• 제목/요약/키워드: Clinical trial,

검색결과 2,106건 처리시간 0.039초

Development of a standardized mucositis and osteoradionecrosis animal model using external radiation

  • Seo, Mi Hyun;Lee, Min Young;Eo, Mi Young;Lee, Suk Keun;Woo, Kyung Mi;Kim, Soung Min
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • 제46권4호
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    • pp.240-249
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    • 2020
  • Objectives: Although the side effects of radiation therapy vary from mucositis to osteomyelitis depending on the dose of radiation therapy, to date, an experimental animal model has not yet been proposed. The aim of this study was to develop an animal model for assessing complications of irradiated bone, especially to quantify the dose of radiation needed to develop a rat model. Materials and Methods: Sixteen Sprague-Dawley rats aged seven weeks with a mean weight of 267.59 g were used. Atraumatic extraction of a right mandibular first molar was performed. At one week after the extraction, the rats were randomized into four groups and received a single dose of external radiation administered to the right lower jaw at a level of 14, 16, 18, or 20 Gy, respectively. Clinical alopecia with body weight changes were compared and bony volumetric analysis with micro-computed tomography (CT), histologic analysis with H&E were performed. Results: The progression of the skin alopecia was different depending on the irradiation dose. Micro-CT parameters including bone volume, bone volume/tissue volume, bone mineral density, and trabecular spaces, showed no significant differences. The progression of osteoradionecrosis (ORN) along with that of inflammation, fibrosis, and bone resorption, was found with increased osteoclast or fibrosis in the radiated group. As the radiation dose increases, osteoclast numbers begin to decrease and osteoclast tends to increase. Osteoclasts respond more sensitively to the radiation dose, and osteoblasts are degraded at doses above 18 Gy. Conclusion: A standardized animal model clinically comparable to ORN of the jaw is a valuable tool that can be used to examine the pathophysiology of the disease and trial any potential treatment modalities. We present a methodology for the use of an experimental rat model that incorporates a guideline regarding radiation dose.

임플란트 식립 후 초기 안정성의 변화 (Initial Changes of Implant Stability from Installation during Early Bone Healing)

  • 박찬진;김대곤;조리라
    • 구강회복응용과학지
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    • 제29권3호
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    • pp.272-279
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    • 2013
  • 골치유 기간 중 임플란트-골 계면에서 일정 수준 이상의 미세동요가 발생하게 되면 임플란트의 골유착이 방해받게 되므로 임플란트 식립 후 초기 골반응에 관해 임플란트 안정성은 하나의 지표가 된다. 본 연구의 목적은 임플란트 식립 후 전향적인 연구를 통해 초기 임플란트 안정성 변화를 추적하여 골치유 양상을 추론하고자 하였다. 총 26명의 환자에게 식립된 30개의 임플란트를 대상으로 하악골에 1회법으로 식립 직후 1주 간격으로 12주간 공진주파수분석을 시행하여 초기 안정성의 변화를 구하였으며 식립 직후와 1개월 간격으로 변연골 흡수 정도를 방사선학적 방법으로 측정하였다. 식립 직후와 각 치유기간 동안의 ISQ값 비교에서 식립 4주에서 6주사이에 골질에 따른 차이를 보였으나(P<0.05), 6주 이후에는 골질군 간에는 임플란트 안정성 변화에 차이가 없었다(P>0.05). 방사선학적 검사에서는 변연골의 차이가 관찰기간내에 유의하게 변화하지 않았다(P>0.05). 임플란트 식립 후 초기 골치유과정은 골흡수과정에 연속적인 과정으로 4주 이후 바람직한 골치유과정이 진행됨을 공진주파수분석으로 관찰할 수 있었다.

적응 요인에 따른 보조부화술 (Assited Hatching, AH)의 효과 (The Effects of Assisted Hatching (AH) According to the Indications)

  • 김지수;강승호;권윤정;손인표;최규완;김수경;전한식;이제규;이승재;박종민
    • Clinical and Experimental Reproductive Medicine
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    • 제25권2호
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    • pp.123-128
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    • 1998
  • Implantation rates remain low following human in vitro fertilization (IVF). Suboptimal culture conditions may limit the ability of embryos to hatch as blastocysts, and artificial opening of the zona pellucida has been proposed as a means to promote subsequent hatching (assisted hatching). In this study, assisted hatching (AH) by zona drilling using acidic Tyrode's solution was performed in 320 patients, due to their age of more than 38 years (group A), the thick zona pellucida (group Z; $ZP\geq0.18{\mu}m$), and failures in implantation more than 3 times in previous IVF-ET trial (group P). This study was designed firstly, to study the effects of AH on the outcomes of IVF-ET according to the indications and secondly, to verify the appropriate application of AH. The results were as follows; 1. There was no difference in pregnancy rate between AH group (26.6%) and non-AH group (26.5%). 2. Assisted hatching (AH) showed significantly higher pregnancy rate of the patients with thick zona pellucid a than those of the patients with age factor and with the history of repeated implantation failure. But in the patients with age factor only, AH resulted in higher pregnancy rate. 3. Interestingly, the patients with complex factors including zona factor (Z: 33.9%; ZA: 30.4%; ZP: 31.6%; ZAP: 21.4%) showed higher pregnancy rates than other complex factors excluding zona factor (A: 24.4%, P: 0%; AP: 10.8%). From these results, AH is more helpful to the patients with thick zona pellucida rather than patients with older age and/or previous repeated implantation failure.

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참죽나무 새순 추출물의 항균 활성과 피부 보습효과에 관한 연구 (Antibaterial Activity and Skin Moisturizing Effect of Cedrela sinensis A. Juss Shoots Extracts)

  • 김선영;이민혜;조나래;박수남
    • 대한화장품학회지
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    • 제36권4호
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    • pp.315-321
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    • 2010
  • 본 연구에서는 피부 상재균에 대한 참죽나무 새순 추출물의 항균 작용과 참죽나무 새순 추출물을 함유하는 크림을 제조하여 인체 피부를 대상으로 보습 효능을 측정하였다. 참죽나무 새순 추출물의 네 가지 피부 상재균에 대한 MIC를 측정한 결과, P. acnes과 S. aureus에 대한 MIC는 각각 0.13 %, 0.03 %로 비교 물질인 methyl paraben보다 더 우수한 항균 활성을 나타내었고, P. ovale과 E. coli에 대한 MIC는 모두 0.25 %로 methyl paraben 보다 낮은 MIC를 나타내었다. 피부 보습 효능을 측정하기 위해, 참죽나무 새순 추출물의 ethyl acetate 분획을 0.25 % 함유하는 크림을 제조하고, 이를 14명의 피실험자의 피부에 도포한 후 피부 수분 보유랑과 경표피 수분 손실량을 각각 30 min, 60 min 간격으로 180 min 동안 측정하였다. 피부 수분 보유량은 placebo 크림에 비하여 참죽나무 새순 추출물 함유 크림이 10 ~ 15 % 정도 더 큰 수분 보유량 증가율을 나타내었다. 경표피 수분 손실량을 측정하였을 때, 무도포(control) 상태의 경표피 수분 손실량은 8.9 g/$m^2h$, 추출물 함유 크림은 6.7 g/$m^2h$으로, 추출물을 함유한 크림이 피부 표면의 수분 손실을 감소시킴을 알 수 있었다. 참죽나무 새순 추출물의 ethyl acetate 분획의 항균 활성과 피부 보습효과에 대한 결과로부터 화장품 원료로서의 가능성을 확인하였다.

저열량 식이요법을 한 폐경 전 비만 여성의 휴식 대사량에 대한 마황과 오수유의 효과 (Effect of Ephedra Sinica and Evodia Rutaecarpa on Resting Metabolic Rate in Obese Premenopausal Women during Low-calorie Diet: A Randomized Controlled Clinical Trial)

  • 김수진;고병표;김형도;김진아;박정미;최승기;전우현;김호준
    • 한방비만학회지
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    • 제4권1호
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    • pp.45-54
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    • 2004
  • Objective: To evaluate the effect of Ephedra Sinica and Evodia Rutaecarpa on resting metabolic rate(RMR), weight and body composition in obese women during low-calorie diet. Methods: We recruited 90 healthy premenopausal women$(body\;mass\;index{\geq}25kg/m^2)$ and randomly assigned to three groups(ephedra group, evodia group and placebo group). Subjects were administered Ephedra Sinica(6g twice a day) or Evodia Rutaecarpa(6g twice a day) or placebo in a double-blind fashion and participated in low-calorie diet for 8 weeks. Resting metabolic rate and body composition were measured at baseline, 4 and 8 weeks. Results: RMR change for 4 weeks was significantly higher in the ephedra group compared with the placebo group(p<.05). But the change for 8 weeks was not significant and the Evodia group showed no significant RMR change. Weight and percent body fat changes for 4 weeks and 8 weeks were significantly higher than the placebo group in the ephedra group(p<.05), but the Evodia group didn't show significant level. Conclusions: This study supports and emphasizes the benefits of herbal medicine in maintaining or increasing RMR during low-calorie diet. Especially Ephedra treatment was effective on significant maintainment of RMR, loss of weight and percent body fat(P<.05).

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Evaluation of the Efficacy of Methylprednisolone, Etoricoxib and a Combination of the Two Substances to Attenuate Postoperative Pain and PONV in Patients Undergoing Laparoscopic Cholecystectomy: A Prospective, Randomized, Placebo-controlled Trial

  • Gautam, Sujeet;Agarwal, Amita;Das, Pravin Kumar;Agarwal, Anil;Kumar, Sanjay;Khuba, Sandeep
    • The Korean Journal of Pain
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    • 제27권3호
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    • pp.278-284
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    • 2014
  • Background: Establishment of laparoscopic cholecystectomy as an outpatient procedure has accentuated the clinical importance of reducing early postoperative pain, as well as postoperative nausea and vomiting (PONV). We therefore planned to evaluate the role of a multimodal approach in attenuating these problems. Methods: One hundred and twenty adult patients of ASA physical status I and II and undergoing elective laparoscopic cholecystectomy were included in this prospective, randomized, placebo-controlled study. Patients were divided into four groups of 30 each to receive methylprednisolone 125 mg intravenously or etoricoxib 120 mg orally or a combination of methylprednisolone 125 mg intravenously and etoricoxib 120 mg orally or a placebo 1 hr prior to surgery. Patients were observed for postoperative pain, fentanyl consumption, PONV, fatigue and sedation, and respiratory depression. Results were analyzed by the ANOVA, a Chi square test, the Mann Whitney U test and by Fisher's exact test. P values of less than 0.05 were considered to be significant. Results: Postoperative pain and fentanyl consumption were significantly reduced by methylprednisolone, etoricoxib and their combination when compared with placebo (P<0.05). The methylprednisolone + etoricoxib combination caused a significant reduction in postoperative pain and fentanyl consumption as compared to methylprednisolone or etoricoxib alone (P<0.05); however, there was no significant difference between the methylprednisolone and etoricoxib groups (P>0.05). The methylprednisolone and methylprednisolone + etoricoxib combination significantly reduced the incidence and severity of PONV and fatigue as well as the total number of patients requiring an antiemetic treatment compared to the placebo and etoricoxib (P<0.05). Conclusions: A preoperative single-dose administration of a combination of methylprednisolone and etoricoxib reduces postoperative pain along with fentanyl consumption, PONV, antiemetic requirements and fatigue more effectively than methylprednisolone or etoricoxib alone or a placebo.

월경전기증후군(月經前期症候群)(Premenstrual Syndrome)에 대한 침치료(鍼治療)의 효과(效果) (Effects of Acupuncture Treatment on the Premenstrual Syndrome: Controlled Clinical Trial)

  • 김성철;김성남;임정아;최창민;심은기;구성태;임정아;하주영;신경림;손인철
    • Journal of Acupuncture Research
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    • 제22권1호
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    • pp.41-60
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    • 2005
  • 본 연구에서는 침 치료가 PMS 증상에 미치는 영향을 알아보기 위하여 침 처치, MSSL-D 작성, 혈액검사, 체열검사 등의 임상시험을 실시한 결과 다음과 같은 결론을 얻을 수 있었다. 1. 침 치료는 월경전기증후군의 증상을 효과적으로 개선하였다. 2. 침의 효과는 신체증상과 정신증상 모두에 효과적이었으며, 대조군 처치도 정신증상에는 증상의 개선을 나타내었다. 3. 월경전기증후군의 증상의 변화와 혈중 progesterone 농도의 변화는 유의한 상관성이 없었다. 윌경전기증후군에서 침 치료는 신체의 좌우의 체표면 온도 차이를 유의하게 조절하였다. 이상의 연구 결과에서, 침 치료가 월경전증후군의 증상개선과 인체 불균형을 조절하는데 유의한 효과가 있음을 보여주었으나, 충분한 수의 여성을 대상으로 하는 임상시험을 통하여 월경전기증후군 에서 다양한 변증에 따른 침의 효과를 증명하는 연구가 필요할 것으로 사료된다.

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모유경구투여가 발뒤꿈치 천자 시 신생아의 통증반응에 미치는 효과 (The effect of oral breast milk on pain response of the neonates during heel lancing)

  • 김경화;박영임;김태임
    • Journal of the Korean Data and Information Science Society
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    • 제27권1호
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    • pp.203-215
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    • 2016
  • 신생아는 통증을 충분히 지각할 수 있는 해부학적 신경구조를 갖추고 있으며, 출생초기 통증경험은 이후 통증자극 경험 시 통증에 대한 민감도를 증가시켜 장기적인 신경해부학적, 행동적 후유증을 동반한다. 따라서 신생아기 통증관리는 신생아 간호의 주요 쟁점이 되고 있다. 본 연구는 진정효과가 있는 것으로 알려진 모유를 이용하여 통증이 동반되는 발뒤꿈치 천자 시 모유경구투여가 신생아의 통증완화에 미치는 효과를 검증함으로써 안전하고 효과적인 신생아 통증관리 중재에 대한 근거를 제시하고자 실시하였다. 연구결과 모유경구투여는 통증을 수반하는 간단한 처치 시 신생아의 통증을 완화시켜 주는데 효과가 있음을 확인할 수 있었다. 본 연구 결과는 모유의 통증완화 효과에 대한 경험적 근거를 제시함으로써 간호 실무에서 통증완화 중재로 널리 활용할 수 있는 계기를 마련한 점에서 의의가 있다. 추후 반복연구를 통한 경험적 근거의 축적과 더불어, 모유경구투여 중재가 독자적 간호중재로서 간호 실무에 적극 활용될 것을 기대하는 바이다.

What is the effect of initial implant position on the crestal bone level in flap and flapless technique during healing period?

  • Al-Juboori, Mohammed Jasim;Ab Rahman, Shaifulizan;Hassan, Akram;Ismail, Ikmal Hisham Bin;Tawfiq, Omar Farouq
    • Journal of Periodontal and Implant Science
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    • 제43권4호
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    • pp.153-159
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    • 2013
  • Purpose: The level of the implant above the marginal bone and flap design have an effect on the bone resorption during the healing period. The aim of this study is to detect the relationship between the level of the implant at the implant placement and the bone level at the healing period in the mesial and distal side of implants placed with flapless (FL) and full-thickness flap (FT) methods. Methods: Twenty-two nonsubmerged implants were placed with the FL and FT technique. Periapical radiographs were taken of the patient at implant placement, and at 6 and 12 weeks. By using computer software, bone level measurements were taken from the shoulder of the healing cap to the first bone implant contact in the mesial and distal side of the implant surface. Results: At 6 weeks, the correlation between the crestal bone level at the implant placement and crestal bone level of the FT mesially was significant (Pearson correlation coefficient=0.675, P<0.023). At 12 weeks, in the FT mesially, the correlation was nonsignificant (Spearman correlation coefficient=0.297, P<0.346). At 6 weeks in the FT distally, the correlation was nonsignificant (Pearson correlation coefficient=0.512, P<0.107). At 12 weeks in the FT distally, the correlation was significant (Spearman correlation coefficient=0.730, P<0.011). At 6 weeks in the FL mesially, the correlation was nonsignificant (Spearman correlation coefficient=0.083, P<0.809). At 12 weeks in the FL mesially, the correlation was nonsignificant (Spearman correlation coefficient= 0.062, P<0.856). At 6 weeks in the FL distally, the correlation was nonsignificant (Spearman correlation coefficient=0.197, P<0.562). At 12 weeks in the FL distally, the correlation was significant (Pearson correlation coefficient=0.692, P<0.018). Conclusions: A larger sample size is recommended to verify the conclusions in this preliminary study. The bone level during the healing period in the FT was more positively correlated with the implant level at implant placement than in the FL.

태극침법이 정신적 스트레스를 가한 20대 소음인 남성의 심박변이도에 미치는 영향 (Effects of Taegeuk Acupuncture on the Autonomic Nervous System by Analyzing Heart Rate Variability in 20's Soeumin)

  • 김남식;김진엽;곽상규;신임희;남상수;김용석
    • Journal of Acupuncture Research
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    • 제30권3호
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    • pp.39-49
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    • 2013
  • Objectives : The purpose of this study is to assess the effect of Taegeuk acupuncture on reducing mental stress by analyzing heart rate variability in Soeumin. Methods : Six Soeumin-diagnosed men participated in this study. They were randomly divided into group A and group B. Each participant went through 4 sessions every week with 1 week of washout period in between each session. HRV was measured three times at every session; at baseline, after administering mentally stressful circumstances and after applying Soeumin Taegeuk acupuncture or Soyangin Taegeuk acupuncture. This study was designed as a crossover clinical trial. Group A participants were treated with two sets of Soeumin Taegeuk and Soyangin Taegeuk acupuncture treatment in respective order (i.e. Soeumin Taegeuk - Soyangin Taegeuk - Soeumin Taegeuk - Soyangin Taegeuk acupuncture treatment). Group B participants were treated with reverse-ordered acupuncture treatment (i.e. Soyangin Taegeuk - Soeumin Taegeuk - Soyangin Taegeuk - Soeumin Taegeuk acupuncture treatment ). Bayesian analysis was performed by using WinBUGS(Ver. 1.4.3) for comparison between Soeumin Taegeuk acupuncture and Soyangin Taegeuk acupuncture. Results : Overall, Soeumin Taegeuk acupuncture tends to reduce LF/HF ratio, LF, HF, LF(Norm) and increase HF(Norm) more than Soyangin Taegeuk acupuncture, but the difference was not statistically significant. In one participant, however, Soeumin Taegeuk acupuncture reduced LF/HF ratio, LF(Norm) and increased HF(Norm) more than Soyangin Taegeuk acupuncture, and the difference was stastatistically significant. Conclusions : This study suggests that Soeumin Taegeuk acupuncture might be an effective means of stabilizing mental stress-induced imbalance of autonomic nervous system for Soeumin.