• 제목/요약/키워드: Adverse events (AE)

검색결과 39건 처리시간 0.022초

Korean Red Ginseng exhibits no significant adverse effect on disease activity in patients with rheumatoid arthritis: a randomized, double-blind, crossover study

  • Cho, Soo-Kyung;Kim, Dam;Yoo, Dasomi;Jang, Eun Jin;Jun, Jae-Bum;Sung, Yoon-Kyoung
    • Journal of Ginseng Research
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    • 제42권2호
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    • pp.144-148
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    • 2018
  • Background: Panax ginseng is a well-known immune modulator, and there is concern that its immune-enhancing effects may negatively affect patients with rheumatoid arthritis (RA) by worsening symptoms or increasing the risk of adverse effects from other drugs. In this randomized, crossover clinical trial, we evaluated the impact of Korean Red Ginseng (KRG) on disease activity and safety in RA patients. Methods: A total of 80 female RA patients were randomly assigned to either the KRG (2 g/d, n = 40) treatment or placebo (n = 40) groups for 8 wk, followed by crossover to the other treatment group for an additional 8 wk. The primary outcome was the disease flare rate, defined as worsening disease activity according to the disease activity score 28 joints-erythrocyte sedimentation rate (DAS28-ESR). The secondary outcomes were development of adverse events (AEs) and patient reported outcomes. Outcomes were evaluated at baseline and 8 wk and 16 wk. The outcomes were compared using the Chi-square test. Results: Of the 80 patients, 70 completed the full study. Their mean age was 51.9 yr, and most exhibited low disease activity (mean DAS28-ESR $3.5{\pm}1.0$) at enrollment. After intervention, the flare rate was 3.7% in each group. During KRG treatment, 10 AEs were reported, while five AEs were developed with placebo; however, this difference was not statistically significant (p = 0.16). Gastrointestinal- and nervous system-related symptoms were frequent in the KRG group. Conclusion: KRG is not significantly associated with either disease flare rate or the rate of AE development in RA patients.

Long-Term Tolerability of Escitalopram in Korean Adolescents

  • Goo, Ae-Jin;Won, Eun-Kyung;Lee, Cheolsoon;Lee, Jong-Il;Jung, Hee-Yeon;Kim, Yeni
    • Journal of the Korean Academy of Child and Adolescent Psychiatry
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    • 제24권4호
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    • pp.207-212
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    • 2013
  • Objectives : We investigated the long-term tolerability of escitalopram in Korean adolescents. Methods : The subjects were 37 adolescents, who had been diagnosed with depressive disorder in accordance to DSM-IV. Clinical effectiveness was assessed by Clinical Global Impression-Improvement (CGI-I) scale at the final follow-up visit. Tolerability was assessed through a medical record of the reason for discontinuation of escitalopram and documented adverse events. Results : The mean duration of treatment was $78.1{\pm}89.5$ days, and the mean dosage was $10.0{\pm}4.4$mg/day. Out of the total 37 patients, two (5%) patients sustained use of escitalopram. Twelve patients (32.4%) discontinued use of escitalopram due to target symptom remission, and 23 patients (61.9%) due to insufficient efficacy. Six patients (16.2%) had at least one documented adverse event. However, no suicidal ideation or self-injurious behavior was reported. Significant differences in clinical symptom improvement efficacy were seen between the patients who were receiving escitalopram for less than 8 weeks (4.3%, 1/13) and those for more than 8 weeks (92.9%, 13/14). There was no significant difference between the tolerability of monotherapy compared to the concomitant use group. Conclusion : The results of this study suggest that long-term use of escitalopram may result in superior efficacy than shortterm use, and is tolerable in Korean adolescents with depression.

Transitional Care for Older Adults with Chronic Illnesses as a Vulnerable Population: Theoretical Framework and Future Directions in Nursing

  • Son, Youn-Jung;You, Mi-Ae
    • 대한간호학회지
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    • 제45권6호
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    • pp.919-927
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    • 2015
  • Purpose: Effective transitional care is needed to improve the quality of life in older adult patients with chronic illness and avoid discontinuity of care and adverse events. The aim of this article is to provide an overview of the key features, broader implications, and the utility of Meleis' transition theory intended for the transitional care of older adults with chronic illnesses. We present the role of nurse in the context of transitional care and propose future directions to increase the quality of nursing care. Methods: The online databases Cumulative Index of Nursing and Allied Health Literature, MEDLINE, and Science Direct were searched for relevant literature published since 1970 along with textbooks regarding nursing theory. Results: An evaluation of the usefulness of transition theory based on transitional care in older adult patients with chronic illnesses is provided. Healthy transition should be the expected standard of nursing care for older adults across all healthcare settings. Conclusion: Nurses need to contribute to the development of transitional care for vulnerable populations; however, transition theory needs to be enhanced through additional theoretical work and repeated evaluations of the applicability in areas of transitional care.

Acupuncture Treatment of Adhesive Capsulitis of the Shoulder: A Randomized Controlled Pilot Trial

  • Kim, Jung-Eun;Kim, Sung-Phil;Kim, Ae-Ran;Park, Hyo-Ju;Kwon, Ojin;Jung, So-Young;Cho, Jung-Hyo;Kim, Joo-Hee;Choi, Sun-Mi
    • Journal of Acupuncture Research
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    • 제35권3호
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    • pp.120-128
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    • 2018
  • Background: Adhesive capsulitis (AC) is a common condition that includes shoulder pain and limited movement. Despite more than 100 years of AC treatment, the most efficacious treatment remains unclear. The aim of this study was to evaluate the feasibility of a randomized controlled trial (RCT) using acupuncture for AC. Methods: Thirty participants with AC were randomly assigned to acupuncture (A) or sham acupuncture (SA) groups. The participants received 15 acupuncture sessions over 6 weeks, and follow-up occurred for an additional 4 weeks thereafter. The primary clinical outcome was the numeric rating scale (NRS) for shoulder pain 6 weeks from the baseline. Secondary outcomes included range of motion (ROM) in the shoulder, the shoulder pain and disability index (SPADI), the EuroQol-5 dimensions (EQ-5D), the Pittsburgh sleep quality index (PSQI), and the patient global impression of change (PGIC). Results: Thirty participants were enrolled out of 37 screened individuals. Recruitment was conducted between August 2014 until May 2015. A total of 28 participants (93%) completed the 6-week intervention, and 26 participants (87%) completed the study. NRS, ROM, SPADI, EQ-5D, PSQI, and PGIC scores improved in both the experimental group and the sham group after 6 weeks, but the difference between the groups was not statistically significant. Adverse events were reported by 12 participants, although these events were not associated with acupuncture. Conclusion: A future RCT for AC may be feasible with some modifications to the recruitment plan and the secondary outcome measurement methods.

슬관절 전치환술 중 지속 정주한 Fentanyl이 압박띠로 인한 심혈관계 변화 및 수술 후 선행 진통에 미치는 효과 (Effect of Intraoperative Continuous I.V. Fentanyl on Tourniquet Induced Cardiovascular Changes and Postoperative Preemptive Analgesia in Total Knee Replacements)

  • 이종원;전종헌;김영선;정미애;심재철;김교상
    • The Korean Journal of Pain
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    • 제18권2호
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    • pp.165-170
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    • 2005
  • Background: It is difficult to treat tourniquet-induced hypertension despite adequate anesthesia, and the mechanism of that is not known. And it may be possible that intraoperative continuous infusion of opioid induces preemptive analgesia postoperatively. We investigated the effect of intraoperative continuous i.v. fentanyl on tourniquet induced cardiovascular changes and postoperative preemptive analgesia in total knee replacements. Methods: Sixty patients were randomly assigned to two groups; In study group ($1.5{\mu}g/kg$ loading and $0.5{\mu}g/kg/hr$ continuous infusion of fentanyl before skin incision and tourniquet inflation) and control group (no treatment). Anesthesia was maintained with enflurane (1-2 MAC) and 50% nitrous oxide in oxygen. Arterial pressure and heart rate were compared between two groups. They received postoperative pain treatment with patient-controlled analgesia (PCA) with fentanyl during the postoperative 48 hours after total knee replacement. Visual analog scale (VAS) scores at either rest or movement were used to assess pain. Total fentanyl dose delivered, number of PCA requests, supplemental analgesics, overall satisfaction score and adverse events were evaluated. Results: There were no significant differences between the two groups on cardiovascular changes by tourniquet induced pain effect. VAS, PCA delivered dose and PCA demands at movement in the 24-48 hour decreased in study group compared with control group (P < 0.05). But there were no significant differences between the two groups on the other time periods except 24-48 hour's patient satisfaction and adverse events. Conclusions: We suggest that intraoperative continuous i.v. fentanyl infusion dose not affect cardiovascular change by tourniquet induced pain. But it may induce preemptive analgesia postoperatively.

Treatment outcome of conservative surgery plus postoperative radiotherapy for extremity soft tissue sarcoma

  • Lee, Ji-Eun;Park, Young-Je;Yang, Dae-Sik;Yoon, Won-Sup;Lee, Jung-Ae;Rim, Chai-Hong;Kim, Chul-Yong
    • Radiation Oncology Journal
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    • 제30권2호
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    • pp.62-69
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    • 2012
  • Purpose: To evaluate the treatment outcome and prognostic factor of postoperative radiotherapy for extremity soft tissue sarcoma (STS). Materials and Methods: Forty three patients with extremity STS were treated with conservative surgery and postoperative radiotherapy from January 1981 to December 2010 at Korea University Medical Center. Median total 60 Gy (range, 50 to 74.4 Gy) of radiation was delivered and 7 patients were treated with chemotherapy. Results: The median follow-up period was 70 months (range, 5 to 302 months). Twelve patients (27.9%) sustained relapse of their disease. Local recurrence occurred in 3 patients (7.0%) and distant metastases developed in 10 patients (23.3%). The 5-year overall survival (OS) was 69.2% and disease free survival was 67.9%. The 5-year local relapse-free survival was 90.7% and distant relapse-free survival was 73.3%. On univariate analysis, no significant prognostic factors were associated with development of local recurrence. Histologic grade (p = 0.005) and stage (p = 0.02) influenced the development of distant metastases. Histologic grade was unique significant prognostic factor for the OS on univariate and multivariate analysis. Severe acute treatment-related complications, Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or 4, developed in 6 patients (14.0%) and severe late complications in 2 patients (4.7%). Conclusion: Conservative surgery with postoperative radiotherapy achieved a satisfactory rate of local control with acceptable complication rate in extremity STS. Most failures were distant metastases that correlate with tumor grade and stage. The majority of local recurrences developed within the field. Selective dose escalation of radiotherapy or development of effective systemic treatment might be considered.

A Case of Bilateral Giant Bullae in Young Adult

  • Park, Ju-Hee;Kim, Junghyun;Lee, Jung-Kyu;Kim, Soo Jung;Lee, Ae-Ra;Moon, Hyeon Jong;Kim, Deog Kyeom
    • Tuberculosis and Respiratory Diseases
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    • 제75권5호
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    • pp.222-224
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    • 2013
  • Giant bullae are large bullae occupying at least one-third of the hemithorax and surgical bullectomy is the treatment of choice. We report a case with symptomatic giant bullae which were resected successfully. A 35-year-old man presented with bilateral giant bullae that occupied almost the entire left hemithorax and a third of the right hemithorax. He was a current smoker with a 30 pack-year history and he presented with dyspnea on exertion. An elective surgical bullectomy was performed with video-assisted thoracoscopic surgery. The patient recovered without any adverse events and stayed well for 1 month after surgery.

Radiation Dose from Computed Tomography Scans for Korean Pediatric and Adult Patients

  • Won, Tristan;Lee, Ae-Kyoung;Choi, Hyung-do;Lee, Choonsik
    • Journal of Radiation Protection and Research
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    • 제46권3호
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    • pp.98-105
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    • 2021
  • Background: In recent events of the coronavirus disease 2019 (COVID-19) pandemic, computed tomography (CT) scans are being globally used as a complement to the reverse-transcription polymerase chain reaction (RT-PCR) tests. It will be important to be aware of major organ dose levels, which are more relevant quantity to derive potential long-term adverse effect, for Korean pediatric and adult patients undergoing CT for COVID-19. Materials and Methods: We calculated organ dose conversion coefficients for Korean pediatric and adult CT patients directly from Korean pediatric and adult computational phantoms combined with Monte Carlo radiation transport techniques. We then estimated major organ doses delivered to the Korean child and adult patients undergoing CT for COVID-19 combining the dose conversion coefficients and the international survey data. We also compared our Korean dose conversion coefficients with those from Caucasian reference pediatric and adult phantoms. Results and Discussion: Based on the dose conversion coefficients we established in this study and the international survey data of COVID-19-related CT scans, we found that Korean 7-year-old child and adult males may receive about 4-32 mGy and 3-21 mGy of lung dose, respectively. We learned that the lung dose conversion coefficient for the Korean child phantom was up to 1.5-fold greater than that for the Korean adult phantom. We also found no substantial difference in dose conversion coefficients between Korean and Caucasian phantoms. Conclusion: We estimated radiation dose delivered to the Korean child and adult phantoms undergoing COVID-19-related CT examinations. The dose conversion coefficients derived for different CT scan types can be also used universally for other dosimetry studies concerning Korean CT scans. We also confirmed that the Caucasian-based CT organ dose calculation tools may be used for the Korean population with reasonable accuracy.

경추증성 척수증의 한의학적 치료에 대한 국내외 연구 동향 (A Review of the Korean Traditional Medicine for Cervical Spondylotic Myelopathy)

  • 변다영;이기언;노지애;김효준;허석원;한시훈
    • 한방재활의학과학회지
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    • 제29권2호
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    • pp.149-158
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    • 2019
  • Objectives This study was performed to research the trends of Korean traditional medicine treatment for cervical spondylotic myelopathy (CSM). Methods Clinical studies about Korean traditional medicine of CSM were searched in 7 online databases. We extracted the characteristics of selected studies according to author, publication year, country, research design, treatment methods, evaluation tools, and adverse events. Results Nineteen studies were selected in online databases. The included studies consist of 8 uncontrolled trial, 7 case reports, 3 randomized controlled trials and 1 non-randomized controlled trials. In these studies, various Korean traditional medicine treatments were performed, and herbal medicine was the most common. The most commonly used outcomes was effective rate. Conclusions This study showed that Korean traditional medicine could be an effective treatment for CSM. It was suggested that various studies should be conducted to provide objective evidence of the therapeutic effects of Korean traditional medicine treatment for CSM.

소아 일과성 고관절 활액막염에 대한 한약의 효과: 체계적 문헌 고찰 및 메타분석 (Effect of Herbal Medicine on Transient Synovitis of Hip in Children: A Systemic Review and Meta-analysis )

  • 홍예나;이영훈;유선애
    • 대한한방소아과학회지
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    • 제37권4호
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    • pp.34-52
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    • 2023
  • Objective This study aimed to evaluate the effect of herbal medicines on transient hip synovitis (TSH) in children. Methods We searched 10 Korean, English, Japanese, and Chinese databases for studies published up to September 19, 2023. Randomized controlled trials (RCTs) evaluating the effect of herbal medicines on TSH levels in children were included. The Cochrane risk of bias was used to evaluate the quality of the studies. A meta-analysis was conducted according to outcome measurements, such as total effective rate (TER), visual analog score (VAS), time to pain relief, and hip joint mobility disorder disappearance time, using the Review Manager website. Results Eleven RCTs were included in this study. TER in the treatment group was significantly higher than in the control group. The duration of pain relief was significantly shorter in the treatment group than in the control group. The VAS score of the treatment group was significantly lower than that of the control group, although the statistical heterogeneity was substantial. The hip joint mobility disorder disappeared in the treatment group treated with external therapy, which was significantly shorter than in the control group. Regarding safety, two of the 11 studies reported that there were no adverse events. Conclusions Herbal medicines are effective in the treatment of TSH in children. However, the safety of herbal medicines should be carefully considered due to the lack of data.