• Title/Summary/Keyword: Adverse events

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

  • Lee, Yu-ra;Oh, Ju-hyun;Seo, Hye-jin;Sung, Jae-yeon;Kong, Geon-sik;Song, Jin-young;Kang, Man-ho;Lee, Hyung-chul;Eom, Gook-hyun;Song, Woo-sub
    • The Journal of Internal Korean Medicine
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    • v.40 no.5
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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.

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

  • Park, Jeong-Hye;Kang, Se-Won
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.22 no.5
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    • pp.423-432
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    • 2021
  • This study developed a scale to measure college students' perceived stress levels for adverse life events that may occur in their daily lives and confirmed its validity and reliability. The scale was developed in accordance with DeVellis' scale development guidelines. Data were collected from 1,242 students of a local university in 2020. The collected samples were randomly separated into two groups (A, B). Group A (N=620) was tested for an initial examination of the performance, exploratory factor analysis, multitrait-multimethod matrix, criterion-related validity, and reliability of each item; and verified with group B (N=622) for confirmatory factor analysis and reliability re-test. As a result, the final scale of 33 items and eight factors were developed. The KMO values were 0.92, and Bartlett's spherical test was significant (χ2=12532.42, p<.001); the number of factors with initial eigenvalues of 1.0 or higher was eight; the cumulative factor loadings of 71.5% and the commonality of each item was 0.56 or higher. The reliability of the scale was Cronbach's alpha 0.94; sub-factors' Cronbach's alpha was 0.78 to 0.90. Therefore, these findings suggest that the scale developed in this study would be useful for measuring the stress levels of daily life for college students.

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

  • Ahn, Jonghyun;Ko, Junhyuk;Kim, Hyungsuk;Rhee, Sung-Min;Lee, Seung Hoon;Kim, Koh-Woon;Chung, Won-Seok;Song, Mi-Yeon;Chung, Seok-Hee;Lee, Jong-soo;Kim, Sung-soo;Cho, Jae-Heung
    • Journal of Korean Medicine Rehabilitation
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    • v.31 no.2
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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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    • v.33 no.6
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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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    • v.16 no.4
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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.

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

  • Son, Jaei;Park, Byung Kyu;Lee, Chan Hee;Ahn, Keum Hui;Kim, Jung Nam;Park, Min Hyun;Choi, Eun Young;Boo, Eun Hui;Kang, Min Jin;Hong, Jung Hwa
    • Health Policy and Management
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    • v.29 no.2
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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.

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

  • Jung, Su Jin;Hwang, Ji Hyun;Oh, Mi Ra;Chae, Soo Wan
    • Journal of Nutrition and Health
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    • v.52 no.3
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    • pp.258-267
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    • 2019
  • Purpose: Upper respiratory tract infections are major causes of the common cold throughout the world. Cordyceps militaris (C. militaris) is a well-known functional food for its anti-fatigue and immunomodulating activities. On the other hand, there are no reports on the protective effect against upper respiratory tract infections (URI). This study was a 12 week randomized, double-blind, and placebo-controlled trial in healthy volunteers. Methods: A total of 100 subjects 20 ~ 70 years of age with a history of at least two colds in the year were enrolled in the study. The participants were required to record any adverse events and rate any cold-related incidents in a diary during the investigation period. The efficacy end point was the symptoms and incidence of URI, and changes in cytokines, IgA and natural killer (NK) cell activity. Results: The Cordyceps militaris group over 12 weeks showed no significant impact on the incidence and symptomatology of URI compared to the placebo group. On the other hand, the experimental group showed significantly higher NK cell activity (p = 0.047) and IgA level (p = 0.035) compared to the placebo group. The NK-cell activity and IgA level were increased significantly by Cordyceps militaris over 12 weeks. Conclusion: The results suggest the possible beneficial immunomodulating effects, but the protective effects on URI could not be demonstrated under these conditions. Additional research will be needed to determine the efficacy and mechanisms of Cordyceps militaris function.

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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    • v.33 no.6
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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.

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 (여성 우울증 환자에서 Aripiprazole과 Bupropion 부가요법의 우울증상 및 안전성에 대한 효과 비교 : 사후분석연구)

  • Keum, Mu-sung;Cheon, Eun-Jin;Lee, Kwang-Hun;Koo, Bon-Hoon;Lee, Young-Ji;Park, Young-Woo;Lee, Jong-hun;Lee, Seung-Jae;Sung, Hyung-Mo
    • Mood & Emotion
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    • v.16 no.3
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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.

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

  • Han, Gajin;Cho, Minji;Park, Eunjoo;Seong, Sin;Kim, Sungsu;Kim, Kwan-Il;Jung, Hee-Jae;Lee, Beom-Joon;Leem, Jungtae
    • The Journal of Korean Medicine
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    • v.40 no.1
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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".