• 제목/요약/키워드: clinical trial center

검색결과 729건 처리시간 0.029초

다기능 보조기구와 체중부하검사 보조기구의 X선 화질 비교 (Comparison of X-ray Image Quality Between Multi-Function Device(MFD) and Weight Bearing Platforms(WBPs))

  • 길종원;이광성
    • 한국방사선학회논문지
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    • 제13권4호
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    • pp.605-611
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    • 2019
  • 본 연구의 목적은 여러 가지 하지입식검사에 적용할 수 있는 Multi-Function Device(MFD)를 제작하여 기존에 사용하던 Weight Bearing Platforms(WBPs)들과 X 선 영상의 비교를 통해 임상 활용을 제안하고자 한다. MFD는 단상(보조기구)를 이용한 Weight Bearing Foot/Ankle, Hindfoot Alignment View 검사시 X선 장치의 X선 관구의 최하 조절 높이를 고려하여 제작하였다. 그리고 Foot/Ankle Phantom으로 MFD와 WBPs에서 Weight Bearing Lateral Foot과 Hindfoot Alignment View를 검사하여 X선 영상의 해상력을 Quick MTF(modulation transfer function)프로그램으로 비교하였다. 연구결과 MFD와 WBPs에서 검사한 두 가지 영상 모두 MTF 50(50% Contrast Spatial Frequency)과 10-90%(10-90% of Maximum Energy Rise Distance) Rise의 C/P(Cycles Per Pixel)평균과 LPH(Lines Per Image Height)평균 모두 유의한 차이는 없었다(p>0.05). 연구에서 제작한 MFD는 환자의 안전과 여러 가지 검사를 복합적으로 수행 할 수 있는 유용한 보조기구로 임상 활용을 제안한다. 또한 정책적으로 보조기구의 활용을 권장한다면 전문 업체의 활성화를 돕는 길이며 의료의 질도 더욱 향상할 수 있을 것이다.

변형 근치적 유방절제술 후 방사선치료에서 볼루스 적용횟수에 대한 고찰 (A Study on the Necessary Number of Bolus Treatments in Radiotherapy after Modified Radical Mastectomy)

  • 홍채선;김종식;김영곤;박영환
    • 대한방사선치료학회지
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    • 제18권2호
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    • pp.113-117
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    • 2006
  • 목 적: 유방암으로 진단 받고 변형 근치적 유방절제술(Modified Radical Mastectomy)후 흉벽에 방사선치료를 시행 받고 있는 환자를 대상으로 볼루스(Bolus) 적용에 따른 흉벽(흉터, 수술봉합부위)의 피부선량 변화를 분석 하여 적절한 볼루스 적용횟수를 얻고자 한다. 대상 및 방법: 유방암으로 진단받고 변형 근치적 유방절제술 후 방사선치료를 받고 있는 4명의 여성 환자(우측 2명 좌측 2명)를 대상으로 하였다. 흉벽 방사선조사는 4 MV광자선으로 매일 2 Gy씩 주 5회, 접선조사로 치료하였고, 총 조사선량은 50 Gy였는데 동측 내유방림프절은 포함하지 않았다. 치료 계획을 위한 전산화단층촬영에서 흉터 부위의 위치 확인을 위해 방사선비투과성물질인 Angio-catheter를 흉터 위에 위치시켰다. 획득한 영상을 이용하여 치료계획을 세웠고, 전산화치료계획장치에서 흉터부위 좌우 2 cm 영역을 포함하는 두께 0.5 cm, 넓이 6 cm의 볼루스를 적용시켰다. 계획한 내용을 바탕으로 볼루스를 적용하지 않은 경우와 볼루스를 적용한 경우에 대하여 선량분포 변화와 피부선량을 비교 분석하였고 열형광선량계 (Thermoluminescent dosimetry: TLD, Harshaw, USA)를 이용하여 관심 부위(흉터 부위 3 지점, 흉터 좌측 1 cm 3지점, 흉터 우측 1 cm 3지점) 9개 지점의 선량을 실측하였다. 결 과: 전산화치료계획장치에서 얻어진 선량분포를 통해 분석한 결과, 볼루스를 적용하지 않은 경우와 볼루스를 적용한 경우 모두에서 흉벽 부위에 $95{\sim}100%$ 선량이 감싸고 있었으나, 흉터 주위 피부선량에 있어서는 볼루스를 적용하지 않은 경우($50{\sim}75%$)와 볼루스를 적용한 경우($100{\sim}105%$)가 큰 차이를 보였다. 선량분포를 통한 관심지점의 피부선량은 볼루스를 적용하지 않은 경우에 비해 볼루스를 적용한 경우에서 환자 1번 23.3%, 환자 2번 35.6%, 환자 3번 34.9%, 환자 4번 41.7%의 선량 증가를 보였다. 볼루스를 적용하지 않은 경우와 볼루스를 적용한 경우의 TLD 평균 측정치는 환자 1번 161.1 cGy 209.3 cGy 환자 2번 150.2 cGy, 200 cGy, 환자 3번 150.5 cGy, 211.4 cGy, 환자 4번 155.5 cGy 198.6 cGy의 결과를 얻었다. 결 론: 본 원에서 변형 근치적 유방절제술 후 흉벽 방사선치료의 가장 적절한 볼루스 적용 횟수는 전 치료횟수의 $50{\sim}60%$ 적용이다.

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The fruit of Acanthopanax senticosus Harms improves arterial stiffness and blood pressure: a randomized, placebo-controlled trial

  • Oh, Eunkyoung;Kim, Youjin;Park, Soo-yeon;Lim, Yeni;Shin, Ji-yoon;Kim, Ji Yeon;Kim, Ji-Hyun;Rhee, Moo-Yong;Kwon, Oran
    • Nutrition Research and Practice
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    • 제14권4호
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    • pp.322-333
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    • 2020
  • BACKGROUND/OBJECTIVES: Arterial stiffness and endothelial dysfunction are 2 of the independent predictors for cardiovascular disease, while Acanthopanax senticosus Harms (ASH) is a traditional medicinal plant that can improve cardiovascular health. This study aimed to investigate the efficacy of the fruit of ASH on vascular function in apparently healthy subjects. SUBJECTS/METHODS: A 12-week, randomized, double-blind, placebo-controlled design, consisting of healthy adults with at least 2 of the following 3 conditions: borderline high blood pressure (BP; 120 mmHg ≤ systolic BP ≤ 160 mmHg or 80 mmHg ≤ diastolic BP ≤ 100 mmHg), smoking (≥10 cigarettes/day), and borderline blood lipid levels (220 ≤ total cholesterol ≤ 240, 130 ≤ low density lipoprotein cholesterol ≤ 165, or 150 ≤ triglyceride ≤ 220 mg/dL). Randomly assigned 76 subjects who received a placebo or 2 doses of ASH fruit (low, 500 mg/day; high, 1,000 mg/day) completed the intervention. Brachial-ankle pulse wave velocity (baPWV), flow-mediated dilation, carotid intima-media thickness, and BP were measured both at baseline and following the 12-week intervention. Endothelial nitric oxide synthase (eNOS) phosphorylation was assessed by western blotting. RESULTS: Compared with the placebo group, the low-dose group showed more significant changes after the 12-week intervention period in terms of systolic BP (0.1 vs. -7.7 mmHg; P = 0.044), baPWV (31.3 vs. -98.7 cm/s; P = 0.007), and the ratio of phospho-eNOS/eNOS (0.8 vs. 1.22; P = 0.037). CONCLUSIONS: These results suggest that ASH fruit extract at 500 mg/day has the potential to improve BP and arterial stiffness via endothelial eNOS activation in healthy adults with smoking and the tendency of having elevated BP or blood lipid parameters.

Report of the 3rd Japan-Korea Workshop on Acupuncture and EBM;Protocol development for the acupuncture trial on the osteoarthritis of the knee

  • Jang, Jun-Hyouk;Kenji, Kawakita;Hahn, Seo-Kyung;Park, Hi-Joon;Lee, Seung-Deok;Kim, Yong-Suk;Norihito, Takahashi;Toshiyuki, Shichidou;Kazunori, Itoh;Eiji, Sumiya;Eiji, Furuya;Hitoshi, Yamashita;Hiroshi, Tsukayama
    • Journal of Acupuncture Research
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    • 제23권6호
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    • pp.239-254
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    • 2006
  • The 3rd Japan-Korea Workshop on Acupuncture and EBM was held at Kanazawa on June $16^{th}$. From Korea team, 4 papers were presented. Dr. Hahn introduced a new approach of data analysis on series of n-of-1 trials using the Bayesian statistics. It offered important information for the future n-of-1 trials. Dr. Park clearly demonstrated the significance of various sham devices proposed and stressed the importance of research questions when we choose the control intervention in RCT. Dr. Lee reported the results of survey in Korean Medical Doctors (KMD) for their point selection and techniques to the distal and local points. Dr. Kim presented the results of face to face survey on the KMD with 28 items for acupuncture treatment on the knee OA. Finally, a draft of protocol was introduced by Dr. Kim. The title was "multi-center, a randomized, single blinded, two arms, parallel-group study to compare the effectiveness and safety of 'individualized acupuncture' and 'standardized minimal acupuncture' in Korean and Japanese patients with knee osteoarthritis (Phase IV)". From Japan team, 7 speakers presented their comments and proposals on the protocol. Dr. Takahashi introduced several issues regarding n-of-1 trials and pointed out the importance of obtaining generalizability from n-of-1 trials. Dr. Shichidou pointed the importance of research design, selection of outcome measures and reduction of biases. Dr. Itoh presented the results of point selection for the knee OA based on the literature survey. Dr. Sumiya introduced several differences between KMD and Japanese acupuncturists based on the questionnaire used in KMD survey. Dr. Furuya demonstrated a result of press tack needle and its sham device on shoulder stiffness. Dr. Yamashita introduced the results of literature survey regarding adverse events occurred by acupuncture on knee OA. Dr.Tsukayama stressed the importance of responsibility of Institutional Review Board (IRB) for the conduction of clinical trials. After several issues were discussed, the need of continued meeting for final protocol development was agreed, then the workshop was closed.

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경막외 스테로이드 주사치료에 실패 후 한방복합치료에 의해 호전된 요추 추간판 탈출증 환자 10례 : 후향적 증례 연구 (Effects of Integrative Korean Medical Treatment for a Failed Epidural Steroid Injections to L-spine Disk Herniation: A Retrospective Case Series)

  • 김지수;김유종;홍제락;김민철;박한솔;김세영;서영우;이상민;서영훈;김기옥;김태훈
    • Journal of Acupuncture Research
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    • 제32권4호
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    • pp.203-211
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    • 2015
  • Objectives : The purpose of this study was to assess the effectiveness of integrative Korean Medical treatments for patients with L-spine disk herniation that showed no response to Epidural Steroid Injections (ESI). Methods : In this study, we reviewed the medical records of ten patients who showed no improvement or relapsed after ESI. The patients each received more than three weeks of integrative treatments at Mokhuri Neck&Back Hospital. The Visual Analog Scale (VAS) and Oswestry Disability Index (ODI) was measured before and after treatment. A statistical analysis to compare before and after treatments was assessed using paired t-test the SPSS 12.0 Windows program. Results : After three weeks of treatment, patients showed a significant decrease in VAS and ODI scores compared to before receiving treatment. VAS scores decreased from $5.3{\pm}1.25$ to $1.9{\pm}0.99$ (p<0.001), and ODI scores decreased from $59.8{\pm}22.2$ to $32.7{\pm}14.11$ (p<0.001). Conclusions : Complex Korean Medical treatment showed effectiveness in the treatment of L-spine HIVD patients that showed no response to ESI, and more objective research is needed.

알쏭이모자반 (Sargassum confusum) 주정추출물이 성인여성 체지방 감소에 미치는 영향 (The effect of Sargassum confusum on reduction of body fat in obese women)

  • 민기성;한 대석;권상오;여경목;김복남;이선영
    • 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.

영양교육과 운동을 병행한 프로그램이 중등도비만여성의 비만도와 행동변화에 미치는 효과 (Effects of Nutrition Education and Exercise Program on Obesity Index and Behavioral Modification in Moderate Obese Women)

  • 장명희;정수진
    • 대한지역사회영양학회지
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    • 제23권4호
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    • pp.318-332
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    • 2018
  • 본 연구에서는 12주 동안 성인 여성 중 체지방률 40% 이상 또는 BMI 30 이상인 여성을 대상으로 37차시의 비만관리 프로그램일환으로 영양교육과 운동중재를 병행 실시하여 대상자의 식습관 및 운동 습관 조사, 신체성분과 식이섭취와 생화학적 지표에 미치는 효과를 살펴보고자 하였다. 1. 조사대상자의 평균 연령은 44.8세였으며 참여자의 55%가 폐경이었다. 2. 체중조절 관심도 변화에서 체중 조절 방법은 식사조절과 운동이 프로그램 참여 전 34.4%에서 프로그램 후 37.5%로 증가하였다(p<0.01). 3. 신체활동 변화에서 중등도 신체활동을 10분 이상 한날은 프로그램 참여 전 3.20일에서 프로그램 후 4.25일로 증가하고, 스트레칭 등 유연성 운동을 한 날은 프로그램 참여 전 2.60일에서 프로그램 참여 후 3.85일로 유의적으로 증가하였다(p<0.01). 4. 바른 식습관 점수 변화는 프로그램 참여 전 4.15점에서 프로그램 참여 후 7.10점으로 유의적(p<0.001)으로 증가하였다. 5. 에너지 및 다량 영양소 섭취는 프로그램 전후간 차이는 없었으나 식이섬유(p<0.01), 철, 칼륨, 비타민A, 비타민 $B_6$, 나이아신의 섭취는 프로그램 참여 전에 비해 프로그램 참여 후에 유의적으로 증가하였다(p<0.05). 6. 혈압과 혈액 생화학적 특성 지표인 TC, 공복혈당 및 TG는 프로그램 참여 전후 간 유의적인 차이는 없었다. 7. 영양교육과 운동 프로그램 종료 후 체중, 체지방률, 복부둘레 및 내방지방 수치는 유의적으로 감소하였으며, 근육양과 신체발달 점수는 유의적으로 증가하였다(p<0.001). 이상의 결과를 볼 때, 중등도 비만여성에서 12주간 영양교육과 운동 중재 프로그램 실시는 식사의 질을 향상시키고 바림직한 식습관의 변화를 유도하였으며 비만도는 감소하면서 근육양이 증가하여 요요현상이 없이 비만관리 프로그램 교육 내용이 긍정적인 영향을 미쳤으며, 향후 장기적인 비만의 지속관리와 체계적인 연구가 계속되어야 할 것으로 사료된다.

Anesthetic efficacy of supplemental buccal infiltration versus intraligamentary injection in mandibular first and second molars with irreversible pulpitis: a prospective randomized clinical trial

  • Zargar, Nazanin;Shojaeian, Shiva;Vatankhah, Mohammadreza;Heidaryan, Shirin;Ashraf, Hengameh;Baghban, Alireza Akbarzadeh;Dianat, Omid
    • Journal of Dental Anesthesia and Pain Medicine
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    • 제22권5호
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    • pp.339-348
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    • 2022
  • Background: To compare the anesthetic efficacy of supplemental buccal infiltration (BI) (1.7 ml) versus intraligamentary (IL) injection containing 0.4 ml of 4% articaine with 1:100.000 epinephrine after an inferior alveolar nerve block (IANB) with 1.7 ml 2% lidocaine in the first and second mandibular molars diagnosed with irreversible pulpitis (IP). Methods: One hundred subjects diagnosed with IP of either the mandibular first (n = 50) or second molars (n = 50) and failed profound anesthesia following an IANB were selected. They randomly received either the IL or BI techniques of anesthesia. Pain scores on a 170 mm Heft-Parker visual analog scale were recorded initially, before, and during supplemental injections. Furthermore, pulse rate was measured before and after each supplemental injection. During the access cavity preparation and initial filing, no or mild pain was assumed to indicate anesthetic success. The chi-square test, Mann-Whitney U test, and independent samples t-test were used for the analyses. Results: The overall success rates were 80% in the IL group and 74% in the BI group, with no significant difference (P = 0.63). In the first molars, there was no significant difference between the two techniques (P = 0.088). In the second molars, IL injection resulted in a significantly higher success rate (P = 0.017) than BI. IL injection was statistically more successful (P = 0.034) in the second molars (92%) than in the first molars (68%). However, BI was significantly more successful (P = 0.047) in the first molars (88%) than in the second molars (64%). The mean pulse rate increase was significantly higher in the IL group than in the BI group (P < 0.001). Conclusions: Both the IL and BI techniques were advantageous when used as supplemental injections. However, more favorable outcomes were observed when the second molars received IL injection and the first molars received BI.

Effects of GV1001 on Language Dysfunction in Patients With Moderate-to-Severe Alzheimer's Disease: Post Hoc Analysis of Severe Impairment Battery Subscales

  • Hyuk Sung Kwon;Seong-Ho Koh;Seong Hye Choi;Jee Hyang Jeong;Hae Ri Na;Chan Nyoung Lee;YoungSoon Yang;Ae Young Lee;Jae-Hong Lee;Kyung Won Park;Hyun Jeong Han;Byeong C. Kim;Jinse Park;Jee-Young Lee;Kyu-Yong Lee;Sangjae Kim
    • 대한치매학회지
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    • 제22권3호
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    • pp.100-108
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    • 2023
  • Background and Purpose: The efficacy and safety of GV1001 have been demonstrated in patients with moderate-to-severe Alzheimer's disease (AD). In this study, we aimed to further demonstrate the effectiveness of GV1001 using subscales of the Severe Impairment Battery (SIB), which is a validated measure to assess cognitive function in patients with moderate-to-severe AD. Methods: We performed a post hoc analysis of data from a 6 month, multicenter, phase 2, randomized, double-blind, placebo-controlled trial with GV1001 (ClinicalTrials.gov, NCT03184467). Patients were randomized to receive either GV1001 or a placebo for 24 weeks. In the current study, nine subscales of SIB-social interaction, memory, orientation, language, attention, praxis, visuospatial ability, construction, and orientation to name-were compared between the treatment (GV1001 1.12 mg) and placebo groups at weeks 12 and 24. The safety endpoints for these patients were also determined based on adverse events. Results: In addition to the considerable beneficial effect of GV1001 on the SIB total score, GV1001 1.12 mg showed the most significant effect on language function at 24 weeks compared to placebo in both the full analysis set (FAS) and per-protocol set (PPS) (p=0.017 and p=0.011, respectively). The rate of adverse events did not differ significantly between the 2 groups. Conclusions: Patients with moderate-to-severe AD receiving GV1001 had greater language benefits than those receiving placebo, as measured using the SIB language subscale.

한국인 기관지 천식 허증(虛證), 실증(實證) 환자와 CD46 유전자 다형성과의 관계 (Exonic SNP (rs7144, 3’-UTR) in CD46 Molecule and Complement Regulatory Protein (CD46) Gene Associated with Excess Syndrome to Categorize Korean Bronchial Asthma Patients)

  • 이매;백현정;박의근;김관일;이범준;김수강;정주호;김진주;김미아;정희재;정승기
    • 대한한방내과학회지
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    • 제36권4호
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    • pp.547-561
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    • 2015
  • Objectives In this study, we divided Korean asthma patients into excess syndrome or deficiency syndrome groups according to clinical phenotype. Genetic analysis was conducted to investigate the association of exonic SNPs in the CD46 gene polymorphism with the clinical phenotype based on the differentiation syndrome of the bronchial asthma patients.Methods There were 95 healthy patients (control group) and 53 asthma patients. (The deficiency syndrome group included 24 and the excess syndrome group 29). We searched the exonic areas of the CD46 gene in the NCBI website SNPs with <0.01 minor allele frequency (MAF) and <0.01 heterozygosity. We finally selected two SNPs: rs138843816, Ser13Phe and rs7144, 3’-UTR. Hardy-Weinberg equilibrium was calculated using SNPStats.Results There were significant differences in the codominant 1 model and the dominant model between the healthy group and the asthma group. There were significant differences between deficiency syndrome group and the excess syndrome group in the genotype frequencies and in the codominant 1 model, the dominant model, and the log-additive model. The allele frequency of rs7144C showed a significant difference between the deficiency syndrome group and the excess syndrome group. Two-SNP haplotype analysis showed a significant difference in frequency in the deficiency syndrome group and in the excess syndrome group. There were significant differences between the healthy group and the excess syndrome group in the codominant 1 model, the dominant model, and the log-additive model. The frequency of the rs7144 C allele exhibited a significant difference in the demonstration. SNP haplotype analysis between the healthy group and the excess syndrome group showed a significant difference in the frequency of the CT haplotype and the CC haplotype.Conclusions The results indicate that two CD46 SNPs (rs138843816, Ser13Phe and rs7144, 3′–UTR) might be associated with the symptomatic excess syndrome in Korean asthma patients.