• Title/Summary/Keyword: Clinically

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Angiotensin Converting Enzyme Gene Polymorphism in Alport Syndrome (알포트증후군 환자에서 안지오텐신전환효소 유전자 다형성의 의의)

  • Kim Ji-Hong;Lee Jae-Seung;Kim Pyung-Kil
    • Childhood Kidney Diseases
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    • v.8 no.1
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    • pp.18-25
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    • 2004
  • Purpose : Alport syndrome is clinically characterized by hereditary progressive nephritis causing ESRD with irregular thickening of the GBM and sensory neural hearing loss. The mutations of type IV collagen gene(COL4A5) located on the long arm of X chromosome is considered responsible for most of the structural abnormalities in the GBM of Alport patients. Since no definite clinical prognostic predictor has been reported in the disease yet, we designed this study to evaluate the significance of genetic polymorphism of the angiotensin converting enzyme in children with Alport syndrome as a prognostic factor for disease progression. Methods : ACE I/D genotype were examined by PCR amplification of the genomic DNA in 12 patients with Alport syndrome and 12 of their family members. Alport patients were divided into two groups; the conservative group, those who had preserved renal function for more than 10 years of age, the early CRF group, those who had progressed to CRF within 10 years of age. Results : The mean age of onset was $3.45{\pm}2.4$ years in the conservative group, $4.4{\pm}1.2$ years in the early CRF group. Sex ratios were 5:3 and 2:1 in each group. Among 12 cases of patients, 4 cases were in early CRF group and their mean duration of onset to CRF was 4.5 yews(8.9 years of age). Eight patients(67%) were in the conservative group and they had normal renal function for more than 10 years of age(mean duration of renal preservation was 10.6 years). The incidence of II type ACE gene were in 25.0%(3 cases), ID type in 41.7%(5 cases), DD type in 33.3%(4 cases). There was no significant difference between Alport patient and normal control(II type 44.3%, ID type 40.9%, DD type 14.8%). The incidence of DD type of early CRF group were higher than that of the conservative group(75% vs 12.5%)(p<0.05). There was no difference in ACE gene polymorphism between normal Alport family members and control group. Conclusion : Even though there was no significant difference of ACE polymorphism between Alport patients and the normal control group, the incidence of DD type is significantly increased in early CRF group which means DD type of ACE polymorphism has a possibility of being a predictor for early progression to CRF in Alport patients.

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Bladder Preserving Treatment in Patients with Muscle Invasive Bladder Cancer (근침윤성 방광암 환자의 방광 보존적 치료 결과)

  • Yu, Jeong-Il;Oh, Dong-Ryol;Huh, Seung-Jae;Choi, Han-Yong;Lee, Hyon-Moo;Jeon, Seong-Soo;Yim, Ho-Young;Kim, Won-Suk;Lim, Do-Hoon;Ahn, Yong-Chan;Park, Won
    • Radiation Oncology Journal
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    • v.25 no.2
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    • pp.70-78
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    • 2007
  • [ $\underline{Purpose}$ ]: This study analyzed the tumor response, overall survival, progression free survival and related prognostic factors in patients with muscle invasive bladder cancer subjected to bladder preserving treatment. $\underline{Materials\;and\;Methods}$: Between August 1995 and June 2004, 37 patients with muscle invasive (transitional cell carcinoma, clinically stage T2-4) bladder cancer were enrolled for the treatment protocol of bladder preservation. There were 33 males and 4 females, and the median age was 67 years (range $38{\sim}86\;years$). Transurethral resection of the bladder (TURB) was performed in 17 patients who underwent complete resection. The median radiation dose administered was 64.8 Gy (range $55.8{\sim}67\;Gy$). The survival rate was calculated by the Kaplan-Meier method. $\underline{Results}$: An evaluation of the response rate was determined by abdomen-pelvic CT and cystoscopy at three months after radiotherapy. A complete response was seen in 17 patients (46%). The survival rate at three years was 54.7%, with 54 months of median survival (range $3{\sim}91$ months). During the study, 17 patients died and 13 patients had died from bladder cancer. The progression free survival rate at three years was 37.2%. There were 24 patients (64.9%) who had disease recurrence: 16 patients (43.2%) had local recurrence, 6 patients (16.2%) had a distant recurrence, and 2 patients (5.4%) had both a local and distant recurrence. The survival rate (p=0.0009) and progression free survival rates (p=0.001) were statistically significant when compared to the response rate after radiotherapy. $\underline{Conclusion}$: The availability of complete TURB and appropriate chemoradiotherapy were important predictors for bladder preservation and survival.

Review of 2015 Major Medical Decisions (2015년 주요 의료판결 분석)

  • Yoo, Hyun Jung;Lee, Dong Pil;Lee, Jung Sun;Jeong, Hye Seung;Park, Tae Shin
    • The Korean Society of Law and Medicine
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    • v.17 no.1
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    • pp.299-346
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    • 2016
  • There were also various decisions made in medical area in 2015. In the case that an inmate in a sanatorium was injured due to the reason which can be attributable to the sanatorium and the social welfare foundation that operates the sanatorium request treatment of the patient, the court set the standard of fixation of a party in medical contract. In the case that the family of the patient who was declared brain dead required withdrawal of meaningless life sustaining treatment but the hospital rejected and continued the treatment, the court made a decision regarding chargeable fee for such treatment. When it comes to the eye brightening operation which received measure of suspension from the Ministry of Health and Welfare for the first time in February, 2011, because of uncertainty of its safety, the court did not accept the illegality of such operation itself, however, ordered compensation of the whole damage based on the violation of liability for explanation, which is the omission of explanation about the fact that the cost-effectiveness is not sure as it is still in clinical test stage. There were numerous cases that courts actively acknowledged malpractices; in the cases of paresis syndrome after back surgery, quite a few malpractices during the surgery were acknowledged by the court and in the case of nosocomial infection, hospital's negligence to cause such nosocomial infection was acknowledged by the court. There was a decision which acknowledged malpractice by distinguishing the duty of installation of emergency equipment according to the Emergency Medical Service Act and duty of emergency measure in emergency situations, and a decision which acknowledged negligence of a hospital if the hospital did not take appropriate measures, although it was a very rare disease. In connection with the scope of compensation for damage, there were decisions which comply with substantive truth such as; a court applied different labor ability loss rate as the labor ability loss rate decreased after result of reappraisal of physical ability in appeal compared to the one in the first trial, and a court acknowledged lower labor ability loss rate than the result of appraisal of physical ability considering the condition of a patient, etc. In the event of any damage caused by malpractice, in regard to whether there is a limitation on liability in fee charge after such medical malpractice, the court rejected the hospital's claim for setoff saying that if the hospital only continued treatments to cure the patient or prevent aggravation of disease, the hospital cannot charge Medical bills to the patient. In regard to the provision of the Medical Law that prohibit medical advertisement which was not reviewed preliminarily and punish the violation of such, a decision of unconstitutionality was made as it is a precensorship by an administrative agency as the deliberative bodies such as Korean Medical Association, etc. cannot be denied to be considered as administrative bodies. When it comes to the issue whether PRP treatment, which is commonly performed clinically, should be considered as legally determined uninsured treatment, the court made it clear that legally determined uninsured treatment should not be decided by theoretical possibility or actual implementation but should be acknowledged its medical safety and effectiveness and included in medical care or legally determined uninsured treatment. Moreover, court acknowledged the illegality of investigation method or process in the administrative litigation regarding evaluation of suitability of sanatorium, however, denied the compensation liability or restitution of unjust enrichment of the Health Insurance Review & Assessment Service and the National Health Insurance Corporation as the evaluation agents did not cause such violation intentionally or negligently. We hope there will be more decisions which are closer to substantive truth through clear legal principles in respect of variously arisen issues in the future.

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A Clinical Evaluation of Splanchnic Nerve Block (내장신경차단에 관한 임상적 연구)

  • Kim, Soo-Yeoun;Oh, Hung-Kun;Yoon, Duek-Mi;Shin, Yang-Sik;Lee, Youn-Woo;Kim, Jong-Rae
    • The Korean Journal of Pain
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    • v.1 no.1
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    • pp.34-46
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    • 1988
  • Intractable pain from advanced carcinoma of the upper abdomen is difficult to manage. One method used to control pain associated with these malignancies is to block off the splanchnic nerve. In 1919 Kappis described a technique by which the splanchnic nerve of the upper abdomen could be anesthetized, using a percutaneous injection. This method has been used for the relief of upper abdominal pain due to hematoma and cancer of the pancreas, stomach, gall bladder, bile duct, and colon. During the Period from November 1968 to January 1986, this method was used in 208 cases of malignancy at Severance Hospital and clinically evaluated. Patients were retroactively grouped according to the stage of development of technique used. Twelve patients who received the treatment in the period from November 1968 to March 1977 were designate4i as group 1, 26 patients from April 1977 to April 1979 as group 2, and 170 from May 1979 to January 1986 as group 3. The results are as follows: 1) The number of patients receiving splanchnic nerve block has been increasing since 1977. 2) A total of 208 patients, including 133 males and 75 females, ranging in age from 18 to 84 and averaging 51. 3) The causes of pain were stomach cancer 90, pancreatic cancer 69, and miscellaneous cancer 49 cases respectively. 4) There were 57.7% who had surgery. and 3.7% of whom had chemotherapy before the splanchnic nerve block was done. 5) These blocks were carried out with the patient in the prone position as described by Dr. Moore. For group 2 and 3, C-arm image intensifier was used. In group 1, a 22 gauze loom long needle was inserted at the lower border of the 12th rib on each aide about 7\;cm from the midline. The average distance from the midline was $6.60{\pm}0.61\;cm$ on the left side and $6.60{\pm}0.83\;cm$ on the right side in group 2, and $5.46{\pm}0.76\;cm$ on the left side and $5.49{\pm}0.69\;cm$ on the right side in group 3. The average depth to which the needle was inserted was $8.60{\pm}0.52\;cm$ on the left side and $8.74{\pm}0.60\;cm$ on the right side in group 2, and $8.96{\pm}0.63\;cm$ on the left side and $9.18{\pm}0.57\;cm$ on the right side in group 3. 6) The points of the inserted needles were positioned in the upper quarter anteriorly, 51.8% on the left side and 54.4% n the right side of the L1 vertebra by lateral roentgenogram in group 3. The inserted needle points were located in the upper and anterolateral part, of the L1 vertebra 68.5% on the left side and 60.6won the right side, on the anteroposterior rentgenogram in group 3. The needle tip was not advanced beyond the anterior margin of the vertebral body. 7) In some case of group 3, contrast media was injected before the block was done. It shows, the spread upward along the anterior mal gin of the vertebral body. 8) The concentration and the average amount of drug used in each group was as follows: In group 1, $39.17{\pm}6.69\;ml$ of 0.5% -l% lidocaine or 0.25% bupivacaine were injected for the test block and one to three days after the test block $40.00{\pm}4.26\;ml$ of 50% alcohol was injected for the semipermanent block. In group 2, $13.75{\pm}4.88\;ml$ of 1% lidocaine were used as the test block and followed by $46.17{\pm}4.37\;ml$ of 50% alcohol was injected as the semipermanent block. In group 3, $15.63{\pm}1.19\;ml$ of 1% lidocaine for test block followed by $15.62{\pm}1.20\;ml$ of pure alcohol and $16.05{\pm}2.58\;ml$ of 50% alcohol for semipermanent block were injected. 9) The result of the test block was satisfactory in all cases. However the semipermanent block was 83.3 percent of the patients in group 1 who received relief from pain for at least 2 weeks after the block, 73.1% in group 2, and 91.8% in group 3. In these unsuccessful cases, 2 cases in group 1 were controlled by narcotics but 7 cases in group 2 and 14 cases in group 3 received the same splanchnic nerve block 1 or 2 times again within 2 weeks. But, in some cases it was 3 to i months before the 2nd block and in 1 cases even 7 years. 10) The most common complications of splanchnic nerve block were hypotensino(25.5%) occasional flushing of the face, nausea, vomiting, and chest discomfort. 11) For the patients in group 3, the supplemental block most commonly used was a continuous epidural block; it was used as a diagnostic block and to afford relief from pain before the splanchnic nerve block was done. 12) The interval between the receiving of the alcohol block and discharge was from 5 to 8 days in 61 cases(31.1%) and from 1 to 2 days in 48 cases(24.5%). From the above results, it can be concluded that the splanchnic nerve block done in the prone position with pure and 50% alcohol immediately after an effective test block with 1% lidocaine under C-arm fluoroscopic control is satisfactory and reliable. How to minimize the repeat block is still a problem to be solved.

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Dose verification for Gated Volumetric Modulated Arc Therapy according to Respiratory period (호흡연동 용적변조 회전방사선치료에서 호흡주기에 따른 선량전달 정확성 검증)

  • Jeon, Soo Dong;Bae, Sun Myung;Yoon, In Ha;Kang, Tae Young;Baek, Geum Mun
    • The Journal of Korean Society for Radiation Therapy
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    • v.26 no.1
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    • pp.137-147
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    • 2014
  • Purpose : The purpose of this study is to verify the accuracy of dose delivery according to the patient's breathing cycle in Gated Volumetric Modulated Arc Therapy Materials and Methods : TrueBeam STxTM(Varian Medical System, Palo Alto, CA) was used in this experiment. The Computed tomography(CT) images that were acquired with RANDO Phantom(Alderson Research Laboratories Inc. Stamford. CT, USA), using Computerized treatment planning system(Eclipse 10.0, Varian, USA), were used to create VMAT plans using 10MV FFF with 1500 cGy/fx (case 1, 2, 3) and 220 cGy/fx(case 4, 5, 6) of doserate of 1200 MU/min. The regular respiratory period of 1.5, 2.5, 3.5 and 4.5 sec and the patients respiratory period of 2.2 and 3.5 sec were reproduced with the $QUASAR^{TM}$ Respiratory Motion Phantom(Modus Medical Devices Inc), and it was set up to deliver radiation at the phase mode between the ranges of 30 to 70%. The results were measured at respective respiratory conditions by a 2-Dimensional ion chamber array detector(I'mRT Matrixx, IBA Dosimetry, Germany) and a MultiCube Phantom(IBA Dosimetry, Germany), and the Gamma pass rate(3 mm, 3%) were compared by the IMRT analysis program(OmniPro I'mRT system software Version 1.7b, IBA Dosimetry, Germany) Results : The gamma pass rates of Case 1, 2, 3, 4, 5 and 6 were the results of 100.0, 97.6, 98.1, 96.3, 93.0, 94.8% at a regular respiratory period of 1.5 sec and 98.8, 99.5, 97.5, 99.5, 98.3, 99.6% at 2.5 sec, 99.6, 96.6, 97.5, 99.2, 97.8, 99.1% at 3.5 sec and 99.4, 96.3, 97.2, 99.0, 98.0, 99.3% at 4.5 sec, respectively. When a patient's respiration was reproduced, 97.7, 95.4, 96.2, 98.9, 96.2, 98.4% at average respiratory period of 2.2 sec, and 97.3, 97.5, 96.8, 100.0, 99.3, 99.8% at 3.5 sec, respectively. Conclusion : The experiment showed clinically reliable results of a Gamma pass rate of 95% or more when 2.5 sec or more of a regular breathing period and the patient's breathing were reproduced. While it showed the results of 93.0% and 94.8% at a regular breathing period of 1.5 sec of Case 5 and 6, it could be confirmed that the accurate dose delivery could be possible on the most respiratory conditions because based on the results of 100 patients's respiratory period analysis as no one sustained a respiration of 1.5 sec. But, pretreatment dose verification should be precede because we can't exclude the possibility of error occurrence due to extremely short respiratory period, also a training at the simulation and careful monitoring are necessary for a patient to maintain stable breathing. Consequently, more reliable and accurate treatments can be administered.

Fracture load and marginal fitness of zirconia ceramic coping by design and coloration (유색 및 백색 지르코니아 세라믹 코핑의 코핑 디자인에 따른 파절 하중과 변연 적합성)

  • Shin, Mee-Ran;Kim, Min-Jeong;Oh, Sang-Chun
    • The Journal of Korean Academy of Prosthodontics
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    • v.47 no.4
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    • pp.406-415
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    • 2009
  • Purpose: The purpose of this study was to compare the marginal fitness and fracture load of the zirconia copings according to the design with different thickness and coloration. Material and methods: The evaluation was based on 80 zirconia copings. Zirconia copings were fabricated in design with different thicknesses using CAD/CAM system (Everset, KAVO dental GmbH, Biberach, Germany). The designs of copings were divided into four groups. The first group consisted of copings with uniform thickness of 0.3 mm. The thickness in the second group was 0.3 mm on the buccal surface and 0.6 mm on the lingual surface. The third group consisted of coping with uniform thickness of 0.6 mm. The thickness in the fourth group was 0.6 mm on the buccal surface and 1mm on the lingual surface. Each group consisted of 10 colored and 10 uncolored copings. Half of the copings (40) processed with a milling system according to the specific design were sent to be given a color (A3) through saturation in special dye by a manufacturing company. Just after sintering, the marginal discrepancies of copings were measured on the buccal, lingual, mesial and distal surfaces of metal die, under a Video Microscope System (sv-35, Sometech, Seoul, Korea) at a magnification of $\times$ 100. It was remeasured after the adjusting of the inner surface. Next, all copings were luted to the metal dies using reinforced cement {GC FujiCEM (GC Corp. Tokyo, Japan)} and mounted on the testing jig in a Universal Testing Machine (Instron 4467, Norwood, MA, USA). The results were analyzed statistically using the one-way ANOVA test. Results: The obtained results were as follow: 1. The measured value of marginal discrepancy right after sintering was the greatest in the contraction of the buccal area in all groups, except for group I2. 2. There was no significant difference of marginal fitness among the groups in the colored zirconia group (P<.05). 3. When the marginal fitness among the groups in the uncolored zirconia group was considered, group II2 had the smallest marginal discrepancy. 4. When the colored and uncolored groups with the same design were compared, there was a significant difference between I1 and II1 groups. In group 2, 3, and 4, the uncolored zirconia had the greatest marginal fitness (P<.05). 5. After adjustment of inner surface, there was no significant difference in the marginal fitness in all groups when color and design of the zirconia coping were compared. 6. The fracture load of CAD/CAM zirconia copings showed significant difference in group 1, 2, 3, and 4. I4 and II4 had the strongest fracture load. 7. When groups with different color and same design were compared, all colored groups showed greater fracture load (P>.05), with no significance. Conclusion: There was difference in the marginal fitness according to the design and coloration of zirconia copings right after sintering, but it was decided that the copings may well be used clinically if the inner surface are adjusted. The copings should be thick enough for the reinforcement of fracture strength. But considering the esthetics of the visible surfaces (labial and buccal surface), the thickness of copings may be a little thin, without giving any significant effect on the fracture strength. This type of design may be considered when giving priority to preservation of tooth or esthetics.

Clinical Differential Diagnosis of Usual Interstitial Pneumonia from Nonspecific Interstitial Pneumonia (통상성 간질성 폐렴과 비특이성 간질성 폐렴의 임상적 감별 진단)

  • An, Chang-Hyeok;Koh, Young-Min;Chung, Man-Pyo;Suh, Gee-Young;Kang, Soo-Jung;Kang, Kyeong-Woo;Ahn, Jong-Woon;Lim, Si-Young;Kim, Ho-Joong;Han, Jeung-Ho;Lee, Kyung-Soo;Kwon, O-Jung;Rhee, Chong-H.
    • Tuberculosis and Respiratory Diseases
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    • v.48 no.6
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    • pp.932-943
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    • 2000
  • Background : Nonspecific interstitial pneumonitis (NSIP) is most likely to be confused with usual interstitial pneumonitis (UIP). Unlike patients witþ UIP, the majority of patients with NSIP have a good prognosis, with most patients improving after treatment with corticosteroids. Therefore it is clinically important to differentiate NSIP from UIP. Up to now, the only means of differentiating these two diseases was by means of surgical lung biopsy. American Thoracic Society (ATS) proposed a clinical diagnostic criteria for UIP to provide assistance to clinicians in its diagnosis without surgical lung biopsy. This study is aimed to investigate whether there were clinical and radiological differences between NSIP and UIP, and the usefulness of ATS clinical diagnostic criteria for UIP in Korea. Methods : We studied 60 patients with UIP and NSIP confirmed by surgical lung biopsy. Clinical manifestations, pulmonary function test, arterial blood gas analysis, bronchoalveolar lavage (BAL), and high resolution computed tomography (HRCT) were evaluated and analyzed by Chi-square test or t-test. The clinical criteria for UIP proposed by ATS were applied to all patients with idiopathic interstitial pneumonia. Results : Forty-two patients with UIP and 18 with NSIP were pathologically identified. Among the 18 patients with NSIP (M : F=1 : 17), the mean age was 55.2$\pm$8.4 (44~73) yr. Among the 42 patients with UIP (M : F=33 : 9), the mean age was 59.5$\pm$7.1 (45~74) yr (p=0.046). Fever was more frequent in NSIP (39%) (p=0.034), but clubbing was frequently observed in UIP (33%) (p=0.023). BAL lymphocytosis was more frequent (23%) (p=0.0001) and CD4/CD8 ratio was lower in NSIP (p=0.045). On HRCT, UIP frequently showed honeycomb appearance (36 of 42 patients) though not in NSIP (p=0.0001). Six of 42 UIP patients (14.3%) met the ATS clinical criteria for IPF, and 3 of 16 NSIP patients (18.8%) met the diagnostic criteria. Conclusion : Being a relatively young female and having short duration of illness, fever, BAL lymphocytosis, low CD4/CD8 ratio with the absence of clubbing and honeycomb appearance in HRCT increase the likelihood of the illness being NSIP. The usefulness of ATS clinical diagnostic criteria for UIP may be low in Korea.

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Plasma Activity of Lysosomal Enzymes in Active Pulmonary Tuberculosis (활동성 폐결핵 환자에서 혈중 리소솜 효소의 활성도)

  • Koh, Youn-Suck;Choi, Jeong-Eun;Kim, Mi-Kyung;Lim, Chae-Man;Kim, Woo-Sung;Chi, Hyun-Sook;Kim, Won-Dong
    • Tuberculosis and Respiratory Diseases
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    • v.42 no.5
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    • pp.646-653
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    • 1995
  • Background: The confirmative diagnosis of pulmonary tuberculosis(Tb) can be made by the isolation of Mycobacterium Tuberculosis(MTb) in the culture of the sputum, respiratory secretions or tissues of the patients, but positive result could not always be obtained in pulmonary Tb cases. Although there are many indirect ways of the diagnosis of Tb, clinicians still experience the difficulty in the diagnosis of Tb because each method has its own limitation. Therefore development of a new diagnostic tool is clinically urgent. It was reported that silica cause some lysosomal enzymes to be released from macrophages in vitro and one of these enzymes is elevated in workers exposed to silica dust and in silicotic subjects. In pulmonary Tb, alveolar macrophages are known to be activated after ingestion of MTb. Activated macrophages can kill MTb through oxygen free radical species and digestive enzymes of lysosome. But if macrophages allow the bacilli to grow intracellularly, the macrophages will die finally and local lesion will enlarge. Then it is assumed that the lysosomal enzymes would be released from the dead macrophages. The goal of this investigation was to determine if there are differences in the plasma activities of lysosomal enzymes, ($\beta$-glucuronidase(GLU) and $\beta$-N-acetyl glucosaminidase(NAG), among the groups of active and inactive pulmonary Tb and healthy control, and to see if there is any possibility that the plasma activity of GLU and NAG can be used as diagnostic indicies of active pulmonary Tb. Methods: The plasma were obtained from 20 patients with bacteriologically proven active pulmonary Tb, 15 persons with inactive Tb and 20 normal controls. In 10 patients with active pulmonary Tb, serial samples after 2 months of anti-Tb medications were obtained. Plasma GLU and NAG activities were measured by the fluorometric methods using 4-methylumbelliferyl substrates. All data are expressed as the mean $\pm$ the standard error of the mean. Results: The activites of GLU and NAG in plasma of the patients with active Tb were $21.52{\pm}3.01$ and $325.4{\pm}23.37$(nmol product/h/ml of plasma), respectively. Those of inactive pulmonary Tb were $24.87{\pm}3.78$, $362.36{\pm}33.92$ and those of healthy control were $25.45{\pm}4.05$, $324.44{\pm}28.66$(nmol product/h/ml of plasma), respectively. There were no significant differences in the plasma activities of both enzymes among 3 groups. The plasma activities of GLU at 2 months after anti-Tb medications were increased($42.18{\pm}5.94$ nmol product/h/ml of plasma) in the patients with active pulmonary Tb compared with that at the diagnosis of Tb(P-value <0.05). Conclusion: The results of the present investigation suggest that the measurement of the plasma activities of GLU and NAG in the patients with active pulmonary Tb could not be a useful method for the diagnosis of active Tb. Further investigation is necessary to define the reasons why the plasma activities of the GLU was increased in the patients with active pulmonary Tb after Tb therapy.

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Clinical Efficacy of Erdosteine in Patients with Acute or Chronic Bronchitis -A Randomized, Double Blind, Comparative Study vs. Ambroxol- (급.만성 기관지염 환자에서 엘도스$^{(R)}$(Erdosteine)의 임상효과 -염산 암브록솔과의 무작위 이중맹검 비교시험-)

  • Kim, Seok-Chan;Lee, Sang-Hoak;Song, So-Hyang;Kim, Young-Kyoon;Moon, Hwa-Sik;Song, Jeong-Sup;Park, Sung-Hak
    • Tuberculosis and Respiratory Diseases
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    • v.44 no.6
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    • pp.1296-1307
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    • 1997
  • Background : Erdosteine is a thiol derivative developed for the treatement of chronic obstructive bronchitis, including acute infective exacerbation of chronic bronchitis. Erdosteine has mucomodulating and antioxidant properties and especially exhibits excellent gastrointestinal tolerability. Methods : The study was conducted as a prospective evaluation, with 2 comparative groups orally treated with erdosteine 300mg (bid.) or ambroxol 30mg (b.i.d.) for 7 days and the design of trial was double-blind. The treatments have been assigned randomly to patients (n=80) with acute or chronic bronchitis. The primary end-point used to determine efficacy in this study was subjective symptoms including expectorating frequence, expectoration volume, expectorating difficulty, expectoration viscosity, cough intensity and dyspnea. The secondary end-points of efficacy was the result of arterial blood gas analysis and pulmonary function test. Safety was evaluated with adverse drug reactions and laboratory tests monitoring. 61 patients was included in the efficacy analysis, due to the fact that 19 patients drop-out for different reasons. The obtained values have been analyzed with paired Hest., ANOVA test., multivariate $t^2$-test, repeated measures analysis of covariance, two sample t-test, loglinear-logit model analysis, Fisher's exact test. Results : 1) There was no significant difference on demographic data and vital signs between erdosteine and ambroxol treated groups. 2) The comparison between erdosteine and ambroxol treated groups showed no significant difference in improvement of each symptom in spite of the more favorable efficacy obtained with erdosteine. No difference on the contrary was observed for arterial blood gas analysis and pulmonary function test. 3) As safety is concerned, no clinical significant changes in laboratory test and symptom were induced in erdosteine and ambroxol treated group and two patients in ambroxol treated group drop-out for adverse reactions in symptom. 4) In the evaluation of final clinical efficacy, erdosteine improved more effectively patient's overall symptoms {very good effect (11/31), good effect (12/31), moderate effect (6/31), no effect (2/31), aggravation (0/31)} than ambroxol {very good effect (6/30), good effect (14/30), moderate effect (5/30), no effect (4/30), aggravation (2/30)}. And the probability of symptomatic improvement by erdosteine compared to ambroxol was 2.5 times. (p<0.05). Conclusion : This study showed that erdosteine was clinically effective and safe drug for treatment of acute and chronic bronchitis.

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A Multicenter, Randomized, Open, Comparative Study for the Efficacy and Safety of Oral Moxifloxacin 400 mg Once a Day and Clarithromycin 500 mg Twice Daily in Korean Patients with Acute Exacerbations of Chronic Bronchitis (한국인의 만성 기관지염의 급성 악화 환자를 대상으로 한 Moxifloxacin 400mg 1 일 1회 요법과 Clarithromycin 500mg 1일 2회 요법의 치료효과 및 안전성 비교)

  • Kim, Seung-Joon;Kim, Seok-Chan;Lee, Sook-Young;Yoon, Hyeong-Kyu;Kim, Tae-Yon;Kim, Young-Kyoon;Song, Jeong-Sup;Park, Sung-Hak;Kim, Ho-Joong;Chung, Man-Pyo;Suh, Gee-Young;Kwon, O-Jung;Lee, Shin -Hyung;Kang, Kyung-Ho;Lee, Eh-Hyung;Hwang, Sung-Chul;Han, Myung-Ho
    • Tuberculosis and Respiratory Diseases
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    • v.49 no.6
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    • pp.740-751
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    • 2000
  • Background : Moxifloxacin is a newly developed drug which is more potent and safe compared to previous fluoroquinolones. This drug effectively eradicates organisms such as beta-lactamase-producing or other resistant bacteria. Moxifloxacin is known to be effective in treating respiratory infections such as Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Chlamydia pneumoniaeme, Legionella spp. and Mycoplasma pneumoniae. Methods : In a multicenter, randomized, open, comparative study, the efficacy and safety of oral moxifloxacin taken 400 mg once a day and clarithromycin taken 500 mg twice daily for 7 days were compared for the treatment of Korean patients with acute exacerbations of chronic bronchitis. Results : A total of 170 patients were enrolled, and they were divided into two groups: 87 in the moxifloxacin group and 83 in the clarithromycin group. Of those enrolled, 76 (35 for bacteriologic efficacy) in the moxifloxacin group and 77 (31 for bacteriologic efficacy) in the clarithromycin group were included in the efficacy analysis. All were included in the safety analysis. Clinical success was noted in 70 (92.1%) of 76 moxifloxacin-treated patients and 71 (92.2%) of 77 clarithromycin-treated patients. Bacteriologic success rate seemed to be higher in moxifloxacin group (73.5%) than in clarithromycin group (54.8%), but statistically insignificant (p=0.098). Drug susceptibility among organisms initially isolated was higher in moxifloxacin group on Streptococcus pneumoniae, Pseudomonas aeruginosa, Klebsiella pneumoniae (p<0.001). Adverse events were reported by 12.8% of 86 patients receiving moxifloxacin and 21.7% of 83 patients receiving clarithromycin. Headache (4.7% vs 4.8%, moxifloxacin group vs clarithromycin group, respectively) and indigestion (2.3% vs 6.0%, moxifloxacin group vs clarithromycin group, respectively) were the most frequent side effects in the two groups. Conclusion : This study demonstrated that for the treatment of acute exacerbations of chronic bronchitis a 7-day course of moxifloxacin 400 mg od was clinically equivalent and microbiologically superior to clarithromycin 500 mg bid.

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