• 제목/요약/키워드: adverse drug reactions

검색결과 198건 처리시간 0.03초

An Open-Label, Multicentre, Observational, Post-Marketing Study to Monitor the Safety and Effectiveness of Umeclidinium/Vilanterol in Korean Patients

  • Eun-Yeong Cho;Jung-Eun Cho;Eun-Bin Lee;Seung Soo Yoo;Jung Hyun Chang
    • Tuberculosis and Respiratory Diseases
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    • 제86권1호
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    • pp.33-46
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    • 2023
  • Background: Umeclidinium/vilanterol (UMEC/VI; ANORO ELLIPTA, GSK) is a commonly used dual bronchodilator. This study evaluated the safety and effectiveness of UMEC/VI in Korean patients with chronic obstructive pulmonary disease (COPD) over a 6-year period. Methods: This was an open-label, multicentre, observational, post-marketing surveillance study. A total of 3,375 patients were enrolled consecutively in 52 hospitals, by 53 physicians, between July 2014 and July 2020. Patients who were administered UMEC/VI (fixed-dose 62.5 ㎍/25 ㎍) at least once and were monitored for safety and effectiveness were included in the analysis. Incidence and severity of adverse events (AEs) reported after administrating at least one dose of UMEC/VI were monitored, including unexpected adverse events (UAEs) and adverse drug reactions (ADRs). Effectiveness of UMEC/VI after 24 weeks of administration was also assessed using physician's evaluation (effective, ineffective/no change, worsening, indeterminable) and lung function improvement. Results: Of 3,375 patients, 3,086 were included in the safety assessment group (mean age±standard deviation: 69.76±8.80 years; 85.9% male [n=2,652]; 73.1% aged ≥65 years [n=2,255]). The overall incidence of AEs was 28.8% (n=890), of which 2.2% (n=67) were ADRs. Serious AEs and UAEs were reported in 181 (5.9%) and 665 (21.6%) patients, respectively, and two patients (<0.1%) reported unexpected severe ADR. Of the 903/3,086 patients analysed for effectiveness, most (82.8%, n=748) showed overall disease improvement after UMEC/VI treatment. Conclusion: This study confirmed UMEC/VI administered to Korean patients according to the prescribing information was well-tolerated and can be considered an effective option for COPD treatment.

Trends in the prescription of opioids and gabapentinoids in patients with failed back surgery syndrome in Korea: a population-based study

  • Jinyoung Oh;Jinseok Yeo
    • The Korean Journal of Pain
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    • 제37권1호
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    • pp.73-83
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    • 2024
  • Background: Failed back surgery syndrome (FBSS) is a chronic condition that is characterized by persistent back pain following one or more spinal surgeries. Pharmacological interventions, such as the use of opioids and gabapentinoids, are frequently used in the treatment of FBSS. However, prolonged and excessive use of these medications can lead to dependence and adverse effects. This study investigates trends in opioid and gabapentinoid prescriptions among patients with FBSS in Korea from 2016 to 2020. Methods: Data from the Health Insurance and Review Agency were analyzed, and claims listing FBSS were selected for the study. Prescription patterns of opioids and gabapentinoids were classified based on the number of days prescribed per year. Results: Of the 390,095 patients diagnosed with FBSS, 41.6% of the patients were prescribed gabapentinoids, and 42.0% of them were prescribed opioids, while 10.6% of the patients were classified as long-term gabapentinoid users, 11.4% as long-term opioid users, and 7.4% of the patients were found to have long-term prescriptions for both drugs. The proportion of patients who received both gabapentinoid and opioid prescriptions increased annually. The doses of opioids prescribed have also increased along with the increase in the number of patients receiving opioid prescriptions. Conclusions: The prescription rates of opioids and gabapentinoids among patients with FBSS in Korea continue to increase steadily, posing potential risks of addiction and adverse effects. Further research is needed to better understand the actual status of addiction in patients with FBSS.

노인 폐결핵의 임상적 특정 (Clinical Features of Pulmonary Tuberculosis In The Elderly)

  • 이재호;황보빈;유철규;이춘택;김영환;한성구;심영수;정희순
    • Tuberculosis and Respiratory Diseases
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    • 제51권4호
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    • pp.334-345
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    • 2001
  • 연구 배경 : 폐결핵은 아직도 노인들에게 있어서 높은 유병률을 보이며 심각한 임상문제로 남아 있다. 그러나 노인 폐결핵은 젊은 연령 군에 비해서 증상이 비전형적이고 약제에 대한 부작용이 많아서 조기 진단 및 치료가 어려운 경우가 많다. 본 연구는 노인 폐결핵의 진단 및 치료에 있어서의 임상 양상이 젊은 연령 군과 비교하여 차이가 있는지 알아보기 위해 시행되었다. 연구 방법 : 1991년 11월에서 1997년 1월까지 서울 시립 보라매병원에서 폐결핵으로 진단, 치료받은 65세 미만인 젊은 연령 군 125명과 65셰 이상인 노인 군 70명올 대상으로 의무기록을 후향적으로 분석하였다. 결 과 : 노인 폐결핵 환자들은 젊은 연령 군에 비하여 식욕 감소(12% vs 31.4%), 전신 쇠약감(20.0% vs 54.3%), 호흡곤란(21.6% vs. 37.1%), 의식 변화(0.8% vs. 15.7%) 등의 비전형적인 증상으로 내원한 경우가 유의하게 많았다. 반변에 젊은 연령인 군에서는 노인 군에 비하여 객혈(32.8% vs. 10.0%), 발열(58.4% vs. 35.7%)의 빈도가 높았다. 기저질환에 있어 노인 군은 젊은 연령 군에 비하여 심혈관 질환과 만성폐쇄성 폐질환의 빈도가 유의하게 높았다. 흉부 X-선 소견 상 폐결핵 병변의 위치는 양군간에 차이가 없었으나 병변의 모양은 노인 군에서 폐렴이나 폐암으로 오인되는 경우가 많았다(8.8% vs. 30.0 %, p<0.05). 양군 간에 객담 항산균 포말 및 배양 검사상 차이는 없었으며, 치료에 대한 반응이나 치료 중 이탈률에도 차이가 없었다. 노인 군에서 젊은 연령 군에 비하여 약제 부작용이 많았고(13.6% vs. 45.7%, p<0.05), 치료 도중 약제 변경도 노인 군에서 많았다(4.9% vs. 25.7%, p<0.05). 젊은 연령 군 125명 중 1명, 노인 군 70명 중 6명이 결핵으로 인해 사망하였다. 결 론 : 노인 폐결핵은 임상적, 방사선학적으로 비전형적인 소견을 보이는 경우가 있으므로 노인에서 폐결핵이 의심될 때는 즉시 객담 도말 및 배양 검사를 시행해야 한다. 노인 폐결핵 환자는 약재 부작용이 사망률도 높았으나 치료에 대한 반응은 대체로 좋고 반응도 빨랐다.

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치명적인 Amiodarone 폐독성 4예 (Four Fatal Cases of Amiodarone-Induced Pulmonary Toxicity)

  • 이승우;이상학;여동승;이숙영;김석찬;김관형;문화식;송정섭;박성학;정은선
    • Tuberculosis and Respiratory Diseases
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    • 제53권6호
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    • pp.662-672
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    • 2002
  • Amiodarone 폐독성은 약제 복용력이 있는 환자에서 새로운 증상과 X-선의 변화가 있을 때 의심하여야 하며 울혈성 심부전이나 폐감염증, 폐색전증, 악성종양 등과 감별하는 것이 중요하다. 진단은 임상적, 방사선학적, 조직학적 소견을 종합하여 내릴 수 있으며 대부분의 경우에는 약제 중단을 통해서 폐독성의 호전을 기대할 수 있으나 일부에서는 호흡부전으로 진행하거나 기존의 심부정맥의 재발 등으로 인하여 사망하는 경우도 있다. 저자들은 심부정맥으로 amiodarone을 사용하던 환자에서 치명적인 폐독성이 발생한 4예를 경험하였기에 이를 문헌고찰과 함께 보고하는 바이다.

비스테로이드 소염제의 최신 사용 지침 (Current Guidelines for Non-Steroidal Anti-Inflammatory Drugs)

  • 박민규;유재두;이규호
    • 대한정형외과학회지
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    • 제55권1호
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    • pp.9-28
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    • 2020
  • 비스테로이드 소염제(non-steroidal anti-inflammatory drugs, NSAIDs)는 세계적으로 관절염과 같은 만성 통증에 가장 흔히 사용되는 약물이며 성분 및 기전에 따라 다양한 종류가 있다. 장기간 사용 시에는 소화기계 및 심혈관계 합병증 등의 다양한 부작용이 발생할 수 있는 것으로 알려져 있다. 기존의 비선택적 NSAID와 유사한 진통 효과를 지니면서 위장관계 내약성을 보완해줄 수 있는 cyclooxygenase-2 (COX-2) 선택적 NSAID가 많은 기대를 모았으나 2004년 및 2005년도에 심혈관계 안전성에 대한 우려로 rofecoxib과 valdecoxib의 허가가 취하되면서 NSAID 약물의 부작용에 관한 관심은 더욱 증가하고 있다. 따라서 각 약물의 부작용 및 상호작용을 고려하여 필요한 약물을 최소한으로 사용하는 것이 매우 중요하다. 본 논문에서는 NSAID 약물을 복용할 때 발생할 수 있는 부작용 및 각 약물의 특성을 숙지하며 비선택적 NSAID 및 COX-2 선택적 NSAID의 사용과 관련된 최근 연구 및 지침에 대해 알아보고자 한다.

Leflunomide에 의한 약물유발 간질성 폐렴 1예 (A Case of Interstitial Pneumonitis Caused by Leflunomide)

  • 이정화;천원석;서영일;엄광석;장승훈;반준우;김동규;정기석
    • Tuberculosis and Respiratory Diseases
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    • 제58권1호
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    • pp.83-88
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    • 2005
  • Leflunomide는 최근에 개발된 항류마티스 약물로서 기존의 약물과 작용기전이 다르면서 효과가 우수하여 활동성 류마티스관절염에 널리 사용되고 있다. 알려진 부작용에는 간독성과 피부독성, 조혈기능부전, 위장관계 증상등이 있는데, 시판후 조사에서는 호흡기계 부작용도 드물지만 경한 정도에서 치명적인 경우까지 모두 보고 되었다. 세계 각 처에서의 시판후 조사에 의하면 호흡기계 부작용으로 사망한 경우가 있어서 심각한 폐독성의 가능성을 시사한다. 우리나라에서는 leflunomide로 인한 호흡기계 부작용에 대한 보고가 없었다. 저자들은 leflunomide에 의한 간질성 폐렴 1예를 경험하였기에 문헌고찰과 함께 보고하는 바이다.

The efficacy and safety of Montelukast sodium in the prevention of bronchopulmonary dysplasia

  • Kim, Sang Bum;Lee, Jang Hoon;Lee, Juyoung;Shin, Seung Han;Eun, Ho Sun;Lee, Soon Min;Sohn, Jin A;Kim, Han Suk;Choi, Byung Min;Park, Min Soo;Park, Kook In;Namgung, Ran;Park, Moon Sung
    • Clinical and Experimental Pediatrics
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    • 제58권9호
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    • pp.347-353
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    • 2015
  • Purpose: The purpose of this study was to evaluate the efficacy and safety of Montelukast sodium in the prevention of bronchopulmonarydysplasia (BPD). Methods: The Interventional study was designed as a multicenter, prospective, and randomized trial, with open labeled and parallel-experimental groups, 66 infants were enrolled and allocated to either the case group (n=30) or the control group (n=36) based on gestational age (GA). Infants in the case group were given Montelukast sodium (Singulair) based on their body weight (BW). Zero week was defined as the start time of the study. Results: The incidence of moderate to severe BPD was not different between the groups (case group: 13 of 30 [43.3%] vs. control group: 19 of 36 [52.8%], P=0.912). Additionally, secondary outcomes such as ventilation index, mean airway pressure and resort to systemic steroids were not significantly different. There were no serious adverse drug reactions in either group, and furthermore the rate of occurrence of mild drug related-events were not significantly different (case group: 10 of 42 [23.8%] vs. control group: 6 of 48 (15.8%), P=0.414). Conclusion: Montelukast was not effective in reducing moderate or severe BPD. There were no significant adverse drug events associated with Montelukast treatment.

Preventive effects of ginseng against atherosclerosis and subsequent ischemic stroke: A randomized controlled trial (PEGASUS trial)

  • Kwon, Boseong;Song, Yunsun;Kim, Joong-Goo;Lee, Dongwhane;Lee, Sang-hun;Cho, Young-Keol;Kim, Jong S.;Suh, Dae Chul
    • Journal of Ginseng Research
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    • 제46권4호
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    • pp.585-591
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    • 2022
  • Background: Korean Red Ginseng (KRG) extract has been shown to have beneficial effects in patients with atherosclerosis, suggesting that KRG extract may be effective in preventing subsequent ischemic stroke in patients with severe atherosclerosis. Methods: This double-blind, placebo-controlled trial randomized patients with severe atherosclerosis in major intracranial arteries or extracranial carotid artery, to ginseng group and placebo group. They were given two 500-mg KRG tablets or identical placebo tablets twice daily for 12 months according to randomization. The primary endpoint was the composite of cerebral ischemic stroke and transient ischemic attack during 12 months after randomization. The secondary endpoints were change in volumetric blood flow of the intracranial vessels and the incidence of newly developed asymptomatic ischemic lesions. Any adverse events were monitored. Results: Fifty-eight patients were randomized from June 2016 to June 2017, 29 to ginseng and 29 to placebo, and 52 (28 and 24, respectively) completed the study. One patient in the placebo group, but none in the ginseng group, experienced ischemic symptoms (p = 0.46). Changes in volumetric blood flow and the presence of ischemic brain lesions did not differ significantly in the two groups, and none of these patients experienced adverse drug reactions. Conclusion: Ginseng was well tolerated by patients with severe atherosclerosis, with these patients showing good compliance with ginseng dosing. Ginseng did not show significant effects compared with placebo, although none of the ginseng-treated patients experienced ischemic events. Long-term studies in larger patient populations are required to test the effect of ginseng.

Development of a predictive model for hypoxia due to sedatives in gastrointestinal endoscopy: a prospective clinical study in Korea

  • Jung Wan Choe;Jong Jin Hyun;Seong-Jin Son;Seung-Hak Lee
    • Clinical Endoscopy
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    • 제57권4호
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    • pp.476-485
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    • 2024
  • Background/Aims: Sedation has become a standard practice for patients undergoing gastrointestinal (GI) endoscopy. However, considering the serious cardiopulmonary adverse events associated with sedatives, it is important to identify patients at high risk. Machine learning can generate reasonable prediction for a wide range of medical conditions. This study aimed to evaluate the risk factors associated with sedation during GI endoscopy and develop a predictive model for hypoxia during endoscopy under sedation. Methods: This prospective observational study enrolled 446 patients who underwent sedative endoscopy at the Korea University Ansan Hospital. Clinical data were used as predictor variables to construct predictive models using the random forest method that is a machine learning algorithm. Results: Seventy-two of the 446 patients (16.1%) experienced life-threatening hypoxia requiring immediate medical intervention. Patients who developed hypoxia had higher body weight, body mass index (BMI), neck circumference, and Mallampati scores. Propofol alone and higher initial and total dose of propofol were significantly associated with hypoxia during sedative endoscopy. Among these variables, high BMI, neck circumference, and Mallampati score were independent risk factors for hypoxia. The area under the receiver operating characteristic curve for the random forest-based predictive model for hypoxia during sedative endoscopy was 0.82 (95% confidence interval, 0.79-0.86) and displayed a moderate discriminatory power. Conclusions: High BMI, neck circumference, and Mallampati score were independently associated with hypoxia during sedative endoscopy. We constructed a model with acceptable performance for predicting hypoxia during sedative endoscopy.

인삼 복용 후 발생한 비출혈 및 심계항진을 주소로 한 소양인 환자 1례 (A Case Study of a Soyangin Patient with Palpitation and Epistaxis that Occurred after Taking Panax Ginseng)

  • 이선영;황민우
    • 사상체질의학회지
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    • 제25권4호
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    • pp.406-413
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    • 2013
  • Objectives The purpose of this case study was to report improvement of palpitation, epistaxis, nausea, and anorexia after treatment with Dojeokgangki-tang gamibang in a middle-aged woman who has been taking Panax Ginseng continually. Methods Upon beginning her Dojeokgangki-tang gamibang regimen the patient was asked to self-evaluate the degree of discomfort in her symptoms using a using a number scale from 0 (no symptoms) to 10 (most severe). Evaluation of palpitation and chest discomfort was made a high priority. Results The palpitation the patient experienced, and self-evaluated as an "8" on the number scale at the time of her admission to the hospital, had disappeared (become "0") by the fourth day of hospitalization. The numerous symptoms which accompanied her palpitations (chest discomfort, nausea, anorexia, general weakness, weight loss, and depression) also improved accordingly. Conclusions Health functional food can pose serious health risks such as sudden bleeding and palpitations in individuals with pre-existing health problems. One must exercise extreme caution in deciding to take such supplements. As seen in the case of the middle-aged woman, the quality of life of patients who had experienced adverse reactions to such supplements can be treated through the administration of Dojeokgangki-tang gamibang.