• Title/Summary/Keyword: Trial Function

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Favorable Outcome in Elderly Asian Patients with Metastatic Renal Cell Carcinoma Treated with Everolimus: The Osaka Urologic Oncology Group

  • Inamoto, Teruo;Azuma, Haruhito;Nonomura, Norio;Nakatani, Tatsuya;Matsuda, Tadashi;Nozawa, Masahiro;Ueda, Takeshi;Kinoshita, Hidefumi;Nishimura, Kazuo;Kanayama, Hiro-Omi;Miki, Tsuneharu;Tomita, Yoshihiko;Yoshioka, Toshiaki;Tsujihata, Masao;Uemura, Hirotsugu
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.4
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    • pp.1811-1815
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    • 2014
  • Background: In clinical trials with no upper age limit, the proportion of older patients is usually small, probably reflecting the more conservative approach adopted by clinicians when treating the elderly. An exploratory analysis of elderly patients in the RECORD-1 Trial showed that patients ${\geq}$ 65 y.o. had superior median PFS than overall RECORD-1 population (5.4 months and 4.9 months, respectively). We investigated the efficacy, relative benefit and safety of Everolimus (EVE) as sequential therapy after failure of VEGFr-TKI therapy for older patients with metastatic renal cell cancer (mRCC), in daily practice. Materials and Methods: 172 consecutive IRB approved patients with mRCC (median age 65, M:F 135/37, 78% clear cell) who received salvage EVE at 39 tertiary institutions between October 2009 and August 2011 were included in this analysis. Some 31% had progressed on sunitinib, 22% on sorafenib, 1% on axitinib, 41% on sequential therapy, and 5% had received other therapy. Patients with brain metastases were not included and 95% of the patients had a ECOG (Eastern Cooperative Oncology Group) performance status (PS) of 0 or 1. Previous radiotherapy was an exclusion criterion, but prior chemotherapy was permitted. Adequate organ function and hematologic parameters were mandatory. EVE administration was approved by the institutional review board at each participating institution and signed informed consent was obtained from all patients. Results: Median time of the whole cohort to last follow-up was 3.5 months (range 0.4-15.2 months). Forty four percent were continuing to take EVE at last followup. There were 86 (50%) patients ${\geq}$ 65 y.o. and 86 (50%) <65 y.o. The percentage of patients who showed PR/SD was higher in the older group than in the younger one (5.9%/61.2% vs 1.2%/46.5%, respectively). Median survival of older patients was also significantly longer (3.5 +/- 0.31 vs 3.1 +/- 0.34, hazard ratio=0.45, CI; 0.255-0.802). Analysis using Cox regression model adjusted for gender, PS, number of metastases, site of metastases, histology, smoking history and age detected an association between age and PFS (p=0.011). The frequency of adverse events in elderly patients treated with EVE was no greater than that in younger patients, although such toxicity may have had a greater impact on their quality of life. Conclusions: Older patients should not generally be excluded from accepted therapies (mTOR inhibitors after failure of VEGFr-TKI therapy) for mRCC.

Ecological Investigations on the Managed Forests in Northwestern Europe and Tree Seed-Orchard System (북구(北歐)의 우량임분(優良林分)의 생태(生態) 및 채종원(採種園) 체계(體系)에 관(關)한 연구(硏究))

  • Kim, Chi Moon
    • Korean Journal of Agricultural Science
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    • v.9 no.1
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    • pp.239-249
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    • 1982
  • The outlines of superior stands, including species mixed, age classes, canopies, and ecological conditions of the stands, were examined in the forests of west Germany, Sweden, and Netherland. The establishment schemes of tree seed orchards for the production of high genetic quality seed were also investigated in the present study. 1. The meteorological conditions, abundant in precipitation and high in relative humidity, prove it to be oceanic climate characteristics in the Scandinavia located in high latitude and north-western part of Europe. The photo periodical characteristics following to day-length and the frost times determine the patterns of tree growth and distribution as well as the tree adaptability due to bud-setting and bud-flushing in Sweden forest. 2. The European forests are generally characterized by dense multistoried forest type composed of upper stories of tall tree species such as Norway spruce, fir, Scots pine and beech, lower stories of shade tolerant poles and saplings of spruce, fir, beech, and floor vegetations covered with birch, oak and hornbeam etc. 3. The single tree selection method and group shelterwood method are commonly applied for silvicultural system but shelterwood method and clearcutting method practiced partially in limited area. Badischer Femelschlagbetrieb and Bayerischer Femelschlagbetrieb are popularized to the regeneration of Schwarzwald but selection method applied in part. 4. Tree cuttings are properly limited so as not to exceed annual increment volume for the sustained yield and the preservation of ecosystem in European forest management. Land preservation and recreation function are more interested with the promotion of wood production in the forest management. 5. Careful attentions are paid to the reforestation of the introduced exotic species, such as Douglas-fir, red oak, pines from America, Japanese larch, Italian poplar etc., with concern against the insect and pest damage, and the meteorological damage. 6. Some intensive studies on tree improvement, such as selection of plus tree, selection of plus stand for seed collection, provenance trial, progeny test of clone, hybrid seed orchard for clone complexing, are performed in the countries and the great part of the seed required for reforestation are supplied from the seed orchard established in Sweden and Netherland.

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The reserch of Kim hong-kyung's view of extra meridians -With the connection yin yang wei qiao mai With four trigram constitution theory- (김홍경의 기경팔맥관(奇經八脈觀)에 관한 연구(硏究) - 음양유교맥(陰陽維蹻脈)과 사상체질(四象體質)의 상관성을 중심으로 -)

  • Jung, Hae-Myeong;Yun, Chang-Yeol
    • Journal of Haehwa Medicine
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    • v.22 no.2
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    • pp.13-21
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    • 2014
  • Subject : Kim hong-kyung(金洪卿)'s view of eight extra meridians Object : Kim hong-kyung has not only deeply studied Saam acupuncture but also the function and characteristics of extra meridian at the same time. Especially, he has tried the study to connect yin yang wei qiao mai(陰陽維蹻脈) with Lee je-ma(李濟馬)'s four trigram constitution theory, therefore the author felt the need to make public the theory and started reserch on the theory. Method : I researched the physiological properties of extra meridians through the past eastern medical literature, I reported on the types of people to show well the properties of extra meridians gathering Kum-oh's verbal explanation when I had classes from him. Result : Kum-oh Kim hong-kyung defined meridians as passways of consciousness and feeling, he interpreted 12 meridians and extra meridians with the view of mind, which has very important meanings in the history of acupuncture in the point of first trial to interpret meridians from this view. He explained Ren mai(任脈) and Du mai(督脈) are meridians which show clearly properties of yin-yang to appear trusts of affirmation and distrusts of denial in the mind, as Ren(任) means entrusting and Du(督) means supervising in English. He explained Chong mai(衝脈) is the meridian representing impulsive man that has a meaning of impulse as being suggested the name of Chong mai, because Chong mai is borrowed from Foot shao yin kidney meridian(足少陰腎經). Dai mai(帶脈) is the meridian representing the characteristics of woman that has a meaning of binding as being suggested from the name of Dai mai which acts when people have something on their flank or they are pregnant, because Dai mai borrowed from Foot shao yang gall bladder meridian. He thought that four trigram divided from yin and yang is innate trigram, so Yang wei mai(陽維脈), Yin wei mai(陰維脈), Yang qiao mai(陽蹻脈), Yin qiao mai(陰蹻脈) among extra meridians have connections with Tai-yang ren(太陽人), Tai-yin ren(太陰人), Shao-yin ren(少陰人), Shao-yang ren(少陽人) of Four trigram constitution theory respectively which was created by Lee je-ma. He explained yang means opponents and wei(維) means binding. Yang wei mai is the meridian to be active when opponents bind or intervene in you, also the meridian is well active to the people who easily criticize others who are rude, to the people who well refuse restraints from organization. Because he explained yin means me and wei(維) means binding. Yin wei mai is the meridian to be active when I bind and intervene in opponents. He also state that the meridian is easily active to the people who have a tendency to gather people and make party apparatus by nature. He explained Yang qiao mai is the meridian to be active in the situation that people are waiting for others to bridge gap because yang means opponents and qiao(蹻) which has a meaning of standing on one's tiptoes means bridging gap between people. He also state the meridian is easily active to Shao yin ren who has a tendency to be passive, to easily settle down and not to move by nature. He explained Yin qiao mai is the meridian to be active in the situation that I bridge gap between me and others to make friends, because yin means me and qiao(蹻) which has a meaning of standing on one's tiptoes means bridging gap between me and others. He also state the meridian is easily active to Shao yang ren who is active in every business and who has remarkable ability to make friends. Conclusion : Kim hong-kyung stated the physiological properties of extra meridians as below. Ren mai is the meridian representing positive confidence which is easily active when people have a mind to trust others, Du mai is the meridian representing negative distrust which is easily active when people have doubts. Chong mai is the meridian representing the characteristics of man that has impulsive characteristics. Dai mai is the meridian representing the characteristics of woman to be easily active when she is pregnant. Yang wei mai has close connections with Tai-yang ren who has a tendency to refuse restraints from others and to criticize on opponent's remarks and behaviors that are wrong. Yin wei mai has close connections with Tai-yin ren, as the meridian is active in the situation that people enjoy restraining and intervening in others. Yang qiao mai has close connections with Shao yin ren, as the meridian is active to the people who are negative and passive by nature. Yin qiao mai has close connections with Shao yang yin who has a strong tendency to make friends easily by nature.

A Study on the Reality and Improvement of Autonomous Police System in Jeju Special Self-Government Province (제주자치경찰 시스템의 실태와 발전모델에 관한 연구)

  • Cho, Chul-Ok
    • Korean Security Journal
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    • no.14
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    • pp.485-516
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    • 2007
  • Jeju Special Self-Government Province adopted an autonomous police system for the first time since 60 years in Korean police. The purpose of autonomous police system is to offer a police service to be suitable in regional conditions. But Jeju autonomous police system for nearly one year after adoption is criticized to be established on the ground of political reason but not local decentralization. Actually Jeju autonomous police has not a clear cut jurisdiction and operation scope because of the jurisdiction duplication between national and autonomous police. The original task is confined on environment and sightseeing so on given to administration police for local self-government. So criminal investigation authority on general crimes is not to Jeuju autonomous police on account of special judicial police. First, it is the structural rationalization of Jeju autonomous police system. It speaks that Jeju provincial police bureau and police station have to be as national police institution, on the other hand, patrol district station and police box have to be as autonomous police institution. Of course, functional division has to be followed. National police performs managing all the assembly and demonstration by the management law on assembly and demonstration including the suppression against any large scale demonstration and disturbance, also the investigation on serious crimes just as international crimes and broaden area crimes including all the felony. Together national police performs the duty concerned to all the foreign affairs and national securities in along with the investigation on traffic accidents. On the other hand, autonomous police performs the function for citizen's life safety as crime prevention and the enforcement on the violation against police operation law, together the traffic management and the regulation on traffic violations. and the investigation on minor crime as simple violence or petty larceny including the management on local big events. Second, the budgetary of autonomous police is rationalized by the share of budgeting between Korean government and Jeju special self-government province. Third, urgent arrest authority on general crime and the rights of claims for the summary trial on minor crimes are given to autonomous police. Of course, this problem is resolved naturally in case of giving the investigation rights to autonomous police on minor crimes.

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Preliminary Result in Patients with Primary Hepatoma Treated by Stereotactic Radiotherapy (원발성 간암에 대한 정위방사선치료의 예비결과)

  • Kang Ki Mun;Choi Ihl Bohng;Kim In Ah;Choi Byung Ock;Kang Young Nam;Chai Gyu Young;Han Sung Tae;Chung Gyu Won
    • Radiation Oncology Journal
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    • v.19 no.1
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    • pp.34-39
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    • 2001
  • Purpose : It is not common to evaluate the response of the fractionated stereotactic radiotherapy (SRT) to primary hepatoma as compared with conventional radiotherapy. The purpose of the study was to take the preliminary result on the clinical trial of primary hepatoma by SRT. Materials and Methods : From July 1999 to March 2000, thirty three patients were hospitalized in the St. Mary's Hospital, and treated with SRT for extracranial tumors. Among them, 13 patients were diagnosed to primary hepatoma and then applied by frameless SRT using 6 MV linac accelerator. There were 12 male and 1 female patients. They had the age of $ 44\~66$ year old (median : 59) and the tumor size of $10\~825\;cc$ (median : 185 cc). SRT was given to them $3\~5$ fractions a week (5 Gy/fraction, $90\%$ isodose line) for $2\~3$ weeks. Median dose of SRT was 50 Gy and the range was $30\~50\;Gy$. Results : Follow-up period ranged from 3 months to 13 months with median of 8 months. After treating SRT to thirteen patients with primary hepatoma, the response of the tumor was examined by abdominal CT : they are classified by 1 complete regression $(7.7\%)$, 7 partial regression $(53.8\%)$, 4 minimal regression $(30.8\%)$, 1 stable disease $(7.7\%)$. The positive responses more than partial remission were 8 patients $(61.5\%)$ after the treatment. The level of serum alpha-fetoprotein (AFP) after the treatment as compared with pretreatment had been $92.3\%$ decreased. There was no severe complication except dyspepsia $84.6\%$, mild nausea $69.2\%$, transient decreased of hepatic function $15.4\%$ and fever $7.7\%$. Conclusion : SRT to the patients with primary hepatoma was potentially suggested to become the safe and more effective tool than the conventional radiotherapy even though there were relatively short duration of follow-up and small numbers to be tested.

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Pulmonary Complications after Surgery for Esophageal Cancer (식도암 수술 후 발생한 호흡기 합병증)

  • Lee, Jang-Hoon;Lee, Jung-Cheul
    • Journal of Chest Surgery
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    • v.39 no.2 s.259
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    • pp.134-139
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    • 2006
  • Background: Complications after surgery for esophageal cancer are various and not rare. Among them, pulmonary complication is well known as one of the most important insults which has negative influence on the postoperative course and results in mortality. So we attempted to analyze the factors which may have relation to postoperative pulmonary complication. Material and Method: The retrospective study was undertaken in 87 patients who underwent curative surgery for esophageal cancer from Jan. 1996 to Aug. 2005. We divided them into two groups, patients with pulmonary complication (group A, n=28), without pulmonary complication (group B, n=59). Statistical analysis was performed with Fisher's exact test. Result: The postoperative pulmonary complication developed in 28 patients ($32\%$). There was no difference between two groups in past medical history, preoperative pulmonary function, surgery time, anastomosis method, pathologic stage, and trial of neoadjuvant therapy. Age and incidence of cervical anastomosis were significantly higher in group A (p=0.001, p=0.023). The rate of routine postoperative ventilator care was significantly higher in group S (p=0.007). Chest tube indwelling time and hospital stay were significantly longer in group A (p=0.011, p=0.001). There were 6 postoperative deaths ($6.8\%$) and 5 deaths were related to pulmonary complication. Pneumonia was the most common cause of death and MRSA (methicillin resistant staphylococcus aureus) was the most common organism in sputum culture. Conclusion: Pulmonary complication after esophageal cancer surgery was the most important cause of death. Pulmonary complication was closely related to patient's age and cervical anastomosis. We think postoperative routine ventilator care is helpful for prevention of pulmonary complications, especially MRSA pneumonia, and reducing mortality.

Radiotherapy for Oral Cavity Cancer (구강암의 방사선치료)

  • Shim Jae Won;Yoo Seong Yul;Koh Kyoung Hwan;Cho Chul Koo;Yun Hyong Geun;Kim Jae Young
    • Radiation Oncology Journal
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    • v.11 no.2
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    • pp.267-275
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    • 1993
  • Eighty five patients of oral cavity cancer, treated with radiation at the Department of Therapeutic Radiology, Korea Cancer Center Hospital, during the period from March 1985 to September 1990 were analyzed retrospectively. Among 85 patients, 37 patients were treated with radiation only and 48 patients were treated with radiation following surgery. And 70 patients received external irradiation only by $^{60}Co$ with or without electron, the others were 7 patients for external irradiation plus interstitial implantation and 8 patients for external irradiation plus oral cone electron therapy. Primary sites were mobile tongue for 40 patients, mouth floor for 17 patients, palate for 12 patients, gingiva including retromolar trigone for 10 patients, buccal mucosa for 5 patients, and lip for 1 patient. According to pathologic classification, squamous cell carcinoma was the most common (77 patients). According to AJC TNM stage, stage I + II were 28 patients and stage III+IV were 57 patients. Acturial overall survival rate at 3 years was $43.9\%,$ 3 year survival rates were $60.9\%$ for stage I + II, and $23.1\%$ for stage III+IV, respectively. As a prognostic factor, primary T stage was a significant factor (p<0.01). The others, age, location, lymph node metastasis, surgery, radiation dose, and cell differentiation were not statistically significant. Among those factors, radiation plus surgery was more effective than radiation only in T3+T4 or in any N stage although it was not statistically sufficient (p<0.1). From those results, it was conclusive that definitive radiotherapy was more effective than surgery especially In the view of pertainig of anatomical integrity and function in early stage, and radiation plus surgery was considered to be better therapeutic tool in advanced stage.

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Combined Transcatheter Arterial Chemoembolization and Local Radiotherapy for Unresectable Hepatocellular Carcinoma (절제불가능 원발성 간암에서 경간동맥 항암 색전술과 국소 방사선의 병용요법)

  • Seong Jinsil;Keum Ki Chang;Han Kwang Hyub;Lee Do Yun;Lee Jong Tae;Chon Chae Yoon;Moon Young Myoung;Kim Gwi Eon;Suh Chang Ok
    • Radiation Oncology Journal
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    • v.16 no.2
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    • pp.159-165
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    • 1998
  • Purpose : The best prognosis for hepatocellular carcinoma can be achieved with surgical resection. However, the number of resected cases is limited due to the advanced lesion or associated liver disease. A trial of combined transcatheter arterial chemoembolization(TACE) and local radiotherapy(RT) for unresectable hepatocellular carcinoma(HCC) was prospectively conducted and its efficacy and toxicity were investigated. Materials and Methods : From 1992 to 1994, 30 Patients with unresectable HCC due either to advanced lesion or to associated cirrhosis were entered in the study Exclusion criteria included the presence of extrahepatic metastasis, liver cirrhosis of Child's class C, tumors occupying more than two-thirds of the whole liver, and an ECOG scale of more than 3. Patient cHaracteristics were : mean tumor size $8.95\pm3.4cm$, serum AFP+ in all patients, portal vein thrombosis in all patients, liver cirrhosis in 22 patients, and UICC stage III and IVA in 10 and 20 patients, respectively. TACE was performed with the mixture of Lipiodol(5ml) and Adriamycin(50mg) and Gelfoam embolizatin. RT(mean dose $44.0\pm9.3Gy$) 10 days with conventional fractionation. Results : An objective response was observed in 19 patients($63.3\%$). Survival rates at 1 2, and 3 years were $67\%,\;33.3\%$ and $22.2\%$, respectively. Median survival was 17 months. There were 6 patients surviving more than 3 years. Distant metastasis occurred in 10 patients, with 8 in the lung only and 2 in both lung and bone, Toxicity included transient elevation of liver function test in all patients, fever in 20, thrombocytopenia in 4, and nausea and vomiting in 1. There was no treatment-related death. Conclusion : Combined TACE and RT appear to produce a favorable response and survival results with minimal toxicity.

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Effects of Dietary Herbaceous Peat on In Vitro Fermentation and Milk Production in Dairy Cows (허브부식토의 사료내 첨가에 따른 In Vitro 발효특성과 젖소의 유생산성에 미치는 영향)

  • Kim, Hyeon-Shup;Park, Joong-Kook;Kim, Hong-Yun;Kim, Sang-Bum;Yang, Seung-Hak;Kim, Chang-Hyun;Ahn, Jong-Ho
    • Journal of The Korean Society of Grassland and Forage Science
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    • v.31 no.2
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    • pp.177-190
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    • 2011
  • This study was conducted to determine effects of dietary herbaceous peat on in vitro fermentation and milk production in dairy cows. Ruminal pH, gas production, VFA (volatile fatty acid), Ammonia-N, and rumen degradability were examined by the addition of three times over 0, 1, and 5% herbaceous peat with substrate of timothy hay, and the change of rumen fermentation characteristics were evaluated. In 0, 3, 12 and 24 hours cultivation, all treatments did not show a significant difference but the control at 6 hours appeared significantly lower pH compared to 1 and 5% treatments (p<0.05). The gas production of the treatments significantly increased until 12 hours of cultivation compared to control (p<0.05), the rumen ammonia concentration showed a tendency to increase until 24 hours in all treatment groups, and there was no significant difference between treatments. About the rumen degradability, 5% treatment showed higher rumen degradability in all hours than control and 1% treatment (p<0.05). Meanwhile, for in vivo trial, 16 heads of Holstein lactation dairy cows were selected for experiment for four weeks in order to research the change of milk yield, milk compositions and change of somatic cell counts of lactation dairy cows by herbaceous peat feeding. The milk yield of vitamin C and herbaceous peat treatments (T3) was 25.0 kg but the control was 23.2 kg, herbaceous peat treatment (T1) was 23.1 kg, and vitamin C treatment (T2) was 23.4 kg, so there was linear increase effect of milk yield by T3. The partial significance of the milk (fat, milk protein, lactose, MUN and SNF) and change of somatic cell count before and after experiment by the control and treatments about change of milk and somatic cell counts (p<0.05) were recognized. About change of milk in the first half (1~2 weeks) and latter half (3~4 weeks) during four weeks of experiments period, the herbaceous peat supplement treatments showed a tendency of significant decrease of quality of milk protein and SNF. The control and treatments did not show significant change of blood nutrients (total protein, cholesterol, NEFA, BUN), liver function component (AST, GGT) and minerals (Ca, P, Mg) before and after experiment. In summary, it is judged that herbaceous peat feeding for lactation dairy cows would be recommendable based on the results of milk, somatic cell count physiologically.

Finite Element Analysis of Bone Stress Caused by Horizontal Misfit of Implant Supported Three-Unit Fixed Prosthodontics (3차원 유한요소법에 의한 임플란트 지지 3본 고정성 가공 의치의 부적합도가 인접골 응력에 미치는 영향 분석)

  • Lee, Seung-Hwan;Jo, Kwang-Hun
    • Journal of Dental Rehabilitation and Applied Science
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    • v.28 no.2
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    • pp.147-161
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    • 2012
  • This study is to assess the effect of horizontal misfit of an implant supported 3-unit fixed prosthodontics on the stress development at the marginal cortical bone surrounding implant neck. Two finite element models consisting of a three unit fixed prosthodontics and an implant/bone complex were constructed on a three dimensional basis. The three unit fixed prosthodontics were designed either shorter (d=17.8mm model) or longer (d=18.0mm model) by 0.1mm than the span of two implants placed at the mandibular second premolar and second molar areas 17.9mm apart. Fitting of the fixed prosthodontics onto the implant abutments was simulated by a total of 6 steps, that is to say, 0.1mm displacement per each step, using DEFORM 3D (ver 6.1, SFTC, Columbus, OH, USA) program. Stresses in the fixed prosthodontics and implants were evaluated using von-Mises stress, maximum compressive stress, and radial stress as necessary. The d=17.8mm model assembled successfully on to the implant abutments while d=18.0mm model did not. Regardless if the fixed prosthodontics fitted onto the abutments or not, excessively higher stresses developed during the course of assembly trial and thereafter. On the marginal cortical bone around implants during the assembly, the peak tensile and compressive stresses were as high as 186.9MPa and 114.1MPa, respectively, even after the final sitting of the fixed prosthodontics (for d=17.8mm model). For this case, the area of marginal bone subject to compressive stresses above 55MPa, equivalent of the $4,000{\mu}{\varepsilon}$, i.e. the reported threshold strain to inhibit physiological remodeling of human cortical bone, extended up to 2mm away from implant during the assembly. Horizontal misfit of 0.1mm can produce excessively high stresses on the marginal cortical bone not only during the fixed prosthodontics assembly but also thereafter.