• 대한불안의학회지
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• 제5권1호
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• pp.8-13
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• 2009

Saccharomyces cerevisiae 효모추출물인 SCP-20은 동물실험에서 항스트레스, 항불안 및 항우울 효과를 보인 바 있다. 본 연구는 정상인을 대상으로 위약통제 이중맹검 연구를 시행하여 SCP-20의 효과를 검증하였다. 선별과정을 거치고 충분한 순응도를 보인 61명의 자원자의 정보가 최종 분석에 사용되었다. 이들은 4주간 SCP-20이 70% 함유된 캡슐, SCP-20 99.5% 함유 캡슐 그리고 위약캡슐 중 한가지를 하루 4회 복용하였다. 4주 뒤 SCP-20 복용군은 위약군에 비해 SRI, BAI 점수에서 유의한 개선을 보였으나,BDI 점수변화는 군간 유의미한 차이가 없었고 집단별 사후검정에서 SCP99.5군만이 복용 전후 유의미한 BDI 점수감소를 보였다. HRV는 유의미한 변화를 보이지 않았다. 부작용은 관찰되지 않았다. SCP-20은 정상인에게 투여하였을 때 위약에 비해 유의하게 항스트레스, 항불안 효과를 보이나 항우울 효과는 명확하지 않았으며, 부작용은 보이지 않았다. 향후 SCP-20의 항우울기능 추가 검증 및 환자군을 대상으로 한 대규모, 장기적 연구가 필요하다.

• 대한화장품학회지
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• 제35권3호
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• pp.219-228
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• 2009

1.0 wt% triclosan과 0.4 wt% 죽염을 함유한 바디워시의 액취 등에 미치는 효과에 대한 연구를 위하여 in vitro 항균시험 및 무작위 배정, 이중맹검, 교차설계로 진행한 임상시험을 실시하였다. 1.0 wt% triclosan과 0.4 wt% 죽염을 함유한 바디워시는 Corynebacterium glutamicum, Corynebacterium xerosis, Corynebacterium jeikeium를 균주로 한 in vitro 항균 실험에서 모두 우수한 항균 효과가 있었다. 1.0 wt% triclosan과 0.4 wt% 죽염을 함유한 바디워시는 액취를 전반적으로 유의성 있게 감소시켰고 그 효과는 최소 9 h 동안 지속되었다. 1.0 wt% triclosan과 0.4 wt% 죽염을 함유한 바디워시는 액와 균수를 유의성 있게 감소시켰고 그 효과는 최소 9 h 동안 지속되었다. 임상시험 기간 동안 피시험자 전체에서 이상반응 증상은 나타나지 않았다. 결론적으로 1.0 wt% triclosan과 0.4 wt% 죽염을 함유한 바디워시는 액취에 대한 감소효과와 피부 안전성이 우수하였다.

• 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.

• Journal of Nutrition and Health
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• 제47권4호
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• pp.229-235
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• 2014

본 연구는 자일로올리고당을 설탕에 적용하여 임상시험을 통해 자일로올리고당 첨가량에 따른 설탕의 GI 저감효과와 혈당저감효과를 확인하였다. 건강한 성인 남녀 11명를 대상으로 표준식품인 포도당과 비교하여 분말 자일로올리고당을 14% 함유한 Xylo 14과 분말 자일로올리고당을 20% 함유한 Xylo 20을 섭취 후 표준식품과 비교식품의 IAUC를 통해 GI를 산출한 결과 Xylo 14는 $60.0{\pm}23.5$로 Medium GI 식품으로 나타났으며, Xylo 20은 $54.3{\pm}17.7$로 Low GI 식품으로 나타났다. 순수한 설탕의 GI 68과 비교하면 각각 11.8%와 20.1% 혈당상승 저감효과를 나타낼 수 있었다. AUC는 15~90분까지 모든 구간에서 유의적인 차이 (p < 0.05)를 나타내었다. 따라서 Xylo 14와 Xylo 20은 혈당 저감효과를 나타냄과 동시에 7~10 g 이상 섭취하면 자일로올리고당의 1일 유효섭취량도 만족시킬 수 있으므로 기능성 설탕으로서의 활용이 기대된다.

• Journal of Nutrition and Health
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• 제37권5호
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• pp.352-363
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• 2004

Lipid-lowering effects of the inulin have been demonstrated in animal, yet attempts to reproduce similar effects in humans have generated conflicting results. In this study, the lipid-lowering potential of inulin and especially its effect on bile acid and neutral sterol excretion were investigated in Korean postmenopausal women. Nineteen postmenopausal women were randomly divided into two groups in a double-blind parallel design and consumed one of two supplements for 12 weeks; placebo of 8g maltodextrins/sucrose mixture (placebo group) or 8g inulin (inulin group). There were no significant changes in body weight during the supplementation period in either inulin or placebo group. Dietary consumption of animal fat in both group tended to decrease after 12 weeks of experiment. Intake of cholesterol was lower in placebo group, whereas the decrease of cholesterol intake in inulin group did not reach statistical significance after 12 weeks. The levels of serum total cholesterol (TC) and LDL-cholesterol (LDL-C) were significantly decreased in both placebo (p＜0.05) and inulin group (p＜0.01) after supplementation for 12 weeks compared with the baseline. The levels of serum triglyceride (TG) and HDL-cholesterol (HDL-C) were not significantly affected by inulin supplements, but atherogenic index (AI) and LDL-C/HDL-C ratio (LHR) as a predictor for coronary heart disease were improved (p＜0.01) significantly after inulin supplementation. Therefore, inulin supplement may decrease the risk of cardiovascular disease via improving blood cholesterol level. Fecal weight and pH were not changed after 12 weeks of supplementation. There were no statistically significant changes for the fecal short-chain fatty acids (SCFAs). In inulin group, fecal deoxycholic acid (DCA) was significantly lowered compared with the baseline (p＜0.05) whereas other bile acids were not changed. During the 12 weeks of intervention, no differences were found in fecal excretion of neutral sterol in the two groups. In summary, dietary inulin decreases serum TC, LDL-C, AI, LHR and lowers excretion of fecal DCA in the Korean postmenopausal women. These results support the use of inulin for reducing risk factors for hyperlipidemic postmenopausal women. However, the exact mechanism (s) responsible for the blood lipid lowering action of inulin including altered fecal bile acid remain to be elucidated.

• 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.

• Journal of Nutrition and Health
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• 제49권3호
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• pp.144-152
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• 2016

본 연구는 귤피가루를 활용하여 모닝빵을 개발하고 이를 대학기숙사에 거주하고 있는 과체중 및 비만인 20대 남 녀에게 섭취하게 해봄으로써 아침결식률을 낮출 수 있는 새로운 식품 소재를 개발하고자 실시되었다. 체중과 BMI의 경우 GB 섭취군과 CPB 섭취군 모두에서 감소하였으며, CPB 섭취군에서 사전에 비해 사후 유의적으로 체중과 BMI가 감소한 것으로 나타났다 (p < 0.05). WHR은 GB 섭취군에서는 증가하는 경향을 보였으나 CPB 섭취군에서는 유의적으로 감소하였다 (p < 0.05). BFM은 두군 모두에서 유의적으로 증가하였으며 (p < 0.05) 군간에 유의성을 띄지 않았다. TC는 GB 섭취군에서는 증가하는 경향을 보였으나 CPB 섭취군에서는 유의적으로 감소하였다 (p < 0.05). HDL은 두군 모두에서 증가하였고 GB 섭취군에서 유의성을 보였다 (p < 0.05). LDL은 두군 모두에서 유의적으로 감소하였으며 (p < 0.05) 군간에 유의성은 없었다. GOT와 GPT는 GB 섭취군과 CPB 섭취군 모두에서 감소하였고 CPB 섭취군에서 유의성을 보였다 (p < 0.05). GB와 CPB를 섭취한 군간에 신체계측치와 혈액생화학적 수치에서 유의적인 차이를 보이는 항목은 없었으나 CPB 섭취군에서 사전에 비해 TC, LDL, GOT, GPT 수치가 유의적으로 감소하였다는 점에서 (p < 0.05) 본 연구는 시간적 흐름에 따라 변화를 추적하는 종단적 연구에 가깝다고 판단되며 본 연구를 통하여서 귤피가 심혈관계질환의 유병률을 낮춰줄 수 있는 잠재적 가능성이 있음을 임상적으로 확인하였다. 따라서 향후 본 연구와 유사한 연구들이 double blind cross-over study와 같은 대규모 임상연구로 진행되어 귤피의 지질관련 효과들을 보다 명확하게 입증해줄 필요성이 있을 것으로 판단된다.

• Journal of Preventive Medicine and Public Health
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• 제37권4호
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• pp.381-389
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• 2004

Objective : To compare the efficacy between SKI306X and Diclofenac by using generalized estimating equations (GEE) methodology in the analysis of correlated bivariate binary outcome data in Osteoarthritis (OA) diseases. Methods : A randomized, double-blind, active comparator-controlled, non-inferiority clinical trial was conducted at 5 institutions in Korea with the random assignment of 248 patients aged 35 to 75 years old with OA of the knee and clinical evidence of OA. Patients were enrolled in this study if they had at least moderate pain in the affected knee joint and a score larger than 35mm as assessed by VAS (Visual Analog Scale). The main exposure variable was treatment (SKI 306X vs. Diclofenac) and other covariates were age, sex, BMI, baseline VAS, center, operation history (Yes/No), NSAIDS (Y/N), acupuncture (Y/N), herbal medicine (Y/N), past history of musculoskeletal disease (Y/N), and previous therapy related with OA (Y/N). The main study outcome was the change of VAS pain scores from baseline to the 2nd and 4th weeks after treatment. Pain scores were obtained as baseline, 2nd and 4th weeks after treatment. We applied GEE approach with empirical covariance matrix and independent(or exchangeable) working correlation matrix to evaluate the relation of several risk factors to the change of VAS pain scores with correlated binary bivariate outcomes. Results : While baseline VAS, age, and acupuncture variables had protective effects for reducing the OA pain, its treatment (Joins/Diclofenac) was not statistically significant through GEE methodology (ITT:aOR=1.37, 95% CI=(0.8200, 2.26), PP:aOR=1.47, 95% CI=(0.73, 2.95)). The goodness-of-fit statistic for GEE (6.55, p=0.68) was computed to assess the adequacy of the fitted final model. Conclusions : Both ANCOVA and GEE methods yielded non statistical significance in the evaluation of non-inferiority of the efficacy between SKI306X and Diclofenac. While VAS outcome for each visit was applied in GEE, only VAS outcome for the fourth visit was applied in ANCOVA. So the GEE methodology is more accurate for the analysis of correlated outcomes.

• 동의생리병리학회지
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• 제22권1호
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• pp.204-208
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• 2008

This study was performed to investigate the effect of the extracts from Injinoryng-San on liver injury patients induced by alcohol. Injinoryung-San was recorded the drug for jaundice at Hwang-Je-Nae-Kyung. Twenty-seven patients who have intaked alcohol above 40 g, every day, 5 years, twenty-seventy ages were selected. After take a written consent, we divide them into experimental groups and control groups by double blind test. Each groups was evaluated every 2 weeks(2,4,6 weeks). After 2 weeks, Injinoryung-San groups significantly decreased GGT in comparison with control groups(p<0.05). After 4 weeks, Injinoryung-San groups significantly decreased MCV, GGT in comparison with control groups(p<0,05). After 6 weeks, Injinoryung-San groups significantly decreased MCV in comparison with control groups(p<0.05). Reviewing these experimental results, it appears that extracts of Injinoryung-San have pharmaceutical efficacy in GGT, MCV on liver injury patients induced by alcohol. But it has not efficacy in AST, ALT. According to drinking alcohol has becomes social problems, we should effort to make efficacious oriental medicines on alcoholic hepatitis.

• Clinics in Shoulder and Elbow
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• 제8권2호
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• pp.141-147
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• 2005

Purpose: The purpose of this study was to compare the effectiveness of postoperative pain control by intravenous patient-controlled analgesia (IV) to the effectiveness of postoperative pain control by continuous intra-lesional infusion of local anesthetics (IL) with or without an interscalene brachial plexus block (ISB) after arthroscopic shoulder surgery. Materials and Methods: We designed this prospective randomized case-controlled double-blind study, and allocated 84 consecutive patients to four groups according to postoperative analgesic method, i.e., Group IV, Group ISBIV, Group IL, and Group ISB-IL after arthroscopic shoulder surgery. Postoperative pain, side effects and supplemental analgesics were recorded at 1 hour and then at every 8 hours for 2 days. Result: The demographic and clinical characteristics of four groups were identical statistically. Interscalene block (Group ISB-IV, Group ISB-IL) was found to be effective at relieving pain and at reducing supplemental analgesic amounts at 1 and 8 hours postoperatively (p<0.05). Patients in the Group ISB-IL had less pain at 16 and 48 hours postoperatively than the other groups (p<0.05). Continuous intra-lesional infusion (Group IL, Group ISB-IL) was superior in reducing analgesic-related side effects (p<0.05). Conclusion: This study suggests that a combination of an interscalene brachial plexus block and continuous intralesional infusion of ropivacaine is an effective and safe method of postoperative pain control in patients after arthroscopic shoulder surgery.