• Title/Summary/Keyword: Clinical Trial

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Study on the Safety of Firefly Luciferase in Human as a Transient Reporter Gene of Oncolytic Virotherapy (항암 바이러스 치료제의 보고유전자로써 반딧불이 루시퍼레이즈의 인체 내 안전성에 대한 연구)

  • Hong, Young Mi;Yoon, Woong Hee;Lee, You Ra;Kim, Soo Ji;Ngabire, Daniel;Narayanasamy, Badrinath;Ornella, Mefotse Saha Cyrelle;Kim, Myunghee;Cho, Euna;Lee, Bora;Hwang, Tae-Ho
    • Journal of Life Science
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    • v.31 no.11
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    • pp.1028-1036
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    • 2021
  • Firefly luciferase (FLuc) can function as an efficient marker in the gene and viral therapies. Nonetheless, its clinical translation has been unaccomplished with the concerns on its exogenous nature and the similarity with human fatty acyl-CoA synthetase. In this study, we aimed to show safety of FLuc by conducting a set of preclinical experiments and a human use. Initially, FLuc permeability across the plasma membrane was investigated by delivering the FLuc-carrying viral vector, OTS-412, or the FLuc recombinant protein. After in vitro infection of OTS-412 into different cancer cell lines, FLuc activity was detected only in the cell lysates, but not in culture media. In addition, recombinant FLuc protein further showed the impermeability against the plasma membrane. Similar result was also observed in the in vivo experiment. After being injected into the VX2 tumor-bearing rabbit, the FLuc exclusively resided within the tumor tissue without being detected in the blood plasma or other organs. Human cancer cell lines originated from various organs were lysed and treated to the FLuc, and none of the human substrates was reactive against the FLuc. As a final step, FLuc recombinant protein was intravenously injected into a human. The luciferase was degraded with the half-life of 20 to 30 minutes in blood, and was untraceable from 1.5 hr after the injection. In addition, the blood plasma was nonresponsive against the fatty acids. Hematological analysis was also comparable between the pre- and post-injection. Altogether, our study collectively demonstrates the safety of the firefly luciferase.

Efficacy evaluation dental plaque and halitosis removal of mouthwash containing sodium chloride (염화나트륨 함유 구중청량제의 치면세균막 및 구취 제거 효능평가)

  • Lee, Jong-Cheon;Cho, Ja-Won;Yoo, Hyun-Jun;Kim, Chan-Ho;Choe, Byeong-Gi
    • Journal of Dental Rehabilitation and Applied Science
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    • v.38 no.1
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    • pp.1-8
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    • 2022
  • Purpose: The purpose of this study was to evaluate the effects of mouthwash containing sodium chloride on dental plaque, gingival inflammation index, and bad breath through clinical trials. Materials and Methods: This trial was designed as 12 weeks and subjects were instructed to put an appropriate amount of the provided standard detergent on a toothbrush and brush their teeth 3 times a day. They were instructed to gargle a mouthwash provided to each group after brushiung. Efficacy was evaluated by performing gingival and periodontal-related index tests, dental plaque changes, and bad breath tests a total of 5 times. All data were statistically analyzed using 2-sample t-test, paired t-test to compare between groups at 95% significance level using IBM SPSS Statistics 24.0. Results: As a result of the PMA index measurement, the gingivitis improvement effect rate of the experimental group compared to the control group was 107.63% after 8 weeks and 73.08% after 12 weeks. As a result of the PHP index measurement, the plaque improvement effect rate of the experimental group compared to the control group was 79.37% after 8 weeks and 74.06% after 12 weeks. As a result of measuring volatile sulfur compounds using Oral Chroma, the effectiveness of improvement in bad breath in the experimental group was 65.06% after 8 weeks and 99.33% after 12 weeks, compared to the control group. Conclusion: As a result of this study, it was confirmed that effective gingivitis alleviation, plaque removal effect and bad breath removal effect can be expected when a mouthwash containing sodium chloride, green tea extract, and sodium monofluorophosphate is used.

The Effects of Functional Tea (Mori Folium, Lycii Fructus, Chrysanthemi Flos, Zizyphi Fructus, Sesamum Semen, Raphani Semen) Supplement with Medical Nutrition Therapy on the Blood Lipid Levels and Antioxidant Status in Subjects with Hyperlipidemia (고지혈증 환자에서 의학영양치료와 병행하여 섭취한 기능성차(상엽, 구기자, 국화, 대추, 참깨, 나복자)의 혈중 지질 농도 저하 및 항산화 효과)

  • Lim, Hyun-Jung;Cho, Kum-Ho;Choue, Ryowon
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.34 no.1
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    • pp.42-56
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    • 2005
  • Hyperlipidemia is one of the risk factors for coronary artery disease. Despite of epidemiological evidence that tea consumption is associated with the reduced risk of coronary heart disease, experimental studies designed to show that drinking tea affects blood lipid concentration or oxidative stress have been unsuccessful. The purpose of this study was to investigate whether functional tea (three servings/day) supplement with medical nutrition therapy (MNT) lead to a beneficial outcomes in mildly hyperlipidemic adults. From February to October, 2003, the 43 hyperlipidemic (23 men, 20 women) subjects (total cholesterol$\geq$200 mg/dL or triglyceride$\geq$150 mg/dL) admitted to K Medical Center were studied. Subjects were randomly divided into 3 groups; placebo tea (PT), half dose of functional tea (HFT), full dose of functional tea (FFT). During 12 weeks of study period, the subjects were given placebo or functional tea daily with MNT. Anthropometric measurements, blood chemical analysis including lipid levels, total superoxide dismutase (SOD) and glutathione peroxidase (GSH-Px) levels, and dietary assessment were carried out at the beginning and end of experiment. The effects of functional tea were compared with the placebo in randomized clinical trial study. The placebo was prepared to match with the functional tea in color and taste. After the 12 weeks of MNT, the subjects had regular and balanced meal pattern. Consumption of foods high in cholesterol and saturated fat, salty foods, fried foods, and instant foods decreased significantly in all three groups (p<0.05). Intake of energy and cholesterol also decreased (p<0.05). Drinking three servings per day (390 mL/day) of functional tea significantly reduced the levels of blood triglyceride (HFT, 42.5%; FFT, 29.4%), total cholesterol (HFT, 8.5%; FFT, 13.7%), and atherogenic index (HFT, 14.6%; FFT, 21.7%). Whereas no changes were found in the LDL-, HDL-cholesterollevels, and LDL/HDL ratio. Plasma homocysteine (Hcy) concentration decreased significantly (p<0.05) in functional tea groups (HFT, 14.9%; FFT, 14.1%). SOD increased significantly (p<0.05) in HFT (8.3%). GSH-Px increased significantly (p<0.05) in FFT (12.8%). In conclusion, the MNT improved the dietary habits, in addition, functional tea supplement decreased blood lipid levels and Hcy, and increased SOD and GSH-Px levels. These results indicate that functional tea consumption may decrease the risk of cardiovascular disease via improving blood lipid levels and antioxidant status.

A Phase I/II Trial of $DCVac/IR^{(R)}$ Dendritic Cell Immunotherapy Combined with Irradiation in Cases of Refractory Colorectal Cancer with Multiple Liver Metastases (기존의 치료에 반응하지 않는 다발성 간전이 대장암 환자에서 방사선조사와 병합한 수지상세포 면역치료의 1, 2상 임상시험)

  • Choi, Young-Min;Lee, Hyung-Sik;Kwon, Hyuk-Chan;Han, Sang-Young;Choi, Jong-Cheol;Chung, Ju-Seop;Kim, Chang-Won;Kim, Dong-Won;Kang, Chi-Duk
    • Radiation Oncology Journal
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    • v.26 no.2
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    • pp.104-112
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    • 2008
  • Purpose: To assess the toxicity and tumor response induced by $DCVac/IR^{(R)}$ dendritic cell(DC) immunotherapy combined with irradiation for refractory colorectal cancer patients with multiple liver metastases. Materials and Methods: Between May 2004 and November 2006, applicants from a pool of refractory colorectal cancer patients with multiple liver metastases were enrolled. The patients were registered after having signed the informed consent form, which had been approved by the Institutional Review Board from the Dong-A University and Busan National University Hospital. DCs were obtained from peripheral blood of each patient, and then cultured in vitro. A total of $6{\times}10^6$ DCs were packed into a vial($DCVac/IR^{(R)}$, 0.5 ml) at the convenience of each patient's schedule. On the day before and on the day of each vaccination, each patient received a 4 Gy radiation dose to the target tumor. On the day of vaccination, the indicated dose of autologous DCs was injected into the irradiated tumor using ultrasound-guided needle injection procedures. A total of four vaccinations were scheduled at three 2-week intervals and one 4 week interval at the Dong-A University and Busan National University Hospital. If the tumor status was deemed to be stable or responding to therapy, an additional vaccination dose or two was approved at 4 week intervals beyond the fourth immunization. A tolerance test for DCs was conducted by injecting a range of doses($3{\times}10^6\;to\;12{\times}10^6$ DCs) after the 3rd injection. Moreover, the maximal tolerable dose was applied to additional patients. Treatment safety was evaluated in all patients who had at least one injection. Treatment feasibility was evaluated by the 10th week by assessing the response of patients having at least 4 injections. For systemic toxicities, the evaluation was performed using the National Cancer Institute Common Toxicity Criteria, whereas adverse effects were recorded using common WHO toxicity criteria. Results: Of the 24 registered patients, 22 received the DCs injections. Moreover, of the 14 patients that applied for the tolerance test, only 11 patients completed it because 3 patients withdrew their testing agreement. A grade 3 or more side effect, which was possibly related to the DC injection, did not occur in additional patients. The $12{\times}10^6$ DC injection was identified as the maximum tolerable dose, and was then injected in an additional 8 patients. Patients tolerated the injection fairly well, with no fatal side effects. In order to assess the feasibility of DC immunotherapy, the response was evaluated in other hepatic lesions outside of the targeted hepatic lesion. The response evaluation was performed in 15 of the 17 patients who received at least 4 injections. Stable and progressive disease was found in 4 and 11 patients, respectively. Conclusion: The DC-based immunotherapy and radiotherapy is theoretically synergistic for the local control and systemic control. The $DCVac/IR^{(R)}$ immunotherapy combined with irradiation was tolerable and safe in the evaluated cases of refractory colorectal cancer with multiple liver metastases. Future work should include well designed a phase II clinical trials.

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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Effect of Geijibokryunghwan and each constituent herb on inhibition of platelet aggregation (계지복령환(桂枝茯笭丸) 및 그 구성약물(構成藥物)의 혈소판응집억제(血小板凝集抑制)에 관(關)한 연구(硏究))

  • Kim, Jong-Goo;Park, Sun-Dong;Park, Won-Hwan
    • The Journal of Dong Guk Oriental Medicine
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    • v.8 no.2
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    • pp.115-129
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    • 2000
  • The cause that the increase of animality fat intakes, under exercise, fatness, adding the stress, advanced age etc., the occurrence rate of the circulation system disease has been increased. And the thrombosis importantly came to the front as the risk factor of these circulation system's disease. Nowadays, the ischemic disease has especially discussed, for example the angina or myocardial infarction, originated in thrombosis that came from the platelet aggregation. In the western medicine, as the cure and prevention, using the aspirin or ticlopidine for platelet aggregation suppressant. But in the , the curing method must be used properly according to the pectoralgia or heartache's kind, state, grade. The platelet do not attache to the normal hemangioendothelial cell. But when it stimulated by endothelium peronia and so on, it attache to the injury endothelium or rise aggregation between the platelet. On this time, it secrete the platelet aggregation inducer as like ADP, thromboxane A2 from the inside of platelet. So it has first defensive function through the aggregation augment that prevent the celerity consumption of blood. But the activation of abnormal platelet occur the platelet grume and thrombogenesis. So it bring up the occlusive angiosis, so to speak, cardiovascular disease, cerebrovascular disease, arterial sclerosis. In oriental medicine, the thrombosis in the category of blood stasis and this blood stasis present the generalise or local blood circulation disturbance that generated by all kinds of pathological fact or blood stream retention accompanying with a series of syndrome. As the syndrome, stabbing pain fixed at certain region, squamous and dry skin, fullness and pain of the chest and hypochondrium, firmness and fullness of the lower abdomen, black stool, dark purple tongue or with ecchymoses and petechiae etc.. has been created. And it becomes the pathopoiesis cause that the convulsion and palpitation, severe palpitatiion, tympanites, the symtom complex with a mass or swelling in the abdomen, insanity, stricken by wind etc.. Moreover, it used the drugs for invigorating blood circulation and eliminating blood stasis or drugs for removing blood stasis for all kinds of syndrome through the blood stasis. And the drugs for activating the blood circulation, such as Salviae Radix, Angelicae Sinensis Radix, Persicae Semen, Achyranthis Radix, Cnidii Rhizoma, Carthami Flos are used for that. And it is used to the herbs of insects that has strong effect about the disintergrating blood stasis such as Hirudo, Scolopendrae Corpus, Buthus, Lumbricus etc.. On this study, It used Geijibokryunghwan(GBH) and the consisting herbs to investigate the influence of platelet aggregation about drugs that used to improvement various symptoms created by the thrombosis in oriental medicine. GBH formula has as formula recorded in the , action of 'eleminating the evil and not impairment of healthy energy' and 'promoting the flow of QI and cold and heat, so used for the expel blood stasis herbs from the ancient. Therefore we investigated the restraint effect of GBH and the consisting herbs about the platelet agregation induced to the ADP, AA or collagen. The conclusion is following. 1. When it added the aggregation inducer after that it added GBH and individual consisting herbs in the PRP, GBH showed the (+) inhibition effect on the platelet aggregation and it showed the (+) inhibition effect in the individual consisting herbs as like Paeoniae Radix and Moutan Cortex Radicis. 2. It showed the (+), (+,++) inhibition effect on the platelet aggregation in Paeoniae Radix Hoelen, Paeoniae Radix Moutan Cortex Radicis, Hoelen Moutan Cortex Radicis etc. 3. In the aggregation inhibition activating on the difference of density, GBH showed strong inhibition effect to the aggregation state induced to collagen, and it showed the inhibition effect in the individual consisting herbs as like Paeoniae Radix and Moutan Cortex Radicis about the aggregation induced by the collagen. 4. It showed the strong inhibition effect about the aggregation induced by the collagen in Paeoniae Radix Hoelen, Paeoniae Radix Moutan Cortex Radicis, Hoelen Moutan Cortex Radicis etc Like this, as confirm GBH and the individual consisting herb's inhibition effect of platelet aggregation, We considerated that GBH and the individual consisting herbs have practical applicational value of clinical trial in the thrombosis caused by platelet aggregation.

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Concurrent Chemoradiotherapy in Locally Advanced Carcinoma of The Uterine Cervix : A Phase I/II Prospective Study (국소적으로 진행된 자궁경부암의 방사선치료와 복합 항암화학요법의 동시치료 결과)

  • Kang One Chul;Choi Eun Kyung;Chung Weon Kuu;Kim Jong Hoon;Chang Hyesook;Kim Yong Man;Kim Young Tak;Nam Joo Hyun;Mok Jung-Eun;Lee Moo-Song
    • Radiation Oncology Journal
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    • v.16 no.3
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    • pp.311-323
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    • 1998
  • Purpose : Prospective, single arm, Phase I/II clinical trial was performed to assess the efficacy and toxicity of the concurrent chemotherapy and definitive radiotherapy (RT) in patients with previously untreated locally advanced carcinoma of the uterine cervix. Methods and Materials : From Mar 1992 to January 1997, a total of 73 patients with advanced cervical carcinoma were entered on the protocol but 5 patients were excluded in analysis because of patients' refusal of treatment. Their ages ranged from 31 to 77 years, median 58 years. The International Federation of Gynecology and Obstetrics (FIGO) stage distribution was as follows: IIB 46, IIIA 2, IIIB 15 and IVA 5. RT consisted of external beam irradiation to 4,140-5,040 cGy/23-28 fractions plus high dose rate intracavitary treatments to deliver a dose of 30-35 Gy to point A in 6-7 fractions. During the intracavitary treatments parametrial boost was delivered for point B dose of 60 Gy in stage IIB and 65 Gy in stage IIIB. Two cycles of concurrent 5-fluorouracil and cisplatin (FP) chemotherapy (5-fluorouracil 1,000 mg/$m^2$/day continuous infusion for 4 days, day 1-4, 29-32 and cisplatin 20 mg/$m^2$/day intravenous bolus for 3 days day 1-3, 29-31) administered starting on day 1 of RT. Results : The median follow-up was 24 months (range 4-68+). Sixty-four patients were evaluable for survival rate in this protocol: The 5-year actuarial and disease-free survival rate were 52$\%$ and 64$\%$, respectively. The 5-rear actuarial survival for stage IIB and III+IVA patients were 58$\%$ and 36$\%$, respectively The 5-year disease-free survival rate for stage IIB and III+IVA patients were 71$\%$ and 40$\%$, respectively. Of the 68 patients evaluated for patterns of failure, overall recurrence rate was 27.9$\%$ (19/68) : local failure in 5.9$\%$ (4/68), distant metastasis in 10.3$\%$ (7/68) and both in 11.8$\%$ (8/68). Of the 64 patients evaluated for response at one month after the completion of treatment the complete response rate was 78$\%$ (50/64). Concurrent chemoradiation appear to be a well-tolerated regimen but there were two treatment-related deaths. Conclusion : Concurrent chemotherapy of FP with high-dose definitive RT in locally advanced carcinoma of the uterine cervix is feasible and effective with acceptable toxicities. This chemoradiation regimen may offer a modest survival benefit for advanced stage. Further follow-up of these patients will evaluate the impact of this regimen on the long-term local control and their survival.

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The Effects of Autologous Blood Pleurodesis in the Pneumothorax with Persistent Air Leak (지속성 기흉에서 자가혈액을 이용한 흉막유착술의 효과)

  • Yoon, Su-Mi;Shin, Sung-Joon;Kim, Young-Chan;Shon, Jang-Won;Yang, Seok-Chul;Yoon, Ho-Joo;Shin, Dong-Ho;Chung, Won-Sang;Park, Sung-Soo
    • Tuberculosis and Respiratory Diseases
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    • v.49 no.6
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    • pp.724-732
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    • 2000
  • Background : In patients with severe chronic lung diseases even a small pneumothorax can result in life-threatening respiratory distress. It is important to treat the attack by chest tube drainage until the lung expands. Pneumothorax with a persistent air leak that does not resolve under prolonged tube thoracostomy suction is usually treated by open operation to excise or oversew a bulla or cluster of blebs to stop the air leak. Pleurodesis by the instillation of chemical agents is used for the patient who has persistent air leak and is not good candidate for surgical treatment. When the primary trial of pleurodesis with common agent fails, it is uncertain which agent should be used f or stopping the air leak by pleurodesis. It is well known that inappropriate drainage of hemothorax results in severe pleural adhesion and thickening. Based on this idea, some reports described a successful treatment with autologous blood instillation for pneumothorax patients with or without residual pleural space. We tried pleurodesis with autologous bood for pneumothorax with persistent air leak and then we evaluated the efficacy and safety. Methods : Fifteen patients who had persistent air leak in the pneumothorax complicated from the severe chronic lung disease were enrolled. They were not good candidates for surgical treatment and doxycycline pleurodesis failed to stop up their air leaks. We used a mixture of autologous blood and 50% dextrose for pleurodesis. Effect and complications were assessed by clinical out∞me, chest radiography and pulmonary function tests. Results : The mean duration of air leak was 18.4${\pm}$6.16 days before ABP (autologous blood and dextrose pleurodesis) and $5.2{\pm}1.68$ days after ABP. The mean severity of pain was $2.3{\pm}0.70$ for DP(doxycycline pleurodesis) and $1.7{\pm}0.59$ for ABDP (p<0.05). There was no other complication except mild fever. Pleural adhesion grade was a mean of $0.6{\pm}0.63$. The mean dyspnea scale was $1.7{\pm}0.46$ before pneumothrax and $2.0{\pm}0.59$ after ABDP (p>0.05). The mean $FEV_1$ was $1.47{\pm}1.01$ before pneumothorax and $1.44{\pm}1.00$ after ABDP (p>0.05). Except in 1 patient, 14 patients had no recurrent pneumothorax. Conclusion : Autologous blood pleurodesis (ABP) was successful for treatment of persistent air leak in the pneumothorax. It was easy and inexpensive and involved less pain than doxycycline pleurodesis. It did not cause complications and severe pleural adhesion. We report that ABP can be considered as a useful treatment for persistent air leak in the pneumothorax complicated from the severe chronic lung disease.

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Combined Modality Therapy with Selective Bladder Preservation for Muscle Invading Bladder Cancer (침윤성 방광암 환자에서 방광 보존 치료)

  • Youn Seon Min;Yang Kwang Mo;Lee Hyung Sik;Hur Won Joo;Oh Sin Geun;Lee Jong Cheol;Yoon Jin Han;Kwon Heon Young;Jung Kyung Woo;Jung Se Il
    • Radiation Oncology Journal
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    • v.19 no.3
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    • pp.237-244
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    • 2001
  • Purpose : To assess the tolerance, complete response rate, bladder preservation rate and survival rate in patients with muscle-invading bladder cancer treated with selective bladder preservation protocol. Method and Materials : From October 1990 to June 1998, twenty six patients with muscle-invading bladder cancer (clinical stage T2-4, N0-3, M0) were enrolled for the treatment protocol of bladder preservation. They were treated with maximal TURBT (transurethral resection of bladder tumor) and 2 cycles of MCV chemotherapy (methotrexate, crisplatin, and vinblastine) followed by $39.6\~45\;Gy$ pelvic irradiation with concomitant cisplatin. After complete urologic evaluation (biopsy or cytology), the patients who achieved complete response were planed for bladder preservation treatment and treated with consolidation cisplatin and radiotherapy (19.8 Gy). The patients who had incomplete response were planed to immediate radical cystectomy. If they refused radical cystectomy, they were treated either with TURBT followed by MCV or cisplatin chemotherapy and radiotherapy. The median follow-up duration is 49.5 months. Results : The Patients with stage T2-3a and T3b-4a underwent complete removal of tumor or gross tumor removal by TURBT, respectively. Twenty one out of 26 patients $(81\%)$ successfully completed the protocol of the planned chemo-radiotherapy. Seven patients had documented complete response. Six of them were treated with additional consolidation cisplatin and radiotherapy. One patient was treated with 2 cycles of MCV chemotherapy due to refusal of chemo-radiotherapy. Five of 7 complete responders had functioning tumor-free bladder. Fourteen patients of incomplete responders were further treated with one of the followings : radical cystectomy (1 patient), or TURBT and 2 cycles of MCV chemotherapy (3 patients), or cisplatin and radiotherapy (10 patients). Thirteen patients of them were not treated with planned radical cystectomy due to patients' refusal (9 patients) or underlying medical problems (4 patients). Among twenty one patients, 12 patients $(58\%)$ were alive with their preserved bladder, 8 patients died with the disease, 1 patient died of intercurrent disease. The 5 years actuarial survival rates according to CR and PR after MCV chemotherapy and cisplatin chemoradiotherapy were $80\%\;and\;14\%$, respectively (u=0.001). Conclusion : In selected patients with muscle-invading bladder cancer, the bladder preservation could be achieved by MCV chemotherapy and cisplatin chemo-radiotherapy. All patients tolerated well this bladder preservation protoco. The availability of complete TURBT and the responsibility of neoadjuvant chemotherapy and chemoradiotherapy were important predictors for bladder preservation and survival. The patients who had not achieved complete response after neoadjuvant chemotherapy and chemoradiotherapy should be immediate radical cystectomy. A randomized prospective trial might be essential to determine more accurate indications between cystectomy or bladder preservation.

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The relationship of nutrition of rice and positive evaluation of the rice-based meal on the physical and emotional self-diagnosis and learning efficiency of the middle and highschool students in the jeonju area (전주 지역 청소년 대상 쌀의 영양과 쌀을 기반으로 한 식사에 대한 긍정적 평가에 따른 신체·정서적 자각증상 및 학습 효능감과의 관련성)

  • Lee, Hyeon Kyeong;Lee, Young Seung;Jung, Soo Jin;Kang, Min Sook;Hwang, Yu Jin;Yoo, Sun Mi;Cha, Yeon Soo;Cho, Soo Muk
    • Journal of Nutrition and Health
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    • v.52 no.1
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    • pp.90-103
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    • 2019
  • Purpose: This study examined the relationship of the nutrition of rice and the positive evaluation of the rice-based meal with the food consumption habits, physical and emotional health status, and learning efficacy of 601 middle and high school students in Jeonju area. Methods: The participants were divided into two groups using cluster analysis in that the participants belonging to the upper groups had a center score of 46.86 (n = 348), while the people belonging to the lower group had a center score of 36.89 (n = 253). Statistical differences were tested for all the relationships between the physical and emotional health symptoms and learning efficacy between the groups at the ${\alpha}=0.05$ level. Results: Significant differences in the physical self-evaluated symptoms were observed in all five items in each cluster (p < 0.05). In the case of the emotional health status, nine out of 10 items showed significant differences between the groups. Similarly, significant differences in all five items in learning efficacy questionnaire were noted (p < 0.05). Positive attitudes of the parents toward having breakfast also showed significant differences among the groups. Conclusion: The nutrition of rice and a positive evaluation of the rice-based meals significantly affect the physical and emotional health status and learning efficacy of juveniles. These findings can be used as baseline information for promoting nutrition education, particularly rice-based breakfast.