• 제목/요약/키워드: Adverse events

검색결과 970건 처리시간 0.03초

한방병원에 입원한 수면 장애를 동반한 말초성 안면신경마비 환자에 대한 한방 치료 1례 (A Case Report of Traditional Korean Medical Treatment of a Patient with Facial Nerve Palsy and Sleep Disorder Hospitalized at a Korean Medicine Hospital)

  • 이유라;오주현;서혜진;성재연;공건식;송진영;강만호;이형철;엄국현;송우섭
    • 대한한방내과학회지
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    • 제40권5호
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    • pp.785-796
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    • 2019
  • Objective: Facial nerve palsy causes both facial muscle malfunction and mental illness. Because a facial nerve palsy lesion shows on the face, it can have serious effects on social relationships and mental health. Many facial nerve palsy patients undergo anxiety, depression, and social phobia. In this study, a facial nerve palsy patient with sleep disorder was admitted to the Korean medicine hospital for treatment. Methods: The patient with facial nerve palsy and sleep disorder was treated with herbal medicines, acupuncture, herbal acupuncture therapy, and physical therapy. We used the House Brackmann grading system and Yanagihara's Unweighted Grading System to assess changes in facial nerve palsy symptoms and the Korean Modified Leeds Sleep Evaluation Questionnaire to assess the sleep disorder. Results: The patient was hospitalized for 18 days and showed a recovery from both facial nerve palsy and sleep disorder symptoms without any adverse events. We conclude that patients with facial nerve palsy should be treated from both the physical and mental health perspectives.

대학생 일상생활 스트레스 측정 도구의 타당도와 신뢰도 (Validity and Reliability of Daily Life Stress Scale for College Students)

  • 박정혜;강세원
    • 한국산학기술학회논문지
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    • 제22권5호
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    • pp.423-432
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    • 2021
  • 본 연구의 목적은 대학생의 일상에서 발생할 수 있는 부정적 생활사건에 대해 개인의 인지된 스트레스 수준을 측정하는 도구를 개발하고, 타당도와 신뢰도를 검증하는 것이다. 도구 개발과정은 DeVellis의 도구 개발 단계와 지침에 따라 수행하였다. 도구의 타당도와 신뢰도 검증을 위해, 2020년 일 대학 재학생 1,242명에게 수집된 자료를 무작위로 2개(A, B) 그룹으로 나누어 분석하였다. A그룹의 표본 (N=620)으로 문항검사, 탐색적 요인분석, 다특성-다방법 행렬, 준거 타당도, 신뢰도를 검증한 후 B그룹의 표본(N=622)으로 확인적 요인분석과 신뢰도 재검증을 수행하였다. 그 결과, 33문항, 8개 하위요인의 최종 도구가 개발되었다. 최종 도구의 탐색적 요인분석 결과, KMO 값은 0.92, Bartlett의 구형성 검정 결과는 유의하였고(χ2=12532.42, p<.001), 초기 고유값 1.0 이상인 요인수는 8개, 누적 요인적재량은 71.5%, 각 문항의 공통성은 0.56 이상이었다. 신뢰도 검증에서도 도구 전체의 신뢰도는 Cronbach's alpha 0.94, 요인별로는 0.78~0.90이었다. 확인적 요인분석과 신뢰도 재검증에서도 유사한 결과가 도출되었다. 그러므로 본 연구에서 개발한 도구를 대학생의 일상 스트레스 수준 측정에 유용하게 사용할 것을 제안한다.

한의 복합 치료가 어깨 관절경 수술 후 급성 통증에 미치는 영향: 후향적 관찰연구 (Effect of Integrative Korean Medicine on Acute Postoperative Pain after Arthroscopic Shoulder Surgery: A Retrospective Observational Study)

  • 안종현;고준혁;김형석;이성민;이승훈;김고운;정원석;송미연;정석희;이종수;김성수;조재흥
    • 한방재활의학과학회지
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    • 제31권2호
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    • pp.69-79
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    • 2021
  • Objectives The purpose of this study was to verify the effect of integrative Korean medicine on acute postoperative pain after arthroscopic shoulder surgery. Methods This study was conducted in a retrospective observational way. Patients who met the inclusion criteria were divided into integrative Korean medicine-treated group (IKM group) and no integrative Korean medicine treated-group (No IKM group). The primary outcome was the difference in the amount of change in pain intensity. The secondary outcome was the difference in pain intensity, opioid consumption over time, and the number of adverse events after surgery. Results The change of numerical rating scale for pain intensity from baseline to IKM group was 3.09±2.12, while 2.64±1.80 in no IKM group, and the difference of change between two groups was statistically significant (p<0.05). Difference in the use of opioid between two groups over time after surgery was also statistically significant (p=0.000). Conclusions The results of this study suggest that integrative Korean medicine can be effective for acute postoperative pain after arthroscopic shoulder surgery.

Prognostic significance of non-chest pain symptoms in patients with non-ST-segment elevation myocardial infarction

  • Kim, Inna;Kim, Min Chul;Park, Keun Ho;Sim, Doo Sun;Hong, Young Joon;Kim, Ju Han;Jeong, Myung Ho;Cho, Jeong Gwan;Park, Jong Chun;Cho, Myeong Chan;Kim, Jong Jin;Kim, Young Jo;Ahn, Youngkeun
    • The Korean journal of internal medicine
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    • 제33권6호
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    • pp.1111-1118
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    • 2018
  • Background/Aims: Chest pain is an essential symptom in the diagnosis of acute coronary syndrome (ACS). One-third of patients with ACS present atypically, which can influence their receiving timely lifesaving therapy. Methods: A total of 617 NSTEMI patients from the Korea Acute MI Registry (KAMIR) and the Korea Working Group on MI (KorMI) databases were analyzed. The study population was divided into two groups by symptoms at presentation (typical symptoms group, 128; atypical symptoms groups, 128). Results: In this study population, 23% of patients presented without chest pain. After propensity score matching, the contact-to-device time ($2,618{\pm}381minutes$ vs. $1,739{\pm}241minutes$, p = 0.050), the symptoms-to-balloon time ($3,426{\pm}389minutes$ vs. $2,366{\pm}255minutes$, p = 0.024), and the door-to-balloon time ($2,339{\pm}380minutes$ vs. $1,544{\pm}244minutes$, p = 0.002) were significantly higher in the patients with atypical symptoms than in those with typical symptoms, respectively. Atypical symptoms were an independent predictor for 1-year mortality (hazard ratio, 2.820; 95% confidence interval, 1.058 to 7.515; p = 0.038). The Kaplan-Meier estimates showed higher risk for 12-month mortality in patients with atypical symptoms (p = 0.048) and no significant difference for 12-month major adverse cardiac events (p = 0.487). Conclusions: Acute myocardial infarction patients with atypical symptoms were not rare in clinical practice and showed a high risk of delayed reperfusion therapy. After imbalance between the groups was minimized by use of propensity score matching, patients who presented atypically had a high mortality rate.

A Pharmacogenomic-based Antidepressant Treatment for Patients with Major Depressive Disorder: Results from an 8-week, Randomized, Single-blinded Clinical Trial

  • Han, Changsu;Wang, Sheng-Min;Bahk, Won-Myong;Lee, Soo-Jung;Patkar, Ashwin A.;Masand, Prakash S.;Mandelli, Laura;Pae, Chi-Un;Serretti, Alessandro
    • Clinical Psychopharmacology and Neuroscience
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    • 제16권4호
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    • pp.469-480
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    • 2018
  • Objective: Pharmacogenomic-based antidepressant treatment (PGATx) may result in more precise pharmacotherapy of major depressive disorder (MDD) with better drug therapy guidance. Methods: An 8-week, randomized, single-blind clinical trial was conducted to evaluate the effectiveness and tolerability of PGATx in 100 patients with MDD. All recruited patients were randomly allocated either to PGATx (n=52) or treatment as usual (TAU, n=48) groups. The primary endpoint was a change of total score of the Hamilton Depression Rating Scale-17 (HAMD-17) from baseline to end of treatment. Response rate (at least 50% reduction in HAMD-17 score from baseline), remission rate (HAMD-17 score ${\leq}7$ at the end of treatment) as well as the change of total score of Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER) from baseline to end of treatment were also investigated. Results: The mean change of HAMD-17 score was significantly different between two groups favoring PGATx by -4.1 point of difference (p=0.010) at the end of treatment. The mean change in the FIBSER score from baseline was significantly different between two treatment groups favoring PGATx by -2.5 point of difference (p=0.028). The response rate (71.7 % vs. 43.6%, p=0.014) were also significantly higher in PGATx than in TAU at the end of treatment, while the remission rate was numerically higher in PGATx than in TAU groups without statistical difference (45.5% vs. 25.6%, p=0.071). The reason for early drop-out associated with adverse events was also numerically higher in TAU (n=9, 50.0%) than in PGATx (n=4, 30.8%). Conclusion: The present study clearly demonstrate that PGATx may be a better treatment option in the treatment of MDD in terms of effectiveness and tolerability; however, study shortcomings may limit a generalization. Adequately-powered, well-designed, subsequent studies should be mandatory to prove its practicability and clinical utility for routine practice.

간호·간병통합서비스 이용환자의 낙상발생률과 낙상의 특성 (Incidence Rate and Characteristics of Falls in Patients Using Comprehensive Nursing Care Service)

  • 손재이;박병규;이찬희;안금희;김정남;박민현;최은영;부은희;강민진;홍정화
    • 보건행정학회지
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    • 제29권2호
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    • pp.172-183
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    • 2019
  • Background: Falls are the most frequent adverse events reported in hospitals. The aim of this study was to investigate the incidence rate and characteristics of falls in patients who used comprehensive nursing care service in National Health Insurance Service Ilsan Hospital. Methods: Incidence rate of falls was investigated in patients using comprehensive nursing care service, from July 2013 to Jun 2017 and compared with those not using this service. The characteristics and risk factors for falls, and fall-related injuries were obtained. Results: Among the 62,445 patients who used the comprehensive nursing care service for 4 years, total of 672 falls were reported. The incidence rate of falls per 1,000 patients-day was 1.15. The percentage of fall-related injuries was 26.9% and that of major injury was 2.2%. Although the incidence rate of all falls was slightly higher in patients using comprehensive nursing care service than those not using this service, falls-related injuries were not correlated with the implementation of this service. Conclusion: The falls could be more frequently detected and reported in comprehensive nursing care service, but there was no difference in fall-related injuries.

건강한 성인을 대상으로 면역증강 및 상기도 감염 예방에 대한 동충하초주정추출물의 유효성 평가 : 이중맹검 플라세보 대조 연구 (Effects of Cordyceps militaris supplementation on the immune response and upper respiratory infection in healthy adults: a randomized, double-blind, placebo-controlled study)

  • 정수진;황지현;오미라;채수완
    • Journal of Nutrition and Health
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    • 제52권3호
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    • pp.258-267
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    • 2019
  • 본 연구는 한국인 건강한 성인에게서 12주간 동충하초 주정추출물의 섭취가 면역기능 증진 및 상기도감염 예방효과에 대해 확인하였다. 면역관련 지표인 NK-cell activity는 시험식품 섭취군이 플라세보군에 비해 유의적으로 증가하여 (p = 0.047) 면역증강 효과에 대해 확인하였다. 또한, 점막 면역에 주요 역할을 하는 항체 IgA 변화량은 시험식품 섭취군에서 플라세보군에 비해 통계적으로 유의하게 증가하였다 (p = 0.035). 본 연구대상자의 상기도감염(URI) 발생률은 시험식품 섭취군과 플라세보군, 두 군 간 유의한 차이는 관찰할 수 없었다. 안전성 평가인 진단검사의학 검사와 활력진후 결과에서도 섭취군 내 및 섭취군 간 의미 있는 변화 또는 차이는 관찰되지 않았다. 본 연구에서 동충하초주정추출물의 섭취가 URI 발생률에 대한 유의한 변화는 관찰할 수는 없었으나 면역지표인 NK-cell 활성 증가와 혈청 IgA 농도 증가를 통해 선천성 면역과 후천성 면역을 증진시키는 작용이 있어, 잠재적인 상기도감염 예방 효과에 관련성 있을 것으로 사료되며, 항생제의 약물 의존도를 낮추며 삶의 질 개선 및 국민보건 향상에 기여할 것으로 사료된다.

Rapid onset of efficacy predicts response to therapy with certolizumab plus methotrexate in patients with active rheumatoid arthritis

  • Kang, Young Mo;Park, Young-Eun;Park, Won;Choe, Jung-Yoon;Cho, Chul-Soo;Shim, Seung-Cheol;Bae, Sang Cheol;Suh, Chang-Hee;Cha, Hoon-Suk;Koh, Eun Mi;Song, Yeong-Wook;Yoo, Bin;Lee, Shin-Seok;Park, Min-Chan;Lee, Sang-Heon;Arendt, Catherine;Koetse, Willem;Lee, Soo-Kon
    • The Korean journal of internal medicine
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    • 제33권6호
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    • pp.1224-1233
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    • 2018
  • Background/Aims: The objective of this study was to determine the efficacy and safety of add-on therapy with certolizumab pegol (CZP) in active rheumatoid arthritis (RA) patients of a single ethnicity. Methods: In this 24-week, phase 3, randomized, double-blind, placebo-controlled trial, eligible patients (n = 127) were randomized 2:1 to subcutaneous CZP + methotrexate (MTX; 400 mg at week 0, 2, and 4 followed by 200 mg every 2 weeks) or placebo + MTX. Results: At week 24, the American College of Rheumatology criteria for 20% (ACR20) response rate was significantly greater with CZP + MTX than with placebo (66.7% vs. 27.5%, p < 0.001). Differences in ACR20 response rates for CZP vs. placebo were significant from week 1 (p < 0.05) and remained significant through week 24. The CZP group reported significant improvement in physical function and disability compared to the placebo group (p < 0.001) at week 24, as assessed by Korean Health Assessment Questionnaire-Disability Index (KHAQ-DI). Post hoc analysis indicated that the proportion of patients who had ACR70 responses, Disease Activity Score 28 (DAS28) low disease activity, and DAS28 remission at week 24 was greater in CZP + MTX-treated patients who achieved a decrease in DAS28 ${\geq}1.2$ (43.8%) at week 4 than in nonresponders. Among 18 (22.2%) and 14 patients (35.0%) in CZP and placebo groups who had latent tuberculosis (TB), none developed active TB. Most adverse events were mild or moderate. Conclusions: CZP treatment combined with MTX in active RA patients with moderate to severe disease activity and an inadequate response to MTX resulted in rapid onset of efficacy, which is associated with better clinical outcome at week 24 and has an acceptable safety profile, especially in an intermediate TB-burden population.

여성 우울증 환자에서 Aripiprazole과 Bupropion 부가요법의 우울증상 및 안전성에 대한 효과 비교 : 사후분석연구 (Comparison of the Bupropion versus Aripiprazole Adjunctive Therapy for the Treatment of Female Depression : Post-Hoc Analyses from a Randomized Prospective Open-Label Multi-Center Study)

  • 금무성;천은진;이광헌;구본훈;이영지;박영우;이종훈;이승재;성형모
    • 우울조울병
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    • 제16권3호
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    • pp.140-151
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    • 2018
  • Objectives : The purpose of this study was to examine effects of adjunctive aripiprazole versus bupropion, on depressive symptoms of female depression. Methods : Sixty six female patients with major depressive disorders were enrolled from a six-week, randomized prospective open-label multi-center study. Participants were randomized to receive aripiprazole (2.5-10 mg/day) or bupropion (150-300 mg/day). Montgomery Asberg Depression Rating Scale, 17-item Hamilton Depression Rating scale (HAM-D17), Iowa Fatigue Scale, Drug-Induced Extrapyramidal Symptoms Scale, Psychotropic-Related Sexual Dysfunction Questionnaire scores, and Clinical Global Impression-Severity (CGI-S) were obtained at baseline and after one, two, four, and six weeks. Changes on individual items of HAM-D17 were assessed as well as on composite scales (anxiety, insomnia and drive), and on four core subscales that capture core depression symptoms. Results : Overall, both treatments improved depressive symptoms, without causing serious adverse events. There were significant differences in the HAM-D17 total score (p=0.046) and CGI-S (p=0.004), between aripiprazole and bupropion augmentation, favoring aripiprazole over bupropion. Aripiprazole revealed significantly greater effect size in depressed mood (p=0.006), retardation (p=0.005), anxiety psychic (p=0.032), and general somatic symptom (p=0.01). Conclusion : While both treatments were effective, results of this study suggested that aripiprazole may be preferable, in treating general and core symptoms of female depression.

폐암 한약제제 임상시험 가이드라인 개발을 위한 한약제제 무작위배정 대조군 임상시험 고찰 (Analysis of Existing Guidelines and Randomized, Controlled, Clinical Trials for Development of [Guideline of Clinical Trial with Herbal Medicinal Product for Lung Cancer])

  • 한가진;조민지;박은주;성신;김성수;김관일;정희재;이범준;임정태
    • 대한한의학회지
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    • 제40권1호
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    • pp.153-173
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    • 2019
  • Objectives: This study aimed to ascertain what should be considered in the "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer" by analyzing the existing guidelines and clinical trials. Methods: The committee searched guidelines and clinical trials about herbal medicine for lung cancer. The searched trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparator, outcomes and trial design. Then, we compared the results of our analysis with the guidelines to identify the issues we will have to consider when making the "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer". Several guidelines for anti-tumor agents and clinical trials with herbal medicine were searched on the national institution homepage. The search terms were as follows: 'lung neoplasm', 'herbal medicine', 'Medicine, Korean traditional', 'Medicine, Chinese Traditional' etc. Results: There was no guideline for clinical trial with herbal medicine for lung cancer. In addition, 7 articles were searched through database searching. All the participants had non-small cell lung cancer. The type of intervention was decoction. Comparators included conventional treatments such as chemotherapy. The outcome measurements used in the studies were quality of life, tumor response, and survival duration, etc. Safety was evaluated by recording adverse events and blood test. Conclusions: Findings were made by reviewing existing guidelines and comparing them with clinical trials for lung cancer and herbal medicinal products. These results will be utilized in the development of "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer".