• 제목/요약/키워드: double-blind

검색결과 542건 처리시간 0.027초

Prognostic Factor Analysis of Overall Survival in Gastric Cancer from Two Phase III Studies of Second-line Ramucirumab (REGARD and RAINBOW) Using Pooled Patient Data

  • Fuchs, Charles S.;Muro, Kei;Tomasek, Jiri;Van Cutsem, Eric;Cho, Jae Yong;Oh, Sang-Cheul;Safran, Howard;Bodoky, Gyorgy;Chau, Ian;Shimada, Yasuhiro;Al-Batran, Salah-Eddin;Passalacqua, Rodolfo;Ohtsu, Atsushi;Emig, Michael;Ferry, David;Chandrawansa, Kumari;Hsu, Yanzhi;Sashegyi, Andreas;Liepa, Astra M.;Wilke, Hansjochen
    • Journal of Gastric Cancer
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    • 제17권2호
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    • pp.132-144
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    • 2017
  • Purpose: To identify baseline prognostic factors for survival in patients with disease progression, during or after chemotherapy for the treatment of advanced gastric or gastroesophageal junction (GEJ) cancer. Materials and Methods: We pooled data from patients randomized between 2009 and 2012 in 2 phase III, global double-blind studies of ramucirumab for the treatment of advanced gastric or GEJ adenocarcinoma following disease progression on first-line platinum- and/or fluoropyrimidine-containing therapy (REGARD and RAINBOW). Forty-one key baseline clinical and laboratory factors common in both studies were examined. Model building started with covariate screening using univariate Cox models (significance level=0.05). A stepwise multivariable Cox model identified the final prognostic factors (entry+exit significance level=0.01). Cox models were stratified by treatment and geographic region. The process was repeated to identify baseline prognostic quality of life (QoL) parameters. Results: Of 1,020 randomized patients, 953 (93%) patients without any missing covariates were included in the analysis. We identified 12 independent prognostic factors of poor survival: 1) peritoneal metastases; 2) Eastern Cooperative Oncology Group (ECOG) performance score 1; 3) the presence of a primary tumor; 4) time to progression since prior therapy <6 months; 5) poor/unknown tumor differentiation; abnormally low blood levels of 6) albumin, 7) sodium, and/or 8) lymphocytes; and abnormally high blood levels of 9) neutrophils, 10) aspartate aminotransferase (AST), 11) alkaline phosphatase (ALP), and/or 12) lactate dehydrogenase (LDH). Factors were used to devise a 4-tier prognostic index (median overall survival [OS] by risk [months]: high=3.4, moderate=6.4, medium=9.9, and low=14.5; Harrell's C-index=0.66; 95% confidence interval [CI], 0.64-0.68). Addition of QoL to the model identified patient-reported appetite loss as an independent prognostic factor. Conclusions: The identified prognostic factors and the reported prognostic index may help clinical decision-making, patient stratification, and planning of future clinical studies.

엉겅퀴 추출물 실리마린의 피부 미백효과 (Hypopigmentary Effect of Milk Thistle Extract Silymarin)

  • 유익동;추수진;류인자;김영희;허광화;김기호;한창성;김수진;김진웅;손의동
    • 대한화장품학회지
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    • 제35권2호
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    • pp.151-158
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    • 2009
  • 천연물로부터 새로운 미백 소재를 개발하기 위하여 식물 추출물들의 미백활성을 조사한 결과, 엉겅퀴의 열매로부터 추출한 silymarin이 우수한 미백효과를 나타내는 것을 발견하였다. Silymarin으로부터 유효 성분을 분리하기 위하여 각종 컬럼 크로마토그래피 및 HPLC 등의 기법을 실시하여 silybin과 isosilybin을 분리한 후 이성질체인 silybin A와B, 그리고 isosilybin A와 B를 각각 순수 분리하였다. Silymarin은 Mel-Ab melanocyte에서 세포독성에 영향을 주지 않는 동시에 멜라닌의 생성을 억제하였고 $IC_{50}$ 값은 28.2 ${\mu}g/mL$이었다. 또한 Silymarin은 cell-based tyrosinase의 활성을 저해하고, western blot 분석 결과 tyrosinase 단백질의 발현을 감소시키는 것을 확인하였다. Silymarin으로부터 분리한 활성 화합물인 silybin 및 isosilybin의 미백 효과를 측정한 결과, 각각 42.25 ${\mu}M$ 및 16.32 ${\mu}M$$IC_{50}$ 값을 가지며 멜라닌의 생성을 억제하였으며 tyrosinase 단백질의 발현을 감소시켰다. Diastereoisomer 형태로 존재하는 silybin A 및 B, 그리고 isosilybin A 및 B의 멜라닌 저해활성을 측정한 결과, 네 가지 화합물 모두 농도 의존적으로 멜라닌의 생성을 억제하는 것으로 나타났다. 또한, 피부 미백 임상연구를 실시한 결과, silymarin 2 % 함유 크림을 사용할 경우 피부 미백 효과가 유효하게 나타남을 확인하였다. 이상의 결과로부터 본 활성물질 silymarin은 피부 미백 효과가 우수한 안전한 화장품 원료로서 사용할 수 있을 것으로 사료된다.

하고초 추출물의 항노화 효과에 관한 연구 (The Study on the Potential Anti-aging Properties of Prunella vulgaris Extract In Vitro and In Vivo)

  • 홍은숙;안기웅;조병기
    • 대한화장품학회지
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    • 제34권2호
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    • pp.129-135
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    • 2008
  • 본 연구에서는 하고초(Prunella vulgaris) 추출물의 항노화 효과에 대하여 알아보고자 하였다. 시험 결과, 하고초 추출물의 콜라겐 생성 촉진 효과는 250 ${\mu}g/mL$ 농도에서 75.7%, MMP-1 생성 억제 효과는 200 ${\mu}g/mL$ 농도에서 90.2%로 나타났고, 엘라스테이즈 활성 억제 효과는 2.0% 농도에서 43.7%로 나타났다. 또한, 하고초 추출물의 항산화 효과 측정을 위한 자유 라티칼 소거 효과 시험 결과 2.0% 농도에서 76.9%의 소거 효과를 나타내었으며, 과산화수소에 의한 세포사멸 억제 효과는 2.0% 농도에서 49.9%로 나타났다. 하고초 추출물의 피부에 대한 영향을 알아보기 위하여 22명(연령분포 : 34세$\sim$48세)의 지원자를 대상으로 실시한 이중 맹검 임상 연구 결과, 하고초 추출물 4.0% 함유 제형을 12주간 도포하였을 때, 대조군과 비교하여 전문가의 육안평가, 모사판을 제작하여 주름의 정도를 분석한 결과 주름 개선에 현저한 효과가 있음을 확인하였다(p<0.05). 이러한 결과를 통해 하고초 추출물은 피부의 탄력과 주름을 효과적으로 개선함으로써, 천연 항노화 소재로 유용하게 이용될 수 있을 것으로 기대된다.

녹용약침과 웅담.우황(BU)약침이 정상인의 심박변이도(HRV)에 미치는 영향 (The Effects of Cervi Pantotrichum Cornu Pharmacopuncture and Bovis calculus.Fel Ursi Pharmacopuncture on the Heart Rate Variability)

  • 이휘용;이진복;조이현;송범용;육태한
    • Journal of Acupuncture Research
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    • 제27권1호
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    • pp.65-74
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    • 2010
  • Objectives : This study was to investigate the effects of Cervi Pantotrichum Cornu Pharmacopuncture and Bovis calculus Fel Ursi Pharmacopuncture on autonomic nervous system with Heart Rate Variability(HRV). Purpose of the trial was to observe what influence Cervi Pantotrichum Cornu Pharmacopuncture and Bovis calculus Fel Ursi pharmacopuncture have on the autonomic nervous system. Methods : 40 healthy male volunteers were divided into two experimental groups, such as Cervi Pantotrichum Cornu Pharmacopuncture group and Bovis calculus Fel Ursi Pharmacopuncture group. Study design was a randomized, double-blind clinical trial. 20 subjects in one experimental group were injected Cervi Pantotrichum Cornu Pharmacopuncture, 20 subjects in other experimental group were injected hydrolyzed Bovis calculus Fel Ursi Pharmacopuncture at GB21(Kyonjong). We measured HRV 7 times : baseline measurement and every 5 minutes for 30 minutes after injection. The SPSS 15.0 for Windows was used to analyze the data by the paired t-test(in group) and independent sample t-test(between the groups). Results A. Time Domain Analysis 1. Analysis of Mean HRV, SDNN and Complexity After injection of Cervi Pantotrichum Cornu Pharmacopuncture, Mean HRV was significantly decreased all the times after injection. SDNN was significantly increased at immediate and 25 minute after injection. Complexity was significantly decreased only at 15 minute after injection. After injection of Bovis calculus Fel Ursi Pharmacopuncture, Mean HRV was significantly decreased all the times after injection. Complexity was significantly decreased at 15 minutes after injection. 2. Analysis of HRV index, pNN50 After injection of Cervi Pantotrichum Cornu Pharmacopuncture, HRV index was significantly increased immediately after injection. pNN50 was significantly decreased at immediately, 20 and 25 minutes after injection. After injection of Bovis calculus Fel Ursi Pharmacopuncture, HRV index was significantly increased immediately after injection. pNN50 was significantly decreased at immediate and 25 minutes after injection. B. Frequency Domain Analysis 1. Analysis of Ln(TP), Ln(HF), Ln(LF), Ln(VLF) After injection of Cervi Pantotrichum Cornu Pharmacopuncture, Ln(TP) was significantly increased at immediate and 25 after injection. Ln(HF) was significantly increased all the times after injection. Ln(LF) was significantly increased at 15, 20 and 25 minutes after injection. Ln(VLF) was significantly increased at immediate and 25 minutes after injection. After injection of Bovis calculus Fel Ursi Pharmacopuncture, Ln(TP) was significantly increased at immediately and 25 after injection. Ln(LF) was significantly increased at 20 and 25 minutes after injection. Ln(VLF) was significantly increased at immediate and 25 minutes after injection. Conclusions : We results suggest that Cervi Pantotrichum Cornu Pharmacopuncture and Bovis calculus Fel Ursi Pharmacopuncture in healthy adult men tend to activate the autonomic nervous system and sympathetic nervous system within normal range.

Mandibular reconstruction with a ready-made type and a custom-made type titanium mesh after mandibular resection in patients with oral cancer

  • Lee, Won-bum;Choi, Won-hyuk;Lee, Hyeong-geun;Choi, Na-rae;Hwang, Dae-seok;Kim, Uk-kyu
    • Maxillofacial Plastic and Reconstructive Surgery
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    • 제40권
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    • pp.35.1-35.7
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    • 2018
  • Background: After the resection at the mandibular site involving oral cancer, free vascularized fibular graft, a type of vascularized autograft, is often used for the mandibular reconstruction. Titanium mesh (T-mesh) and particulate cancellous bone and marrow (PCBM), however, a type of non-vascularized autograft, can also be used for the reconstruction. With the T-mesh applied even in the chin and angle areas, an aesthetic contour with adequate strength and stable fixation can be achieved, and the pores of the mesh will allow the rapid revascularization of the bone graft site. Especially, this technique does not require microvascular training; as such, the surgery time can be shortened. This advantage allows older patients to undergo the reconstructive surgery. Case presentation: Reported in this article are two cases of mandibular reconstruction using the ready-made type and custom-made type T-mesh, respectively, after mandibular resection. We had operated double blind peer-review process. A 79-year-old female patient visited the authors' clinic with gingival swelling and pain on the left mandibular region. After wide excision and segmental mandibulectomy, a pectoralis major myocutaneous flap was used to cover the intraoral defect. Fourteen months postoperatively, reconstruction using a ready-made type T-mesh (Striker-Leibinger, Freibrug, Germany) and iliac PCBM was done to repair the mandible left body defect. Another 62-year-old female patient visited the authors' clinic with pain on the right mandibular region. After wide excision and segmental mandibulectomy on the mandibular squamous cell carcinoma (SCC), reconstruction was done with a reconstruction plate and a right fibula free flap. Sixteen months postoperatively, reconstruction using a custom-made type T-mesh and iliac PCBM was done to repair the mandibular defect after the failure of the fibula free flap. The CAD-CAM T-mesh was made prior to the operation. Conclusions: In both cases, sufficient new-bone formation was observed in terms of volume and strength. In the CAD-CAM custom-made type T-mesh case, especially, it was much easier to fix screws onto the adjacent mandible, and after the removal of the mesh, the appearance of both patients improved, and the neo-mandibular body showed adequate bony volume for implant or prosthetic restoration.

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.

쌀 유래 세라마이드를 함유한 미용보조제의 피부미용개선 효과 (Improvement of Skin Moisture Capacity through Dietary Beauty Supplement Containing Ceramides Derived from Rice)

  • 김태수;이성표;박소이;양웅석;강명화;무라이 히로미치;오카다 타다시;이재환;박일범;박현준
    • 한국식품과학회지
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    • 제44권4호
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    • pp.434-440
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    • 2012
  • 쌀 유래 세라마이드를 함유한 미용보조제의 섭취에 관한 위약 대조, 이중 맹검 연구가 건조함으로 인해 항상 피부가 거친 경향이 있었던 33명의 피험자들에게 실시되어 다음과 같은 결과가 얻어졌다. 섭취 6주 후 피부과적 진단에 따르면 건조함, 홍조, 화장 유지력, 가려움 등의 관찰항목에서 플라시보 군 및 세라마이드군 모두에서 개선효과가 있었으나 플라시보 군 에서는 개선율이 43.8%인 반면, 세라마이드 군의 개선율은 64.7%로 높았다. 수분량, 유분량, pH 측정결과를 보면, 플라시보 군과 세라마이드 군 모두에서 유분량 및 pH 관련하여 유의한 변화는 없었다. 그러나 수분량에서는 플라시보 군에서 유의한 변화가 없었던 반면, 세라마이드 군에서는 6주 후 유의한 수분량 증가가 있었다. 3차원 현미경 경피분석시스템에 의한 분석결과에 따르면, 세라마이드 군에서는 Kurtosis, 유연성지수(SEsm), 거�s지수(SEr), 각질 및 인설 지수(SEsc), 주름지수(SEw)가 유의하게 개선되었으나 플라시보 군에서는 어떠한 유의한 변화도 관찰되지 않았다. 이는 이중맹검법으로 실시된 이번 연구에서 피부과적 진단이 명백한 플라시보 효과를 보인 점과 대비된다. 이로써 의사들에 의한 관찰과 더불어 과학적이고 객관적인 측정에 의해 세라마이드는 피부건조함과 거�s을 개선하는 데 효과가 있음이 입증되었고 경구섭취로 그 효과가 나타났다. 상기 결과는 쌀 유래 세라마이드 보조제의 장기간에 걸친 섭취가 보습, 피부의 유연성 유지에 효과적이고 따라서 효과적인 피부미용식품임을 보여준다.

Cranberry Juice to Reduce Bladder Biofilms and Infection in Geriatric and Spinal Cord Injured Patients with Dysfunctional Bladders

  • Reid, Gregor;Potter, Patrick;Lam, Dominique;Warren, Diny;Borrie, Michael;Hayes, Keith
    • Preventive Nutrition and Food Science
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    • 제8권1호
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    • pp.24-28
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    • 2003
  • There is evidence to suggest that cranberry juice supplements improve the health of the urinary tract by inhibiting the binding of fimbriated uropathogenic E. coli to the bladder mucosa. In patients with neurogenic bladders, urinary tract infections (UTI) are particularly common and often poorly managed by antibiotic treatment. A double-blind, randomized, placebo-controlled trial was undertaken on 29 geriatric and spinal cord injured patients with dysfunctional bladders. They received three times daily at mealtimes a 4 oz bottle of cranberry juice (Ocean Spray Cranberries, USA) or a specially prepared synthetic placebo drink. Two episodes of UTI arose in week one of cranberry intake and none thereafter, compared to four episodes of UTI in 4 placebo patients in weeks four, six and 10. Mean bacterial adhesion counts on bladder cells of the patients rose during the first month of treatment in 71 % of the placebo patients compared to only 31 % of cranberry patients (p < 0.001). The difference persisted to some extent for the second and third months. Bacterial adhesion levels correlated with culture findings (higher adhesion and higher viable counts in urine) (p < 0.001), positive leukocyte nitrite tests (136$\pm$131 bacteria per cell versus 52$\pm$86 in negative tests) (p < 0.001), and higher white blood cell counts (> 10) per high power field (126$\pm$125 versus 48$\pm$85 bacteria per cell) (p<0.001). E. coli was the most frequently isolated organism (40% samples) followed by K. pneumoniae (17%) and a number of other uropathogens. Group B Streptococci, and coagulase negative Staphylococcus were recovered from urine in 4 samples but were not associated with any red blood cell presence. The daily intake of cranberry juice, in amounts which are not detrimental to long term compliance, appeared to have a role in reducing the risk of bladder colonization and infection in a highly susceptible patient population.

Dextranase 함유 구강 세정액의 치태 억제 및 치은염 예방 효과에 관한 임상적 연구 (A Clinical Trial of Dextranase-Containing Mouthwash on the Inhibition of Plaque Formation and Gingivitis)

  • 송우성;손은주;김도만;정현주
    • Journal of Periodontal and Implant Science
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    • 제31권2호
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    • pp.371-388
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    • 2001
  • A novel glucanhydrolase(DXAMase) 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-dependentadherent microbial film and DXAMase has been strongly bound to hydroxyapatitie. These in vitro properties of Lipomyces starkeyi DXAMase are desirable for its application as a dental plaque control agent. This study was performed to determine the adjunctive oral hygiene benefits and safety of dextranase(Lipomyces starkeyi KSM 22 DXAMase)-containing mouthwash when used alongside normal tooth-brushing. This 6-month 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, 3 and 6 months, subjects were scored for plaque accumulation(Turesky modification of Quingley-Hein's plaque index), gingivitis status($L\ddot{o}e$ and Silness gingival index), and 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 daily after toothbrushing. All the groups showed significant increase in plaque accumulation since 1 month of experiment. During 6 months' period, the Dextranase mouthwash group showed the least increase in plaque accumulation, compared to the Chlorhexidine mouthwash and placebo groups. As for gingival inflammation, all the groups showed significant increase during 6 months of experiment. The Experimental group(Dextranase mouthwash) also showed the least increase in gingival index score, compared to the Positive control(Chlorhexidine mouthwash)as well as the Negative control(placebo)groups. Whereas the tooth stain was increased significantly in the Positive control group, compared to the baseline score and the Negative controlgroup since 3 months of mouthrinsing. It was significantly increased after 6 months in the Experimental group, still less severe than the Positive control group. As for the oral side effect, the Experimental group showed less tongue accumulation, bad taste, compared to the Positive control group. From these results, mouthrinsing with Lipomyces starkeyi KSM 22 dextranase provided adjunctive benefits to toothbrushing, comparable to 0.12% chlorhexidine mouthwash in inhibition of plaque accumulation and gingival inflammation and local side effects were if anything less frequent and less intense than chlorhexidine, with long-term use of the mouthwash. 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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