• 제목/요약/키워드: Test & Evaluation (T&E)

검색결과 198건 처리시간 0.028초

Bioequivalence Evaluation of Two Brands of Zolpidem Tartrate 10 mg Tablets(Zanilo and Stilnox) in Healthy Male Volunteers

  • Ryu, Ju-Hee;Lee, Heon-Woo;Lee, Hyun-Su;Kang, Il-Mo;Seo, Ji-Hyung;Kang, Jin-Yang;Lee, Kyung-Tae
    • Journal of Pharmaceutical Investigation
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    • 제36권5호
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    • pp.343-348
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    • 2006
  • The purpose of the present study was to evaluate the bioequivalence of two zolpidem tartrate tablets, Stilnox tablet(Sanofi-aventis Korea, reference product) and Zanilo tablet(ChoDang Pharm Co., Ltd., Korea, test product), according to the guidelines of Korea Food and Drug Administration(KFDA). After adding an internal standard(cimetropium), 250 ${\mu}L$ plasma samples were extracted using 1.3 mL of ethyl acetate. Extracted compounds were analyzed by HPLC with triple-quadrupole mass spectrometry. This method for determination of zolpidem is proved accurate and reproducible with the limit of quantitation of 1 ng/mL in human plasma. Twenty-four healthy male Korean volunteers received each medicine at the zolpidem tartrate dose of 10 mg in a $2{\times}2$ crossover study. There was one-week washout period between the doses. Plasma concentrations of zolpidem were monitored for over a period of 8 hr after the administration. $AUC_{0-t}$(the area under the plasma concentration-time curve) was calculated by the linear trapezoidal rule. $C_{max}$(maximum plasma drug concentration) and $T_{max}$(time to reach $C_{max}$) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed $AUC_{0-t}$ and $C_{max}$. No significant sequence effect was found for all of the bio-availability parameters indicating that the crossover design was properly performed. The 90% confidence intervals for the log transformed data were acceptable range of log 0.8 to log 1.25(e.g., log 0.92-log 1.06 for $AUC_{0-t}$, log 0.96-log 1.13 for $C_{max}$). The major parameters, $AUC_{0-t}$ and $C_{max}$ met the criteria of KFDA for bioequivalence indicating that Zanilo tablet is bioequivalent to Stilnox tablet.

색 온도 및 술자의 숙련도에 따른 비색 능력 평가 원저 (Evaluation of color matching ability according to the color temperature and the experience of practitioner)

  • 김지현;김선재;이근우;심준성;윤준호
    • 대한치과보철학회지
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    • 제50권4호
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    • pp.299-304
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    • 2012
  • 연구 목적: 4,000 K와 5,500 K의 색 온도를 가진 광원 하에서 치과 보철과 의사 및 치과대학 학생의 색조 비교 및 선택 능력을 평가하여 술자의 경험이 색조 선택에 영향을 주는지를 알아보고자 한다. 연구 대상 및 방법: 분광 광도계를 사용하여 색 견본을 측색한 후, 명도 값이 비슷하고 채도 값이 차이 나는 5개 탭을 선택하여 3개의 세트(a, b, c)를, 채도값이 유사하고 명도값이 차이가 나는 5개 탭을 선택하여 3개의 세트(d, e, f)를 만들었다. 각각 4,000 K, 5,500 K 색 온도의 광원 하에서 무작위로 선택된 한 개의 색 견본을 치과 보철과 의사 10명과 치과대학 학생 10명에게 제시하고 동일한 색 견본을 동일한 세트 내에서 고르게 한 다음, 제시된 색조 탭과 피험자가 선택한 색조 탭 간의 색차(${\Delta}E$) 값을 계산하여 비색 능력의 차이를 비교하였다. 광원의 색 온도 및 술자의 숙련도에 따른, 각각의 색 견본에서의 색차 값을 계산하고 95%의 신뢰 수준에서 t-test 를 시행하여 결과의 유의성을 검정하였다. 결과: 4,000K와 5,500K 광원 하에서 색차 값은 각각 $1.62{\pm}2.0$, $1.33{\pm}1.7$로 색 온도 조건에 따른 색조 선택의 차이는 나타나지 않았다(P=.398). 숙련자군과 비 숙련자군 간의 색차 값은 각각 $1.34{\pm}1.7$, $1.61{\pm}2.0$으로 각 군 간 색조 선택의 차이 또한 나타나지 않았다(P=.221). 결론: 동일한 색 견본을 동일한 광원 조건 하에서 비색하는 경우, 술자의 숙련도에 따른 색조 선택 능력에 차이가 없다.

노인의 균형유지 능력에 영향을 미치는 요인 (Factors Related to Balance Ability in Healthy Elderly)

  • 김원호;이충휘;정보인;조상현
    • 한국전문물리치료학회지
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    • 제5권3호
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    • pp.21-33
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    • 1998
  • The purposes of this study were to ascertain differences of the sensory system, central processing system, effector system, and balance ability according to general characteristics (sex, fall experience, and age), and to identify the contributions of the sensory, central processing, and effector system to balance ability in 83 healthy elderly subjects. The subjects were elderly (over 60 years) who live in Wonju City. All subjects participated in six tests (position sense test, visual acuity, vestibular stepping test, Mini-Mental Status Exam-Korea, strength of dorsiflexors, and Berg Balance Test). Collected data were analyzed by the independent t-test, one-way ANOVA, and stepwise multiple regression. The results were as follows: 1. The results of the six tests according to sex showed that vestibular function was significantly better in women than in men. But visual acuity, cognitive function, strength of dorsiflexors, and balance ability were significantly better in men than in women (p<0.05). 2. There were no significant differences in position sense, visual acuity, vestibular function, cognitive function, strength of dorsiflexors, and balance ability between fallers and non-fallers (p>0.05). 3. However, the results of the six tests according to age (group A: 60-69 years, group B: 70-79 years, group C: 80-89 years) showed significant differences in five tests. In the Scheff$\acute{e}$ test, position sense, visual acuity, and cognitive function showed significantly different results between in group A and group C: the strength of the dorsiflexors was significantly different between in group A and group B, and balance ability was significantly different between in group A and group C, and between in group B and group C (p<0.05). 4. Cognitive function and position sense were positively associated with balance ability. Their power of explanation regarding balance ability was 38% (p<0.05). These results suggest that cognitive function and position sense play an important role in balance ability. This would seem to suggest that programs for evaluation or improvement of elderly's balance ability in the elderly should consider cognitive function and position sense.

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알레르기 비염에 관한 임상적 연구 (A clinical study of allergic rhinitis)

  • 채병윤
    • 대한한의학회지
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    • 제21권3호
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    • pp.149-165
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    • 2000
  • As recent developments of Immunology and Nuclear medicine, serum IgE and IgG values are helpful in the diagnosis and evaluation of the therapeutic effects of nasal allergies. But in Korea, air pollution and the increased use of food additives have become leading factors in nasal allergies, It seems to be induced by environmental change, especially industrialization and urbanization, so allergic rhinitis in our environment has changed in accordance with the changes made in the living environment. Therefore this study is attempted in order to observe a clinical analysis which places more importance on allergic rhinitis. We studied 200 patients who had visited Kyunghee Oriental Medical Center with allergic rhinitis from January 1, 1999 to December 31, 1999 The results were as follows: 1. The sex distribution was 114 males(57%) and 86 females(43%). In age distribution, the average age was 25. In males, ages ranged from 3 to 66 years old and the average was 23.81. In females, ages ranged from 4 to 67 years old and the average was 28.57. The peak age was 30~39 years old(24%); under 9 years old and 10~19 years old were each 18%; 20~29 years old was 22%; 40~49 years old was 11 %; over 50 years old 6.5%. The gulf between males and females showed a statistically significant difference(P<0.025). 2. In the age of onset, male' s maximum was 62.5, minimum was 0.25; female s maximum was 59.5, minimum was 0.2. Under 9 years old was the most with 34%(male 24%, female 10%), 10~19 years old was 18%, 20~29 years old was 22.5%, 30~39 years old was 13.50%, over 40 years old was 12%, The gulf between males and females were showed statistically significant difference.(p<0.014) 3. The average duration of the disease was 5.67 years. In male and female, the maximum was 30, the minimum was 0.05; under 5 years old was the most with 62%(male 34.50%, female 27.50%); 6~10 years old was 23%. So, under 10 years old was 85%. There was no statistically significant difference in the duration of disease. 4. Regarding type of residence, 47.50% of patients with allergic rhinitis lived in apartments, 52.50% lived in houses. In males, 29.50% lived in apartments, 27.50% lived in houses. In females, 18% lived in apartments, 25% lived in houses. There was no statistically significant difference in the residence by T-test and chi-test. 5. In the distribution of season, spring is the most with 29.5% of patients, winter 28%, fall 25.5%, and summer 17%. But there was no statistically significant difference. 6. After observing 200 patients with allergic rhinitis, classifying main symptoms into 5 types, sneezing was the main symptom in 177cases(88.50%), nasal obstruction in 176cases(88%), rhinorrhea in 169cases(84.5%), post nasal discharge in 87cases(43.50%), and itching in I04cases(52%). The Cumulus ration is 98.50% and symptoms overlapped with an average 3.57±0.1 times but in an analysis of variance of these symptoms, the gulf between males and females was not recognized as statistically significant by T-test and ANOVA. 7. Patients whose families have allergic diseases account for 90 cases(45%) : 49cases(24.50%) male and 41cases(20.50%) female. There were 4 cases (71.11 %) whose families have allergic rhinitis, 9cases(10%) of asthma, and 7.78% with allergic dermatitis. There were 61 (67.80%) cases of patients whose parents have allergic diseases; cases wherein the patient s child had allergic diseases numbered 13 (14.45%); and cases with a sibling with allergic diseases totalled 16cases (17.80%). There was no statistically significant difference in allergic disease regarding sex, parents, or siblings by chi-test. 8. Blood type: For males, type A is the most common, with 37cases(18.5%), followed by type B with 32cases(16%), type O 28cases(l4%) and type AB 13cases(6.5%). For females, type B is the most common, with 30cases(15%), followed by type O with 23cases(l1.5%), type A with 18cases(9%) and type AB with 13cases(6.5%). There was no statistically significant difference in blood type by chi-test. 9. In the selection of prefered food, most patients prefer cool food, with 98 such cases(49%), tepid food in 54cases(27%) and warm food in 48cases(24%). These showed a statistically significant difference in the selection of prefered food between males and females by chi-test(p<0.009). 10. The state of Past History was classified into II types. chronic hypertrophic rhinitis is the most common with 11cases (18.64%), tonsil and adenoid hypertrophy is 8cases(l3.56%), sinusitis is 6cases(10.17%), nasal septum deviation is 4cases, nasal polyp is 2cases, others are 10cases(l6.95%). No statistically significant difference in past history between males and females was shown, but a statistically significant difference was shown when males and females were compared with total cases by T-test(p<0.002, P<0.0008). 11. Regarding complications, 37 patients (28.91%) had sinusitis: 22cases(17.19%) in male, 15cases(11.72%) in female. Chronic hypertrophic rhinitis was found in 15cases(11.72%). Others are under 10%. There was no statistically significant difference in the type of complications between males and females, but a statistically significant difference was shown when males and females were compared with total cases by T-test(P<0.00l, P<0.007). 12. In the treatment, medication was used 1691 times, an average of 2.58 times. No.34 was used 370 times for 124 cases, an average of 2.98 times. No. 152 was used 318 times for 106 cases, an average of 3.00 times. No.151 was used 307 times for 97cases, an average of 3.16 times. No. 31 was used 117 times for 33 cases, an average of 3.55 times. No 25 was used 116 times for 33 cases, an average of 3.52 times. 13. In the duration of treatment, the most frequent is 1 week(69cases, 34.50%), the maximum is 20weeks, and the minimum is 1week. A treatment period of 2~3 weeks accounted for 32% of cases, a period of 4~5weeks accounted for 13.5%. The gulf between males and females showed a statistically significant difference in the duration of treatment.(p<0.01). There was a statistical significance when the males were compared with total cases by ANOVA(P<0.03). 14. A comparison between before-treatment and after-treatment showed a statistically significant difference in treatment by T-test (p<0.01) and F-test (p<0.0058).

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PPG 2차 미분을 이용한 정상인과 당뇨병 환자의 말초혈관 탄성도 비교 (Comparison of peripheral vascular compliance between normal and diabetic groups using the second derivative of photoplethysmogram)

  • 김성우;이주형;남기창;김수찬;차은종;김덕원
    • 전자공학회논문지SC
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    • 제44권4호통권316호
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    • pp.15-20
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    • 2007
  • 현재, 우리나라 당뇨병의 유병률은 빠른 속도로 증가하고 있으며 당뇨병의 유병기간이 길수록 각종 합병증이 발생하여 더욱 심각한 증상을 나타내는데, 그 중 비만 및 고혈당, 당대사장애로 인한 당뇨병성 혈관합병증과 말초 혈관 경화증이 많이 발병하고 있는 실정이다. 따라서 본 연구에서는 광혈류량 측정법(Photoplethysmography)으로 손가락 및 발가락에서 얻어진 맥파의 2차 미분분석을 통해 연령이 비슷한 정상인 50명과 당뇨병으로 확진된 50명의 말초 혈관 탄성도를 객관적으로 비교하고자 하였다. PPG 파형의 2차 미분 분석에 사용되는 평가 인자는 a, b, c, d, e 이고, b/a는 혈관의 탄성도를 의미하며 탄성도가 떨어질수록 b/a의 절대 값은 감소하게 된다. 정상인 50명의 PPG 2차 미분 b/a값은 $-1.09{\pm}0.14$, 당뇨병 환자 50명의 PPG 2차 미분 b/a값은 $-0.81{\pm}0.09$로 정상인에 비해 당뇨병 환장의 말초혈관 탄성도가 감소하였으며, Independent t-test 검정 결과 통계적으로 유의한 차이를 보였다(p<0.05). 본 연구에서는 PPG 파형의 2차 미분 분석을 통하여 정상인과 혈관합병증 발병율이 높은 당뇨병 환자의 말초혈관 탄성도를 비교하였으며, 향후 비침습적이고 간단한 방법으로 당뇨병 환자의 말초혈관 탄성도와 혈관 경화정도를 객관적으로 평가하고 진단함으로써 당뇨병 환자들의 심혈관계질환 사전예방과 치료효과 판정에 도움을 줄 것으로 기대한다.

Effective Thyroxine Ratio(E.T.R)의 진단적(診斷的) 가치(價値) (Diagnostic Evaluation of Effective Thyroxine Ratio)

  • 이명철;최성재;노흥규;이홍규;고창순;이문호
    • 대한핵의학회지
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    • 제9권2호
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    • pp.13-22
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    • 1975
  • The purpose of the present study is to evaluate the diagnostic value of the ETR test as compared to other thyroid function tests in normal persons, patients with thyroid disorders and patients with alterations of thyroxine-binding proteins. The ETR values were obtained from 35 cases as normal control, 63 hyperthyroid patients, 56 euthyroid patients, 23 hypothyroid patients, 10 pregnant women, 5 women taking oral contraceptive medication, 8 liver cirrhosis patients and 4 nephrotic syndrome patients. The results obtained were as follows. 1. The mean value of ETR obtained from the normal controls was $0.99{\pm}0.06$. 2. The mean ETR values of various thyroid states were $1.25{\pm}0.16$ in hyperthyroidism, $0.99{\pm}0.08$ in euthyroidism and $0.82{\pm}0.05$ in hypothyroidism and significant difference was found between these groups. 3. Seven out of 63 hyperthyroid patients(11.1%) and 2 out of 23 hypothyroid patients(8.7%) had ETR values within normal range and among the 56 euthyroid patients 6(10.7%) had ETR values outside normal range, so the diagnostic compatibility of ETR was 89.4% in thyroid diseases. 4. Even though the ETR value was well correlated with $^{131}I$-thyroid uptake rate, serum $T_3$ resin uptake rate and serum $T_4$, a high positive correlation was found (r=0.79) between ETR and $T_7$. 5. The mean ETR values from patients with alteration in TBG binding capacity were $0.99{\pm}0.05$ in pregnant women, $0.98{\pm}0.04$ in women with oral contraceptive medication, $1.04{\pm}0.09$ in liver cirrhosis patients and $0.94{\pm}0.02$ in nephrotic syndrome patients and most of them (85.2%) had ETR values within normal range. Our results, therefore, suggests that the ETR estimation does offer the simplest and most reliable single procedure for the screening and diagnosis of various thyroid diseases as a indirect indicator of serum-free thyroxine concentration without essential influence of changes in the thyroxine-binding proteins in serum.

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대학급식소 고객의 손 위생에 대한 미생물학적 위해 평가 (Evaluation of Microbiological Hazards of Hygiene by the Customers' Hands in University Foodservice Operation)

  • 박해정;배현주
    • 한국식품영양과학회지
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    • 제35권7호
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    • pp.940-944
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    • 2006
  • 급식소 고객의 손 위생실태를 파악하여 향후 소비자 위생교육의 계획 수립을 위한 기초자료를 제공하고자 점심식사 시간에 대학교 내 학생식당을 찾은 일부 남녀 대학생을 대상으로 손 세척에 대한 설문조사와 손의 미생물 검사를 실시하였다. 조사대상자 190명의 1일 평균 손 세척횟수는 전체 평균 6.46회였다. 일반세균, 대장균군, 대장균, 황색포도상구균에 대한 미생물 검사를 실시한 결과 일반세균수는 평균 3.11 log CFU/hand로 $0.70{\sim}6.47\;log\;CFU/hand$가 검출되었고, 대장균군수는 평균 1.06 log CFU/hand로 검출되지 않은 경우부터 최대 5.04 log CFU/hand까지 검출되었다. 대장균은 조사대상자 전원이 검출되지 않았으며, 황색포도상구균의 검출율은 20.5%였다. 고객의 성별에 따른 손의 미생물학적 위해 분석의 차이검정 결과 남자가 여자에 비해 일반세균수(p<0.001)와 대장균군수(p<0.05)가 유의적으로 높게 검출되었다. 황색포도상구균도 남자가 여자에 비해 더 많은 수가 검출되었으나 유의적인 차이는 없었다. 손 세척횟수에 따른 미생물학적 위해분석의 차이검정 결과 일반세균수는 손 세척횟수가 4번 이하일 때 평균 3.25 log CFU/hand, $5{\sim}7$번일때 2.75 log CFU/hand, 8번 이상일 때 2.75 log CFU/hand로 손 세척횟수가 증가함엠 따라 유의적으로 감소하였다(p<0.001). 대장균은 전혀 검출되지 않았으며, 대장균군과 황색포도상구균의 검출량은 손세척 횟수에 따른 유의적인 차이는 없었다. 점심시간 전 손 세척여부에 다른 미생물학적 위해분석의 차이검정 결과 일반세균수는 점심시간 전 손 세척을 항상 하는 경우가 전혀 하지 않는 경우에 비해 유의적으로 낮게 검출되었다(p<0.005).

탄소섬유 배합비에 따른 전도성 그라우트 재료의 주입특성평가 (Injection Characteristics Evaluation of Conductive Grout Material According to Carbon Fiber Mixing Ratio)

  • 최효준;조완제;허형석;방태완;윤찬영
    • 한국지반환경공학회 논문집
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    • 제24권1호
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    • pp.15-23
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    • 2023
  • 그라우팅 공법은 연약지반의 차수 및 보강을 목적으로 시공되는 공법이다. 그라우트가 지반 내에 주입될 때, 지반을 구성하는 지반의 형태, 토립자의 크기, 공극율 및 지하수의 유무에 따라 그라우트가 침투 및 확산하는 형태가 다양하게 나타나고 있으나, 그라우팅 설계 시에는 이러한 요인을 적용하기 어려운 실정이다. 따라서, 본 연구에서는 전도성 재료를 함유한 그라우트를 지반내로 주입하는데 있어서 전도성 재료 첨가에 따른 그라우트의 침투 성능을 파악하기 위하여 실내시험을 수행하였다. 주입시험에서는 전도성 재료를 혼합수의 0%, 3% 및 5%를 그라우트에 첨가하고, 원지반 조건을 자갈과 규사로 구성된 다양한 지반으로 조성하였다. 전도성 그라우트는 전용주입장치를 사용하여 모형지반 내로 압력에 의해 주입되면서 주입시간(t), 압력(p), 유속(v) 및 주입량(q)를 계측하고, 모형지반 내 주입된 경화체를 채취하여 침투성능을 평가하였다. 그라우트 주입실험 결과에서는 전도성 재료의 사용량과 그라우트 주입율은 역의 관계를 나타내었으며, 모형지반 토립자 크기에 따라 침투형태가 변화되는 것을 확인하였다. 전도성 재료를 함유한 그라우트는 지반 내 침투가 비교적 양호하고 경화체의 강도 및 내구성이 우수하여 그라우트의 침투범위 측정을 위한 첨가제로 사용하는 것이 가능하다고 판단하였다.

특발성 성조숙증 여아의 유형별 분류에 따른 신체발육 및 성호르몬 분비 (The Physical growth and secretion of sex hormone in girls with Idiopathic precocious puberty)

  • 권미영;김명
    • 디지털융복합연구
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    • 제12권9호
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    • pp.283-290
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    • 2014
  • 본 연구는 조기 2차 성징을 주호소로 내원하여 특발성 성조숙증으로 진단받은 여아의 진단 유형에 따른 신체발육, 성호르몬 분비의 특성을 파악하고자 시도하었다. 2차 조기성숙을 주호소로 내원한 여아 중 기질적 원인으로 인한 경우를 제외한 성조숙증 여아들을 진성 성조숙증과 가성 성조숙증으로 분류하여, 내원 당시 연령, 출생 시 체중, 2차 성징 발현 나이, 부모 및 조부모 키, 키, 체중, 골연령, 체질량지수 등을 조사하였다. 또한 성호르몬 분비정도를 비교분석하였다. 수집된 자료는 SPSS 20.0 통계프로그램을 이용하여, 평균과 표준편차 그리고 Student t-test로 분석하였다. 본 연구결과 진성 성조숙증이 47명(38.9%), 가성 성조숙증이 66(61.1%)였다. 진성 성조숙증집단에서는 신장 및 체중 표준편차점수가 유의한 수준으로 증가되어 있었으며(p<.05), 성호르몬 검사 상 황체형성호르몬(LH), 난포자극호르몬(FSH) 그리고 에스트라디올(Estradiol)의 기저치가 가성 성조숙증에 비해 유의하게 높았다(p<.05).

치과임플란트 치료와 관련된 상악구치부의 임상적 연구 (CLINICAL STUDY ON KOREAN POSTERIOR MAXILLAE RELATED TO DENTAL IMPLANT TREATMENT)

  • 이두한;이성현;황주홍;이정근
    • Maxillofacial Plastic and Reconstructive Surgery
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    • 제32권1호
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    • pp.27-31
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    • 2010
  • Purpose of study: The purpose of this study was to provide adequate diagnostic guideline for the maxillary sinuses prior to dental implant treatment for edentulous posterior maxillary areas. For this purpose, our procedure involves the estimation of the remaining alveolar bone height, the examination of the anatomical variation in the maxillary sinuses (e.g. sinus septum), and the evaluation of the incidence of preoperative pathological conditions in the maxillary sinuses. Materials and Methods: We selected 189 patients to undergo computerized tomography (CT) in order to account for the posterior maxillary anatomy found in patients of Korean ethnicity. We evaluated the following using Dentascan software: Remaining alveolar bone height, incidence of sinus septum, and rate of preoperative pathologic conditions in the maxillary sinus. The average amount of remaining alveolar bone height was analyzed using the student's t-test for differences according to anatomical site, and the ANOVA was used for the differences according to age group with the level of significance set at 0.05. Results: Alveolar bone heights of upper first premolar, second premolar, first molar, and second molar was 12.24 mm, 10.37 mm, 7.16 mm, and 7.15 mm, respectively with statistical significance (P < 0.05). Incidence of sinus septum as an anatomic variation was 17 out of 189 cases (9.0%). Incidence of mucosal thickening as a pathologic variation was 82 out of 189 cases (43.4%). Conclusion: In treatment planning of posterior maxillary edentulous area of Koreans, the consideration of augmentation surgery for maxillary sinus is required in maxillary molar area before dental implant installation, and preoperative screening of the asymptomatic maxillary sinuses can be regarded as a reasonable preoperative procedure in the planning of dental implant treatment on the posterior maxillary edentulous area.