• Title/Summary/Keyword: Adverse drug events

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Comparison of Efficacy of Overlapped Versus Long Eluting Stent in Acute Myocardial Infarction Patients with Diffuse Long Lesion (미만성 긴 병변이 있는 급성심근경색환자에서 긴 단일 용출 스텐트 시술과 중첩 스텐트 시술의 효과 비교)

  • Kim, Won Hyo;Kim, In Soo;Kong, Chang gi;Han, Jae Bok
    • Journal of the Korean Society of Radiology
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    • v.14 no.3
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    • pp.319-336
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    • 2020
  • The purpose of this study was to compare the outcomes of two interventional methods, overlapping drug-eluting stents (DES) and long DES, for long-term clinical outcomes in patients with acute myocardial infarction (AMI). A total of 438 patients with AMI (65.9±11.0 years, 306 males) from June 2008 to March 2019 who had diffuse long coronary artery lesion, more than 30mm were divided into two groups; group I (overlapped DES group; n=140) and group II (long DES group; n=298). We compared the incidences of major adverse cardiac events [MACEs; cardiac death, myocardial infaction (MI), target lesion revascularization (TLR) and stent thrombosis (ST)] during 12 months between the two groups. Everolimus-eluting stent was more commonly used in group II than in group I (28.1% vs. 51.8% p<0.001). Mean lesion diameter was slightly longer in group II (3.1±0.3mm vs. 3.2±0.3mm, p=0.042), and prevalence of ACC/AHA lesion type C was higher in group I (41.7% vs. 25.4%, p<0.001). Incidences of MACEs during 12 months were higher in group I than group II (18.5% vs. 14.4%, p=0.034). The rates of cardiac death (2.1% vs. 4.4%, p=0.667), MI (5.0% vs. 2.7%, p=0.260) and stent thrombosis rate (0.7% vs. 1.7%, p=0.669) were similar between the two groups. However, TLR rate was higher in group I (10.7% vs. 5.6%, p=0.041). In multivariate logistic regression analysis, presence of diabetes mellitus [Hazard ratio (HR) 2.383, 95% confidence interval (CI) 1.332-4.260, p=0.003] and use of paclitaxel-eluting stent (HR) 2.367, 95% CI 1.371-4.086, p=0.002) were independent predictors of 12-month MACEs, without significant differences in prevalence between the two groups. In AMI patients with diffuse long lesion, TLR rate was higher in the overlapped DES group during 12-month follow-up. Presence of diabetes and use of paclitaxel-eluting stent were independent predictors of MACEs.

Treatment Adherence of Osmotic-Controlled Release Oral Delivery System Methylphenidate in Korean Children and Adolescents with Attention-Deficit Hyperactivity Disorder (주의력결핍 과잉행동장애 아동에서 Osmotic-Controlled Release Oral Delivery System Methylphenidate의 치료순응도)

  • Kim, Bongseog;Lee, Jeong-Seop;Kim, Eui-Jung;Sung, Hyung-Mo;Shin, Yun Mi;Hwang, Seong-Hye;Yoo, Hanik K.
    • Journal of the Korean Academy of Child and Adolescent Psychiatry
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    • v.25 no.2
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    • pp.65-72
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    • 2014
  • Objectives : The objective of this study was to evaluate the treatment duration and adherence of osmotic-controlled release oral delivery system (OROS) methylphenidate for treatment of attention-deficit hyperactivity disorder (ADHD). Methods : A total of 843 children with ADHD were recruited : 213 children (25.3%) who had previously taken medications for ADHD and 630 drug-na$\ddot{i}$ve children (74.7%) were recruited. The dosage was adjusted according to the clinician's judgment. The primary efficacy endpoint of this study was treatment retention rate, which was estimated at Week 12 and Week 20 using the Kaplan-Meier curve. The Swanson, Nolan and Pelham-IV (SNAP-IV), Clinical Global Impression-Severity (CGI-S), Clinical Global Impression-Improvement, and the side effect rating scale were measured at every visit. Remission rates were presented based on SNAP-IV and CGI-S, respectively. Results : The treatment retention rate at 12 weeks and at 20 weeks was 76.2% and 66.8%, respectively. Divided according to 6-8, 9-11, 12-14 and 15-18 years of age, younger children tended to show a statistically higher treatment retention rate (p=.02). Based on SNAP-IV and CGI scores, children with better response to medication showed tendencies of statistically higher treatment retention rate. The most common adverse events included loss of appetite (7.1%) and insomnia (3.3%). There was no serious adverse event related to the treatment, such as death. Conclusion : The use of OROS methylphenidate for treatment of ADHD was safe and tolerable for children. In this study, lower age and better treatment response showed a statistically significant relationship with higher treatment adherence. Boys showed a trend of high treatment adherence. The treatment adherence at 20 weeks was satisfactory, however, the treatment adherence after 20 weeks showed a sharp decrease. Therefore, treatment persistence for six months after the beginning of ADHD treatment is important. In addition, the positive role of psycho-education for children and parents is necessary for increasing treatment adherence.

Efficacy and Safety of Herb Medication According to Cold-heat Tendency of Knee Osteoarthritis Patients (퇴행성 슬관절염 환자의 한열 성향에 따른 한약 제제의 유효성과 안전성 비교)

  • Song, Ji-Yeon;Kim, Min-Jung;Sung, Won-Seok;Kim, Pil-Kun;Goo, Bon-Hyuk;Kwak, Hyun-Young;Kim, Ji-Hye;Kim, Dong-Hyuk;Park, Yeon-Cheol;Seo, Byung-Kwan;Baek, Yong-Hyeon;Choi, Do-Young;Lee, Jae-Dong;Park, Dong-Suk
    • Journal of Acupuncture Research
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    • v.29 no.5
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    • pp.97-108
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    • 2012
  • Objectives : To demonstrate the importance of syndrome differentiation in clinical research of herb medication, through the comparative study on efficacy and safety of herb medication according to cold-heat tendency of OA knee patients. Methods : During December 2010 to July 2011, 138 knee OA patients were randomly assigned to WIN-34B 600mg(300mg, b.i.d.), 1,200mg(600mg, b.i.d.) and placebo b.i.d. for 8 weeks. Patient were re-classified into cold-heat tendency group according to cold-heat questionnaires. To investigate efficacy and safety, we assessed the 100mm pain VAS at baseline and 8 weeks later, and we monitored adverse event of patients during treatment period. Results : 1. Efficacy study : In WIN-34B 1,200mg group, VAS mean changes of heat tendency group showed slightly increase than those of cold tendency, but no significant difference within two groups. In heat tendency group, WIN-34B 1,200mg group showed a significant decrease of VAS compared to placebo group. but there were no significant difference in cold tendency group. 2. Safety study; In WIN-34B 600mg group, incidence of adverse events of cold tendency group was higher than those of heat tendency, but not in WIN-34B 1,200mg group. Conclusions : This study suggests that WIN-34B tend to have more efficacy in heat tendency-knee OA patients and WIN-34B is safe drug relatively, regardless of cold-heat tendency. In further clinical research on efficacy and safety of WIN-34B, stratification using syndrome differentiation is required.

The Effect of Traditional Korean Medical Treatment on Low Back Pain during Pregnancy: a Report on Three Cases (한방 복합치료를 시행한 임신 중 요통 환자 치험 3례)

  • Lee, Su Yeon;Ryu, Soo Hyeong;Kim, Hong Guk;Ryoo, Dek Woo;Kim, Sung Jin;Jeong, Seong Mok;Goo, Bon Hyuk;Kim, Min Jeong;Park, Yeon Cheol;Baek, Yong Hyeon;Nam, Sang Soo;Seo, Byung Kwan
    • Journal of Acupuncture Research
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    • v.33 no.3
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    • pp.197-205
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    • 2016
  • Objectives : To report the clinical application and safety of Traditional Korean Medical treatment for patients with low back pain during pregnancy. Methods : Three patients who suffered from low back pain during pregnancy were treated with acupuncture, pharmacopuncture, moxibustion, and herbal medicine for 12 to 21 days. Numeric rating scale (NRS) of low back pain and Oswestry Disability Index (ODI) were checked to measure the outcome. A liver function and renal function test was carried out to identify any drug-induced liver or renal injury, and any adverse events were monitored thoroughly until delivery. Results : Low back pain reduced on NRS in all cases, and no serious adverse effects were found in the patients or infants. Conclusion : This study suggests that Traditional Korean Medical treatment is a candidate therapy for relieving low back pain during pregnancy, and also is safe for both patients and infants.

A Preliminary Study on the Inhibitory Effect of Chunghyul-dan on Stroke Recurrence on Patients with Small Vessel Disease

  • Cho, Ki-Ho;Jee, Nam-gue;Jung, Woo-Sang;Park, Seong-Uk;Moon, Sang-Kwan;Ko, Chang-Nam;Kim, Young-Suk;Jung, Woo-Sang
    • The Journal of Korean Medicine
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    • v.28 no.1 s.69
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    • pp.224-236
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    • 2007
  • Background : Chunghyul-dan is a combinatorial herbal medicine; previous studies reported it had therapeutic effects for microangiopathy, a major part in the progression of small vessel disease, as well as having anti-hypertensive, anti-hyperlipidemic, anti-apoptotic, anti-oxidative, and anti-inflammatory activities. Therefor, we examined the inhibitory effect of Chunghyul-dan on stroke recurrence in patients with small vessel disease. Methods : We prescribed Chunghyul-dan at 600 mg a day to patients with small vessel disease, and monitored stroke recurrence, drug compliances, and adverse effect for 1 year. We then performed follow-up brain MRI to find new vascular lesions after 1 year of Chunghyul-dan medication. For the subjects lost to follow-up, we assessed their prognosis after 1 year by telephone. Results : There were 73 subjects treated with Chunghyul-dan for 1 year; new vascular events were found in 3. Of the 85 subjects lost to follow-up, fifty four could be contacted, and eight of them had stroke recurrence. One year of Chunghyul-dan medication reduced the odds ratio of stroke recurrence by 75% compared to the subjects lost to follow-up and the rate increased to 88%, when adjusted for other relevant risk factors for stroke recurrence. These reductions were much higher than those of aspirin and other kinds of conventional anti-platelets. There was no adverse effect in any of the study subjects. Conclusions : We suggest Chunghyul-dan could be useful for inhibition of stroke recurrence. Further study with a randomized controlled trial is needed to confirm this suggestion.

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Developing national level high alert medication lists for acute care setting in Korea (국내 급성기 의료기관 고위험 의약품 목록 도출)

  • Han, Ji Min;Heo, Kyu-Nam;Lee, Ah Young;Min, Sang il;Kim, Hyun Jee;Baek, Jin-Hee;Rho, Juhyun;Kim, Sue In;Kim, Ji yeon;Lee, Haewon;Cho, Eunju;Ah, Young-Mi;Lee, Ju-Yeun
    • Korean Journal of Clinical Pharmacy
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    • v.32 no.2
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    • pp.116-124
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    • 2022
  • Background: High-alert medications (HAMs) are medications that bear a heightened risk of causing significant patient harm if used in error. To facilitate safe use of HAMs, identifying specific HAM lists for clinical setting is necessary. We aimed to develop the national level HAM list for acute care setting. Methods: We used three-step process. First, we compiled the pre-existing lists referring HAMs. Second, we analyzed medication related incidents reported from national patient safety incident report data and adverse events indicating medication errors from the Korea Adverse Event Reporting System (KAERS). We also surveyed the assistant staffs to support patient safety tasks and pharmacist in charge of medication safety in acute care hospital. From findings from analysis and survey results we created additional candidate list of HAMs. Third, we derived the final list for HAMs in acute care settings through expert panel surveys. Results: From pre-existing HAM list, preliminary list consisting of 42 medication class/ingredients was derived. Eight assistant staff to support patient safety tasks and 39 pharmacists in charge of medication safety responded to the survey. Additional 44 medication were listed from national patient safety incident report data, KAERS data and common medications involved in prescribing errors and dispensing errors from survey data. A list of mandatory and optional HAMs consisting of 10 and 6 medication classes, respectively, was developed by consensus of the expert group. Conclusion: We developed national level HAM list for Korean acute care setting from pre-existing lists, analyzing medication error data, survey and expert panel consensus.

A Study on the Medication in an early Implementation Period of Separation System of Pharmacy and Clinic in Seoul (의약분업 초기의 서울지역 외래환자의 투약실태)

  • Cho Won Sun
    • Journal of Korean Public Health Nursing
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    • v.15 no.2
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    • pp.398-411
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    • 2001
  • The separation system of pharmacy and clinic has begun on the purpose of preventing drug misuse and abuse since July 1st of 2000. The system revealed some conflicts between doctors. pharmacists and consumers. Consequently pharmaceutical law and related policies undergone some change. Now in an early period of the implementation of the system, the necessity to examine relevance of those policies and law enforcement to medical doctors' prescriptions pattern evolves. This study tries to verify the pattern through a field study. For the purpose, 930 prescriptions collected in May of 2001, from a pharmacy located in Gangnam-gu in Seoul, were analysed. The prescriptions were issued from several clinics: 459 prescriptions from otorhinolaryngological clinic(ENT), 177 from internal medicine clinic(IM), 130 from ophthalmic clinic(Opt), 52 from obstetric and gynecologic clinic(OB & GY), and 112 from miscellaneous clinics. ENT, IM, Opt. OB & GY are situated in a clinic building of 40m distance. The general findings are following: 1) $88.8\%$ of the total patients came from 5clinics in nearby single clinic building. 2) Average prescribing days were 6.2 days and the average number of used drugs were 4.0 drugs, i.e. 2-4 times of WHO criteria 1-2 drugs. 3) Use of antibiotics in the oral administration drugs rated $71.8\%(WHO: \;22.7\%)$ 4) Use of injection rated $31.3\%(WHO:\;17.2\%)$ 5) $96.2\%$ of the patients use multiple antibiotics in the injection and oral administration together. 6) The patients had multiple disease : ENT patients 1.7 disease and 1M patients has 2.7 disease in average and several regular prescribing types evolved particularly in the ENT prescription. With this result we found that drugs. especially antibiotics are still abused a lot, and there were significant differences in the number of used drugs and prescrbing days between the clinics. It implies somes differences of the preparation work and time for pharmacists. And preparation can be done in advance by pharmacists' own efforts through noticing regular prescribing types. The study suggests the followings: 1) Patient counseling should be done to minimize the incidence of adverse events. 2) The enforcement of the standardized differential preparation price system should be reconsidered. 3) Preparation of typical regularly appeared prescription in advance. which is regarded as 'a prearranged work between doctors and pharmacists' and has been prohibited should be reconsidered. 4) Drug utilization review program should be established to prevent drugs abuse. especially antibiotics abuse.

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Effect of Prophylactic Ibuprofen in Preterm Infants Less than 1,250 g in Birth Weight (1,250 g 미만 미숙아에서 예방적 Ibuprofen의 효과)

  • Yeo, Mun-Soo;Choi, Kyung-Vin;Lee, Hyun-Ju;Park, Hyun-Kyung;Kim, Chang-Ryul;Seol, In-Joon
    • Neonatal Medicine
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    • v.18 no.2
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    • pp.234-239
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    • 2011
  • Purpose: Ibuprofen is used for prevention and treatment of patent ductus arteriosus as an alternative drug of indomethacin in very premature infants. We aimed to determine the effect of prophylactic ibuprofen on patent ductus arteriosus and clinical outcomes in preterm infants less than 1,250 g. Methods: A retrospective review of 39 preterm infants who were admitted to our neonatal intensive care unit from November 2009 to July 2010 was performed. Patients were divided into a prophylactic group (n=13) and a matched historical control group (n=26), where prophylactic ibuprofen were administrated within 24 hours after birth. The rate of ductal closure, side-effects of drug treatment and clinical outcomes were compared between two groups. Results: Comparison of the prophylactic and control groups revealed no significant differences in the rate of ductal closure (69.2% vs 77.7%, P=0.825) and surgical ligation (23.1% vs 30.8%, P=0.719). Occurrence of bowel perforation was more frequent in the prophylactic group than the control group, but was not significant (30.8% vs 11.5%, P=0.194). The frequency of intraventricular hemorrhage (grade${\geq}$3) and other outcomes did not differ between the groups. Conclusion: Ibuprofen prophylaxis in preterm infants did not decrease the rate of ductal closure, the need for surgical ligation and the incidence of intraventricular hemorrhage. Further studies are needed to investigate the beneficial effect and associated adverse events attributed to ibuprofen prophylaxis.

The Effect of Cheonmagudeung-eum for Hypertension: A Systematic Review and Meta-analysis (고혈압에 대한 천마구등음의 효과 : 체계적 문헌고찰과 메타분석)

  • Kang, Ki-wan;Kang, Ja-yeon;Jeong, Min-jeong;Kim, Hong-jun;Sun, Seung-ho;Jang, In-soo
    • The Journal of Internal Korean Medicine
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    • v.39 no.1
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    • pp.22-43
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    • 2018
  • Objective: The purpose of this study is to investigate the effect of Cheonmagudeung-eum (CGE) for essential hypertension by systematic review and meta-analysis. Methods: The period of literature search was until October 30, 2016, and 14 electronic databases were utilized as search engines. The evaluation for the risk of bias (RoB) was conducted by using the Cochrane Risk of Bias Tool. The meta-analysis was performed by synthesizing outcome data, including total effective rate (TER), systolic blood pressure (SBP), diastolic blood pressure (DBP), and the incidence of adverse events. Result: There were a total of 64 RCTs using CGE on adult essential hypertension. In the RoB evaluation, most of the items were unclear, and the qualities of studies were rated low. The concurrent treatment of CGE and antihypertensive drug (AHD) showed a significant hypotensive effect since the risk ratio (RR) of TER was 1.17 times (95% CI 1.14, 1.20, p<0.01) higher than that of AHD alone. In addition, the mean difference (MD) appeared low as 8.73 mm/Hg in SBP (95% CI -11.36, -6.09, p<0.01) and 5.81 mm/Hg in DBP (95% CI -7.50, -4.12, p<0.01). Conclusion: Through this study, it was identified that the combined treatment of CGE and AHD on hypertension would be more effective than that of AHD treatment alone. However, due to the low quality of the selected original articles, the significance of this conclusion is somewhat limited, and we hope that this would be complemented through more rigorous RCTs in the future.

Evaluation of NSAID Usage and Appropriateness for Prevention of NSAID-Related Ulcer Complications (비스테로이드소염제로 인한 궤양 합병증 예방을 위한 비스테로이드소염제 사용 현황 및 적절성 평가)

  • Cho, Jungwon;Lee, Eunsook;Shin, Wan Gyoon
    • Korean Journal of Clinical Pharmacy
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    • v.22 no.3
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    • pp.211-219
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    • 2012
  • Nonsteroidal antiinflammatory drugs (NSAIDs) are used in the treatment of extensive diseases related to various symptoms; inflammation, pain and fever. NSAIDs work by blocking prostaglandin synthesis, but adverse drug events (ADEs) have been increasing dramatically such as gastrointestinal bleeding, perforation and stenosis, a kind of serious ADEs. Therefore, NSAID-related ulcer complication guidelines have been announced containing various risk factors and symptoms. Thus, this study aims to evaluate of NSAID usage and appropriateness for prevention of NSAID-related ulcer complication based on American journal of gastroenterology (AJG) guideline 2009. Further, the study suggests Korean guideline for prevention of NSAID-related ulcer compared to AJG guideline. For this study, data was collected through electronic medical record (EMR) at Seoul national university of Bundang hospital. The primary end point was a composite of NSAID-related ulcer risk factor, types of NSAIDs, co-prescribed NSAID ulcer prevention drugs and NSAID-related ulcer after taking NSAID. The risk factors include over 65 years, high dose NSAID, previous ulcer history and taking drugs (e.g. aspirin, anticoagulant and steroid) causing ulcer. If a patient has 3 or 4 factors, that patient was classified high risk group. And if 1 or 2 factors that patient was classified moderate risk group. The patient who has no risk factor was in low risk group. I studied 8,120 patients who received NSAID from 1 January 2009 to 31 December 2009. High risk group was 16(0.2%), moderate risk group was 4,364(53.7%), and low risk group was 3,740(46.1%). The results show that high risk group should be prescribed COX-2 inhibitors with ulcer prevention drugs, and moderate or low risk group need traditional NSAIDs with ulcer prevention drugs. This may be different with 2009 AJG guideline because AJG guideline suggested taking COX-2 inhibitor alone in moderate group or taking traditional NSAID alone in low risk group could get higher ulcer complication. The results indicated that choosing preventive drug is important in case that how many risk factors the patients have. The proper drugs would be helpful for safe and effective NSAID usage in each patient group.