• 제목/요약/키워드: Blind Control

검색결과 466건 처리시간 0.029초

Risk of Breast Cancer and Total Malignancies in Rheumatoid Arthritis Patients Undergoing TNF-α Antagonist Therapy: a Meta-analysis of Randomized Control Trials

  • Liu, Yang;Fan, Wei;Chen, Hao;Yu, Ming-Xia
    • Asian Pacific Journal of Cancer Prevention
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    • 제15권8호
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    • pp.3403-3410
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    • 2014
  • Context: Interest exits in whether TNF-alpha antagonists increase the risk of breast cancer and total malignancies in patients with rheumatoid arthritis (RA). Objectives: To analyze the risk of malignancies, especially breast cancer, in patients with RA enrolled in randomized control trials (RCTs). Methods: A systematic literature search for RCTs from 1 January 1998 to 1 July 2013 from online databases, such as PubMed, WILEY, EMBASE, ISI web of knowledge and Cochrane Library was conducted. Studies included RCTs that compared the safety of at least one dose of the five TNF-${\alpha}$ antagonists with placebo or methotrexate (MTX) (or TNF-${\alpha}$ antagonists plus MTX vs placebo plus MTX) in RA patients for more than 24 weeks and imported all the references into document management software EndNote${\times}6$. Two independent reviewers selected studies and extracted the data about study design, patients' characteristics and the type, number of all malignancies. Results: 28 RCTs from 34 records with 11,741 patients were analyzed. Of the total, 97 developed at least one malignancy during the double-blind trials, and breast cancer was observed in 17 patients (17.5% of total malignancies). However, there was no statistically significant increased risk observed in either the per protocol (PP) model (OR 0.65, 95%CI [0.22, 1.93]) or the modified intention to treat (mITT) model (OR 0.75, 95%CI [0.25, 2.21]). There were also no significant trend for increased risk of total malignancies on anti-TNF-${\alpha}$ therapy administered at approved doses in either model (OR, 1.06, 95%CI [0.64, 1.75], and OR, 1.30, 95%CI [0.80, 2.14], respectively). As to the two models, modified intention to treat model analysis led to higher estimation than per protocol model analysis. Conclusions: This study did not find a significantly increased risk of breast cancer and total malignancies in adults RA patients treated with TNF-${\alpha}$ antagonists at approved doses. However, it cannot be ignored that more patients developed malignancies with TNF-${\alpha}$ antagonists therapy compared with patients with placebo or MTX, in spite of the lack of statistical significance, so that more strict clinical trials and long-term follow-up are needed, and both mITT and PP analyses should be used in such safety analyses.

알쏭이모자반 (Sargassum confusum) 주정추출물이 성인여성 체지방 감소에 미치는 영향 (The effect of Sargassum confusum on reduction of body fat in obese women)

  • 민기성;한 대석;권상오;여경목;김복남;이선영
    • Journal of Nutrition and Health
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    • 제47권1호
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    • pp.23-32
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    • 2014
  • 해조류인 알쏭이 모자반 추출물의 섭취로 인한 체지방 감소 효능을 평가하고자 이중맹검법을 사용하여 BMI 23 이상의 과체중 혹은 비만 성인 여성에게 8주간 알쏭이 모자반 추출물을 섭취하게 한 후 체격지수, 혈액 분석, 식사섭취상황 등을 조사하였다. 최종 대조군은 14명, 실험군은 16명이었으며 1일3회 각 4개의 캡슐을 섭취시켰다. 인체시험 결과 시험전후 비교시 대조군에 비하여 시험군의 체지방률과 체지방량, 허리둘레가 지속적으로 유의하게 감소하였으며 혈청 트리글리세롤과 렙틴농도가 더욱 유의하게 감소하였고 변배설량은 유의하게 증가하여 지방 배설효과를 기대할 수 있었다. 시험기간 동안 7명의 피험자가 심각하지 않은 부작용으로 시험에서 탈락하였으나 건강상 불편함을 호소하는 피험자 수의 두 군간의 차이는 보이지 않았다. 따라서 알쏭이 모자반 추출물은 8주간 섭취 시 심각한 부작용을 유발하지 않으면서 피험자의 허리둘레, 체지방율과 함께 혈청 렘틴 수치를 유의하게 감소시킬 수 있고 배변횟수를 유의하게 증가시켜 특히 복부비만을 해소할 수 있는 비교적 안전한 기능성 소재로 기대되므로 작용기전을 설명할 수 있는 심층 연구가 필요로 된다.

웃음요법이 퇴행성 슬관절염 노인의 관절통증, 관절기능상태, 우울에 미치는 효과 (Effects of Laughter Therapy on Joint Pain, Functional Status of Knee Joint and Depression in Elderly with Degenerative Knee Arthritis)

  • 이임선;박효정
    • 한국산학기술학회논문지
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    • 제21권9호
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    • pp.440-449
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    • 2020
  • 본 연구는 웃음요법이 퇴행성 관절염 노인 환자의 관절 통증, 관절기능 이상, 우울에 주는 효과를 확인하기 위해 시도되었다. 단일맹검, 무작위 배정을 통해 S시의 경로당 및 복지관을 이용중인 65세 이상 퇴행성 슬관절염 노인을 대상으로 실험군 26명, 대조군 26명을 선정하였다. 2019년 1월 8일부터 3월 11일까지 주 2회, 회당 60분, 8주, 총 16회의 웃음요법을 적용하고 그 효과를 VAS, 압통역치, WOMAC, 한국형 노인 우울 단축형 척도로 측정하였다. 연구결과 퇴행성 슬관절염 노인의 통증 역치(p=.012)와 통증, 관절경직, 신체기능을 측정하는 관절기능상태(p<.001), 우울(p<.001)은 대조군에 비해 실험 후 개선되어 웃음요법이 효과가 있음이 확인되었다. 웃음요법은 육체적 또는 지적 활동을 통해 웃음을 경험할 수 있는 치료적 개입으로 침습적인 시술이 이루어지지 않고 약간의 훈련으로 간호사들이 쉽게 적용할 수 있는 장점이 있으므로 웃음요법을 지역사회 및 임상 현장에서 퇴행성 슬관절염 노인의 통증을 완화시키고 우울을 개선하는 중재방법으로 활용할 수 있을 것으로 사료된다.

이압요법이 암환자의 불면증에 미치는 효능 : 무작위배정, 단일맹검, 위약대조군 연구 (Effect of Auricular Acupress Therapy on Insomnia of Cancer Patients : Randomized, Single Blinded, Placebo Controlled Trial)

  • 정인숙;김정선;유화승
    • 대한약침학회지
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    • 제13권2호
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    • pp.93-100
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    • 2010
  • Background: Auricular acupressure is one of the traditional health care treatments in oriental medicine. Approximately, 30~40% of the cancer patients have said to be suffering from insomnia and half of them having chronic and severe insomnia at the same time. Insomnia caused cancer patients feel more pain, fatigue, depression and anxiety and it sometimes let the power to have the best of cancer pull down. Objective: To investigate how effective the auricular acupressure treatment to cancer patients suffering from insomnia. Methods: We recruited participants from East-West Cancer Center of Daejeon University. Finally, of the people whose age range from 20 to 75, 12 patients who got less than 40 points from the score of Oh's sleeping score (OSS) were recruited. Single-blind, randomized pilot study was performed. The treatment group received auricular acupressure treatment (AAT) on active points and the control group had received sham acupressure treatment (SAT) for five times. Sleep parameters were checked by using OSS and numeric rating scale (NRS). We checked the scale everytime, both before and after treatment. We analyzed the data statistically by using independent T-test, paired T-test and analysis of variance (ANOVA) test. (p<0.05) Results: Twelve cancer patients participated in this pilot study and there was no significant difference between control and treatment group. Only 7 of them had completed the whole treatment process, 4 patients of AAT group and 3 participants of SAT. The OSS of AAT group had increased from $34.0{\pm}4.3$ to $39.5{\pm}3.1$ and that of SAT group had increased from $38.3{\pm}3.5$ to $40.0{\pm}0.0$. There was no significant difference between them. The NRS of AAT group had increased from $6.3{\pm}2.9$, $04.8{\pm}2.1$ and that of SAT group had increased from $7.0{\pm}1.0$ to $5.0{\pm}2.6$. No significant difference was observed between them. Conclusion: Although both groups did not show significant differences, most of the experimental participants showed increasing OSS and NRS after treatments. Significant participants' number will be needed in the next study.

Chicken Egg Yolk Antibodies (IgY) for Prophylaxis and Treatment of Rotavirus Diarrhea in Human and Animal Neonates: A Concise Review

  • Thu, Hlaing Myat;Myat, Theingi Win;Win, Mo Mo;Thant, Kyaw Zin;Rahman, Shofiqur;Umeda, Kouji;Nguyen, Sa Van;Icatlo, Faustino C. Jr.;Higo-Moriguchi, Kyoko;Taniguchi, Koki;Tsuji, Takao;Oguma, Keiji;Kim, Sang Jong;Bae, Hyun Suk;Choi, Hyuk Joon
    • 한국축산식품학회지
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    • 제37권1호
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    • pp.1-9
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    • 2017
  • The rotavirus-induced diarrhea of human and animal neonates is a major public health concern worldwide. Until recently, no effective therapy is available to specifically inactivate the rotavirion particles within the gut. Passive immunotherapy by oral administration of chicken egg yolk antibody (IgY) has emerged of late as a fresh alternative strategy to control infectious diseases of the alimentary tract and has been applied in the treatment of diarrhea due to rotavirus infection. The purpose of this concise review is to evaluate evidence on the properties and performance of anti-rotavirus immunoglobulin Y (IgY) for prevention and treatment of rotavirus diarrhea in human and animal neonates. A survey of relevant anti-rotavirus IgY basic studies and clinical trials among neonatal animals (since 1994-2015) and humans (since 1982-2015) have been reviewed and briefly summarized. Our analysis of a number of rotavirus investigations involving animal and human clinical trials revealed that anti-rotavirus IgY significantly reduced the severity of clinical manifestation of diarrhea among IgY-treated subjects relative to a corresponding control or placebo group. The accumulated information as a whole depicts oral IgY to be a safe and efficacious option for treatment of rotavirus diarrhea in neonates. There is however a clear need for more randomized, placebo controlled and double-blind trials with bigger sample size to further solidify and confirm claims of efficacy and safety in controlling diarrhea caused by rotavirus infection especially among human infants with health issues such as low birth weights or compromised immunity in whom it is most needed.

YGF251 투여에 의한 인체내 혈중의 IGF-1 분비량 변화 효과 (Effect of YGF251 on Secretion Of IGF-1 in Human Blood)

  • 김재수;박준홍;조한성;박점석;홍억기
    • KSBB Journal
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    • 제17권4호
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    • pp.403-408
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    • 2002
  • 인체의 다양한 기능을 증진시키는 작용을 하는 것으로 알려진 IGF-I의 생체내 분비를 촉진시키기 위해 천연 생약재성분으로 구성된 YGF251을 개발하였고 YGF251의 효능을 측정하였다. 이중 맹검 시험 방식으로 40세에서 70세 사이의 성인 남녀 31명을 대상으로 IGF-I을 비롯하여 체중, 혈압, 간기능 검사 및 신장기능 검사를 실시하였다. YGF251 및 위약 투석 후의 IGF-I 함량변화에 대한 대응표본 검정결과는 YGF251 투여군에서 투여 전에는 245.6 ng/mL 이었는데 1개월 투여 후에는 269.3 ng/mL, 2개월 투여 후에는 275.6 ng/mL으로 유의하게 증가하였다 (p<0.05). 한편 위약 투여군에서는 투여 전에는 280.0 ng/mL이었으나 1개월 투여 후에는 239.2 ng/mL, 2개월 투여 후에는 230.2 ng/mL으로 유의하게 감소하는 결과를 보였다(p<0.05). 혈중 insulin함량은 실험군의 경우 YGF251 을 1개월 투여후 평균치로써 2배 정도의 증가를 보였으며 위약 투여군에서는 36% 정도 감소된 것으로 나타났다. 또한 YGF251투여에 의한 체중 및 혈압의 변화는 거의 나타나지 않았다. YGF251 투여에 의해 나타날수 있는 간기능 및 신장기능 변화를 관찰 하기 위해 여러 항목들의 수치는 측정 오차 범위내에서의 변화만을 나타내었다.

상아세관 폐쇄에 대한 2종의 상아질 지각 과민 체치제와 Er,Cr:YSGG 레이저의 효과 (Effect of two dentin desensitizers and Er,Cr:YSGG laser for dentinal tubule occlusion)

  • 김나송;강정경;류재준
    • 대한치과의사협회지
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    • 제48권6호
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    • pp.469-477
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    • 2010
  • The purpose of this study was to evaluate the effect of two dentin desensitizers and Er,Cr:YSGG laser for dentinal tubule occlusion. Twenty recently extracted single-rooted human teeth were used to obtain root dentinal fragments. The crowns were cut approximately 1mm below the cementum enamel junction(CEJ). A second cut was used to remove the apex of the root. Subsequently, a longitudinal cut was made in order to obtain 2 fragments from each root sample. The cementum from the cervical portion was removed using a high-speed diamond-coated bur in order to expose the dentin. To open dentinal tubules, forty samples were treated with 50% citric acid for 2 min and then rinsed under distilled water for 1 min. These were divided into four groups of ten samples each. The first group served as a control group. In group 2, the samples were irradiated with the Er,Cr:YSGG laser(Waterlase MD, Biolase, USA). In group 3, the samples were treated with Bisblock and ONE-STEP PLUS(Bisco, USA). In group 4, the samples were treated with Gluma comfort bond & Desensitizer(Heraeus Kulzer, Germany). All the samples were examined using Scanning electron microscopy(Hitachi, S-4700, Japan) with two different magnifications(X2000, X5000). These images were assessed by one examiner who was blind to the experimental procedure, using the index of smear layer removal. The distribution of smear layer removal grades was tested using Fisher's exact test. On the order hand, in order to evaluate the occluding effect of two dentin desensitizers and Er,Cr:YSGG laser, the number of exposed dentinal tubules was counted in each group. These were evaluated using the Kruskal-Wallis test with significance predetermined $\alpha$=0.05. There were statistically significant differences between the three groups(Er,Cr:YSGG laser, Bisblock+ONE-STEP PLUS, Gluma comfort bond & Desensitizer) and control group.

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
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    • 제31권2호
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    • pp.401-420
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    • 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.

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민감성 치아에 대한 수산화인회석 함유 치약의 임상적 효과 (The clinical effects of a hydroxyapatite containing toothpaste for dentine hypersensitivity)

  • 김수환;박준범;이철우;구기태;김태일;설양조;이용무;구영;정종평;류인철
    • Journal of Periodontal and Implant Science
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    • 제39권1호
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    • pp.87-94
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    • 2009
  • Purpose: The aim of this study was to compare the effectiveness of hydroxyapatite containing toothpaste with positive control toothpastes in reducing dentine hypersensitivity. Materials and methods: This clinical trial was a double-blind, randomized, parallel group comparison of two, namely hydroxyapatite containing toothpaste and strontium chloride containing toothpaste. A total of 55 subjects were included in this study. The subjects were given randomly assigned one of the two toothpastes after received tooth brushing instruction at baseline. Some clinical indices(PI, GI, PD), verbal rating score(VRS) for sensitivity to stimulus, the effect in relieving sensitivity and visual analogue scale(VAS) for sensitivity at baseline, week 2, week 4 and week 8 were assessed. All data were evaluated by intention-to-treat analysis. Results: Overall, PI and GI scores were significantly reduced compare baseline in all groups(p<0.05). In addition, there was significant difference in PI at 4 weeks and in GI at 4, 8 weeks between groups. The proportions of subjects relieved sensitivity were 70.4% in experimental group and 57.1% in control group at 8 weeks respectively. The VRS for sensitivity to three kinds of stimuli and VAS for sensitivity decreased according to time, there was no overall difference between two groups(p>0.05). Conclusion: This study demonstrated that the new hydroxyapatite containing toothpaste was similarly effective in reducing dentine hypersensitivity with pre-existing benchmark toothpaste.

전자궁 적출술 후 자가통증조절장치를 이용하여 정맥과 경막외로 투여된 Alfentanil의 진통효과 비교 (Patient Controlled Analgesia of Alfentanil after a Total Abdominal Hysterectomy: A Comparison of the Intravenous and Epidural Route)

  • 최수경;윤석화;이준화;황재하;정우석;김윤희;이원형
    • The Korean Journal of Pain
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    • 제20권2호
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    • pp.169-173
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    • 2007
  • Background: Although the use of intravenous patient controlled analgesia (IVPCA) has been compared to the use of patient conrolled epidural analgesia (PCEA), there is no optimal administration route of alfentanil for the treatment of postoperative pain. This randomized double-blind study compared the efficacy of the use of IVPCA and PCEA for postoperative pain and the side effects after a total abdominal hysterectomy (TAH). Methods: Sixty patients undergoing a TAH were randomly assigned to receive either IVPCA (Group I) or PCEA (Group E) for the infusion of alfentanil for postoperative pain control. In both groups, a loading dose of $750{\mu}g$ alfentanil was administered. All patients received the same continuous infusion rate (0.3 mg/h), bolus dose (0.15 mg), and lockout time (15 min). The incidence of side effects, the VAS (visual analog scale) of pain, blood pressure, and heart rate were checked for 20 hours after the loading dose injection. Results: The VAS of pain was not significantly different between the two groups of patients. The onset of the analgesic effect was significantly more rapid in the Group I patients than in the Group E patients. There was no difference in side effects for either group. Conclusions: When considering multiple factors such as the onset of analgesia, technical difficulties or infection after the procedure, IVPCA using alfentanil is more useful than PCEA for postoperative pain control after a TAH.