• 제목/요약/키워드: Adverse events (AE)

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작은 크기의 재발성 간세포암에 대한 구제치료로 소분할 방사선치료: 국소 제어율과 안전성 (Hypofractionated Radiotherapy for Small-sized Hepatocellular Carcinoma as Salvage Therapy: Sustained Local Control and Safety)

  • 배선현;박희철;임도훈;이정애;최문석;이준혁;고광철;백승운;유병철
    • Radiation Oncology Journal
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    • 제28권2호
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    • pp.85-90
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    • 2010
  • 목 적: 크기가 작은 5 cm 미만의 재발성 간세포암 환자를 대상으로 소분할 방사선치료 후 종양의 반응, 국소제어율 및 소분할 방사선치료와 연관된 부작용을 평가하였다. 대상 및 방법: 2006년부터 2007년까지 국소요법으로 치료한 후 재발한 간세포암 환자 중 구제치료로 소분할 방사선치료를 받은 12명의 환자를 대상으로 후향적 분석을 시행하였다. 소분할 방사선치료의 적용기준은 종양의 크기가 5 cm 미만이고, 중요 정상조직에 인접하지 않으면서, 간세포암에 의한 간문맥 종양 혈전증이 없으며, 처방된 방사선량의 50%가 조사되는 정상 간 용적이 15% 미만인 경우로 제한하였다. 소분할 방사선치료의 1회 조사량은 5 Gy였고, 주 5회 치료하여 2주 동안 총 50 Gy를 조사하였다. 종양의 반응도는 방사선치료 종료 후 3개월에 시행된 간 컴퓨터단층촬영으로 평가하였다. 치료와 연관된 부작용은 Common Terminology Criteria for Adverse Events version 3.0으로 평가하였다. 방사선치료 종료 후 추적관찰기간은 8~33개월(중앙값 18개월)이었다. 결 과: 방사선치료 후 3개월에 시행한 간 컴퓨터단층촬영에서 완전관해율은 41.7%였고 추적관찰기간에 확인한 전체 완전관해율은 58.3%였다. 방사선치료 부위 내 국소제어율은 83.3%였다. 두 명을 제외한 모든 환자에서 간 내 재발이 발생하였다. 전체 환자의 1년 및 2년 생존율은 각각 90.0%, 67.5%였다. 치료와 연관된 부작용은 3명의 환자가 치료 중 1도의 오심, 식욕부진이 발생하였고 방사선치료 종료 후 복수가 진행한 환자가 1명 있었다. 3도 이상의 중대한 부작용은 없었다. 결 론: 작은 크기의 재발성 간세포암의 구제 치료로서 소분할 방사선치료는 58.3%의 완전관해율과 83.3%의 국소 제어율을 보여주었다. 소분할 방사선치료로 5 Gy씩 총 50 Gy를 조사하는 것은 치료와 연관된 심각한 독성 없이 비교적 안전하고 효과적인 방법으로 판단된다.

소아청소년 자폐성 스펙트럼 장애에서 SSRI 장기 사용에 대한 후향적 분석 (Retrospective Analyses of Long-Term Use of SSRI in Children and Adolescents with Autism Spectrum Disorder)

  • 구애진;박진박;이종일;진혜경;김예니
    • 생물정신의학
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    • 제19권4호
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    • pp.205-210
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    • 2012
  • Objectives The purpose of this study was to investigate clinical profile, efficacy, and safety of long-term treatment with selective serotonin reuptake inhibitors (SSRIs) in Korean autism spectrum disorders (ASDs) patients. Methods Effectiveness was assessed through a retrospective review of self-reported target symptom improvement at the last follow-up visit. Changes in illness severity and improvement were measured using the Clinical Global Impression-Severity (CGI-S) of illness and Clinical Global Impression-Improvement (CGI-I) Scales. Tolerability was assessed through a review of the reason for discontinuation of SSRI and documented adverse events. Results A total of 21 ASDs patients (aged 9 to 19 years) treated with SSRI during July 2010 to July 2011 in department of child and adolescent psychiatry of Seoul National Hospital were identified. The mean duration of SSRI treatment was 47.9 (standard deviation = 36.9) months (range 0.7-114.5), and the mean fluoxetine equivalent dosage of SSRIs was $27.1{\pm}10.8$ mg. Nineteen (90.5%) patients were using concomitant medication. We found that SSRIs were prescribed for symptoms of agitation, stereotyped behavior, aggression, depression, impulsivity and self-injury in ASDs. Ten patients (47.6%) reported improvement in their target symptom after SSRI treatment based on CGI-I scores (CGI-I ${\leq}$ 2). The side effects were reported in 5 patients (23.8%) ; vomiting (n = 2, 9.5%), excessive mood elevation (n = 1, 4.8%), insomnia (n = 1, 4.8%), somnolence (n = 1, 4.8%) and decreased appetite (n = 1, 4.8%). Self-injurious behavior was reported in one patient (4.8%). Conclusions The results of this study suggest that SSRIs may be used effectively in children and adolescents diagnosed with ASDs. However, safety issues need to be considered carefully when choosing SSRIs for treatment. Future controlled trials are needed to confirm these findings.

Loperamide로 억제된 위장관 운동에 대한 사관혈의 자침효과: 무작위배정, 단일눈가림, 교차설계, 대조 임상시험 (A Crossover Clinical Trial to Determine the Effect of Siguan(Four Gates) Points on Gastrointestinal Motility Suppressed by Loperamide Administration)

  • 오달석;정소영;김애란;강위창;박지은;구창모;최준용;정희정;최선미;손창규
    • 대한한의학회지
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    • 제29권1호
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    • pp.1-6
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    • 2008
  • Objective : To investigate the therapeutic effect of manual acupuncture at Siguan (four gates, bilateral LI4 and LR3) on suppression of gastrointestinal motility. Methods : A single blind, randomized, sham-acupuncture controlled, crossover study was conducted. Twenty healthy male subjects were admitted at hospital, and gastrointestinal motility suppression was induced by loperamide administration. Just after intake of 20 radio-markers, four gates or sham acupoint treatments were administered every 12 hours, 4 times over 48 hours. Gastrointestinal motility was evaluated by radiographic distribution of the radiomarkers at stomach or ileum, ascending, transverse, descending colon, sigmoid/rectum, and outside body at serial time points (0, 6, 12, 24, and 48 h). Results : Four gates acupuncture activated gastrointestinal movement as evidenced by significantly changed distributionof radio-makers at 6, 12, and 48 hours (P < 0.0001, P = 0.001, and P = 0.03, respectively) in Cochran-Mantel-Haenszel statistics. No serious adverse events occurred in either group. Conclusions : This study showed a scientific clinical relevance of four gates acupuncture to gastrointestinal disorders.

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만성 피로증후군과 특발성 만성 피로에 대한 침 치료 효과: 무작위 대조 예비 임상연구 (Acupuncture for Chronic Fatigue Syndrome and Idiopathic Chronic Fatigue: a Pilot Randomized Controlled Trial)

  • 김정은;강경원;김애란;김주희;김태훈;박효주;신미숙;이민희;이상훈;이승훈;정소영;정희정;홍권의;최선미
    • Journal of Acupuncture Research
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    • 제29권5호
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    • pp.109-118
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    • 2012
  • Objectives : The aim of this study was to evaluate the effectiveness and safety of acupuncture for chronic fatigue syndrome and idiopathic chronic fatigue. Methods : A randomized, controlled pilot trial was conducted. Twenty-four participants were randomized into one of the two groups: an acupuncture group(n=12) and wait-list group(n=12). The treatment group received 12 sessions of acupuncture over 4 weeks. Eight points($GV_{20}$; bilateral GB20, $BL_{11}$, $BL_{13}$, $BL_{15}$, $BL_{18}$, $BL_{20}$, and $BL_{23}$) were selected for needling. The control group did not receive acupuncture treatment during study period and follow-up were done in the $5^{th}$ and $9^{th}$ weeks after randomization in both groups. The primary outcome was fatigue severity scale(FSS) and the secondary outcomes included a short form of stress response inventory(SRI-short form), beck depression inventory(BDI), and insomnia severity index(ISI). Safety was assessed at every visit. Results : There were statistically significant differences in the between group values of FSS at $5^{th}$ weeks after randomization(p=0.0002), SRI-short form, BDI, and ISI at $5^{th}$, $9^{th}$ weeks after randomization(p<0.01). There were no adverse events. Conclusions : The results suggest that acupuncture is associated with benefits on the short-term outcomes in chronic fatigue syndrome and idiopathic chronic fatigue.

Protocol of a Nationwide Observational Study among Patients with Nontuberculous Mycobacterium Pulmonary Disease in South Korea (NTM-KOREA)

  • Kwak, Nakwon;Choi, Hongjo;Jeon, Doosoo;Jhun, Byung Woo;Jo, Kyung-Wook;Kang, Young Ae;Kwon, Yong-Soo;Lee, Myungsun;Mok, Jeongha;Shim, Tae-Sun;Shin, Hong-Joon;Whang, Jake;Yim, Jae-Joon
    • Tuberculosis and Respiratory Diseases
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    • 제83권2호
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    • pp.141-146
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    • 2020
  • Background: The burden of nontuberculous mycobacterial (NTM) pulmonary disease (PD) is increasing globally. To understand the treatment outcomes and prognosis of NTM-PD, a unified registry is needed. In this project, we aim to construct a multicenter prospective observational cohort with NTM-PD in South Korea (NTM-KOREA). Methods: The primary objective of this study is to analyze treatment outcomes according to the species. In addition, recurrence rate, adverse events, the impact of each drug on treatment outcomes as well as the impact of characteristics of mycobacteriology will be analyzed. The inclusion criteria for the study are as follows: fulfilling the criteria for NTM-PD having one of the following etiologic organisms: Mycobacterium avium complex, M. abscessus subspecies abscessus, M. abscessus subspecies massiliense, or M. kansasii; receiving the first treatment for NTM-PD after enrollment; age >20 years; and consenting to participate in the study. Seven institutions will participate in patient enrollment and about 500 patients are expected to be enrolled. Participants will be recruited from 1 March 2020 until 19 March 2024 and will be observed through 19 March 2029. During the follow-up period, participants' clinical course will be tracked and their clinical data as well as NTM isolates will be collected. Conclusion: NTM-KOREA will be the first nationwide observational cohort for NTM-PD in South Korea. It will provide the information to optimize treatment modalities and will contribute to deeper understanding of the treatment outcomes and long-term prognosis of patients with NTM-PD in South Korea.

알코올성 지방간 환자에 있어 전침 치료의 효과: 무작위 배정 대조군 연구 (The Effects of Electroacupuncture for Treatment of Patients with Non-Alcoholic Fatty Liver Disease: Prospective Randomized Controlled Study)

  • 이창형;김병석;최애련;김경순;곽민아;김승모
    • 한방비만학회지
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    • 제15권1호
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    • pp.1-8
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    • 2015
  • Objectives: The aim of this study was to evaluate the effectiveness and safety of electroacupuncture for non-alcoholic fatty liver disease (NAFLD). Methods: A randomized, controlled pilot trial was conducted. Twenty-two participants were randomized into one of the two groups: an acupuncture group (n=11) and wait-list group (n=11). The treatment group received 8 sessions of electroacupuncture over 8 weeks. Twenty points (CV4, CV12, both LR14, GB26, ST25, ST34, ST40, ST36, SP4, SP6, LR3) were selected for needling. The control group did not receive acupuncture treatment during study period and followup were done in the 4th and 8th weeks after randomization in both groups. The primary outcome was body fat computed tomography and the secondary outcomes included blood test (aspartate aminotransferase, alanine transferase, triglyceride, total cholesterol, high density lipoproteincholesterol, low density lipoprotein-cholesterol, blood sugar test, ${\gamma}$-guanosine triphosphate) and body composition test (body mass index, weight, body fat mass, body fat rate, waist hip ratio). Safety was assessed at every visit. Results: There was no significant differences in between the experimental group and control group. There were no adverse events. Conclusions: The results suggest that In patients with NAFLD, electroacupuncture treatment did not induce worsening of liver disease and liver function, but it was no improvement symptoms of fatty liver. Study of herb medicine treatments and other acupuncture therapy of NAFLD are required later.

배암차즈기의 투여가 고형암환자에 미치는 영향을 평가하기 위한 선행적 인체적용시험 (Effect of Salvia plebeia Extract on Patients with Solid Cancer: A Preliminary Clinical Trial Protocol)

  • 이보람;표숙진;김애란;곽은빈;최장기;유화승;정환석;조종관
    • 대한한의학방제학회지
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    • 제30권4호
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    • pp.241-248
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    • 2022
  • Objective : The purpose of this trial is to observe the preliminary effects of Salvia plebeia (SP) extract on quality of life in patients with solid cancer. Methods : This is a prospective, open-label, single-arm, and single-dose clinical trial. Twenty participants who have been diagnosed with solid cancer between the ages of 20 and 65 will be included. All participants will be administered SP granules for 12 weeks. Data will be collected at 4, 8, and 12 weeks after enrollment. The primary outcome is quality of life, using the Korean version of the Functional Assessment Cancer Therapy-General questionnaire. Secondary outcomes include tumor markers in blood tests for each cancer type, soluble programmed death-ligand 1, the percentage of natural killer cells among lymphocytes, ratio of T-helper and T-suppressor cells, ratio of total T, T-helper, T-suppressor, and B cells in lymphocytes, level of C-reactive protein, and tumor size via radiology examination. Safety will be assessed by clinical laboratory tests and monitoring of adverse events. Discussion : This study aims to observe the effects of an oral administration of SP preparations in patients with solid cancer on changes in quality of life and an improvement in immune function. It is expected to provide objective evidence of the effect and safety of SP for patients with solid cancer. Trial registration: KCT0007315 (Clinical Research Information Service)

곰피추출물의 간기능 개선 효과 평가를 위한 12주, 무작위배정, 이중맹검, 위약-대조 인체적용시험 (The Effects of Ecklonia stolonifera Extracts on Improvement of Hepatic Function: a Double-Blind, Randomized, Placebo-Controlled Clinical Study)

  • 김정희;김은진;강다혜;김형빈;장재영;엄애선;김종욱
    • 한국식품위생안전성학회지
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    • 제37권3호
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    • pp.198-205
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    • 2022
  • 본 연구에서는 경증 또는 중등도 간기능 이상 소견자를 대상으로 ESE의 간기능 개선 효과를 평가하기 위해 시험식품군과 대조식품군으로 나누어 단일기관, 위약대조, 무작위배정, 이중눈가림 평행 인체적용시험으로 연구를 수행하였다. 12주간 ESE 420 mg(210 mg/포, 1일 2회)을 함유한 시험식품 또는 대조식품을 섭취하였을 때 ESE의 간 기능 개선 유효성과 안전성을 평가하였다. 유효성 평가 결과, 섭취 후 시험식품군은 대조식품군과 비교하여 ALT, AST, γ-GT 수준이 유의하게 감소하였다. 반면, 지질대사 지표는 두 군간의 의미 있는 차이를 보이지 않았다. 또한, 비알콜성 시험대상자군을 대상으로 분석하였을 때도 ALT 및 AST 수준이 유의하게 감소하였으며 γ-GT의 경우 감소하는 경향성을 보였다. 안전성 평가로서 혈액, 소변, 활력 징후를 검사한 결과 대부분 항목에서 시험식품군과 대조식품군 군간 차이가 없었으며 몇몇 유의성이 나타난 지표도 임상적 의미는 없었다. 따라서 ESE는 간기능 개선에 도움을 줄 수 있을 것으로 보이며 안전한 식품 소재로 판단된다.

고형암에 대한 항암화학요법 치료 중 병발한 결핵의 특성 (Characteristics of Tuberculosis Detected during Chemotherapy for a Solid Tumor)

  • 김덕겸;이세원;강영애;윤영순;유철규;김영환;한성구;심영수;임재준
    • Tuberculosis and Respiratory Diseases
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    • 제58권3호
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    • pp.285-290
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    • 2005
  • 연구 배경 : 면역 기능 저하를 초래하여 결핵의 재활성화에 관여할 것으로 생각되는 주기적인 항암화학요법치료 중인 고형암 환자에서 발생한 결핵의 임상적 특징과 치료 반응을 파악하고자 하였다. 대상 및 방법 : 2000년 1월부터 2004년 7월까지 국내 일개 3차 병원에서 항암화학요법 치료 중에 세균학적으로, 병리학적으로 또는 임상적으로 진단된 결핵 환자 중 기존에 알려진 결핵 재활성화의 위험 요인이 없는 22명을 대상으로 후향적 연구를 시행하였다.. 결 과: 22명의 평균 연령은 56.5세(21세-78세)였고, 남녀비는 3.4:1였다. 폐결핵이 가장 흔한 양상이었으며 (20례, 90.9%), 기저 질환으로 위암 (10례, 45.4%)과 림프종(4례, 18.2%)이 흔하였으며, 폐암, 두경부암, 유방암, 자궁경부암 및 난소암 순이었다. 15례 (68.2%)에서 환자가 흉부 방사선 사진 상 결핵 반흔이 있었다. 간기능이 저하된 1명을 제외한 21명이 isoniazid와 rifampicin을 기본으로 하는 초치료를 시작하였으며, 평균 치료기간은 $9.9{\pm}2.4$개월이었다. 기저 질환으로 사망한 5명을 제외하면 70.6%의 환자가 치료를 완료하였다. 결 론 : 항암화학요법 치료 중에 발생한 결핵의 임상적인 특징 및 치료에 대한 반응은 기존에 보고된 일반 인구에서 발생한 폐결핵의 특성과 크게 다르지 않았다.