• Title/Summary/Keyword: randomization

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Radiofrequency Ablation Using a Separable Clustered Electrode for the Treatment of Hepatocellular Carcinomas: A Randomized Controlled Trial of a Dual-Switching Monopolar Mode Versus a Single-Switching Monopolar Mode

  • Jae Won Choi;Jeong Min Lee;Dong Ho Lee;Jung-Hwan Yoon;Yoon Jun Kim;Jeong-Hoon Lee;Su Jong Yu;Eun Ju Cho
    • Korean Journal of Radiology
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    • 제22권2호
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    • pp.179-188
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    • 2021
  • Objective: This study aimed to prospectively compare the efficacy, safety, and mid-term outcomes of dual-switching monopolar (DSM) radiofrequency ablation (RFA) to those of conventional single-switching monopolar (SSM) RFA in the treatment of hepatocellular carcinoma (HCC). Materials and Methods: This single-center, two-arm, parallel-group, randomized controlled study was approved by the Institutional Review Board. Written informed consent was obtained from all patients upon enrollment. A total of 80 patients with 94 HCC nodules were randomized into either the DSM-RFA group or SSM-RFA group in a 1:1 ratio, using a blocked randomization method (block size 2). The primary endpoint was the minimum diameter of the ablation zone per unit time. The secondary endpoints included other technical parameters, complication rate, technique efficacy, and 2-year clinical outcomes. Results: Significantly higher ablation energy per unit time was delivered to the DSM-RFA group than to the SSM-RFA group (1.7 ± 0.2 kcal/min vs. 1.2 ± 0.3 kcal/min; p < 0.001). However, no significant differences were observed between the two groups for the analyzed variables, including primary endpoint, regarding size of the ablation zone and ablation time. Major complication rates were 4.9% in the DSM-RFA group and 2.6% in the SSM-RFA group (p = 1.000). The 2-year local tumor progression (LTP) rates of the HCC nodules treated using DSM-RFA and SSM-RFA were 8.5% and 4.7%, respectively (p = 0.316). The 2-year LTP-free survival rates of patients in the DSM-RFA and SSM-RFA groups were 90.0% and 94.4%, respectively (p = 0.331), and the 2-year recurrence-free survival rates were 54.9% and 75.7%, respectively (p = 0.265). Conclusion: Although DSM-RFA using a separable clustered electrode delivers higher ablation energy than SSM-RFA, its effectiveness failed to show superiority over SSM-RFA in the treatment of HCC.

Pubmed분석을 통한 경추통과 경추 척추증의 임상연구 최신동향 및 평가도구에 관한 고찰 (Review of Research Trends and Evaluation Tools for Clinical Studies of Neck Pain and Cervical Spondylosis : Using the Pubmed Database)

  • 김명관;김영일;김은석;정인철;박양춘;전주현
    • 동의생리병리학회지
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    • 제32권4호
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    • pp.232-246
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    • 2018
  • The purpose of this research is to contribute to clinical researches on neck pain and cervical spondylosis by reviewing the latest research trends and evaluation tools through the analyses of clinical studies on neck pain and cervical spondylosis over the last 5 years. 70 papers satisfying the selection conditions among the RCT papers that had been searched as "neck pain" or "cervical spondylosis" at Pubmed(https://www.ncbi.nlm.nih.gov/pubmed) from March 2011 to February 2016 were targeted. Papers were numbered in order of their publication dates and analyzed by classifying their contents into 1) pain classification, 2) treatment type, 3) treatment duration, 4) treatment time, 5) number of participants, 6) evaluation tools and methods of research, and 7) evaluation duration. 55 papers targeted chronic neck pain, 6 papers acute and subacute neck pain, and 2 papers subacute and chronic neck pain. In comparison by intervention, 43 papers corresponded to physical therapy, 3 papers to acupuncture, 1 to herbal fomentation, 5 to medication, and 18 papers corresponded to multilateral comparisons comparing the efficacy by various interventions. In research period, there were 50 papers based on treatment period, 16 papers based on the number of treatments, and 4 papers based on different periods depending on each group. In treatment duration, the cases from 1 month or more to less than 3 months were most, followed by the cases of less than 1 month, and the cases from 3 months or more to less than 6 months. In treatment frequency, the number of treatments of the treatment group was the same as that of the control group in 51 papers, and many treatments were conducted by the methods of acupuncture, manual therapy, and injection therapy in cases of once or twice of treatments, and physical therapy and electroacupuncture corresponded mainly to the cases from 3 times or more to less than 10 times of treatments, and retrospective observation and exercise programs corresponded mainly to the cases of more than 30 times of treatments. In the number of subjects of the researches, the cases from 50 or more to less than 100 were most, followed by the cases from 20 or more to less than 50. There were 7 evaluation tools cited 10 times or more: VAS, NRS, PPT, NDI, NPQ, CROM, and SF-36. In evaluation period, 37 papers evaluated only during the treatment period, and 33 papers conducted follow-up. In follow-up period, the cases of less than 3 months were most, followed by the cases from 6 months or more to less than 1 year, and the cases from 3 months or more to less than 6 months. When planning clinical researches on cervical pain in the future, appropriate intervention methods, frequency and duration of treatment, period of follow-up, appropriate number of subjects and selection of evaluation tools for objective validity will have to be considered. In addition, randomization, double-blind, etc. will have to be considered for researches with high basis level.

토모테라피의 자동영상정합 분석 (Analysis of Automatic Rigid Image-Registration on Tomotherapy)

  • 김영록;조광환;정재홍;정주영;임광채;김용호;문성권;배선현;민철기;김은석;여승구;서태석;최보영;민정환;안재억
    • 대한방사선기술학회지:방사선기술과학
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    • 제37권1호
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    • pp.37-47
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    • 2014
  • 본 연구는 토모테라피(Accuray Inc, Sunnyvale, CA, USA)의 자동영상정합 과정에서 조정인자에 따른 종축과 회전축의 오차를 분석하였다. 다섯그룹(두부, 경부, 흉부, 복부, 골반부)으로 구분된 총 50명의 치료가 종료된 환자를 대상으로 하였고, 총 500개의 megavoltage computed tomography (MVCT) 영상을 분석하였다. 모의치료에서 kilovoltage computed tomography (kVCT)영상을 얻었고, 치료계획을 위하여 토모테라피 Hi-Art II 치료계획시스템(Accuray Inc, Sunnyvale, CA, USA)을 사용하였다. 매 회 치료 전 자동영상정합 과정을 시행하였고, 종축과 회전축의 오차를 기록하였다. 종축과 회전축의 일치도(adjustments)에서 자동영상정합을 분석하기 위하여 총 아홉 가지 조정인자를 적용하였고, 각 그룹의 계통적(systematic, ${\Sigma}$)과 통계적(random, RMS) 오차에 대하여 종합적 평균오차(overall mean value, M)를 구했다. 각 그룹 간 회전축 일치도의 종합적 평균오차에서 밀도와 해상도에 따른 다양한 조정인자에 의한 차이를 보였다. 밀도와 해상도가 높아짐에 따라 회전축 일치도에서 편차가 작았다. 그러므로, 토모테라피에서 "full-image"모드와 "standard"해상도를 이용한 자동영상정합은 정확한 오차 확인이 가능하고, 환자 재위치잡이(repositionning) 및 보정(correcting)에 도움이 될 것으로 사료된다.

중풍환자(中風患者)의 불면증(不眠症)에 피내침(皮內針)의 유효성(有效性) 및 적응증(適應證) 평가(評價) (The Effect of Intradermal Acupuncture on The Patients suffering from Insomnia after Stroke)

  • 이상호;김은주;김이동;윤상필;이차로;홍진우;정동원;문상관;조기호;김영석
    • 대한한방내과학회지
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    • 제25권1호
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    • pp.138-148
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    • 2004
  • Objective : Insomnia is the disorder of initiation or maintenance in sleeping that results in daytime sleepiness and dysfunction, and it arises from multiple psychological, physiological and environmental factors. A number of stroke patients suffer from insomnia are classified as sleep disorder patients with physical illness. In addition, insomnia may have profound deleterious effects on the natural course of stroke. We are to assess the effectiveness of intradermal acupucture on stroke combined with insomnia. Methods : We recruited hospitalized patients with insomnia after stroke. Then, the subjects were allocated into a treatment group and a control group by randomization. The treatment group received intradermal acupuncture therapy at He-7(神門), EH-6(內關) correctly. However in control group, intradermal acupuncture were just attached to He-7(神門), EH-6(內關) without insertion. Treatment over time at first day and second day a various indexes were repeatedly checked such as sleep latency, total sleep time, sleep quality, condition on awakening, ability of concentration, morning sleepiness, Insomnia Severity Index, and Athens Insomnia Scale. In the second analysis, we divided the treatment group into a response and a non-response group by their response to intradermal acupuncture. With the acupuncture treatment, accompanied symptoms were checked Results : Among thirty two subjects, two of them were dropped out: One complained the pain from needle insertion, and the other underwent the change of his herbal medication. At baseline investigation with the residual 30 subjects, the control and the treatment group were assessed to have an equal comparability. In the treatment group, sleep latency, total sleeping time, a number of awakenings, sleep quality and ability of concentration showed improvement significantly compared with the control group. The non-response Group showed symptoms such as nausea and halitosis, belching and acid regurgitation, abundant expectoration, while Responder Group showed palpitation, oppressed feelings in chest and sleep disorder. Conclusions: The result of this clinical study suggests that the intradermal acupuncture at He-7(神門), EH-6(內關) is one of the effective treatments for the insomnia after stroke.

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기관지 결핵 환자에서 부산피질 스테로이드 투여가 기관지 협착의 완화에 미치는 영향 (The Effect of Corticosteroid on the Treatment of Endobronchial Tuberculosis)

  • 모은경;김호중;김동규;최정은;박명재;현인규;이명구;정기석
    • Tuberculosis and Respiratory Diseases
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    • 제44권2호
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    • pp.409-418
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    • 1997
  • 배 경 : 기관지 결핵은 임상적으로 진단이 쉽지 않아 조기 진단과 적절한 치료가 이루어지지 않았을 경우 기도협착 및 이에 수반된 원위부 폐의 허탈로 합병증을 남길 수 있다. 기관지 협착을 방지 또는 치료하기 위해 부신피질 스테로이드 병행투여되기도하나 3세 이상의 항결핵 화학요법만으로도 기관지 결핵의 치료가 충분하며, 스테로이드 병용군과 비교할 때 차이가 없다는 보고도 나오고 있다. 이에 저자들은 기관지 결핵 환자에서 부신피질 스테로이드 병용 치료의 효과를 증명하기 위해 기관지 협착이 있는 초치료 환자를 대상으로 하여 무작위로 스테로이드 투여군과 비투여군으로 나누어 전향적 연구를 시행하였다. 방 법 : 기관지 내시경을 시행하여 기관지 세척액 항산균 도말과 배양검사, 기관지 병변의 조직검사를 시행하였다. isoniazid 400mg, rifampin 450mg, ethambutol 800mg, pyrazinamide 1500mg을 경구로 투약하고 40mg을 2개월간 병용 투여후 1개월에 걸쳐 감량하였다. 치료 후 2개월째와 9개월째에 기관지 내시경을 시행하여 기관지 결핵병변의 위치, 육안적 분류의 형태, 협착의 정도를 측정하였다. 결 과 : 대상환자는 25명이었으며 이들에서 관찰된 병변은 모두 47병변이 있었다. 이중 부신피질스테로이드 투여 군은 27병변이 있었고 비투여 군운 20병변이 있었다. 스테로이드 투여군에서는 호전이 없었던 경우가 10개 병변이었으며 25%의 호전을 보인 경우가 5개, 50%의 호전을 보인 경우가 3개, 75%의 호전을 보인 경우가 2개병변에서 있었고, 부신피질 스테로이드 투여군에서는 호전이 없었던 경우가 3개 병변이었으며 25%의 호전을 보인 경우가 3개, 50%의 호전을 보인 경우가 9개, 75%의 호전을 보인 경우가 2개 병변에서 있었고, 100%의 호전을 보인 경우도 2개에서 있었다.(p < 0.05) 육안적 분류에 따른 아형별로 살펴보면 부종형인 경우 부신피질 스테로이드 비투여 군에서는 호전이 없었던 경우가 6개 병변이었으며 25%의 호전을 보인 경우가 1개병변에서 있었고, 부신피질 스테로이드 투여군에서는 호전이 없었던 경우가 1개 병변이었으며 25%의 호전을 보인 경우가 2개, 50%의 호전을 보인 경우가 5개에서 었었다.(p<0.05) 결 론 : 기관지 결핵의 육안적 분류상 침윤형의 형태보다는 부종형 기관지결핵의 기관지협착을 완화시키는 데에 부신피질스테로이드의 효과가 있을 것으로 생각되며 향후 적절한 스테로이드 용량 및 투여기간에 대한 연구가 필요할 것으로 사료된다.

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A Randomized Phase III Study of Patients With Advanced Gastric Adenocarcinoma Without Progression After Six Cycles of XELOX (Capecitabine Plus Oxaliplatin) Followed by Capecitabine Maintenance or Clinical Observation

  • Guk Jin Lee;Hyunho Kim;Sung Shim Cho;Hyung Soon Park;Ho Jung An;In Sook Woo;Jae Ho Byun;Ji Hyung Hong;Yoon Ho Ko;Der Sheng Sun;Hye Sung Won;Jong Youl Jin;Ji Chan Park ;In-Ho Kim;Sang Young Roh;Byoung Yong Shim
    • Journal of Gastric Cancer
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    • 제23권2호
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    • pp.315-327
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    • 2023
  • Purpose: Oxaliplatin, a component of the capecitabine plus oxaliplatin (XELOX) regimen, has a more favorable toxicity profile than cisplatin in patients with advanced gastric cancer (GC). However, oxaliplatin can induce sensory neuropathy and cumulative, dose-related toxicities. Thus, the capecitabine maintenance regimen may achieve the maximum treatment effect while reducing the cumulative neurotoxicity of oxaliplatin. This study aimed to compare the survival of patients with advanced GC between capecitabine maintenance and observation after 1st line XELOX chemotherapy. Materials and Methods: Sixty-three patients treated with six cycles of XELOX for advanced GC in six hospitals of the Catholic University of Korea were randomized 1:1 to receive capecitabine maintenance or observation. The primary endpoint was progression-free survival (PFS), analyzed using a two-sided log-rank test stratified at a 5% significance level. Results: Between 2015 and 2020, 32 and 31 patients were randomized into the maintenance and observation groups, respectively. After randomization, the median number of capecitabine maintenance cycles was 6. The PFS was significantly higher in the maintenance group than the observation group (6.3 vs. 4.1 months, P=0.010). Overall survival was not significantly different between the 2 groups (18.2 vs. 16.5 months, P=0.624). Toxicities, such as hand-foot syndrome, were reported in some maintenance group patients. Maintenance treatment was a significant factor associated with PFS in multivariate analysis (hazard ratio, 0.472; 95% confidence interval, 0.250-0.890; P=0.020). Conclusions: After 6 cycles of XELOX chemotherapy, capecitabine maintenance significantly prolonged PFS compared with observation, and toxicity was manageable. Maintenance treatment was a significant prognostic factor associated with PFS.