• 한국임상약학회지
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• 제28권2호
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• pp.88-94
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• 2018

Background: We strived to evaluate the status of nivolumab use and associated factors on the clinical efficacy of the drug. Methods: The study was retrospectively conducted in patients who had been administered nivolumab at least once at the cancer center of Seoul National University Hospital from June 2015 to April 2017. Data were collected from electronic medical records. A medication-use evaluation was performed based on the American Society of Health-System Pharmacists mediation-use guidelines. Results: Sixty-six of the 74 patients (89.2%) showed indications approved for nivolumab use by the Korean Ministry of Food and Drug Safety (MFDS; n=55) or the US Food and Drug Administration (FDA; n=11). Approximately 73.0% of the patients were administered the approved dose of 3 mg/kg but 25.7% were administered an unapproved fixed dose of 100 mg. The overall response rate was 21.7%, and the response rate of non-small cell lung cancer patients, who accounted for the largest number of indications, was 18.8%. Adverse reactions were found in 90.1% of the patients and were mostly mild (86%). The expression of programmed death-ligand 1 (PD-L1) was analyzed as a factor affecting treatment response (p=0.028, odds ratio [OR]=11.331). Conclusion: PD-L1 expression was found to affect treatment response. However, caution is required while using an unapproved dosage and in the absence of monitoring for effectiveness and safety. Therefore, an effective protocol or instruction manual for the proper use of nivolumab should be considered.

• 한국임상약학회지
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• 제32권1호
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• pp.27-36
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• 2022

Background: Medication-related problems (MRPs) frequently occur during the discharge period. Elderly patients, particularly, are at high risk for these problems due to polypharmacy and the use of potentially inappropriate medications. The purpose of this study was to build and implement collaboration between general hospital and community pharmacies to address MRPs among high-risk elderly patients before/after discharge. Methods: This retrospective study was conducted between June and December of 2020. The inclusion criteria were patients with aged ≥65 years; residents of Jeonju; discharged from Jeonbuk National University hospital; either on medication of exceeding 10 medications (or high-risk medications) after hospitalization through the emergency room, or having severe illness. Patients received medication reconciliation and counselling by hospital pharmacists before discharge and home-visit pharmaceutical care as follow-up by community pharmacists after discharge. Results: Twenty-two patients agreed to home-visit pharmaceutical services. Fifteen and 11 patients completed the first and second home-visit pharmaceutical care service, respectively. Forty-two MRPs were identified in 15 patients. The types of high-frequency MRPs were incorrect administration of drug, adverse drug reactions, medication non-compliance, drug-drug interactions, lifestyle modifications, and expired medication disposal. After consultation with the pharmacist, 34 out of 42 MRPs were resolved. Conclusions: Transitional care for high-risk elderly patients before and after discharge was successfully built and implemented through a collaboration between general hospital and community pharmacies. This study suggests that home-visit pharmaceutical services may have positive effects on the safe use of drugs during the transition period; however, additional research is needed to expand on these findings.

• 생물정신의학
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• 제2권1호
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• pp.131-139
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• 1995

Clozapine은 정형적 항정신병약물에 반응하지 않는 불응성 정신분열증 환자에게 효과적이며, 추체외로부작용이 적은 비정형적 향정신병약물로 보고되고있다. 따라서 저자들은 불응성 정신분열증환자를 대상으로 clozapine의 항정신병효과 및 부좌용에 대해 대표적 전형적 항정신병약물인 haloperidol과 비교연구하였다. 대상환자를 clozapine투여군(17명) 과 haloperidol 투여군 (16명)으로 나누어 12주 동안 각각의 약물을 투여하는 전향적 개방대조연구를 하였다. 두가지 약물의 치료효과와 부작용은 BPRS, PANSS, Simpson-Angus Rating Scale 및 Adverse Events-Somatic Symptoms를 사용하여 평가하였다. 약물투여 12주후 clozapine투여군이 76.5% 에서 치료반응을 보인데 비해 haloperidol투여군은 31.2%의 치료반응을 보임으로써 두약물 투여군간에 유의한 차이가 있었다. BPRS와 PANSS 척도상 clozapine투여군이 haloperidol투여군에 비하여 BPRS, PANSS 양성증상 및 일반증상 척도는 약물투여 8주후부터, PANSS 음성척도는 약물투여 4주후부터 12주까지 일관성있게 지속적으로 의미있는 호전을 보였다. Clozapine투여군에서는 타액분비(70.6%), 졸리움(52.9%), 변비(29.4%) 및 저혈압(23.4%)이, haloperidol투여군은 진전(37.5%), 정좌불능(25.0%), 강직(18.8%) 및 무운동(18.8%)이 흔히 보고되었다. 하지만 두약물 투여군 모두에서 대부분 경미하고 환자가 견딜 정도였다. Clozapine투여군에서 약물투여 전에 비해서 약물투여 12주후 백혈구와 호중구의 유의한 변화는 없었다. 이상의 결과를 종합해볼 때, clozapine은 정형적 항정신병약물에 치료효과가 없거나 추체외로부작용 때문에 약물투여가 어려운 경우의 한국인 불응성 정신분열증환자에게 효과적인 비정형적 항정신병약물이다.

• 셀메드
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• 제10권2호
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• pp.15.1-15.9
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• 2020

Introduction: Buthūr Labaniyya (Acne vulgaris) is a multifactorial disorder of the pilosebaceous units characterized by non-inflammatory and inflammatory clinical lesions. Several Unani medications have been used for centuries to treat acne. Objectives: Evaluation of safety and efficacy of Tila-i Muhāsā in patients with acne vulgaris Materials and Methods: This clinical study was conducted in patients with acne vulgaris. Patients applied Tila-i Muhāsā or 5% Benzoyl Peroxide (BPO) once daily for 6 weeks. Assessment of efficacy was carried out by Global Acne Grading System (GAGS) and Patient Global Assessment (PGA) scores. In addition, overall severity of acne was evaluated on a 5-point Cook's acne grading scale using photographic standards. Assessment of safety was performed through adverse drug reactions, local dermal tolerability, vital signs, and routine laboratory investigations. Results: A total of 60 patients (30 in each group) completed 6 weeks of treatment. The mean percentage reduction in GAGS score at 6 weeks from baseline in Unani group (66.97%) and BPO group (59.09%) was statistically significant (P<0.0001). After 6 weeks of therapy, the mean percentage reduction in PGA score compared to baseline in Unani group (57.44%) and BPO group (50.23%) was statistically significant (P<0.0001). No serious adverse events were reported in both groups; however, mild adverse events occurred more frequently in BPO group (30%) compared to Unani group (10%). Conclusion: Tila-i Muhāsā was found to be effective and safe in the treatment of acne vulgaris. However, further clinical studies with larger sample size and longer duration of therapy need to be conducted.

• Gut and Liver
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• 제12권6호
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• pp.694-703
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• 2018

Background/Aims: Limited data exist comparing the safety and efficacy of direct-acting antivirals (DAAs) in hepatitis C virus (HCV) monoinfected and HCV/human immunodeficiency virus (HIV) coinfected patients in the real-world clinic practice setting. Methods: All HCV monoinfected and HCV/HIV coinfected patients treated with DAAs between January 2014 and October 2017 in community clinic settings were retrospectively analyzed. Pretreatment baseline patient characteristics, treatment efficacy, factors affecting sustained virologic response at 12 weeks (SVR12) after treatment, and adverse reactions were compared between the groups. Results: A total of 327 patients were included in the study, of which 253 were HCV monoinfected, and 74 were HCV/HIV coinfected. There was a statistically significant difference observed in SVR12 when comparing HCV monoinfection and HCV/HIV coinfection (94% and 84%, respectively, p=0.005). However, there were no significant factors identified as a predictor of a reduced response. The most common adverse effect was fatigue (27%). No significant drug interaction was observed between DAA and antiretroviral therapy. None of the patients discontinued the treatment due to adverse events. Conclusions: In a real-world setting, DAA regimens have lower SVR12 in HCV/HIV coinfection than in HCV monoinfection. Further studies involving a higher number of HCV/HIV coinfected patients are needed to identify real predictors of a reduced response.

• 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.

• 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.

• 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.

• 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.

• 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.