• Title/Summary/Keyword: Double-blind

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Effects of Polycan on bone Metabolism in healthy Perimenopausal Women: a 12-week Randomized, Double-blind, Placebo-controlled study (폴리칸이 중년 여성의 골대사에 미치는 영향: 12주간의 무작위배정, 이중눈가림, 플라세보 대조 연구)

  • Kim, Min-Gul;Ha, Ki-Chan;Back, Hyang-Im;Kim, Sun-Young;Kim, Joo-Wan;Kim, Ki-Young;Cho, Hyung-Rae;Chae, Han-Jung;Chae, Soo-Wan;Kim, Dal-Sik
    • Korean Journal of Clinical Pharmacy
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    • v.21 no.4
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    • pp.297-304
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    • 2011
  • 배경: 골다공증은 골대사의 불균형으로 인해 골 흡수가 골 형성보다 많아져 골밀도가 감소함으로서 발생한다. 골다공증의 이상적인 치료목표는 골형성을 증가시키거나 골소실을 방지하여 골량을 현 상태로 유지하는 것이다. 따라서 향후 발생되는 골소실을 에방하는 것이 골다공증의 원칙적이고 효과적인 치료방법이 될 것이다. 본 연구에서는 흑효모 중 $Aureobasidium$ $pullulans$으로부터 유래한 폴리칸(베타-글루칸)이 중년여성의 골대사에 미치는 영향을 규명하고자 하였다. 연구방법: 골대사에 대한 폴리칸의 효과를 규명하기 위해 12주간의 무작위배정, 이중눈가림, 플라세보 대조 임상연구를 수행하였다. 총 60명(폴리칸 투여군30명, 플라세보 투여군 30명)의 중년 여성 피험자가 등록되어 이 중 총 58명의 피험자가 최종적으로 12주간의 임상연구를 종료하였다. 결 과: 폴리칸(150 mg/d) 투여 12주 후, 폴리칸 투여군은 요 중 Deoxypyridinoline (DPD) 농도가 유의적인 감소를 보였다($P$=0.014). 혈청 중 Osteocalcin(OSC) 농도는 두 군 모두에서 유의적으로 증가하였으며, bone-specific alkaline posphatase (bALP) 와 collagen type 1 cross-linked C-telopeptide (CTx)는 유의적 변화가 보이지 않았다. 폴리칸은 골밀도(BMD)와 혈청 부갑상선 호르몬(iPTH)에 대해 유의적인 변화를 보이지 않았으나, 24시간 요 중 Ca 배설량은 폴리칸 투여군에서 유의하게 감소되었다($P$=0.028). 또한 폴리칸 투여군에서 고밀도지단백 콜레스테롤(HDL-cholesterol) 농도의 증가 경향 및 중성지방(triglyceride)의 유의적인 감소가 보였다. 임상연구 기간 중에 발생한 이상반응은 두 군간에 유의적인 차이를 보이지 않았다. 결 론: 본 연구에서는 폴리칸이 골대사 및 지질에 대해 일부 개선효과가 있음을 보여주었다. 그러나, 골다공증 예방 측면에서 보다 장기적인 임상연구와 피험자 수를 확대하여 골대사 및 지질대사에 대한 폴리칸의 예방적 효과를 규명할 필요가 있을것으로 사료된다.

The effect of Chiljehyangbuhwan on the abdomial & palmar temperature in the primary dysmenorrhea patients (칠제향부환(七製香附丸)이 원발성(原發性) 월경통(月經痛) 환자(患者)의 복부(腹部) 및 수장부(手掌部) 온도(手掌部 溫度)에 미치는 영향(影響))

  • Lee, Chang-Hoon;Cho, Jung-Hoon;Jang, Jun-Bock;Lee, Kyung-Sub;Yoon, Young-Jin
    • Journal of Oriental Medical Thermology
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    • v.5 no.1
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    • pp.46-58
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    • 2006
  • Purpose: We intended to observe the relations between Chiljehyangbuhwan and abdominal & palmar temperature according to primary dysmenorrhea severity. Methods: We selected the 100 primary dysmenorrhea patients by the screening tests (first screening test-inquiry, second screening test-clinical test. additionally WHR (Waist-to-Hip ratio) by Inbody 2.0). By the fixed blocked randomization and double blind method, Chiljehyangbuhwan or placebo was administered for 1 menstration period. Finally, 69 patients remainded. Before and after administration, we measured 4 points abdominal temperature (Chon-jung (CV17), Chung-wan(CV12), Kwan-won(CV4). Chung-guk(CV3)) by DITI(DOREX Inc., USA). And then we checked the difference of temperature $({\Delta}T)$ between CV17 and CV12/CV17 and CV4/CV17 and CV3/CV12 and CV4/CV12 and CV3. Also, we measured 2 points (palmar region, upper front of forearm) for the difference of palmar temperature $({\Delta}T)$. Then, we checked palmar temperature minus upper front of forearm temperature and took an average of right and left ${\Delta}T.$ After that. we compared ${\Delta}T$ with primary dysmenorrhea severity evaluated by VRS (verbal rating scale) and MVRS (multidimensional verbal rating scale). In dysmenorrhea severity. we standardized scale score and 3-group-severity by score (mild, moderate. severe). Besides, we compared palmar ${\Delta}T$ with abdominal ${\Delta}T$. For statistics, we used ANOVA and Spearman's rho correlations. SPSS 13.0 for windows. Results: In case of MVRS, though Chiljehyangbuhwan was correlated to abdominal ${\Delta}T$(CV12 and CV3/CV12 and CV4). it was not correlated to palmar ${\Delta}T$. In case of VRS, though Chiljehyangbuhwan was not correlated to abdominal ${\Delta}T$. it was correlated to palmar ${\Delta}T$. However. palmar ${\Delta}T$ was not correlated to abdominal ${\Delta}T$. Statistically they showed significant result (p<0.05). Conclusion: The primary dysmenorrhea patients showed that severity by MVRS was connected with abdominal ${\Delta}T$ (CV12 and CV3/CV12 and CV4) and severity by VRS was connected with palmar ${\Delta}T$ after Chiljehyangbuhwan administration. So we can consider Chiljehyangbuhwan partially effects the abdominal & palmar temperature according primary dysmenorrhea severity. However, palmar temperature was not correlated to abdominal temperature. Therefore, we need further study.

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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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    • v.17 no.2
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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.

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

  • Yoo, Ick-Dong;Choo, Soo-Jin;Ryoo, In-Ja;Kim, Young-Hee;Xu, Guang-Hua;Kim, Ki-Ho;Han, Chang-Sung;Kim, Su-Jin;Kim, Jin-Woong;Son, Eui-Dong
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.35 no.2
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    • pp.151-158
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    • 2009
  • We found that silymarin exhibited the inhibitory effect on melanogenesis in a spontaneously immortalized mouse melanocyte cell line, Mel-Ab. Silymarin is a standardized extract obtained from the dried seeds of milk thistle (Silybum marianum Gaertn.). Silymarin significantly prevented melanin production in a dose-dependent manner with an $IC_{50}$ value of 28.2 ${\mu}g/mL$ without effects on cell viability. Also, silymarin inhibited tyrosinase activity in melanocyte, while it did not affect the catalytic activity of cell-free tyrosinase. Furthermore, Western blot analysis indicated that silymarin decreased the expression of tyrosinase protein. Silybin A/B and isosilybin A/B were also able to inhibit melanin production and tyrosinase expression in protein level. Double blind study on the clinical efficacy of a cream containing 2 % silymarin showed that silymarin have a significant skin whitening effect. Therefore, this study suggests that silymarin may be useful as a natural skin whitening agent.

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

  • Hong, Eun-Suk;Ahn, Gi-Woong;Jo, Byoung-Kee
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.34 no.2
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    • pp.129-135
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    • 2008
  • In this study, the potential anti-aging properties of Prunella vulgaris extract were investigated. According to our results, Prunella vulgaris extract increased collagen synthesis(74.7% at 250 ${\mu}g/mL$) and decreased on MMP-1 synthesis(90.2% at 200 ${\mu}g/mL$) and elastase activity(43.7% at 2.0%). Furthermore, it also showed free radical scavenging activity(76.9% at 2.0%) and reduced $H_2O_2$-induced cytoxicity(49.9% at 2.0%). A double-blind clinical study to investigate the effect of Prunella vulgaris extract on the skin's surface was conducted with 22 healthy volunteers, aged 34 to 48 years. The volunteers applied a cream formula with 4.0% of Prunella vulgaris extract, or placebo cream, on each crow's feet twice a day for 12 weeks. Skin wrinkles were evaluated with the naked eye and instrumental image analysis of silicone replicas, followed by statistical analysis. Twelve weeks after application of cream formula with 4.0% of Prunella vulgaris extract, we found significant improvement of facial wrinkle. Moreover, silicone replica analysis confirmed notable improvement in average of R2 and R3 at 12 weeks(p<0.05). These results demonstrate that Prunella vulgaris provides a remarkable and significant tensor and anti-wrinkle effect on the skin, which could be of great use in anti-aging skin care products.

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

  • Lee, Hwi-Yong;Lee, Jin-Bok;Cho, Yi-Hyun;Song, Beom-Yong;Yook, Tae-Han
    • Journal of Acupuncture Research
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    • v.27 no.1
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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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    • v.40
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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.

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

  • Son, Eun-Ju;Kim, Young-Jun;Kim, Do-Man;Chung, Hyun-Ju
    • Journal of Periodontal and Implant Science
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    • v.31 no.2
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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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The clinical effects of a hydroxyapatite containing toothpaste for dentine hypersensitivity (민감성 치아에 대한 수산화인회석 함유 치약의 임상적 효과)

  • Kim, Su-Hwan;Park, Jun-Beom;Lee, Chul-Woo;Koo, Ki-Tae;Kim, Tae-Il;Seol, Yang-Jo;Lee, Yong-Moo;Ku, Young;Chung, Chong-Pyung;Rhyu, In-Chul
    • Journal of Periodontal and Implant Science
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    • v.39 no.1
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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.

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

  • Kim, Tae-Su;Lee, Sung-Pyo;Park, So-I;Yang, Woong-Suk;Kang, Myung-Hwa;Murai, Hiromichi;Okada, Tadashi;Lee, Jae-Hwan;Park, Il-Bum;Park, Hyun-Jun
    • Korean Journal of Food Science and Technology
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    • v.44 no.4
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    • pp.434-440
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    • 2012
  • A placebo-controlled double-blind ingestion study of a beauty supplement containing rice-derived ceramide was performed. Thirty three subjects who always tended to have rough skin due to dryness participated in the study. Dermatological diagnosis by physicians showed that the supplement significantly improved dryness and itching of the skin. On measurement of water content in the skin, the supplement was shown to significantly increase water content in the skin. On microscopic three-dimensional analysis of the epidermis, the supplement was shown to improve smoothness, exfoliation, and short-term ingestion of the supplement containing rice derived ceramide, which is very effective as skin beautifying food.