• 제목/요약/키워드: Clinical Trial Design

검색결과 275건 처리시간 0.039초

한방병원에 내원한 파킨슨 증후군 환자 증례군 보고 (Case Series of Patients with Parkinson Syndrome visited in Oriental Medicine Hospital)

  • 이승엽;김미영;김영지;최원우;민인규;선종주;홍진우;나병조;정우상;문상관;조기호;김영석
    • 대한중풍순환신경학회지
    • /
    • 제8권1호
    • /
    • pp.34-39
    • /
    • 2007
  • Objective : To report cases of patients with Parkinson's syndrome. Design : Case-series Patients and methods : 35 of patients with Parkinson's syndrome who visited Department of Cardiovascular and Neurologic Diseases of Kyunghee Oriental Medical Center were treated by acupuncture and herbal medicine from May until December 2007. 35 patients were participated in this study. 21 patients were dropped out during the trial, and we evaluated symptom progress of 14 patients by using several questionnaires such as Unified Parkinson's Disease Rating Scale(UPDRS), modified Hoehn & Yahr stage (H&Y stage) and Schwab & England ADL scale(S&E ADL scale). Results : The whole group consists of 14 male patients and 21 female patients. Mean±SD age range is 64.5±8.4. There were no significant differences of the demographic and clinical characteristics between the case group and drop-out group. The mean±SD medical treatment period of the Case group were 8.4±6.3weeks, the mean±SD of the total score in first medical treatment UPDRS section 1~3 were 29.6±11.0, the mean±SD of the final score were 27.1±12.6, all of which showed significant improvement(p=0.007). There were no significant changes on the H&Y stage and S&E ADL scale. Conclusion : Patients with Parkinson's syndrome who visited Department of Cardiovascular and Neurologic diseases of Kyunghee Oriental Medical Center had a tendency of showing improvement in clinical symptoms.

  • PDF

캥거루 케어가 미숙아와 어머니에게 미치는 효과 : 체계적 문헌고찰 및 메타분석 (Effects for kangaroo care: systematic review & meta analysis)

  • 임정희;김가은;신영희
    • 한국산학기술학회논문지
    • /
    • 제17권3호
    • /
    • pp.599-610
    • /
    • 2016
  • 본 연구는 미숙아와 어머니를 대상으로 캥거루 케어 효과를 비교하기 위해 수행된 체계적 문헌고찰 및 메타분석 연구이다. 2015년 2월까지 출간된 무작위 임상실험연구를 검토하였으며, 국내문헌은 연구설계수준에 따른 제한 없이 비무작위 임상실험연구를 포함하였다. 문헌은 Ovid-Medline, CINAHL, PubMed와 국내 DB인 KoreaMed, 국립중앙도서관, 국회도서관, 국가과학기술전자도서관, KISS, RISS, 한국의학논문을 통해 ((kangaroo OR KC OR skin-to-skin) AND (care OR contact)) AND (infant OR preterm OR Low Birth Weight OR LBW), ((캥거루 OR 캉가루 OR 캉가루식) AND (케어 OR 간호 OR 관리 OR 돌보기 OR 피부접촉)) 등을 주요어로 조합하여 검색하였으며, 선택배제과정을 거쳐 최종 25편(n=3051)의 문헌이 분석에 포함되었다. 문헌에 대한 질평가는 SIGN에서 제시한 평가도구를 사용하였으며, 질평가 결과는 16편에서 ++, 9편에서 +로 평가되어 전반적으로 비뚤림 위험은 없는 것으로 판단하였다. 미숙아를 대상으로 한 캥거루 케어의 효과에 대한 메타분석 결과, 미숙아 사망률, 중증 감염/패혈증 발생률, 저체온 발생률, 병원입원기간, 모유수유율, 수면상태, 어머니의 불안, 어머니 역할수행 자신감, 어머니 역할수행 만족도에서 통계적으로 유의한 효과가 있었으며, 고체온 발생률, 미숙아의 성장발달(신장, 체중), 모아애착, 우울, 스트레스는 유의미한 차이가 없었다. 국내에서 캥거루 케어에 대한 무작위 임상실험연구 수가 적어 효과크기에 대한 확증적 결과를 얻는 데에는 다소 제한이 있었으므로 향후 이와 관련된 무작위 임상실험연구의 효과검증에 대한 노력이 지속적으로 이루어져야 할 것으로 사료된다.

Near Infrared Spectroscopy for Diagnosis: Influence of Mammary Gland Inflammation on Cow´s Milk Composition Measurement

  • Roumiana Tsenkova;Stefka Atanassova;Kiyohiko Toyoda
    • Near Infrared Analysis
    • /
    • 제2권1호
    • /
    • pp.59-66
    • /
    • 2001
  • Nowadays, medical diagnostics is efficiently supported by clinical chemistry and near infrared spectroscopy is becoming a new dimension, which has shown high potential to provide valuable information for diagnosis. The investigation was carried out to study the influence of mammary gland inflammation, called mastitis, on cow´s milk spectra and milk composition measured by near infrared spectroscopy (NIRS). Milk somatic cell counts (SCC) in milk were used as a measure of mammary gland inflammation. Naturally occurred variations with milk composition within lactation and in the process of milking were included in the experimental design of this study. Time series of unhomogenized, raw milk spectral data were collected from 3 cow along morning and evening milking, for 5 consecutive months, within their second lactation. In the time of the trial, the investigated cows had periods with mammary gland inflammation. Transmittance spectra of 258 milk samples were obtained by NIRSystem 6500 spectrophotometer in 1100-2400 nm region. Calibration equations for the examined milk components were developed by PLS regression using 3 different sets of samples: samples with low somatic cell count (SCC), samples with high SCC and combined data set. The NIR calibration and prediction of individual cow´s milk fat, protein, and lactose were highly influenced by the presence of mil samples from animals with mammary gland inflammation in the data set. The best accuracy of prediction (i.e. the lower SEP and the higher correlation coefficient) for fat, protein and lactose was obtained for equations, developed when using only “healthy” samples, with low SCC. The standard error of prediction increased and correlation coefficient decreased significantly when equations for low SCC milk were used to predict examined components in “mastitis” samples with high SCC, and vice versa. Combined data set that included samples from healthy and mastitis animals could be used to build up regression models for screening. Further use of separate model for healthy samples improved milk composition measurement. Regression vectors for NIR mild protein measurement obtained for “healthy” and “mastitic” group were compared and revealed differences in 1390-1450 nm, 1500-1740 nm and 1900-2200 nm regions and thus illustrated post-secretory breakdown of milk proteins by hydrolytic enzymes that occurred with mastitis. For the first time it has been found that monitoring the spectral differences in water bands at 1440 nm and 1912 nm could provide valuable information for inflammation diagnosis.

상지 협응 움직임을 기반으로 한 과제중심적 접근 훈련이 발달성 협응 장애아동의 글씨쓰기 능력에 미치는 효과 (The Effects of Upper Limb Coordinated Movement Based Task Oriented Approach on Improving Handwriting Performance in Children With Developmental Coordination Disorder)

  • 김미지
    • 재활치료과학
    • /
    • 제5권1호
    • /
    • pp.77-87
    • /
    • 2016
  • 목적 : 상지 협응 움직임을 기반으로 한 과제중심적 접근 훈련이 발달성 협응 장애아동의 한글 글씨쓰기 능력에 미치는 영향을 알아보며 각 접근이 한글 글씨 쓰기 수행의 질과 글씨쓰기 준비기술에 미치는 영향을 비교하고자 한다. 연구방법 : 본 연구는 5~10세의 발달성 협응장애 아동 40명을 대상으로 무작위 추출을 통해 두 집단으로 나뉘어 사전-사후 검사로 진행하였다. 두 집단은 과제중심접근 중재군과 과정중심접근 중재군으로 5주 동안 40분씩 주 2회 중재를 받았다. 글씨쓰기 수행은 한글 자모 쓰기 검사로 측정하고, 글씨쓰기 준비요소인 상지 운동 기능, 시 지각 기능과 시 운동기능은 각각 운동 유창성 평가(Bruininks-Oseretsky Test of Motor Proficiency-2: BOT-2)중 미세운동조절의 하위검사 일부, 한국판 시 지각 발달 검사(Korean-Developmental Test of Visual Perception-2: K-DTVP-2), 개정된 시 운동기술 평가(Test of Visual Motor Skills-Revised: TVMS-R)로 평가하였다. 고찰 : 본 연구는 과제중심접근법을 적용하여 발달성 협응 장애아동의 글씨쓰기 수행도를 향상시킨다는 임상적 근거를 제공하는데 의의가 있다. 또한 과정중심접근법과 과제중심접근법이 글씨쓰기 준비기술의 향상에 어떠한 영향을 끼치는 지에 대한 결과를 확인하여 보다 효과적인 글씨쓰기 중재방법을 제시하는 초석이 될 수 있을 것이라 생각한다.

The fruit of Acanthopanax senticosus Harms improves arterial stiffness and blood pressure: a randomized, placebo-controlled trial

  • Oh, Eunkyoung;Kim, Youjin;Park, Soo-yeon;Lim, Yeni;Shin, Ji-yoon;Kim, Ji Yeon;Kim, Ji-Hyun;Rhee, Moo-Yong;Kwon, Oran
    • Nutrition Research and Practice
    • /
    • 제14권4호
    • /
    • pp.322-333
    • /
    • 2020
  • BACKGROUND/OBJECTIVES: Arterial stiffness and endothelial dysfunction are 2 of the independent predictors for cardiovascular disease, while Acanthopanax senticosus Harms (ASH) is a traditional medicinal plant that can improve cardiovascular health. This study aimed to investigate the efficacy of the fruit of ASH on vascular function in apparently healthy subjects. SUBJECTS/METHODS: A 12-week, randomized, double-blind, placebo-controlled design, consisting of healthy adults with at least 2 of the following 3 conditions: borderline high blood pressure (BP; 120 mmHg ≤ systolic BP ≤ 160 mmHg or 80 mmHg ≤ diastolic BP ≤ 100 mmHg), smoking (≥10 cigarettes/day), and borderline blood lipid levels (220 ≤ total cholesterol ≤ 240, 130 ≤ low density lipoprotein cholesterol ≤ 165, or 150 ≤ triglyceride ≤ 220 mg/dL). Randomly assigned 76 subjects who received a placebo or 2 doses of ASH fruit (low, 500 mg/day; high, 1,000 mg/day) completed the intervention. Brachial-ankle pulse wave velocity (baPWV), flow-mediated dilation, carotid intima-media thickness, and BP were measured both at baseline and following the 12-week intervention. Endothelial nitric oxide synthase (eNOS) phosphorylation was assessed by western blotting. RESULTS: Compared with the placebo group, the low-dose group showed more significant changes after the 12-week intervention period in terms of systolic BP (0.1 vs. -7.7 mmHg; P = 0.044), baPWV (31.3 vs. -98.7 cm/s; P = 0.007), and the ratio of phospho-eNOS/eNOS (0.8 vs. 1.22; P = 0.037). CONCLUSIONS: These results suggest that ASH fruit extract at 500 mg/day has the potential to improve BP and arterial stiffness via endothelial eNOS activation in healthy adults with smoking and the tendency of having elevated BP or blood lipid parameters.

Report of the 3rd Japan-Korea Workshop on Acupuncture and EBM;Protocol development for the acupuncture trial on the osteoarthritis of the knee

  • Jang, Jun-Hyouk;Kenji, Kawakita;Hahn, Seo-Kyung;Park, Hi-Joon;Lee, Seung-Deok;Kim, Yong-Suk;Norihito, Takahashi;Toshiyuki, Shichidou;Kazunori, Itoh;Eiji, Sumiya;Eiji, Furuya;Hitoshi, Yamashita;Hiroshi, Tsukayama
    • Journal of Acupuncture Research
    • /
    • 제23권6호
    • /
    • pp.239-254
    • /
    • 2006
  • The 3rd Japan-Korea Workshop on Acupuncture and EBM was held at Kanazawa on June $16^{th}$. From Korea team, 4 papers were presented. Dr. Hahn introduced a new approach of data analysis on series of n-of-1 trials using the Bayesian statistics. It offered important information for the future n-of-1 trials. Dr. Park clearly demonstrated the significance of various sham devices proposed and stressed the importance of research questions when we choose the control intervention in RCT. Dr. Lee reported the results of survey in Korean Medical Doctors (KMD) for their point selection and techniques to the distal and local points. Dr. Kim presented the results of face to face survey on the KMD with 28 items for acupuncture treatment on the knee OA. Finally, a draft of protocol was introduced by Dr. Kim. The title was "multi-center, a randomized, single blinded, two arms, parallel-group study to compare the effectiveness and safety of 'individualized acupuncture' and 'standardized minimal acupuncture' in Korean and Japanese patients with knee osteoarthritis (Phase IV)". From Japan team, 7 speakers presented their comments and proposals on the protocol. Dr. Takahashi introduced several issues regarding n-of-1 trials and pointed out the importance of obtaining generalizability from n-of-1 trials. Dr. Shichidou pointed the importance of research design, selection of outcome measures and reduction of biases. Dr. Itoh presented the results of point selection for the knee OA based on the literature survey. Dr. Sumiya introduced several differences between KMD and Japanese acupuncturists based on the questionnaire used in KMD survey. Dr. Furuya demonstrated a result of press tack needle and its sham device on shoulder stiffness. Dr. Yamashita introduced the results of literature survey regarding adverse events occurred by acupuncture on knee OA. Dr.Tsukayama stressed the importance of responsibility of Institutional Review Board (IRB) for the conduction of clinical trials. After several issues were discussed, the need of continued meeting for final protocol development was agreed, then the workshop was closed.

  • PDF

모유경구투여가 발뒤꿈치 천자 시 신생아의 통증반응에 미치는 효과 (The effect of oral breast milk on pain response of the neonates during heel lancing)

  • 김경화;박영임;김태임
    • Journal of the Korean Data and Information Science Society
    • /
    • 제27권1호
    • /
    • pp.203-215
    • /
    • 2016
  • 신생아는 통증을 충분히 지각할 수 있는 해부학적 신경구조를 갖추고 있으며, 출생초기 통증경험은 이후 통증자극 경험 시 통증에 대한 민감도를 증가시켜 장기적인 신경해부학적, 행동적 후유증을 동반한다. 따라서 신생아기 통증관리는 신생아 간호의 주요 쟁점이 되고 있다. 본 연구는 진정효과가 있는 것으로 알려진 모유를 이용하여 통증이 동반되는 발뒤꿈치 천자 시 모유경구투여가 신생아의 통증완화에 미치는 효과를 검증함으로써 안전하고 효과적인 신생아 통증관리 중재에 대한 근거를 제시하고자 실시하였다. 연구결과 모유경구투여는 통증을 수반하는 간단한 처치 시 신생아의 통증을 완화시켜 주는데 효과가 있음을 확인할 수 있었다. 본 연구 결과는 모유의 통증완화 효과에 대한 경험적 근거를 제시함으로써 간호 실무에서 통증완화 중재로 널리 활용할 수 있는 계기를 마련한 점에서 의의가 있다. 추후 반복연구를 통한 경험적 근거의 축적과 더불어, 모유경구투여 중재가 독자적 간호중재로서 간호 실무에 적극 활용될 것을 기대하는 바이다.

What is the effect of initial implant position on the crestal bone level in flap and flapless technique during healing period?

  • Al-Juboori, Mohammed Jasim;Ab Rahman, Shaifulizan;Hassan, Akram;Ismail, Ikmal Hisham Bin;Tawfiq, Omar Farouq
    • Journal of Periodontal and Implant Science
    • /
    • 제43권4호
    • /
    • pp.153-159
    • /
    • 2013
  • Purpose: The level of the implant above the marginal bone and flap design have an effect on the bone resorption during the healing period. The aim of this study is to detect the relationship between the level of the implant at the implant placement and the bone level at the healing period in the mesial and distal side of implants placed with flapless (FL) and full-thickness flap (FT) methods. Methods: Twenty-two nonsubmerged implants were placed with the FL and FT technique. Periapical radiographs were taken of the patient at implant placement, and at 6 and 12 weeks. By using computer software, bone level measurements were taken from the shoulder of the healing cap to the first bone implant contact in the mesial and distal side of the implant surface. Results: At 6 weeks, the correlation between the crestal bone level at the implant placement and crestal bone level of the FT mesially was significant (Pearson correlation coefficient=0.675, P<0.023). At 12 weeks, in the FT mesially, the correlation was nonsignificant (Spearman correlation coefficient=0.297, P<0.346). At 6 weeks in the FT distally, the correlation was nonsignificant (Pearson correlation coefficient=0.512, P<0.107). At 12 weeks in the FT distally, the correlation was significant (Spearman correlation coefficient=0.730, P<0.011). At 6 weeks in the FL mesially, the correlation was nonsignificant (Spearman correlation coefficient=0.083, P<0.809). At 12 weeks in the FL mesially, the correlation was nonsignificant (Spearman correlation coefficient= 0.062, P<0.856). At 6 weeks in the FL distally, the correlation was nonsignificant (Spearman correlation coefficient=0.197, P<0.562). At 12 weeks in the FL distally, the correlation was significant (Pearson correlation coefficient=0.692, P<0.018). Conclusions: A larger sample size is recommended to verify the conclusions in this preliminary study. The bone level during the healing period in the FT was more positively correlated with the implant level at implant placement than in the FL.

실험적 치은염에서 dextranase 함유 구강 세정액의 양치 효과 (The Effect of Dextranase-Containing Mouthwash in Human Experimental Gingivitis)

  • 손은주;김영준;김도만;정현주
    • Journal of Periodontal and Implant Science
    • /
    • 제31권2호
    • /
    • pp.401-420
    • /
    • 2001
  • A novel glucanhydrolase from a mutant of Lipomyces starkeyi(KSM 22)has been shown effective in hydrolysis of mutan, reduction of mutan formation by Streptococcus mutans and removal pre-formed sucrose-dependent adherent microbial film and Lipomyces starkeyi KSM 22 dextranase has been strongly bound to hydroxyapatitie. These in vitro properties of Lipomyces starkeyi KSM 22 dextranase are desirable for its application as a dental plaque control agent. This study was performed to determine oral hygiene benefits and safety of dextranase(Lipomyces starkeyi KSM 22 dextranase)-containing mouthwash in human experimental gingivitis. This 3-week clinical trial was placebo-controlled double-blind design evaluating 1U/ml dextranase mouthwash and 0.12% chlorhexidine mouthwash. A total 39 systemically healthy subjects, who had moderate levels of plaque and gingivitis were included. At baseline, 1, 2 and 3 weeks, subjects were scored for plaque(Silness and $L{\ddot{o}e$ plaque index and plaque severity index), gingivitis($L{\ddot{o}e$ and Silness gingival index), and at baseline and 3 weeks of experiment, subjects were scored for plaque(Turesky-Quingley-Hein's plaque index and plaque severity index), tooth stain(Area and severity index system by Lang et al). Additionally, oral mucosal examinations were performed and subjects questioned for adverse symptoms. Two weeks after pre-experiment examinations and a professional prophylaxis, the subjects provided with allocated mousewash and instructed to use 20-ml volumes for 30s twice dailywithout toothbrushing. All the groups showed significant increase in plaque accumulation since 1 week of experiment. During 3 weeks' period, the dextranase group showed the least increase in plaque accumulation of Silness and $L{\ddot{o}e$ plaque index, compared to the chlorhexidine and placebo groups, but chlorhexidine group showed the least increase inplaque accumulation of Turesky-Quingley-Hein's plaque index. As for gingival inflammation, all the groups showed significant increase during 3 weeks of experiment. The dextranase group also showed the least increase in gingival index score, compared to the chlorhexidine as well as the placebo groups. Whereas the tooth stain was increased significantly in the chlorhexidine group, compared to the baseline score and the placebo group since 3 weeks of mouthrinsing. It was significantly increased after 3 weeks in the dextranase group, still less severe than the chlorhexidine group. As for the oral side effect, the dextranase group showed less tongue accumulation, bad taste, compared to the chlorhexidine group. From these results, mouthrinsing with Lipomyces starkeyi KSM 22 dextranase was comparable to 0.12% chlorhexidine mouthwashin inhibition of plaque accumulation and gingival inflammation and local side effects were if anything less frequent and less intense than chlorhexidine, in human experimental gingivitis. All data had provided positive evidence for Lipomyces starkeyi KSM 22 dextranase as an antiplaque agent and suggested that further development of dextranase formulations for plaque control are warranted.

  • PDF

회전법과 변형스틸맨법의 치면세균막 감소 효과 비교 (Comparison of Dental Biofilm Reduction between Rolling Method and Modified Stillman Method)

  • 한예슬;임순연;조영식
    • 치위생과학회지
    • /
    • 제12권6호
    • /
    • pp.660-665
    • /
    • 2012
  • 본 연구는 회전법과 변형 스틸맨법간의 치면세균막 감소효과를 비교하기 위하여 천안 소재 대학교 31명의 대학생을 대상으로 무작위 배정한 순수실험을 설계하여 치면세균막 관리프로그램을 시행한 결과 다음과 같은 결과를 얻었다. 1. 중재 전후에 따른 각 잇솔질의 치면세균막 관리를 비교한 결과 중재 전에 측정한 SPS Score와 ${\Delta}R30$에서 두 잇솔질 방법간의 차이는 나타났으나(p<0.05), 나머지 측정값들과 중재 후의 측정값에서 유의한 관련성을 보이지 않았다(p>0.05). 2. 각 잇솔질 방법에 따른 중재 전 후의 치면세균막 관리를 비교한 결과 PCR, QLF-PCR, ${\Delta}R30$, ${\Delta}R60$에서 회전법과 변형 스틸맨법 집단은 통계적으로 유의한 차이가 있었다(p<0.05). 또한, 회전법보다 변형 스틸맨법 집단에서 치면세균막 지수는 더 큰 감소를 보였고, 잇솔질 교육 중재를 실행한 후 치면세균막 지수가 감소하는 것으로 나타났다. 3. PCR과 QLFD 촬영 측정값의 관계에서 PCR과 육안검사 QLF-PCR의 관계, SPS Score와 그 하위 척도 ${\Delta}R$값들의 상관관계는 보였으나, PCR와 QLF값의 상관관계는 보이지 않았다. 이상의 결과를 종합해보면, 회전법과 변형스틸맨법의 치면세균막 관리 효과는 통계적으로 유의하지 않았으나, 회전법보다 변형 스틸맨법 집단에서 치면세균막 감소차이는 더 큰 것으로 확인되었고, 잇솔질 교육을 실행함으로써 치면세균막 지수가 감소하는 것으로 나타났다.