• Title/Summary/Keyword: Clinical trial center

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Nonpharmacologic Pain Relief with Oral 25% Dextrose or/and Pacifier for Newborn Infants (신생아에서 비약물적 통증조절을 위한 25% 경구 포도당과 인공 젖꼭지 사용의 효과)

  • Kim, Min-Kyung;Kim, In-Ah;Jung, Min-Hee;Han, Myung-Ki;Park, Kie-Young;Kim, Bong-Seong;Jin, Hyun-Seong
    • Neonatal Medicine
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    • v.18 no.2
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    • pp.353-358
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    • 2011
  • Purpose: The goal of this study was to compare the efficacy of oral 25% dextrose treatment or/and pacifier for analgesia in healthy newborns during intramuscular injection of a hepatitis B vaccine. Methods: A prospective, randomized, partially blinded, clinical trial was performed in 132 healthy newborns. They were assigned randomly to 4 treatment groups: control group (2 mL distilled water), dextrose group (2 mL 25% dextrose), pacifier group, dextrose+pacifier group (pacifier coating with 25% dextrose) during intramuscular injection of hepatitis B vaccine. For all groups, Neonatal Infant Pain Scale (NIPS), Neonatal Facial Coding System (NFCS), Premature Infant Pain Profile (PIPP) scores were evaluated before the injection, during the injection, and at 2 minutes after the injection. Pain scores were compared among the 4 groups. Results: Maternal and neonatal characteristics were similar among the 4 groups. 25% dextrose treatment led to lower NIPS pain scores during injection (6.4${\pm}$0.9 vs. 5.5${\pm}$1.7, P=0.01) and after injection (1.6${\pm}$2.0 vs. 0.6${\pm}$0.9, P=0.01) and NFCS pain scores after injection (1.5${\pm}$2.3 vs. 0.7${\pm}$0.8, P=0.04) than control group. The number of neonates who feel the pain (indication of scores: NIPS${\geq}$4, NFCS${\geq}$3) decreased (9 (23.1%) vs. 0 (0%), P=0.04 via NIPS, 7 (17.9%) vs. 0 (0%), P=0.02 via NFCS). However, all treatment groups did not decreased PIPP scores, compared with the control group. Conclusion: Oral 25% dextrose is effective than distilled water or using pacifier with or without 25% dextrose in reducing pain during intramuscular injection of hepatitis B vaccinations. Further study based on this preliminary study need about nonpharmacologic management of pain in newborns.

The Usefulness and Safety of Natural Stent in a Canine Model of Tracheal Stenosis (Nd-YAG laser를 이용한 기관협착 동물모델에서 Natural 스텐트의 안전성 및 유효성 -Dumon 스텐트와의 비교 실험-)

  • Kim, Ho-Joong;Koh, Won-Jung;Suh, Gee-Young;Chung, Man-Pyo;Kim, Jhin-Gook;Suh, Soo-Won;Kwon, O-Jung
    • Tuberculosis and Respiratory Diseases
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    • v.53 no.4
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    • pp.431-438
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    • 2002
  • Background : In order to investigate the usefulness and safety of Natural Stent, we performed this study in a canine model of tracheal stenosis induced using Nd-YAG laser. Materials and Methods : After tracheal stenosis was induced in 12 Mongrel dogs using Nd-YAG laser, either Dumon (n=6) or Natural (n=6) stent was inserted into the trachea. To assess the degree of stent migration and mucostasis, bronchoscopy was performed every week for 4 weeks, after which all stents were removed. One week after stent removal, tracheal stenosis was evaluated by bronchoscopy. Results : The degree of stent migration was not different between the dogs with Dumon stent ($3.0{\pm}0.8$) and those with Natural ($2.0{\pm}1.0$), nor was the degree of mucostasis, at Dumon ($1.7{\pm}0.5$) and Natural Stent ($1.5{\pm}0.6$), respectively. One week after stent removal, the degree of tracheal stenosis was not different between the Dumon ($1.5{\pm}0.5$) and the Natural group ($1.0{\pm}0.4$). In addition, there was no death and the degree of tracheal stenosis remained always within the safe limit (less than 2.0) in all animals. Conclusion : In a canine model of tracheal stenosis induced using Nd-YAG laser, the usefulness and safety of Natural Stent were similar to those of Dumon Stent. A clinical trial is necessary to document the usefulness and safety of Natural Stent in patients with tracheal stenosis.

Combined Effects of Gamma-irradiation and Hyperthermia on the Human Cell Lines for Various Temperatures and Time Sequences (감마선과 온열치료 병용시 세포 치사 능력 증강에 관한 실험적 연구)

  • Koh Kyung Hwan;Cho Chul Koo;Park Woo Yoon;Yoo Seong Yul;Yun Hyong Geun;Shim Jae Won;Lee Mi Jung
    • Radiation Oncology Journal
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    • v.11 no.1
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    • pp.51-58
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    • 1993
  • We tried to establish the theoretical basis of clinical use of combined modality of hyperthermia and radiation therapy. For this purpose, we made an in vitro experiment in order to get the synergistic and/or additive effects on the cell killing of hyperthermia combined with radiation therapy by using the microwave-hyperthermia machine already installed at our department. In our experiment, we use two human cell lines: MKN-45 (adenocarcinoma of stomach) and K-562 (leukemia cell lines). In cases of combined treatments of hyperthermia and gamma-irradiation, the therapeutic effect was the highest in the simultaneous trial. Hyperthermia after gamma irradiation showed slightly higher therapeutic effect than that before irradiation without significant difference, but its effect was the same in the interval of 6 hours between hyperthermia and irradiation. The higher temperature and the longer treatment time were applied, the higher therapeutic effects were observed. We could observe the thermoresistance by time elapse at $43^{\circ}C$. When hyperthermia was done for 30 minutes at the same temperature, thermal enhancement ratio (TER) at DO. 01 (dose required surviving fraction of 0.01) were $2.5{\pm}0.08,\;3.75{\pm}0.18$, and $5.0{\pm}0.15\;at\;436{\circ}C,\;44^{\circ}C,\;and\;45^{\circ}C$ respectively in K-562 leukemia cell lines. Our experimental data showed that more cell killing effect can be obtained in the leukemia cell lines, although they usually are known to be radiosensitive, when treated with combined hyperthermia and radiation therapy. Furthermore, our data show that leukemia cell lines may have various intrinsic radiosensitivity, especially in vitro experiments. The magnitude of cell killing effect, however, will be less than that of MKN-45.

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Radiotherapy for Oral Cavity Cancer (구강암의 방사선치료)

  • Shim Jae Won;Yoo Seong Yul;Koh Kyoung Hwan;Cho Chul Koo;Yun Hyong Geun;Kim Jae Young
    • Radiation Oncology Journal
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    • v.11 no.2
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    • pp.267-275
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    • 1993
  • Eighty five patients of oral cavity cancer, treated with radiation at the Department of Therapeutic Radiology, Korea Cancer Center Hospital, during the period from March 1985 to September 1990 were analyzed retrospectively. Among 85 patients, 37 patients were treated with radiation only and 48 patients were treated with radiation following surgery. And 70 patients received external irradiation only by $^{60}Co$ with or without electron, the others were 7 patients for external irradiation plus interstitial implantation and 8 patients for external irradiation plus oral cone electron therapy. Primary sites were mobile tongue for 40 patients, mouth floor for 17 patients, palate for 12 patients, gingiva including retromolar trigone for 10 patients, buccal mucosa for 5 patients, and lip for 1 patient. According to pathologic classification, squamous cell carcinoma was the most common (77 patients). According to AJC TNM stage, stage I + II were 28 patients and stage III+IV were 57 patients. Acturial overall survival rate at 3 years was $43.9\%,$ 3 year survival rates were $60.9\%$ for stage I + II, and $23.1\%$ for stage III+IV, respectively. As a prognostic factor, primary T stage was a significant factor (p<0.01). The others, age, location, lymph node metastasis, surgery, radiation dose, and cell differentiation were not statistically significant. Among those factors, radiation plus surgery was more effective than radiation only in T3+T4 or in any N stage although it was not statistically sufficient (p<0.1). From those results, it was conclusive that definitive radiotherapy was more effective than surgery especially In the view of pertainig of anatomical integrity and function in early stage, and radiation plus surgery was considered to be better therapeutic tool in advanced stage.

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The Usefulness of Noninvasive Positive Pressure Ventilation as a New Weaning Method (새로운 이탈방법으로서 비침습적 양압환기법의 유용성)

  • Shim, Tae-Sun;Koh, Youn-Suck;Lee, Sang-Do;Kim, Woo-Sung;Kim, Dong-Soon;Kim, Won-Dong;Lim, Chae-Man
    • Tuberculosis and Respiratory Diseases
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    • v.46 no.4
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    • pp.500-511
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    • 1999
  • Background: Noninvasive positive pressure ventilation (NPPV) using facial or nasal mask have been widely used for several years in stable patients with chronic neuromuscular disease or central alveolar hypoventilation, and recently have been tried in patients with acute respiratory failure. In a few studies, NPPV was also used to rescue the patients with post-extubation respiratory failure. However, yet it has not been adopted as a weaning method in patients on long-term mechanical ventilation. So we performed this prospective clinical study to evaluate the usefulness of NPPV as a weaning method after removing endotracheal tube intentionally in patients on long-term mechanical ventilation. Method: Twelve patients who had been on invasive mechanical ventilation over 10 days were enrolled and 14 trials of NPPV were done. All had failed at least one weaning trial and showed ventilator dependence(pressure support requirement between 8-15cm $H_2O$, and PEEP requirement between 5-10cm $H_2O$), so tracheostomy was being considered. After removing the endotracheal tube, NPPV was applied using facial mask. Respiratory rate, arterial blood gas, pressure support level, and PEEP level were monitored just before intended extubation, at 30 minutes, 1 to 6, 6 to 12, 12 to 24 hours, 2nd day, and 3rd day following initiation of NPPV, and just before weaning from NPPV. The successful weaning was defined as spontaneous breathing off the ventilator for 48 hours or longer without respiratory distress. Results: The weaning through NPPV after intended extubation was successful in 7(50%) of 14 trials, and tracheostomy could be avoided in them. There were no differences in age, sex, APACHE III score, duration of invasive mechanical ventilation, baseline respiratory rate, $PaCO_2$ $PaO_2/FiO_2$, and ventilatory requirement(PS and PEEP) between the success and failure groups. In the success group, respiratory rate, pH, $PaCO_2$, and $PaO_2/FiO_2$ were not different between invasive MV and NPPV period. But in the failure group, pH decreased after 30 minutes of NPPV initiation compared with that of invasive MV($7.40\pm0.08$ vs. $7.34\pm0.06$, p<0.05). The causes of failure were worsening of ABG(n=3), retained tracheal secretion(n=2), mask intolerance(n=1), and flail chest(n=1). Conclusion: NPPV may be worth trying as a bridge method in weaning patients on long-term invasive mechanical ventilation.

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Treat-to-Target Strategy for Asian Patients with Early Rheumatoid Arthritis: Result of a Multicenter Trial in Korea

  • Song, Jason Jungsik;Song, Yeong Wook;Bae, Sang Cheol;Cha, Hoon-Suk;Choe, Jung-Yoon;Choi, Sung Jae;Kim, Hyun Ah;Kim, Jinseok;Kim, Sung-Soo;Lee, Choong-Ki;Lee, Jisoo;Lee, Sang-Heon;Lee, Shin-Seok;Lee, Soo-Kon;Lee, Sung Won;Park, Sung-Hwan;Park, Won;Shim, Seung Cheol;Suh, Chang-Hee;Yoo, Bin;Yoo, Dae-Hyun;Yoo, Wan-Hee
    • Journal of Korean Medical Science
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    • v.33 no.52
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    • pp.346.1-346.11
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    • 2018
  • Background: To evaluate the therapeutic benefits of the treat-to-target (T2T) strategy for Asian patients with early rheumatoid arthritis (RA) in Korea. Methods: In a 1-year, multicenter, open-label strategy trial, 346 patients with early RA were recruited from 20 institutions across Korea and stratified into 2 groups, depending on whether they were recruited by rheumatologists who have adopted the T2T strategy (T2T group) or by rheumatologists who provided usual care (non-T2T group). Data regarding demographics, rheumatoid factor titer, anti-cyclic citrullinated peptide antibody titer, disease activity score of 28 joints (DAS28), and Korean Health Assessment Questionnaire (KHAQ) score were obtained at baseline and after 1 year of treatment. In the T2T group, the prescription for disease-modifying antirheumatic drugs was tailored to the predefined treatment target in each patient, namely remission (DAS28 < 2.6) or low disease activity (LDA) ($2.6{\leq}DAS28$ < 3.2). Results: Data were available for 163 T2T patients and 162 non-T2T patients. At the end of the study period, clinical outcomes were better in the T2T group than in the non-T2T group (LDA or remission, 59.5% vs. 35.8%; P < 0.001; remission, 43.6% vs. 19.8%; P < 0.001). Compared with non-T2T, T2T was also associated with higher rate of good European League Against Rheumatism response (63.0% vs. 39.8%; P < 0.001), improved KHAQ scores (-0.38 vs. -0.13; P = 0.008), and higher frequency of follow-up visits (5.0 vs. 2.0 visits/year; P < 0.001). Conclusion: In Asian patients with early RA, T2T improves disease activity and physical function. Setting a pre-defined treatment target in terms of DAS28 is recommended.

The E-mail Survey on the Neck Pain for Acupuncture and Moxibustion Clinical Guideline (경항통에 관한 침구임상 진료지침 개발을 위한 전자우편 설문조사)

  • Kim, Hyun-Wook;Kim, Sung-Soo;Nam, Dong-Woo;Kim, Eun-Jung;Hong, Kwon-Eui;Kim, Sung-Chul;Kim, Sun-Woong;Lee, Jae-Dong;Kim, Kap-Sung;Lee, Geon-Mok
    • Journal of Acupuncture Research
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    • v.26 no.3
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    • pp.67-80
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    • 2009
  • Objectives : The purpose of this survey is the development on the neck pain for acupuncture and moxibustion clinical guideline. Methods : The survey questionnaire was developed by the committee of experts who major in acupuncture & moxibustion or statistics for acupuncture clinical trial protocol development. The questionnaires were distributed via e-mail to 75 members of Korean Acupuncture & moxibustion society. 57 members completed answers, and the computerized data were analyzed by SPSS 17.0 statistical program. Results and Conclusions : 1. The first selected pattern identification on the neck pain This study shows that the meridian pattern identification was selected 35 times(61.4%), the pattern identification based on cause of disease was selected 8 times(14.0%), the visceral pattern identification was selected 7 times(12.3%), the other pattern identification was selected 4 times(7.0%), Qi blood yin yang pattern identification was selected 2 times(3.5%), according to symptoms was selected 1 time(2.4%). 2. Meridian pattern identification Small intestine meridian of hand Taeyang was used 39 times(18.1%), Large intestine meridian of hand Yangmyeong and Bladder meridian of foot Taeyang was used 34 times(15.7%), Gall-bladder meridian of foot Soyang was 32 times(14.8%), Tripple energizer meridian of hand Soyang was used 31 times(14.4%), Governor meridian was used 30 times(13.9%), Lung meridian of hand Taeeum was used 8 times(3.7%), Heart meridian of hand Soeum and Pericarduim meridian of hand Gworeum was used 4 times(1.9%). 3. Pattern identification based on cause of disease Wind-Cold-Dampness was used 31 times(17.5%), Accumulation of the collateral by Phelgm-Dampness was used 16 times(14.0%), affection by exopathogen Wind-Cold(stiff neck, sprain of cervical) was used 13 times (11.4%), Defecient-Cold was used 10 times(8.8%), affection by exopathogen Wind-Dampness was used 9 times(7.9%), Deep Invasion by Wind-Cold was used 8 times(7.0%), Wind-Cold was used 7 times (6.1%), Wind-Cold was used 6 times(5.3%), Accumulation in the Center by Phelgm-Dampness, Imparement of bou fluid by Pathogenic Heat, Wind-Heat with Dampness was used 5 times(4.4%), affection by exopathogen Wind-Dampness and Accumulation of the collateral by Wind-Cold was used 4 times(3.5%), Invasion of Dampness-Heat was used 2 times(1.8%). 4. Visceral pattern identification Rising of the Liver yang was used 16 times(41%), Yin deficiency of Liver and Kidney+pathogens was used 15 times(38.5%), Yin deficiency of Liver and Kidney was used 8 times(20.5%) on this survey.

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A Prospective Randomized Comparative Clinical Trial Comparing the Efficacy between Ondansetron and Metoclopramide for Prevention of Nausea and Vomiting in Patients Undergoing Fractionated Radiotherapy to the Abdominal Region (복부 방사선치료를 받는 환자에서 발생하는 오심 및 구토에 대한 온단세트론과 메토클로프라미드의 효과 : 제 3상 전향적 무작위 비교임상시험)

  • Park Hee Chul;Suh Chang Ok;Seong Jinsil;Cho Jae Ho;Lim John Jihoon;Park Won;Song Jae Seok;Kim Gwi Eon
    • Radiation Oncology Journal
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    • v.19 no.2
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    • pp.127-135
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    • 2001
  • Purpose : This study is a prospective randomized clinical trial comparing the efficacy and complication of anti-emetic drugs for prevention of nausea and vomiting after radiotherapy which has moderate emetogenic potential. The aim of this study was to investigate whether the anti-emetic efficacy of ondansetron $(Zofran^{\circledR})$ 8 mg bid dose (Group O) is better than the efficacy of metoclopramide 5 mg lid dose (Group M) in patients undergoing fractionated radiotherapy to the abdominal region. Materials and Methods : Study entry was restricted to those patients who met the following eligibility criteria: histologically confirmed malignant disease; no distant metastasis; performance status of not more than ECOG grade 2; no previous chemotherapy and radiotherapy. Between March 1997 and February 1998, 60 patients enrolled in this study. All patients signed a written statement of informed consent prior to enrollment. Blinding was maintained by dosing identical number of tablets including one dose of matching placebo for Group O. The extent of nausea, appetite loss, and the number of emetic episodes were recorded everyday using diary card. The mean score of nausea, appetite loss and the mean number of emetic episodes were obtained in a weekly interval. Results : Prescription error occurred in one patient. And diary cards have not returned in 3 patients due to premature refusal of treatment. Card from one patient was excluded from the analysis because she had a history of treatment for neurosis. As a result, the analysis consisted of 55 patients. Patient characteristics and radiotherapy characteristics were similar except mean age was $52.9{\pm}11.2$ in group M, $46.5{\pm}9.5$ in group O. The difference of age was statistically significant. The mean score of nausea, appetite loss and emetic episodes in a weekly interval was higher in group M than O. In group M, the symptoms were most significant at 5th week. In a panel data analysis using mixed procedure, treatment group was only significant factor detecting the difference of weekly score for all three symptoms. Ondansetron $(Zofran^{\circledR})$ 8 mg bid dose and metoclopramide 5 mg lid dose were well tolerated without significant side effects. There were no clinically important changes In vital signs or clinical laboratory parameters with either drug. Conclusion : Concerning the fact that patients with younger age have higher emetogenic potential, there are possibilities that age difference between two treatment groups lowered the statistical power of analysis. There were significant difference favoring ondansetron group with respect to the severity of nausea, vomiting and loss of appetite. We concluded that ondansetron is more effective anti-emetic agents in the control of radiotherapy-induced nausea, vomiting, loss of appetite without significant toxicity, compared with commonly used drug, i.e., metoclopramide. However, there were patients suffering emesis despite the administration of ondansetron. The possible strategies to improve the prevention and the treatment of radiotherapy-induced emesis must be further studied.

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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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A Delphi Study For Treatment Standardization of Coldness in hands and Feet (수족냉증 치료 표준화를 위한 델파이 연구)

  • Sun, Seung-Ho;Go, Ho-Yeon;Ko, Seungwoo;Cho, Yoon-Young;Shin, Ji-Hye;Kim, Tae-Hoon;Choi, Dong-Jun;Lee, Jin-Moo;Jang, Jun-Bok;Jung, Ki-Yong;Song, Yun-Kyung;Go, Seong-Gyu;Choi, You-Kyung;Lim, Eun-Mee;Park, Jong-Hyeong;Jeon, Chan-Yong
    • Journal of Society of Preventive Korean Medicine
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    • v.19 no.3
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    • pp.131-140
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    • 2015
  • Objective : The purpose of this study is to figure out the treatment of coldness in hands and Feet by using Delphi survey. Method : This study was approved by institutional review boards at Kyung Hee University. Self recording type delphi survey were sent by e-mail to 55 Korean medicine specialists (19 gynecologist, 36 internal medical doctors) who treat coldness in hands and Feet. And replies were analyzed. As this study is cross sectional study, simple descriptive analysis was applied. Results & Conclusion : Herbal medicine, acupuncture and moxibustion were mainly applied and extract (granule), pharmacopuncture, bee venom pharmacopuncture and cupping therapy were also added case by case. Treatment was done twice a weak for 4 months. Cupping therapy was done at GB21 and SI11. Bee venom pharmacopuncture and Kidney yang deficiency pharmacopuncture were applied at ST36, GB21, CV4 and LR3. As extract (granule) Ijungtang, Dangguisayeokgaosuyusaenggangtang and Dangguisayeoktang were mainly used and as herbal medicine formula Palmijihwangwon, Bojungikgitang, Ijungtang, Danggwisayeok-gaosuyusaenggangtang and Danggwisayeoktang were mainly prescribed. Comprehensive treatment of acupuncture, moxibustion and herbal medicine was considered to have more effective and more rapid result than single treatment of herbal medicine have.