• Title/Summary/Keyword: clinical disease

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Clinical effects of combination anorganic bovine-derived hydroxyapatite matrix(ABM)/cell binding peptide (P-15) in periodontal intrabony defects (치주 골내낭에서 anorganic bovine-derived hydroxyapatite matrix(ABM)/cell binding peptide(P-15)의 임상적효과)

  • Won, Mi-Sook;Paik, Jeong-Won;Kim, Chang-Sung;Cho, Kyoo-Sung;Chai, Jung-Kiu;Kim, Chong-Kwan;Choi, Seong-Ho
    • Journal of Periodontal and Implant Science
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    • v.32 no.3
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    • pp.565-576
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    • 2002
  • The ultimate goal of periodontal therapy is the regeneration of periodontal tissue which has been lost due to destructive periodontal disease. To achieve periodontal regeneration, various kinds of methods have been investigated and developed, including guided tissue regeneration and bone graft. Bone graft can be catagorized into autografts, allografts, xenografts, bone substitutes. And materials of all types have different biological activity and the capacity for periodontal regeneration, but ideal graft material has not been developed that fits all the requirement of ideal bone graft material. Intensive research is underway to identity, purify, synthesize a variety biologic modulators that may enhance wound healing and regeneration of lost tissues in periodontal therapy. The present study evaluates the effects of ABM/P-15 on the periodontal regeneration in intrabony defects of human. We used thirty four 2-wall or 3-wall osseous defects in premolars and molars of chronic peridontitis patient that have more than 5mm pockets and more than 3mm in intrabony defect. 12 negative control group underwent flap procedure only, 11 positive control group received DFDBA graft with flap procedure, and 11 experimental group received ABM/P-15 graft with flap procedure. The changes of probing pocket depth, loss of attachment and bone probing depth following 6months after treatment revealed the following results: 1. The changes of probing pocket depth showed a statistically significant decrease between after scaling and 6months after treatment in negative control(2.0${\pm}$0.9mm), positive control(3.0${\pm}$0.9mm), and experimental group (3.4${\pm}$1.5mm) (P<0.01). Significantly more reduction was seen in experimental group compared to negative control group (P<0.05). 2. The changes of loss of attachment showed a statistically significant decrease between after scaling and 6months after treatment in positive control(2.0${\pm}$0.6mm), and experimental group (2.2${\pm}$l.0mm) except negative control group(0.1${\pm}$0.7mm) (P<0.01). Significantly more reduction was seen in both experimental and positive control group compared to negative control group(P<0.05). 3. The changes of bone probing depth showed a statistically significant decrease between after scaling and 6months after treatment in positive control(2.7${\pm}$l.0mm), and experimental group (3.4${\pm}$1.3mm) except negative control(0.l${\pm}$0.9mm) (9<0.01). Significantly more reduction was seen in both experimental and positive control group compared to negative control group (P<0.05). The results suggest that the use of ABM/P-15 in the treatment of periodontal intrabony defects can reduce loss of attachment and bone probing depth more than flap operation only. It suggests that ABM/P-15 may be an effective bone graft material for the regeneration of periodontal tissue in intrabony defects.

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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The Study of Comparative Legal Review According to Data Exclusivity of Pharmaceutical Marketing Authorization - In preparation for the development of drugs and vaccine of COVID-19 - (의약품 자료독점권(Data Exclusivity)에 대한 비교법적 고찰 - COVID-19 치료제 및 백신 개발을 대비하여 -)

  • Park, Jeehye
    • The Korean Society of Law and Medicine
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    • v.21 no.1
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    • pp.223-259
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    • 2020
  • With COVID-19 spreading rapidly around the world, research and development issues on treatments and vaccines for the virus are of high interest. Among them, Remdesivir was the first to show noticeable therapeutic effects and began clinical trials, with each country authorizing the use of the drug through emergency approval. However, Gilead Co., Ltd., the developer of Remdesivir, received a lot of criticism from civic groups for submitting the application for the marketing authorization as an orphan drug. This is because when a new drug got a marketing authorization as an orphan drug could be granted an exclusive status for seven year. The long-term exclusive status of an orphan drug comes from the policy purpose of motivating pharmaceutical companies to develop treatment opportunities for patients suffering from rare diseases, which was not appropriate to apply to infectious disease treatments. This paper provides a review of the problems and improvement directions of the domestic system through comparative legal consideration against the United States, Europe and Japan for the statutes which give exclusive status to medicines. The domestic system has a fundamental problem that it does not have explicit provisions in the statute in the manner of granting exclusive status, and that it uses the review system to give it exclusive status indirectly. In addition, in the case of orphan drugs, the "Rare Diseases Management Act" and the "Regulations on Examination of Items Permission and Reporting of Drugs" provide overlapping review periods, and despite the relatively long monopoly period, there seems to be no check clause to recover exclusive status in the event of a change in circumstances. Given that biopharmaceuticals are difficult to obtain patents, the lack of such provisions is a pity of domestic legislation, although granting exclusive rights may be a great motivation to induce drug development. In the United States, given that the first biosimilar also has a one-year monopoly period, it can be interpreted that domestic legislation is quite strictly limited to granting exclusive status to biopharmaceuticals. The need for improvement of the domestic system will be recognized in that it could undermine local pharmaceutical companies' willingness to develop biopharmaceuticals in the future, and in that it is also necessary to harmonize international regulations. Taking advantage of the emergence of COVID-19 as an opportunity, we look again at the problems of the domestic system that grants exclusive rights to medicines and hope that an overall revision of the relevant legislation will be made to establish a unified legal basis.

Seasonal Distribution of T Serotyping and emm Genotyping of Group A Streptococci Obtained from Children with Streptococcal Infections in Masan, Korea, 2003~2004 (2003~2004년 경남 마산 지역에서 분리된 A군 연쇄구균의 T 혈청형과 emm 유전자형의 계절별 분포)

  • Jeon, Ho-Sang;Park, Hwa-Jin;Lee, Hee-Joo;Ma, Sang-Hyuk;Cha, Sung-Ho
    • Pediatric Infection and Vaccine
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    • v.12 no.1
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    • pp.52-60
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    • 2005
  • Purpose : The aim of this study is to know seasonal distribution of group A streptococci obtained from one center using emm genotyping and T serotyping in Masan from 2003 through 2004. Methods : Among children who visited the Changwon Fatima Hospital at Masan, Korea from June 2003 through February 2004, 100 patients who had clinical findings of acute pharyngitis, scarlet fever, and cellulitis were confirmed as GAS by culture, and were enrolled in our study. All obtained GAS were sent to the WHO Collaborative Center for Reference and Research on Streptococci, University of Minnesota, Minneapolis for T serotyping and emm genotyping. We classified these results again according to seasonal and disease's entities. Results : 19 different T serotypes was typed. T4(27.5%), T1(17.6%), T6(13.7%), and T12(13.7%) serotypes were relatively common in summer, while T4(28.3%), T12(15.2%), and T12/B3264(8.7%) were common in winter. T4 and T12 were persistent all year around. Distribution of T serotypes in 89 patients with pharyngotonsillitis were T4(26.7%), T12(14.0%), T1(12.8%), and T6(11.6%) in order of frequency. 15 different emm genotypes was typed. The number of emm 1, emm 6, emm 9, and emm 44 genotypes decreased or disappeared in winter, and the number of emm 3, emm 12, and emm 89 genotypes increased or reappeared in winter. Conclusion : Because T serotyping and emm genotyping are useful tools for evaluating epidemiology and pathogenesis of group A streptococci, we should monitor these strains every year, and should serotype and genotype GAS obtained from the invasive streptococcal infections.

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Clinical Investigation about the Result of Surgically Treated Myasthenia Gravis (중증 근무력증의 수술적 치료결과에 대한 임상적 고찰)

  • 김대현;황은구;조규석;김범식;박주철
    • Journal of Chest Surgery
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    • v.36 no.1
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    • pp.15-20
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    • 2003
  • Myasthenia gravis is a rare autoimmune disease involving acetylcholine receptor and its autoantibody on neuromuscular junction. The methods of treatment are medical treatment and surgical thymectomy. In this paper we analyzed the result of thymectomy and the factors affecting the postoperative symptom improvement. Material and method : This study obtained medical records of 37 patients who received the thymectomy for myasthenia gravis from March 1986 to December 1998. Result Out of 37 cases, 21 cases(57%) showed improvement, of which 8 cases (50%) in the group of thymoma(n=16), and 13 cases (62%) in the group of thymic hyperplasia(n=21) showed the improvement of symptoms. Postoperative complications were respiratory insufficiency due to aggravation of symptoms after operation, including tracheal intubation for ventilator support in 9 cases, pneumonia in 3 cases, pneumothorax in 2 cases and left vocal cord palsy in 1 case. There was one postoperative mortality. The relation between postoperative improvement and sex(P=0.3222), age(P=0.7642), thymic pathologic variants,(P=0.4335) and classification of thymoma(P=0.20) showed no statistically significant correlation. However, the lower grade of preoperative symptoms can predict the lower grade of postoperative symptoms significantly(P=0.0032). Follow up study to 36 postoperative survivors was performed in October 2002 based on the out-patient records and call with patients. Out of 36 cases, 33 cases(91.7%) could be investigated and 3 cases could not. Mean follow up period was 83.2 months. Out of 33 cases, 25 cases(75.8%) showed symptomatic improvement, of which 8 cases(53.3%) in the group of thymoma(n=15) and 17 cases(94.4%) in the group of thymic hyperplasia(n=18) showed the improvement of$\boxUl$ symptoms. Conclusion : In myasthenia gravis, thymectomy showed the good improvement, and more important factor affecting the improvement of symptoms was the grdae of preoperative symptoms. Also midterm and long term follow up results showed good symptomatic improvement.

Comparison of Clinical Usefulness between N-13 Ammonia PET/CT and Tc-99m Sestamibi SPET in Coronary Artery Disease (관상동맥질환에서 N-13 암모니아 PET/CT와 Tc-99m 세스타미비 SPECT의 임상 유용성 비교)

  • Kong, Eun-Jung;Cho, Ihn-Ho;Chun, Kyung-Ah;Won, Kyu-Chang;Lee, Hyung-Woo;Park, Jeong-Sun;Shin, Dong-Gu;Kim, Young-Jo;Shim, Bong-Seop
    • Nuclear Medicine and Molecular Imaging
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    • v.42 no.5
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    • pp.354-361
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    • 2008
  • Purpose: N-13 ammonia uptake and retention in the myocardium is related to perfusion and metabolism. There are several potential advantages of N-13 ammonia positron emission tomography (PET) to detect myocardial ischemia, such as higher spatial resolution, greater counting efficiencies, and robust attenuation correction. But there are few reports comparing Tc-99m myocardial perfusion single photon emission tomography (MPS) and N-13 ammonia PET. We thus compared adenosine stress N-13 ammonia PET/CT and Tc-99m sestamibi MPS in patients with suspected coronary artery stenosis. Materials and Methods: Seventeen patients (male 13 : $63{\pm}11$ years old) underwent adenosine stress N-13 ammonia PET/CT (Discovery ST, GE), Tc-99m sestamibi MPS (dual head gamma camera, Hawkeye, GE) and coronary angiography within 1 week. N-13 ammonia PET/CT and Tc-99m sestamibi MPS images were assessed with a 20-segment model by visual interpretation and quantitative analysis using automatic quantitative software (Myovation, GE). Results: Both sensitivities and specificities of detecting an individual coronary artery stenosis were higher for N-13 ammonia PET/CT than Tc-99m sestamibi MPS (PET/CT: 91%/89% vs MPS: 65%/82%). N-13 ammonia PET/CT showed reversibility in 52% of segments that were considered non-reversibile by Tc-99m sestamibi MPS. In the 110 myocardial segments supplied by the stenotic coronary artery, N-13 ammonia PET/CT showed higher count densities than Tc-99m MPS on rest study (p < 0.01), and the difference of count density between the stress and the rest studies was also larger on N-13 ammonia PET/CT. Conclusion: Adenosine stress N-13 ammonia PET/CT had higher diagnostic sensitivity and specificity, more reversibility of perfusion defects and greater stress/rest uptake differences than Tc-99m sestamibi MPS. Accordingly, N-13 ammonia PET/CT might offer better assessment of myocardial ischemia and viability.

The Evaluation of Usefulness of Wide Beam Reconstruction Method on Segmental Perfusion and Regional Wall Motion in Myocardial Perfusion SPECT (심근관류 SPECT의 분절별 관류 및 국소벽 운동에서 Wide Beam Reconstruction기법의 유용성 평가)

  • Seong, Yong-Joon;Kim, Tae-Yeob;Moon, Il-Sang;Cho, Seong-Wook;Woo, Jae-Ryong
    • The Korean Journal of Nuclear Medicine Technology
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    • v.15 no.1
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    • pp.51-57
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    • 2011
  • Purpose: The aim of this study is to identify clinical usefulness of Wide Beam Reconstruction (WBR) which is called Xpress.cardiac$^{TM}$ to confirm the agreement between segmental perfusion and regional wall motion in myocardium compared to conventional OSEM method. Materials and Methods: Subjects were separated two groups. First group was composed of 20 normal control group. Second group was composed of 10 patients (abnormal group) who had coronary artery disease. Subjects underwent myocardial perfusion SPECT ($^{201}Tl$ rest and $^{99m}Tc$-MIBI stress). Image acquisition and reconstruction were that rest stage was each step per 30, 15 seconds and stress stage was each step per 25, 13 seconds, OSEM and WBR methods were applied. Segmental perfusion and regional wall motion were applied 20-segment model of QPS, QGS algorithm in AutoQuant. Status of perfusion was composed of 5 point scoring system (0=normal, 1=mild, 2=moderate, 3=severe hypokinesia, 4=dyskinesia). Status of regional wall motion was also composed of 5 point scoring (0=normal, 1=mild, 2=moderate, 3=severe hypokinesia, 4=dyskinesia). We evaluated the agreement between conventional OSEM and WBR through automatic quantification value. Results: The agreement of rest segmental perfusion between conventional OSEM and WBR in normal patients was 99% (396/400, k=0.662, p<0.0001) and one of rest regional wall motion was 83.8% (335/400, k=0.283), the agreement of stress segmental perfusion was 95.8%(383/400, k=0.656), one of stress regional wall motion was 87.3% (349/400, k=0.390). The match rate of rest segmental perfusion in abnormal patients was 83% (166/200, k=0.605, p<0.0001) and one of rest regional wall motion was 55.5% (111/200, k=0.385), the agreement of stress segmental perfusion was 79.5% (159/200, k=0.682), one of stress regional wall motion was 63.5% (127/200, k=0.486). Conclusion: Compared to conventional OSEM, WBR method had a good agreement of segmental perfusion in myocardium in normal and abnormal groups. However regional wall motion showed meaningful low agreement. Although WBR offers high resolution and contrast ratio, it is not useful method for gated myocardial perfusion SPECT.

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Attenuation of Experimental Autoimmune Hepatitis in Mice with Bone Mesenchymal Stem Cell-Derived Exosomes Carrying MicroRNA-223-3p

  • Lu, Feng-Bin;Chen, Da-Zhi;Chen, Lu;Hu, En-De;Wu, Jin-Lu;Li, Hui;Gong, Yue-Wen;Lin, Zhuo;Wang, Xiao-Dong;Li, Ji;Jin, Xiao-Ya;Xu, Lan-Man;Chen, Yong-Ping
    • Molecules and Cells
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    • v.42 no.12
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    • pp.906-918
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    • 2019
  • MicroRNA-223-3p (miR-223-3p) is one of the potential microRNAs that have been shown to alleviate inflammatory responses in pre-clinical investigations and is highly encased in exosomes derived from bone mesenchymal stem cells (MSC-exosomes). MSC-exosomes are able to function as carriers to deliver microRNAs into cells. Autoimmune hepatitis is one of the challenging liver diseases with no effective treatment other than steroid hormones. Here, we examined whether MSC-exosomes can transfer miR-223-3p to treat autoimmune hepatitis in an experimental model. We found that MSC-exosomes were successfully incorporated with miR-223-3p and delivered miR-223-3p into macrophages. Moreover, there was no toxic effect of exosomes on the macrophages. Furthermore, treatments of either exosomes or exosomes with miR-223-3p successfully attenuated inflammatory responses in the liver of autoimmune hepatitis and inflammatory cytokine release in both the liver and macrophages. The mechanism may be related to the regulation of miR-223-3p level and STAT3 expression in the liver and macrophages. These results suggest that MSC-exosomes can be used to deliver miR-223-3p for the treatment of autoimmune hepatitis.

A Study on Epidemiologic Characteristics of Recurrent Abdominal Pain in Elementary School Children (반복성 복통증 환아의 역학적 특징에 관한 조사)

  • Oh, Sang-Hyun;Yang, Eun-Seok;Park, Sang-Kee;Park, Young-Bong;Park, Jong;Park, Sang-Hak;Moon, Kyung-Rye
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.2 no.1
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    • pp.21-29
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    • 1999
  • Purpose: The aims of this study are to examine clinical characteristics, patterns of medical care utilization, and factors which determine medical care utilization of elementary school children with recurrent abdominal pain (RAP), to find posssible factors influencing the onset and the course of the disorder. Method: We performed questionnaires in Kwangju on children from two primary schools from June,1 1998 to June 30 and carried out statistical analysis. Result: 1) Total number of questionnaires were 1417. 715 were male and 702 were female and the ratio of male to female was 1.02:1. Average age was 10.3 years. 2) 268 children had RAP (18.9%), boys 132 (18.4%), girls136 (19.2%). 3) The duration of the pain within 10 minutes was 68.5%. 178 children with RAP (66.3%) visited the doctor. The utilization pattern of medical facilities of the pupils with RAP; the most frequently utilized medical facility was pediatrics (35.2%) and the order ran as internal medicine (31.5%), and pharmacy (29.25). The utilization pattern of medical facilities for the older students; the utilization rate of pediatrics decreased, but internal medicine increased. The major factors affecting the selection of the medical facility were geographic accessibility, kindness of the personnel, good results and traffic convenience. 4) Symptoms which were accompanied with abdominal pain were headache (44.5%), chest pain (28.2%), dizziness (26.6%), vomiting (9%), and 119 children (44.5%) had no accompanied symptoms. 5) In 95 children (35.3%) abdominal pain, occured at postprandial time, in 55 children (20.5%) before meal and in 39 children (14.7%) at school. The highest incidence rate of RAP was observed on Monday (21.4%), and the lowest on Saturday (8.7%). 6) The most frequent involved part of the abdomen was periumbrical area (38%) and the order ran as epigastrium and suprapubic area. The most frequent characteristics of abdominal pain were burning pain (36.9%) and the order ran as dull, cramping and colicky pain. Conclusion: RAP is a frequent disease entitiy in children. Too many times children with RAP are treated by other departments instead of Pediatrics. A child has a peculiar growth and development which is different to those from an adult with advancing years. So, it is necessary to choose special medical care and an adequate medical facility.

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Analysis of the Tumor Necrosis Factor-${\alpha}$ Promoter Polymorphism in Children with Henoch-Sch$\"{o}$nlein Purpura (Henoch-Sch$\"{o}$nlein 자반증에서 Tumor Necrosis Factor-${\alpha}$ 유전자 다형성 분석)

  • Yang, Hye-Ran;Ko, Jae-Sung;Seo, Jeong-Kee
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.10 no.1
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    • pp.11-19
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    • 2007
  • Purpose: Henoch-Sch$\"{o}$nlein purpura (HSP) is a systemic vasculitis involving the skin, joints, gastrointestinal tract, and kidney. Although the pathogenesis of HSP is still unclear, tumor necrosis factor (TNF-${\alpha}$) is regarded as an important cytokine contributing to the disease. The goal of this study was to determine the role of TNF-${\alpha}$ in the pathogenesis of HSP, and to evaluate the TNF-${\alpha}$ polymorphism for genetic susceptibility to HSP. Methods: From March 2004 to November 2005, 40 children with HSP and 32 healthy controls were included. Serum TNF-${\alpha}$ levels were measured using the ELISA method during the acute and convalescent phase of HSP. The genotypic and allelic frequencies of the TNF-${\alpha}$ gene polymorphisms at positions -308 and -238 were evaluated in patients and controls. Results: Serum TNF-${\alpha}$ levels were $23.17{\pm}11.31$ pg/mL in the acute phase of children with HSP and $10.56{\pm}5.59$ pg/mL in the convalescent phase (p=0.000). There was no significant correlation between the serum TNF-${\alpha}$ levels and the clinical scores of HSP (r=0.310, p=0.070). The genotypic frequency of the TNF-${\alpha}$ -308 polymorphism in children with HSP was not significantly different compared to healthy controls (GG 80%, GA 20% vs. GG 93.8%, GA 6.2%; p=0.094). The genotypic frequency of the TNF-${\alpha}$ -238 polymorphism in children with HSP was not significantly different (GG 97.5%, GA 2.5% vs. GG 93.8%, GA 6.3%; p=0.429). Conclusion: TNF-${\alpha}$ is assumed to be the main cytokine associated with the pathogenesis of HSP during the acute phase. However, the presence of TNF-${\alpha}$ gene polymorphisms at positions -308 and -238 did not distinguish children with HSP from normal controls.

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