• 한국식품위생안전성학회:학술대회논문집
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• 한국식품위생안전성학회 2004년도 추계심포지움 및 학술발표회 : 건강기능식품의 안전성 평가와 개발
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• pp.59-70
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• 2004

A randomized double-blind placebo-controlled study was conducted on 63 subjects to determine the antihypertensive effect of a vegetable drink in which sardine protein hydrolysates containing a dipeptide, Valyl-Tyrosine (VY), were incorporated. The subjects, consisting of people with mild hypertension, high-normal blood pressure and normal blood pressure, were randomly divided into test (male/female=25.6, average age 50.1${\pm}$10.4 years old) and control groups (26/6, 49.0${\pm}$5.0). Each subjects in the test group was given 195g of the vegetable drink containing 0.5g of sardine peptides (sardine protein hydrolysates) with 0.4 mg of VY (test drink) once a day for 13 weeks in a row, and subjects in the control group were given the same amount of the vegetable drink without sardine peptides (control drink) in the same manner. In the test group, 40 subjects with mild hypertension of high-normal blood pressure (130 mmHg${\leq}$systolic blood pressure (SBP)<160 mmHg and/or 80 mmHg${\leq}$diastolic blood the start of the test to 134.4${\pm}$11.1 mmHg during the first week of the test period, after which similar values were seen throughout the test period (13 weeks). Compared to the control group, the difference in SBP from vaseline was statistically significant in the test group throughout the intake period. DBP also decreased significantly from 88.0${\pm}$7.9 mmHg at baseline to 83.5${\pm}$8.6 mmHg after 13 weeks. In the control group, SBP and DBP were 140.8${\pm}$8.4 mmHg and 90.5${\pm}$6.6 mmHg respectively at the start of the test, and neither decreased during the test period. In subjects with normal blood pressure, neither those in the test group nor those in the control group showed a significant change in SBP and DBP during the test period. An excessive ingestion test was performed on 25 subjects with hypertension, mild hypertension, high-normal blood pressure, and normal blood pressure by giving 585g (3 times the recommended amount of intake) of the test drink for 14 days in a row. As a result, a significant decrease of blood pressure was observed in the hypertension, mild hypertension and high-normal blood pressure groups, but no excessive decline in blood pressure or any side-effects were associated with any subjects during the test period. In the groups with normal blood pressure, the excessive ingestion of the test drink did not affect blood pressure. In these two studies, physical check-ups and biochemical analyses of blood and urine were also conducted in all subjects, and no abnormalities were observed. These results suggest that the test drink containing sardine protein hydrolysates exhibited the antihypertensive effect in only the subjects with mild hypertension or high-normal blood pressure. No adverse effects were observed in either hypertensive of normotensive subjects.

• Pediatric Gastroenterology, Hepatology & Nutrition
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• 제5권2호
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• pp.174-180
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• 2002

목 적: 총정맥영양법의 합병증인 간담도계 장애시 ursodeoxycholic acid (UDCA) 투여는 독성이 있는 내인성 담즙의 분비를 촉진하여 간손상을 감소시키는 역할을 하는 것으로 알려져 있다. 그러나 대부분의 연구는 합병증 발생 후 치료에 관한 것이어서 본 연구자들은 UDCA를 총정맥영양법의 시작과 동시에 조기 투여할 경우 그 예방효과를 이중맹검 위약대조군 연구로써 알아보고자 하였다. 방 법: 2000년 5월부터 2002년 5월까지 10일 이상의 총정맥영양을 받은 13명의 환아를 대상으로 하였다. 총정맥영양 시작과 동시에 UDCA를 투여받는 시험군 7명, 위약을 투여받는 대조군 6명을 이중맹검법으로 구분하였다. 연령은 생후 1일부터 13세까지이고 환아들의 진단은 경관영양이 불가능한 미숙아와 뇌성마비아, 만성설사, 거식증, 췌장염, 주기성 구토증 등이었다. 총정맥영양의 기간은 10일에서 70일까지였다. 주기적으로 간기능을 비롯한 검사항목등을 측정하였으며 총정맥영양의 기간, 조성, 투여속도, 열량 등이 조사 기록되었고 total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase에 대하여 군간 비교하였다. 결 과: Mixed procedure model을 이용한 분석에서 시험군을 reference로 하였을 때 대조군의 autoregressive coefficient 값은 total bilirubin의 경우 0.4419 (p=0.0651), AST는 -0.0431 (p=0.7923), ALT는 0.2398 (p=0.2416), 그리고 alkaline phosphatase는 0.2459 (p=0.1922)였다. 결 론: 총정맥영양과 UDCA를 초기부터 동시 투여하였을 때 total bilirubin은 대조군에 비하여 상승하지 않는 것으로 나타났으나 통계적으로 유의하지는 않았다.

• 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.

• Journal of Dental Anesthesia and Pain Medicine
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• 제19권1호
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• pp.55-66
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• 2019

Background: Postoperative nausea and vomiting (PONV) frequently occurs following bimaxillary orthognathic surgeries. Compared to opioids, Nefopam is associated with lower incidences of PONV, and does not induce gastrointestinal tract injury, coagulopathy, nephrotoxicity, or fracture healing dysfunction, which are common side effects of Nonsteroidal anti-inflammatory drugs. We compared nefopam- and fentanyl-induced incidence of PONV in patients with access to patient-controlled analgesia (PCA) following bimaxillary orthognathic surgeries. Methods: Patients undergoing bimaxillary orthognathic surgeries were randomly divided into nefopam and fentanyl groups. Nefopam 120 mg or fentanyl $700{\mu}g$ was mixed with normal saline to a final volume of 120 mL. Patients were given access to nefopam or fentanyl via PCA. Postoperative pain intensity and PONV were measured at 30 minutes and 1 hour after surgery in the recovery room and at 8, 24, 48, and 72 hours after surgery in the ward. The frequency of bolus delivery was compared at each time point. Results: Eighty-nine patients were enrolled in this study, with 48 in the nefopam (N) group and 41 in the fentanyl (F) group. PONV occurred in 13 patients (27.7%) in the N group and 7 patients (17.1%) in the F group at 8 hours post-surgery (P = 0.568), and there were no significant differences between the two groups at any of the time points. VAS scores were $4.4{\pm}2.0$ and $3.7{\pm}1.9$ in the N and F groups, respectively, at 8 hours after surgery (P = 0.122), and cumulative bolus delivery was $10.7{\pm}13.7$ and $8.6{\pm}8.5$, respectively (P = 0.408). There were no significant differences in pain or bolus delivery at any of the remaining time points. Conclusion: Patients who underwent bimaxillary orthognathic surgery and were given nefopam via PCA did not experience a lower rate of PONV compared to those that received fentanyl via PCA. Furthermore, nefopam and fentanyl did not provide significantly different postoperative pain control.

• Journal of Ginseng Research
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• 제42권4호
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• pp.571-576
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• 2018

Background: Korean Red Ginseng (KRG) has been used in Asia for its various biological effects, but no studies have investigated the safety of its long-term intake. Therefore, the present study evaluated the safety of KRG intake for 24 weeks. Methods: We randomized 1,000 participants in a 1:1 ratio into two groups, which were treated daily with 2 g of KRG or a placebo for 24 weeks. The primary endpoint was all adverse events and adverse drug reactions (ADRs) that occurred after KRG or placebo administration, which were reported at week 4, 12, and 24 after the baseline visit. Results: In total, 192 and 211 participants experienced adverse events in the KRG and placebo groups (39.2% and 42.0%, respectively; p = 0.361), and 59 and 57 KRG- and placebo-treated individuals reported ADRs (12.0% and 11.4%, respectively; p = 0.737). The frequently occurring ADRs were pruritus (2.0%), headache (1.6%), diarrhea (1.4%), and dizziness (1.2%) in the KRG group and pruritus (2.0%), headache (1.8%), dizziness (1.6%), rash (1.4%), and diarrhea (1.2%) in the placebo group. Discontinuation of drug administration due to ADRs was reported in 13 participants, six (1.2%) and seven (1.4%) in the KRG and placebo groups, respectively (p = 0.814). No significant abnormal changes were revealed by anthropometric, laboratory, and vital sign measurements in the KRG group compared with those in the placebo group. Conclusion: The present study confirms the safety and tolerability of daily intake of 2 g of KRG for 24 weeks by healthy adults.

• 스트레스연구
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• 제26권4호
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• pp.305-311
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• 2018

화병은 뚜렷한 스트레스 사건과 관련되어 가슴의 답답함, 열감, 치밀어 오름, 억울하고 분한 감정 등이 나타나는 증후군이다. 본 논문에서는 화병에 대한 황련해독탕의 임상시험 결과를 교감신경의 활성도를 반영한다고 알려져 있는 심박변이도의 저주파(0.04~0.15 Hz) 영역 값을 중심으로 분석하여 다음과 같은 결과를 얻었다. 첫째, 황련해독탕 시험군에서 초기 심박변이도 저주파 값이 클수록 불면 증상의 개선 정도가 작게 나타났다. 둘째, 위약과 비교했을 때, 황련해독탕은 복용 7일 후 심박변이도 저주파 값을 유의하게 감소시켰다. 셋째, 화병 증상 중 가슴이 답답함, 치밀어 오름, 분노가 심박변이도 저주파 값과 유의미한 상관성이 있었다. 이를 바탕으로 심박변이도는 화병 환자를 평가할 때 유용할 것이라고 기대된다.

• 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.

• Preventive Nutrition and Food Science
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• 제6권1호
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• pp.51-56
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• 2001

This study was carried out to evaluate whether antioxidant nutrient suppplementation with $\alpha$-tocopherol, vitamin C, $\beta$-carotene, and selenium reduces the lipid peroxide levels and increases the antioxidative enzyme activities in patients with coronary hart disease. Eighty nine patients participated in a randomized, double-blind, placebo-controlled trial. The antioxidant group (45 patients) was given daily doses of $\alpha$-tocopherol (400 IU), vitamin C (50 mg), $\beta$-carotene (15 mg), and selenium (50 $\mu\textrm{g}$) and forty four patients received a placebo. Thirty eight subjects (84.4%) of the antioxidant group and thirty nine subjects (88.6%) of the placebo group completed the three-month supplementation. Serum levels of tocopherol, vitamin C and $\beta$-carotene significantly increased in the antioxidant group compared with the baseline (p<0.05). Thiobarbituric acid-reactive substances(TBARS) decreased significantly (0.6 nmol MDA/mL) in the antioxidant group compared with that (0.09 nmol MDA/mL) in the placebo group (p=0.03). However, antioxidant supplementation did not affect the level of oxidized-LDL measured as autoantibodies against oxidized-LDL. The superoxide dimutase activity in red blood cells increased in the antioxidant group compared with the baseline (p<0.05). However, glutathione peroxidase activities did not change after supplementation in both groups, and catalase activity significantly decreased in the placebo group (p<0.05). These results suggest that antioxidant supplementation for 3 months with $\alpha$-tocopherol, vitamin C, $\beta$-carotene and selenium in patients with coronary heat disease may be partially protective against oxidative stress.

• Journal of Ginseng Research
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• 제40권3호
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• pp.260-268
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• 2016

Background: During the aging process, skin shows visible changes, characterized by a loss of elasticity and the appearance of wrinkles due to reduced collagen production and decreased elasticity of elastin fibers. Panax ginseng Meyer has been used as a traditional medicine for various diseases due to its wide range of biological activities including skin protective effects. Ginsenosides are the main components responsible for the biological activities of ginseng. However, the protective activities of an enzymatic preparation of red ginseng against human skin aging have not been investigated. Methods: The efficacy of an enzyme-treated powder complex of red ginseng (BG11001) in preventing human skin aging was evaluated by oral administration to 78 randomized individuals. All patients were requested to take three daily capsules containing either 750 mg of BG11001 or a placebo vehicle for 24 wk; at the end of the testing period, skin roughness, elasticity, and skin water content were measured. Results: BG11001 significantly reduced the average roughness of eye wrinkles and the Global Photo Damage Score compared with the placebo, although there were no significant differences in arithmetic roughness average between the groups. In addition, gross elasticity and net elasticity values increased, and transepidermal water loss level decreased, indicating improved skin elasticity and moisture content. Conclusion: In conclusion, enzyme-treated red ginseng extract significantly improved eye wrinkle roughness, skin elasticity, and moisture content. Moreover, enzyme-treated red ginseng extract would be useful substance as a bio-health skin care product.

• The Korean journal of internal medicine
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• 제33권6호
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• pp.1224-1233
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• 2018

Background/Aims: The objective of this study was to determine the efficacy and safety of add-on therapy with certolizumab pegol (CZP) in active rheumatoid arthritis (RA) patients of a single ethnicity. Methods: In this 24-week, phase 3, randomized, double-blind, placebo-controlled trial, eligible patients (n = 127) were randomized 2:1 to subcutaneous CZP + methotrexate (MTX; 400 mg at week 0, 2, and 4 followed by 200 mg every 2 weeks) or placebo + MTX. Results: At week 24, the American College of Rheumatology criteria for 20% (ACR20) response rate was significantly greater with CZP + MTX than with placebo (66.7% vs. 27.5%, p < 0.001). Differences in ACR20 response rates for CZP vs. placebo were significant from week 1 (p < 0.05) and remained significant through week 24. The CZP group reported significant improvement in physical function and disability compared to the placebo group (p < 0.001) at week 24, as assessed by Korean Health Assessment Questionnaire-Disability Index (KHAQ-DI). Post hoc analysis indicated that the proportion of patients who had ACR70 responses, Disease Activity Score 28 (DAS28) low disease activity, and DAS28 remission at week 24 was greater in CZP + MTX-treated patients who achieved a decrease in DAS28 ${\geq}1.2$ (43.8%) at week 4 than in nonresponders. Among 18 (22.2%) and 14 patients (35.0%) in CZP and placebo groups who had latent tuberculosis (TB), none developed active TB. Most adverse events were mild or moderate. Conclusions: CZP treatment combined with MTX in active RA patients with moderate to severe disease activity and an inadequate response to MTX resulted in rapid onset of efficacy, which is associated with better clinical outcome at week 24 and has an acceptable safety profile, especially in an intermediate TB-burden population.