6% in the PB-salt administration group from 2 days to 5 days. These results suggest that PB-salt might have some unidentified ingredient to be changed in the course of processing, making it superior to other salts.

Significant Genotype Difference in the CYP2E1 PstI Polymorphism of Indigenous Groups in Sabah, Malaysia with Asian and Non-Asian Populations

  • Goh, Lucky Poh Wah;Chong, Eric Tzyy Jiann;Chua, Kek Heng;Chuah, Jitt Aun;Lee, Ping-Chin
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.17
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    • pp.7377-7381
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    • 2014
  • CYP2E1 PstI polymorphism G-1259C (rs3813867) genotype distributions vary significantly among different populations and are associated with both diseases, like cancer, and adverse drug effects. To date, there have been limited genotype distributions and allele frequencies of this polymorphism reported in the three major indigenous ethnic groups (KadazanDusun, Bajau, and Rungus) in Sabah, also known as North Borneo. The aim of this study was to investigate the genotype distributions and allele frequencies of the CYP2E1 PstI polymorphism G-1259C in these three major indigenous peoples in Sabah. A total of 640 healthy individuals from the three dominant indigenous groups were recruited for this study. Polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) at G-1259C polymorphic site of CYP2E1 gene was performed using the Pst I restriction enzyme. Fragments were analyzed using agarose gel electrophoresis and confirmed by direct sequencing. Overall, the allele frequencies were 90.3% for c1 allele and 9.7% for c2 allele. The genotype frequencies for c1/c1, c1/c2 and c2/c2 were observed as 80.9%, 18.8%, and 0.3%, respectively. A highly statistical significant difference (p<0.001) was observed in the genotype distributions between indigenous groups in Sabah with all Asian and non-Asian populations. However, among these three indigenous groups, there was no statistical significant difference (p>0.001) in their genotype distributions. The three major indigenous ethnic groups in Sabah show unique genotype distributions when compared with other populations. This finding indicates the importance of establishing the genotype distributions of CYP2E1 PstI polymorphism in the indigenous populations.

Prevention of Olanzapine-induced Toxicities of Weight Gain and Inflammatory Reactions by Coadministration with Green Tea or its Major Component Phenolic Epigallocatechin 3-Gallate in Mouse

  • Kim, Chul-Eung;Mo, Ji-Won;Kim, Jin;Kang, Ju-Hee;Park, Chang-Shin
    • Molecular & Cellular Toxicology
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    • v.3 no.2
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    • pp.127-131
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    • 2007
  • Chronic treatment with olanzapine (OLZ), an atypical antipsychotic drug, is associated with the adverse effects of weight gain, hyperglycemia and/or hypertriglyceridemia. Green tea or epigallocatechin gallate (EGCG), one of the most abundant green tea polyphenols, significantly reduces or prevents an increase in glucose levels, lipid markers and/or body weight. We hypothesized that combined treatment with OLZ and green tea extract (GTE) or EGCG may prevent body weight gain and increase of the lipid markers. ICR male mice weighing an average of 30.51 g (n=32) at the beginning of the experiment were used. OLZ, OLZ+GTE and OLZ+EGCG were administered for 27 d in the drinking water, and then the levels of fasting glucose, nitric oxide (NO), and a typical lipid marker triglyceride (TG) were determined in plasma. The body weight and food intake were also compared. The chronic treatment of OLZ increased the average body weight compared with that of controls. In the presence of GTE or EGCG, the OLZ-induced increase in body weight was significantly prevented. Furthermore, in the OLZ group, the plasma levels of glucose, NO and TG were significantly increased, whereas GTE or EGCG prevented these increases. These results implicate that OLZ may induce systematic inflammatory reaction, and suggest that GTE or EGCG can protect against OLZinduced weight gain, hyperglycemia and hypertriglyceridemia.

The literatural study on the oriental cognizance and acupuncture-moxibustion therapy of osteoporosis (골다공증(骨多孔症)의 한의학적(韓醫學的) 인식(認識)과 침구치료(鍼灸治療)의 문헌연구(文獻硏究))

  • Kim, Dong-Soo;Kim, Young-Il
    • Journal of Haehwa Medicine
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    • v.18 no.1
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    • pp.9-18
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    • 2009
  • Objectives and Methods: The treatments of osteoporosis in occidental medicine are need complementations for reason of low-continuation and adverse-drug-reaction. So we would have literature centered consideration both oriental medical cognition and acupuncture-moxibustion therapy in osteoporosis. Results: 1. Deficiency of bone marrow caused by heat in the kidney and deficiency of kidney Gi, is causative of osteoporosis in pathology in oriental medicine. 2. Bone flaccidity and bone impediment are similar with osteoporosis. Withered bone comes under pathogenesis of bone flaccidity. And heavy debilitating disease of the bone is exacerbation of bone impediment. 3. In acupuncture-moxibustion therapy of osteoporosis, Bladder Meridian of Foot Taeyang, Kidney Meridian of Foot Soeum, Gallbladder Meridian of Foot Soyang, Lung Meridian of Hand Taeeum, Large Intestine Meridian of Hand Yangmyeong, Spleen Meridian of Foot Taeeum, Conception Channel, Stomach Meridian of Foot Yangmyeong, and Heart Meridian of Hand Soeum are used much in the order named. 4. In acupuncture-moxibustion therapy of osteoporosis, Hyeonjong(GB39, 7times), Daejeo(BL11, 3times), Sanggwan(GB3, 2times), Sinsu(BL23, 2times), Gyeoksu(BL17, 2times), Honmun(BL47, 2times), Buryu(KI7, 2times), Taebaek(SP3, 2times), Sanggu(SP5, 2times), Sangnyeom(LI9, 2times) are used much in the order named. Conclusions: In treatment of osteoporosis, we could make full use of acupuncture-moxibustion therapy. And we need active and persistent study about osteoporosis.

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A Survey on the Current Status of Human Research Protection Program Settlement and Subject Protection Activities in Korea (국내 임상시험 및 대상자 보호프로그램 도입 현황과 안전관 리체계에 대한 설문조사 연구)

  • Park, Sinyoung;Cho, Su Jin;Seo, Kyung Jeong;Kim, Jin Seok
    • The Journal of KAIRB
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    • v.3 no.2
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    • pp.28-36
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    • 2021
  • Purpose: The purpose of this study is to assess the status of the Human research Protection Program (HRPP) within a hospital or a research institute in Korea. Methods: Survey was conducted during June 12th-21th 2019. Survey was distributed to the members of Korean Association of IRB (KAIRB) through each IRB office. Descriptive statistics were performed using SPSS ver. 26. Results: A total of 86 people responded, and 75 (87.0%) answered that they have perceived the HRPP. Seventy out of 86 respondents (81.4%) were conducting internal audit, several institutions were operated simultaneously the other form of audits such as IRB audit, system audit. Regarding the management of Suspected Unexpected Serious Adverse Reaction (SUSAR), 62.8% answered that they have regulation that can decide to suspend the study when there is a risk to subject safety. Among the respondents, 66.3% performed 'Help desk.' Conclusion: In this study, we assessed the current status of HRPP operation at each research institution based on Ministry of Food and Drug Safety (MFDS) HRPP guidelines. The HRPP accredited institution operated the subject protection activities according to this program, and even if the HRPP was not officially operated, the related activities were conducted focusing on the cases that could have a significant impact on the safety of research subjects. In order to ensure the quality of domestic clinical trials and to stably establish the HRPP, efforts at the individual institution level will be required.

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A Case of Bronchospasm after Intravenous Hydrocortisone Succinate injection in an Asthmatics (Hydrocortisone 정주후 기관지수축이 발생한 기관지 천식 1예)

  • Lee, Young-Soo;Yong, Suk-Joong;Shin, Kye-Chul;Joo, Yong-Jin;Kim, Kwang-Ho;Lee, Sang-Chul;Han, Byung-Keun
    • Tuberculosis and Respiratory Diseases
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    • v.41 no.5
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    • pp.568-573
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    • 1994
  • Corticosteroids are widely used in the treatment of various diseases because of its potent antiinflammatory effect. According to recent knowledge, bronchial asthma is also chronic inflammatory disease. Therefore antiinflammtory agent such as cromoyln sodium and corticosteroid is highly recommended for treament of chronic bronchial asthma. Especially hydrocortisone succinate (Solu-Cortef) is commonly used for treament to acute asthmatic attack via intravenous injection due to have rapid therapeutic onset and short duration. Since Sunaga et al. reported acute asthma attack after hydrocortisone injection in 1973, several cases of bronchospam with or without angioedema and urticaria after intravenous injection of hydrocortisone have been reported. We experienced a case of severe bronchospasm and acute respiratory failure after intraveous injection of hydrocortisone succinate in 64 year-old female asthmatic patient who visited to emergency room for acute asthmatic attack. About 5 minites after Solu-Cortef injection, a severe bronchospasm with arterial hypoxemia was developed. In order to confirm the suspected relationship between the offending drug(Solu-Cortef) and acute bronchospasm, we examed intravenous and inhalation provocation test by hydrocortisone succinate and methylprednisolone(control). After administration of hydrocortisone succinate via intravenous and inhalation route, severe asthmatic attack occurred. But administration of intravenous methylprednisolone and orall triamcinolone and saline were not provoke bronchospasm. Skin test using hydrocortisone sodium succinate was also positive. Administration of hydrocortisone is very serious to asthmatic patient with hydrocortisone hypersensitivity. Therefore, the clinician must be have history taking about previous adverse reaction of steroid before its clinical use. And methylprednisone may be useful and safe drug to the treatment of acute asthmatic patient with hydrocortisone hypersensitivity.

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Clinical Effects of Prothinoamide, Cycloserine, Para-Aminosalicylic Acid, Ofloxasine in Retreatment of Pulmonary Tuberculosis (폐결핵 재치료 환자에서 Prothionamide, Cycloserine, Paraminosalicylic acid, Ofloxasine을 이용한 경구 4제 요법의 임상 효과)

  • Hong, Jae-Rak;Yoo, Min-Kyu;Jeong, Jae-Man;Kim, Young-Jun;Son, Mal-Hyeon
    • Tuberculosis and Respiratory Diseases
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    • v.43 no.5
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    • pp.693-700
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    • 1996
  • Background : Antituberculous therapy is set a short-term therpy used isoniazid(INH), rifampin(RFP), ethambutol(EMB), pyrazinamide(PZA) from 1970s' and treatment rate has been very improved. But drug interruption or irregular medication due to side effects and resistance of drug are serious problem to retreatment cases, specially. Ofloxasine(OFX), developed from Quinolone at 1980's is effective not only other respiratory infectious disease but also pulmonary tube rculosis. And this is useful drug instead of injection agents for retreatment patients who have side effects to other drugs, lived far distance from medical clinics. So, we will evaluate theffectiveness as four oral drugs involving OFX. Method : A retrospective study was made through the regular follow up of smear positive cases,who treated by four drug, namely, prothionamide (PTA) cycloserine(CS), OFX, paraminosalicylic acid(pAS). Results: 1) Out of 66case with positive sputum AFB smear, 42(64%)cases achieved the negative conversion. 2) Considering the negative conversion in all group, 34 case (52%) of sputum conversion occured within first 6 months, on the extent of diease was minimal, moderate, far advanced pulmonary tuberculosis, sputum AFB smear negative response to treatment was 100%, 78%, 46% respectively. 3) The roentgenological improvement occured in 38(58%), extent of diease was minimal, moderately, far advanced pulmonary tuberculosis, Roentgenological improvement to retreatment was 75%, 64%, 46%. 4) When the drnation of patients illness was less than 1 year, 1 to 3 years, 3 10 5 years and more than 5 years, sputum AFB smear negative response to retreatment was 100%, 88%, 80%, 52 %. 5) On side effects, major problems are gastrointestinal troubles, mild liver function abnormality, psychotic problemes, and skin problem(urticaria, itching sensation). Conclusion : The duration & extents of patients illness was shorter & minimal, sputum AFB smear negative response rate was better. Radiologic response is better as shorter duration and minimal extent of diease. But, as diease is longer duration & far advanced, sputum negative conversion & Roentgenological improvement is poor and limited. The adverse reaction was mainly observed gastrointestinal troubles(indigestion, abdominal pain, nausea, vomiting, diarrhea) and are well controled by symptomatic management in most patients, as regard to tolerance to the secondary drugs.

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