• 제목/요약/키워드: Add-on trials

검색결과 19건 처리시간 0.022초

Polyethylene Glycol 처리한 아크릴 운동용 양말의 축열 . 방열성과 수분전달 특성이 착용 성능에 미치는 영향 (The Effect of Thermal Storage/Release and Moisture Transport Properties of Polyethylene Glycol-Treated Acrylic Athletic Socks on the Wear Performance)

  • 조길수;이은주
    • 한국의류학회지
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    • 제19권1호
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    • pp.36-50
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    • 1995
  • The purpose of this study was 1) to estimate the improvement of thermal storage/release and moisture transport properties of PEG-treated acrylic athletic socks and suggest the optimum add-on for PEG treatment, 2) to investigate wear performance of untreated cocks and two kinds of socks treated with PEG of minimum and optimum add-on respectively, and 3) to consider the effect of thermal storage/release and moisture transport properties of PEG- treated socks on the wear performance and the subjective comfort zone. Thermal activities of specimens treated by PDC were evaluated on a DSC by measuring the heat of fusion on heating and the heat of crystallization on cooling. Moisture regain, absorption speed, wickability, water retenti on value, and water-vapor permeability were measured. In the wear trials that the subjects performed a subsequent exercise protocol wearing three differently treated socks in a conditioned environment ($14\pm2^{\circ}C$, 65$\pm$2% R.H.), microclimate temperature and humidity, and subjective wear sensations including thermal sensation, wettedness, softness, fit, and overall comfort were obtained. PEC-treated specimens with more than 20% add-on showed thermal storage on heating and thermal release on cooling by a DSC and the heat contents of treated ones were generally proportional to the add-ons. Moisture transport properties were highly improved after PEG treatment and increased rapidly with increasing add-on. The tendencies were, however, relaxed above 50% add-on and the treated knits were much stiffer above that add-on. In the wear trials of untreated, PEG add-on 20%, and 50% acrylic socks, the changes of microclimate temperature of 50% socks were significantly less than that of 20% socks. PEG add-on 50% socks showed significantly less changes of microclimate humidity than other two kinds of socks. Three kinds of socks showed significant differences in overall comfort and add-on 50% socks were accepted more comfortable than other two kinds of socks. Comfort zone of foot was extended after PEG treatment on socks and it implied that the subjects wearing PEG- treated socks felt comfortable in wider ranges of microclimate temperature and humidity.

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2×k 교차설계법에서 생물학적 동등성 추가시험의 통계적 절차 (Statistical procedures of add-on trials for bioequivalence in 2×k crossover designs)

  • 우화형;박상규
    • Journal of the Korean Data and Information Science Society
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    • 제25권6호
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    • pp.1181-1193
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    • 2014
  • 현재 식품의약품안전처에서는 2008년 7월부터 $2{\times}2$ 교차설계법으로 수행된 제제간의 생물학적 동등성 입증이 실패했을 때 1회에 한하여 추가시험을 허용하고 있다. 하지만 최근 생체이용률의 변동계수가 30% 이상인 고변동성 제제가 많이 등장하면서 $2{\times}2$ 교차설계법에 의한 생물학적 동등성 시험수행에 지나치게 많은 피험자가 소요되면서 그 대안으로 $2{\times}4$ 혹은 $2{\times}3$ 교차설계법을 활용해야 하는 필요성이 증대되고 있다. 본 연구에서는 $2{\times}4$ 혹은 $2{\times}3$ 교차설계법에 기반한 제제의 생물학적 동등성 평가의 추가시험에 대한 통계적 절차를 제안하고 논의하고자 한다.

생물학적 동등성 시험에서 추가시험의 일관성 검정에 대한 소고 (Some Remarks on Consistency Test of Add-on Test in Bioequivalence Trials)

  • 하명호;박상규
    • Communications for Statistical Applications and Methods
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    • 제19권1호
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    • pp.47-55
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    • 2012
  • 식품의약품안전청에서는 제제간의 생물학적 동등성의 입증이 실패했을 경우 추가시험을 허용하는 시험 기준을 2008년 7월부터 시행하고 있다. 생물학적 동등성 시험의 추가시험규정은 원시험에서의 동등성 평가가 불충분한 시험 예수 때문에 실패했을 때 별도의 재시험 시험계획서를 제출하지 않고 피험자수를 증가시켜 다시 시험하여 제제간의 동등성을 평가할 수 있는 근거를 마련한 점에 긍정적이다. 하지만 최근 추가시험의 규정에 따라 군당 12명 이상의 피험자를 사용했을 경우 오히려 추가시험의 일관성 검정 규정을 만족하지 못하여 추가시험이 실패되는 경우가 자주 발생하고 있어 추가시험규정에 대한 불만이 고조되고 있다. 본 연구에서는 이러한 상황이 발생되는 통계적 원인을 살펴보고 현 기준을 일본 규정처럼 조금 더 일반화하게 되면 추가시험을 더 폭넓게 사용할 수 있는 것을 제안하고자 한다.

전파환경분석을 통한 방향탐지기 최적배치에 관한 연구 (Optimal Disposition of Direction Finder using EM Wave Propagation Analysis)

  • 양종원;최준호;권도백;강희석;박철순
    • 한국군사과학기술학회지
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    • 제10권2호
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    • pp.170-179
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    • 2007
  • This paper introduces the optimal disposition of direction finder using EM(Electro-magnetic) wave propagation analysis which is based on LR(Longley-Rice) propagation model and the characteristics of direction finder, emitter and terrain. Initial model is simulated and modified to minimize propagation error as a result of the field trials. Proposed analysis used line-of-sight analysis and mountain-top extraction algorithm to optimize the disposition in the assigned area and the result can be displayed in the 3D map in order of the percentage coverage for direction finding possibility area.

한약제제 무작위 대조군 연구에서 대조군 설계의 문제점과 대안 (Problems and Countermeasures of Control Group Design in Randomized Controlled Trials of Herbal Medicine)

  • 윤영희;최인화
    • 한방안이비인후피부과학회지
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    • 제21권2호
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    • pp.94-101
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    • 2008
  • Objectives : To discuss the types of control groups in randomized controlled trials (RCTs) of herbal medicine, and to provide suggestions for improving the design of control group in future clinical trials. Methods : We reviewed the 8 articles about clinical trial design of Chinese herbal preparation which were published from 2005 through 2008. We selected those articles from CNKI(中國知識基礎施設工程(http://www.cnki.net)). Results : It is necessary to have control group in randomized controlled trials(RCTs) of Korean herbal preparation. But there are problems in the selection of appropriate control group drug. This paper lists several problems about the choice of control drug and puts forward some proposals and countermeasures. There are problems such as ethics and manufacturing matching placebo and positive control herbal drug. Conclusion : To improve the quality of control group design, we introduce standard drug plus placebo drug method and add-on research for placebo control group design, double dummy technique, using negative control drug or composite control drug for active control group design.

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건선 환자에서 아시트레틴 치료에 추가한 한방 약욕 효과 : 체계적 문헌 고찰과 메타 분석 (Add-on Effect of Herbal Bath Combined with Acitretin Treatment in Patients with Psoriasis : Systemic Review and Meta-analysis)

  • 전서연;박수진;이지은;김규석
    • 한방안이비인후피부과학회지
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    • 제36권3호
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    • pp.74-98
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    • 2023
  • Objectives : This study aims to evaluate the add-on effect of herbal bath combined with acitretin in patients with psoriasis. Methods : We searched randomized controlled trials(RCTs) reporting the effect of herbal bath and acitretin combined treatment for psoriasis in 10 electronic databases from their inception to January 2023. Study collection, data extraction, and risk of bias assessment were performed by two independent researchers. Data synthesis and risk of bias evaluation was conducted using Revman 5.4. Results : Ten RCTs with 1,008 subjects were included. Herbal bath and acitretin combined treatment group showed higher average total effective rate than acitretin alone group(RR 1.39; 95% CI: 1.15-1.68, P=0.0006, I2 =0%). Herbal bath and additional treatments such as phototherapy(NB-UVB) and oral herbal medicine, combined with acitretin group also showed higher average total effective rate than acitretin alone group(RR 1.81; 95% CI: 1.47-2.22, P<0.00001, I2 =43%). Herbal bath and phototherapy(NB-UVB) combined with acitretin group also showed higher average total effective rate than acitretin alone group(RR 1.51; 95% CI: 1.18-1.93, P=0.0009, I2 =0%). The overall risk of bias of the included studies was unclear or of high risks. Conclusions : This review showed that the add-on of herbal bath combined with acitretin treatment could be more effective than acitretin alone treatment in patients with psoriasis. However, because of few included studies, heterogeneity between studies, and insufficient quality of included studies, further well-designed RCTs are needed to confirm the add-on effect of herbal bath on psoriasis.

Low-Level Laser Therapy including Laser Acupuncture for Non-Specific Chronic Low Back Pain: Systematic Review and Meta-Analysis

  • Yeum, Hyewon;Hong, Yejin;Nam, Dongwoo
    • Journal of Acupuncture Research
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    • 제38권1호
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    • pp.8-19
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    • 2021
  • Low-level laser therapy including laser acupuncture (LLLT/LA) has been widely used for non-specific chronic low back pain (NCLBP). However, there is no critically appraised evidence of its potential benefits. This study aimed to evaluate the effectiveness of LLLT/LA for NCLBP. There were 12 databases (MEDLINE, CENTRAL, EMBASE, KoreaMed, KMBASE, KISS, NDSL, KISTI, OASIS, CNKI, CiNII, J-stage) searched for randomized controlled trials using LLLT/LA for NCLBP up until June 2019. The primary outcome was pain intensity and functional status/disability due to NCLBP. A random-effects meta-analysis was conducted on 20 studies involving 1,323 participants. LLLT/LA showed a significant positive effect on pain relief scores compared with sham treatments (SMD -0.51, 95% CI: -0.88 to -0.13; χ2 = 31.12, I2 = 74%). Alone, the therapy showed a significant positive effect on function/disability scores (30 participants, MD -11.90, 95% CI: -17.37 to -6.43). As an add-on treatment, it showed a significant positive effect on pain relief (80 participants, MD -5.10, 95% CI: -9.31 to -0.88; χ2 = 28.99, I2 = 97%) and improved function/disability scores (120 participants, MD 5.44, 95% CI: 2.19 to 8.68; χ2 = 4.07, I2 = 75%). Among 20 studies, 9 studies reported no adverse events and 1 study reported mild adverse events. LLLT/LA may be an alternative or add-on treatment for NCLBP.

항고혈압 약물 3종 복합제에 대한 선진 외국의 임상자료 심사사례 비교 (Comparison of Clinical Development and Evaluation of Triple Antihypertensive Therapy in Advanced Foreign Countries)

  • 왕소영;손수정;엄정윤;임화경;임숙;강승호;이선희
    • 한국임상약학회지
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    • 제23권3호
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    • pp.239-247
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    • 2013
  • Background: Fixed drug combinations are formulations containing two or more active ingredients in a single dosage form. Such combination therapies are commonly applied to improve efficacy, reduce adverse events and replace co-administration, etc. National and international guidelines for hypertension treatment recommend addition of other classes of antihypertensive drugs rather than incremental dose of mono-therapy, when blood pressure is not adequately controlled. Thus, many dual combinations of antihypertensive drugs have been approved and pharmaceutical companies are recently interested in developing antihypertensive triple combinations. Clinical trial designs for the fixed combinations are various depending on the target patients, dosage and clinical endpoints. Thereby, further discussions for the clinical trials of antihypertensive triple therapies are required regarding the indication claimed. Conclusion: This article provides a review for the assessment of the label and medical reports of the clinical trials on antihypertensive triple therapies in advanced foreign countries.

Effectiveness of Acupuncture and Acupotomy for Trigger Finger: A Systematic Review and Meta-Analysis

  • Hae-Won Hong;Myung-In Jeong;Hyun-Il Jo;Sun-Ho Lee;Ka-Hyun Kim;Sung-Won Choi;Jae-Won Park;Ji-Su Ha
    • Journal of Acupuncture Research
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    • 제40권2호
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    • pp.111-128
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    • 2023
  • Trigger finger is a common cause of hand disability that results in finger catching, clicking, or locking. Conventional treatment options such as medication, injection, and surgery have limitations. Studies have indicated that acupuncture and acupotomy can be effective in treating trigger finger. However, no review regarding these treatment modalities has been published yet. This review included randomized controlled trials published until January 2023, investigating acupuncture-related interventions. The primary outcomes of interest included the effectiveness rate (ER) and pain intensity, measured using a visual analog scale (VAS) and Numerical Rating Scale (NRS), and secondary outcomes were the Quinnell grade (QG) and recurrence rate (RR). Adverse events (AEs) have also been reported wherever available. Overall, 19 studies were included, and results demonstrated that arcedge acupuncture improved the ER and QG and reduced NRS, and acupuncture was effective in reducing VAS. Compared with conventional surgery, acupotomy alone improved the ER and QG and lowered VAS and RR, with relatively fewer AEs. Acupotomy add-on treatment was more effective than conventional treatment; however, careful interpretation is needed for VAS. Acupotomy add-on treatment was more effective than acupotomy alone. However, the overall results must be interpreted with caution because of study quality, small sample size, and heterogeneity of the results.

고위험군 가와사끼병에서 스테로이드 추가 요법의 효과 (Corticosteroids Add-on Therapy in the Acute Phase of Kawasaki Disease)

  • 강선미;문은경;인수미;길홍량
    • Clinical and Experimental Pediatrics
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    • 제45권12호
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    • pp.1571-1576
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    • 2002
  • 목 적: 최근 들어 가와사끼병 치료에서 고전적인 치료(정맥 내 감마 글로불린+아스피린) 이외에 과거에 금기시 되었던 스테로이드 병용 요법의 다양한 임상적 결과가 보고되고 있어 가와사끼병 고위험군(Harada score 4점 이상)에서 스테로이드 추가 요법의 임상적 효과를 평가 하고자 하였다. 방 법: 1996년부터 2001년까지 충남대학교병원에서 가와사끼병으로 진단된 96명을 대상으로 급성기의 치료 방법에 따라 3군으로 나누어 비교하였다. 가와사끼병 급성기에 A군은 아스피린(100 mg/kg/day)과 정맥내 감마 글로불린 2 g/kg 1회; B군은 아스피린(100 mg/kg/day)과 정맥내 감마 글로불린 1 g/kg 1회; C군은 B군에 prednisolone(2 mg/kg/day)을 추가 하였고 2주간에 걸쳐 점차 용량을 감소하여 중단하였으며, 재치료시에는 methyl-prednisolone 대용량 요법을 사용하였다. 모든 군에서 급성기 이후 8주간 저용량 아스피린을 사용하였다. 임상적, 심혈관계, 및 혈액학적 평가는 급성기, 급성기 직후, 및 아급성기인 치료 8주 후 시행하였다. 결 과 : 관상 동맥 이상 빈도와 혈액학적 이상 정도는 세 치료군에 유의한 차이는 없었으나 치료 후 해열까지의 기간 및 재치료율에 있어서는 스테로이드 추가 요법 군에서 유의한 감소를 보였다. 결 론 : 스테로이드 추가 요법은 IVGG 단일요법과 비교해 볼 때 관상동맥 질환의 발생, 입원기간 등에서 동등한 치료 효과를 보이며, 해열기간, 재치료율 등에 유의한 감소를 보여 가와사끼병 고위험군에 대한 일차적인 치료법으로 고려될 수 있다.