• 제목/요약/키워드: blinding

검색결과 111건 처리시간 0.027초

갱년 및 폐경 후 여성의 안면홍조에 대한 침 치료 다기관 임상연구 : 수행보고 및 방법론적 교훈 (Methodologic Lessons Learned from Multicenter, Randomized, Controlled Clinical Trial of Acupuncture for Hot Flashes in Peri- and Postmenopausal Women)

  • 김건형;김동일;황덕상;이진무;김형준;윤현민;정희정;강경원;이명수;최선미
    • 대한한방부인과학회지
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    • 제23권1호
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    • pp.42-52
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    • 2010
  • Purpose: This report aims to administer methodologic issues around recently conducted multicenter study for evaluating the effects of acupuncture on menopusal hot flashes and discuss practical issues for further implementation of acupuncture clinical trial for hot flashes. Methods: Study process were mentioned, and issues related to avoiding risk of bias, designing appropriate control group, optimal outcome measurement, potential different effects of menopausal status on study outcomes, and suggestions for developing future clinical trials are discussed. Results: Shortcomings of our multicenter study include lack of allocation concealment and assessor blinding, subjective outcome measurement, short-term follow-up, and fixed acupuncture regimen despite pragmatic purpose of this study. Improving trial design, using objective or validated outcomes, assessing long-term effects of acupuncture, and individualizing acupuncture regimen are needed in future clinical trials. Conclusion: We expect these practical discussions to enable researchers to plan and develop future well-designed clinical trials for evaluating the effects of acupuncture on hot flashes or other women's health issues.

말초성 안면신경마비에 대한 약침병행치료 효능의 임상적 고찰 - 자하거 약침과 Sweet Bee Venom을 중심으로 - (The Clinical Research of the Effectiveness of Pharmacopuncture Complex Therapy on Peripheral Facial Paralysis - Hominis Placenta Pharmacopuncture Therapy and Sweet Bee Venom Therapy -)

  • 박재흥;장선희;이창환;구지영;전대성;안창범;김철홍;송춘호;윤현민
    • Journal of Acupuncture Research
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    • 제27권2호
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    • pp.79-87
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    • 2010
  • Objectives : The aim of this study is to investigate the effect of Hominis Placenta pharmacopuncture therapy and sweet bee venom therapy on peripheral facial paralysis. Methods : Clinical studies were done 36 patients who were treated peripheral facial paralysis to Dept. of Acupuncture and Moxibusition, of Oriental Medicine Dong-Eui University from June 15, 2009 to January 5, 2010. Subjects were randomly divided into 2 groups. : Hominis Placenta Pharmacopuncture treated group (group A, n=18), sweet bee venom treated group (group B, n=18). In group A, we treated patients with dry needle acupuncture and Hominis Placenta pharmacopuncture therapy. In group B, we treated patients with dry needle acupuncture and sweet bee venom therapy. All process of treatment were performed by double blinding method. To investigate the effectiveness of treatment applied for two groups, we used Yanagihara's unweighed grading system at before treatment, after 1week, 2weeks, 3weeks and 4weeks of treatment. Results : The Yanagihara's scores of group B were higher than those of group A, but not statistically significant. The improvement indexs of group A and group B were different, but not statistically significant. Conclusions : There were no significant differences statistically between Hominis Placenta pharmacopuncture therapy and sweet bee venom therapy on peripheral facial paralysis.

초기 말초성 안면신경마비에 대한 단무지 안추 신전법 병행 치료 효능의 임상적 고찰 (The Clinical Research of the Effectiveness of "Danmuji Anchu Traction technique" on Acute Peripheral Facial Paralysis)

  • 박재흥;이창환;이유환;권기순;윤현민;전대성;한민석
    • 척추신경추나의학회지
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    • 제6권1호
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    • pp.43-52
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    • 2011
  • Objectives : The aim of this study is to investigate the effectiveness of combining "Danmuji Anchu Traction technique" on acute peripheral facial paralysis. Methods : Clinical studies were done 36 patients who were treated acute peripheral facial paralysis to Dept. of Acupuncture and Moxibustion, of Oriental Medicine Hospital Dongeui University from July 10, 2009 to September 15, 2010. subjects were randomly divided into 2 groups. : Complex oriental medical treatment without "Danmuji Anchu Traction technique" treated group (Group A, n=18), Complex oriental medical treatment with "Danmuji Anchu Traction technique" treated group (Group B, n=18). All process of treatment were performed by double blinding method. To compare the effectiveness of treatment applied for two groups, we used Yanagihara's unweighed grading system at before treatment, after 1week and 2weeks of treatment. Results: The Yanagihara's Scores of Group B and Improvement Indexes of Group B were higher than those of Group A, and showed significant difference statistically. "Danmuji Anchu Traction technique" can be available for relieving symptoms related with Acute Peripheral Facial Paralysis. And there were significant differences statistically between Complex oriental medical treatment without "Danmuji Anchu Traction technique" and Complex oriental medical treatment with "Danmuji Anchu Traction technique" on Acute Peripheral Facial Paralysis. Conclusions: These results suggested that "Danmuji Anchu Traction technique" effected for Acute Peripheral Facial Paralysis.

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Evaluation of Ascorbic Acid Treatment in Clinical and Subclinical Mastitis of Indian Dairy Cows

  • Naresh, Ram;Dwivedi, S.K.;Swarup, D.;Patra, R.C.
    • Asian-Australasian Journal of Animal Sciences
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    • 제15권6호
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    • pp.905-911
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    • 2002
  • A study was carried out to assess the therapeutic effect of ascorbic acid in mastitis of dairy cows. The herd with a population of 250-275 lactating cows was screened for clinical and subclinical mastitis for a period of 5 months. Based on inclusion and exclusion criteria, eighteen animals each with clinical and subclinical mastitis in one quarter only were selected as study population. Twelve cows (group A) with normal udder and health were also selected as a healthy control. Clinical mastitis cows were grouped as B (n=12) and C (n=6). Cows of group B were treated with ascorbic acid at 25 mg/kg, subcutaneously for 5 consecutive days and intramammary infusion (Ampicillin sodium 75 mg and Cloxacillin sodium 200 mg/infusion) based on antibiotic sensitivity test, till complete recovery. Group C cows received only intramammary infusion till the complete recovery. Eighteen subclinical mastitis cows were divided in group D (n=12) and E (n=6). Cows of group D were treated with ascorbic acid at 25 mg/kg subcutaneously for 5 consecutive days while group E did not receive any treatment. California mastitis test (CMT), somatic cell count (SCC), physical changes of udder and milk were used to diagnose and classify the mastitis. Evaluation of the therapy was based on CMT score and physical changes of udder and milk. Sample size calculation was also performed but was not followed for control groups due to scarcity of cases. Adequate blinding was done when and where required to avoid the biases. Confounding variables like herd, age of the cow, stage of the lactation, season and geographical region were duly considered and adequate blocking was followed. Ascorbic acid was administered in clinical and subclinical cases even after cure considering its immunostimulatory and healing inducing effects. The recovery rate was faster in cases of clinical mastitis treated with ascorbic acid along with an intramammary infusion (group B) than the quarters of group C cows. Quarter wise the average duration/number (3.16${\pm}$0.11 days) of antimicrobial intramammary infusion was significantly (p<0.01) less in group B than that of average duration/number (5.33${\pm}$0.20 days) of group C. Subclinical mastitis cows treated with ascorbic acid showed 83.33% recovery while 16.77% did not respond to treatment till last day of study. Cows of group E (untreated) did not recovered from the mastitis. Subjective parameters viz. swelling, pain reflex of udder and physical changes in milk from quarter of ascorbic acid treated cows (group B) disappeared earlier than that of group C cows. It is concluded from this study that the ascorbic acid might be useful as an adjunct in case of clinical mastitis to get quick recovery with less number of intramammary infusions. High recovery rate in subclinical mastitis quarters of group D cows is appreciable and opens a new avenue to conduct further trials in a larger population in various field conditions. However, the pharmacology of ascorbic acid with particular reference to health of mammary gland needs to be investigated.

실제 환경을 고려한 천장텍스의 석면안정화제 처리 연구 (A Study of Asbestos Stabilizer Treatment Considering the Actual Environment of Ceiling Materials)

  • 신현규;최용규;전보람;하주연;선일식;박화미
    • 한국산업보건학회지
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    • 제26권2호
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    • pp.139-146
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    • 2016
  • Objectives: This study aimed to confirm the optimal processing conditions of the asbestos stabilizer by considering various actual environments at the time of stabilization treatment of the ceiling materials containing asbestos with asbestos stabilizer. Methods: The anti-scattering performances of the asbestos stabilizer were confirmed by considering the method and quantity of the asbestos stabilizer treated, comparing the loss weight by measuring the weight of ceiling materials prior to and after having treated 30, 50, 100, 200, and 400 of stabilizer using the brush and spray. The effects of backside dust and steel frame structure on the performances of the stabilizer was also confirmed by comparing samples with and without the dust on the rear surface removed by wiping the ceiling material specimens and the blinding treatment simulated by using tape. Results: The asbestos stabilization treatment using the brush method in comparison with the use of a spray has reduced stabilizer loss, resulting in better anti-scattering performance. In addition, the stabilizer loss is increased with increasing treatment quantity; as a result, treating a larger quantity of stabilizer does not improve the performance. For the conditions related to ceiling materials, the anti-scattering performance is enhanced by removing the backside dust and spreading the stabilizer evenly on the masking portion by steel frame structures. Conclusions: Based on these results, it is determined that the appropriate choice of the tool used for the treatment of the asbestos stabilizer and the appropriate quantity of asbestos stabilizer were needed at the time of actual stabilization processing of the ceiling materials containing asbestos. Moreover, this study confirmed that preliminary processing and verification of the structure at which the ceiling materials are installed can enhance the effectiveness of prevention of the scattering of asbestos into the air.

화병 진료지침 개발을 위한 한약 임상시험 방법론 연구 (The Systematic Review of Clincal Trial(s) Intervening Traditional Korean Herbal Medicine: Extension of Developing Clinical Guideline for Hwa-byung)

  • 김석환;박보라;최금애;임현주;이상룡;정대규;김락형;김태헌;김경옥;정인철
    • 동의신경정신과학회지
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    • 제20권2호
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    • pp.163-176
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    • 2009
  • Objectives : To address most probable and suitable method for designing clinical trial intervening Traditional Korean Herbal Medicine on hwa-byung. Study Design : A systematic review of research studies of complementary and/or alternative medical(CAM) treatment of depression, and of domestic clinical trials of Traditional Korean Medicine, and of Chinese clinical trials of Traditional Chinese Medicine. Methods : Randomized, controlled trials(RCTs) of treatment of depression intervening herbal medicine were searched through MEDLINE, Cochrane Library, and CNKI databases. Also, domestic RCTs intervening Traditional Korean Herbal Medicine were searched through Korean Traditional Knowledge Portal and Korean studies Information Service System(KISS). Studies were evaluated using Iadad scale and self-designed tool for this study. Results : Thirty four RCT studies( 10 from MEDLINE, 16 from CNKI, 8 domestic studies) of herbal medicine met inclusion criteria. Mean Jadad score of studies published in English was 2.8${\pm}$0.79, in Chinese 1.94${\pm}$0.77, and in Korean 2.75${\pm}$0.71. Twenty one percent of studies included pattern differentiation in their inclusion criteria. Twenty nine percent of studies used combined treatment of herbal and conventional medicine. Among studies on depression, 9% included Complementary Medical assessing tools. Conclusions : There is shortage of domestic clinical trial involving herbal medicine. In China, studies tend to focus on investigating effect of Combined treatment of herbal and conventional medicine on depression. Clinical trial(s) of hwa-byung should provide good internal validity by describing methodology for randomization, double-blinding, and attrition. Also, specific guideline for clinical trial, including Traditional Korean Medical aspects across inclusion criteria, and assessing tools is needed.

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만성요통환자에 대한 Bee Venom과 Sweet Bee Venom의 치료효능 비교 연구 (The comparison of Effectiveness between Bee Venom and Sweet Bee Venom Therapy on Chronic Lower Back Pain.)

  • 김재홍;장선희;윤현민;안창범;장경전;김철홍;송춘호;최하나
    • 대한약침학회지
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    • 제11권4호
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    • pp.15-24
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    • 2008
  • Objective The aim of this study is to investigate if Sweet Bee Venom(SBV) Therapy has the equal effect in comparison with Bee Venom (BV) Therapy on Chronic Lower Back Pain. Methods Clinical studies were conducted to 39 patients who were treated Chronic Lower Back Pain in Dept. of Acupuncture and Moxibustion, Dongeui University from March 1 to June 30, 2008. Subjects were randomly devided into 2 groups : BV treated group(Group A, n=19), SBV treated group(Group B, n=20) In BV treated group(Group A), we treated patients with dry needle acupuncture and BV Therapy. In SBV treated group(Group B), we treated patients with dry needle acupuncture and SBV Therapy. All process of treatment were performed by double blinding method. 1. To estimate the efficacy of venom in controlling pain, we have checked Visual Analog Scale(VAS). 2. For evaluating functional changes of patients, we have checked Oswestry Lower Back Disability Questionnaire(ODI). 3. To estimate Itching which is the most prominent symptom of allergic reaction, we have checked Visual Analog Scale(VAS). Results 1. In controlling pain, the results of BV treated group(Group A) is more effective than that of SBV treated group(Group B). 2. In promoting function, the results of BV treated group (Group A) is more effective than that of SBV treated group(Group B). 3. In controlling itching, the results of SBV treated group(Group B) is more effective than that of BV treated group(Group A). Conclusions According to the study, SBV Therapy shows more effective result than BV Therapy in controlling itching. But BV Therapy is more effective than SBV Therapy in controlling pain and promoting function.

Is the Mixed Use of Magnetic Resonance Enterography and Computed Tomography Enterography Adequate for Routine Periodic Follow-Up of Bowel Inflammation in Patients with Crohn's Disease?

  • Jiyeon Ha;Seong Ho Park;Jung Hee Son;Ji Hun Kang;Byong Duk Ye;So Hyun Park;Bohyun Kim;Sang Hyun Choi;Sang Hyoung Park;Suk-Kyun Yang
    • Korean Journal of Radiology
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    • 제23권1호
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    • pp.30-41
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    • 2022
  • Objective: Computed tomography enterography (CTE) and magnetic resonance enterography (MRE) are considered substitutes for each other for evaluating Crohn's disease (CD). However, the adequacy of mixing them for routine periodic follow-up for CD has not been established. This study aimed to compare MRE alone with the mixed use of CTE and MRE for the periodic follow-up of small bowel inflammation in patients with CD. Materials and Methods: We retrospectively compared two non-randomized groups, each comprising 96 patients with CD. One group underwent CTE and MRE (MRE followed by CTE or vice versa) for the follow-up of CD (interval, 13-27 months [median, 22 months]), and the other group underwent MRE alone (interval, 15-26 months [median, 21 months]). However, these two groups were similar in clinical characteristics. Three independent readers from three different institutions determined whether inflammation had decreased, remained unchanged, or increased within the entire small bowel and the terminal ileum based on sequential enterography of the patients after appropriate blinding. We compared the two groups for inter-reader agreement and accuracy (terminal ileum only) using endoscopy as the reference standard for enterographic interpretation. Results: The inter-reader agreement was greater in the MRE alone group for the entire small bowel (intraclass correlation coefficient [ICC]: 0.683 vs. 0.473; p = 0.005) and the terminal ileum (ICC: 0.656 vs. 0.490; p = 0.030). The interpretation accuracy was higher in the MRE alone group without statistical significance (70.9%-74.5% vs. 57.9%-64.9% in individual readers; adjusted odds ratio = 3.21; p = 0.077). Conclusion: The mixed use of CTE and MRE was inferior to MRE alone in terms of inter-reader reliability and could probably be less accurate than MRE alone for routine monitoring of small bowel inflammation in patients with CD. Therefore, the consistent use of MRE is favored for this purpose.

QPS 프로그램에서 Myocardial extract 적용에 따른 임상적 유용성 평가 (The Evaluation of Clinical Usefulness on Application of Myocardial Extract in Quantitative Perfusion SPECT)

  • 윤종준;임영현;이무석;송현석;정지욱;박세윤;김재환;김정욱
    • 핵의학기술
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    • 제15권2호
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    • pp.88-93
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    • 2011
  • 게이트 심근관류 SPECT의 정량적 평가를 위해 사용되는 자동화된 정량화 소프트웨어(AutoQUANT)는 획득 자료 처리과정에 따라 측정치 오차가 발생할 것으로 예상된다. 동일한 환자를 대상으로 다른 조건의 변화 없이 QPS (Quantitative Perfusion SPECT) 프로그램에서 Myocardial extract 전후에 따른 정량적 지표를 구하여 평가하고자 한다. 2010년 6월부터 2010년 12월까지 부산대학교병원 핵의학과에서 Tc-99m MIBI 게이트 심근관류 SPECT를 시행한 환자 중 51명(남:여=34:17, 평균나이 $66.45{\pm}9.92$)을 대상으로 하였다. 심근의 단축단면상을 이용하여 원형 관심영역은 배후영역을 제외한 심근영역에서 설정한 자료를 획득하였다. AutoQUANT를 이용한 QPS 프로그램에서 일과성허혈확장(Transient Ischemic Dilation, TID), 부하기 관류결손 범위율의 합(Extent of Stress Defect, ESD)과 부하기 관류점수 합(Summed Stress Score, SSS)을 구하여 비교 분석하였다. QPS 프로그램에서 Myocardial extract 적용 전과 적용 후 정량적 지표의 상관계수는 TID (r=0.98), ESD (r=0.99), SSS (r=0.99) 모두 좋은 상관관계를 보였다. 95% 신뢰수준에서 TID (p=0.78), ESD (p=0.31), SSS (p=0.19) 모두 통계적으로 유의한 차이가 없었다. 육안분석에서는 판독에 영향을 줄 수 있을 만한 영상의 차이는 발견할 수 없었다. QPS 프로그램에서 Myocardial extract 적용 전과 적용 후 정량적 지표(TID, ESD, SSS)는 모두 좋은 상관관계가 있다는 것을 확인할 수 있었고, 통계적으로 유의한 차이를 보이지 않았다. Myocardial extract 영상처리기법이 비교적 간단하여 심근관류 SPECT 영상의 질을 올릴 수 있을 것으로 사료된다.

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흉부 디지털촬영에서 입사표면선량 예측 (Prediction of Entrance Surface Dose in Chest Digital Radiography)

  • 이원정;정순철
    • 한국방사선학회논문지
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    • 제13권4호
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    • pp.573-579
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    • 2019
  • 환자 피폭선량 관리에 입사표면선량(ESD, entrance surface dose)이 국내외적으로 진단참고준위(국내 흉부촬영 $340{\mu}Gy$)로 사용되고 있지만, ESD측정을 위해서는 선량계가 필요하다. 하지만 대부분 병의원에서는 선량계가 구비되어 있지 않고 정기검사 시 전문 업체 측정에 의해 확인할 수 있다. 따라서 본 연구에서는 흉부 디지털촬영에서 사용자가 쉽게 ESD를 예측할 수 있는 방법에 대해 알아보았다. 흉부 디지털촬영에서 평판형 디텍터(FP, Flat-panel detector)와 IP (Imaging plate detector)를 대상으로 하였고, ESD는 선량계(XI-Platinum, Unfors, Sweden)를 흉부 팬텀(07-646 Duke QC chest phantom, Supertech, Elkhart, USA)의 중앙 표면에 부착시킨 후, 튜브와 디텍터를 180cm 거리를 유지시켜 각 노출조건 조합(관전압과 노출선량)에서 3회 반복측정한 후 평균값을 얻었다. 흉부 팬텀 영상의 다이콤 헤더 정보에서 FP영상은 선량면적곱(DAP, dose-area product)을 확인하였고, IP영상에서는 노출 지수(EI, exposure index)를 확인하였다. 단순선형회귀분석을 통해 FP촬영에서 DAP로부터, IP촬영에서 EI로부터 ESD를 예측할 수 있는 회귀방정식($y={\alpha}+{\beta}X$, ${\alpha}$=직선의 절편, ${\beta}$=직선의 기울기)을 구하였다. FP가 IP 보다 유의하게 낮은 선량을 보였고($85.7{\mu}Gy$ vs. $124.6{\mu}Gy$, p=0.017), 두 디텍터 모두 ESD와 화질 간에 높은 양의 상관성을 보였다. FP에서 수정된 R 제곱(adjusted R2)은 0.978로 ESD의 변동은 DAP 변동에 의해 97.8%의 높은 설명력을 보였다. 단순 회귀식은 $ESD=0.407+68.810{\times}DAP$ 이었다. 위의 회귀식을 이용하여 국내 권고선량($340{\mu}Gy$)과 같은 DAP를 추정한 결과($DAP=0.021+0.014{\times}340{\mu}Gy$), DAP는 4.781 이었다. IP에서 수정된 R 제곱(adjusted R2)은 0.645로 ESD의 변동은 EI 변동에 의해 64.5%의 설명력을 보였다. 단순 회귀식은 $ESD=-63.339+0.188{\times}EI$ 이었다. 위의 회귀식을 이용하여 국내 권고선량($340{\mu}Gy$)과 같은 EI를 추정한 결과($EI=565.431+3.481{\times}340{\mu}Gy$), EI는 1748.97 이었다. 흉부 디지털 촬영에서는 팍스 워크스테이션 영상의 다이콤 헤더 정보에서 ESD를 사용자가 쉽게 예측할 수 있다.