• 한국데이터정보과학회:학술대회논문집
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• 2006.11a
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• pp.161-165
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• 2006

• Proceedings of the Korean Society of Applied Pharmacology
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• 1994.04a
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• pp.313-313
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• 1994

대상환자는 40예중 37예에서 평가가 가능하였고 남녀비는 11:26. 중앙연령 42세 이었으며 대상질환은 위선암 12에, 유방암 10예. 골옥종 5예등 이었다. rhGM-CSF에 의한 부작용은 150.250 $\mu\textrm{g}$/$m^2$/d 용량군에서는 Grade I-II의 전신쇠약감, 근육통.심계항진등이 관찰되었으나 특별한 조치없이 회복되었다. 350$\mu\textrm{g}$/$m^2$/d 용량군에서는 8예에서 WHO grade II-III의 전신쇠약, 전신열감, 흉부압박감, 호흡곤란 등을 호소하였고 1예에서 투여 1일러 WHO gradeIII의 피부반응이 나타났으며, 이 중 2예에서는 rhGM-CSF를 250 $\mu\textrm{g}$/$m^2$/d로 감량투여후 상시 증상이 소실되었다. rhGM-CSF 투여전의 대조기와 투여기의 혈액학적 소견 비교시. 평균 중성구 최저치는 세 용량군에서 모두 관찰기에 비해 시험기어서 증가하였고. 평균 총 백혈군 최저치는 150.350 $\mu\textrm{g}$/$m^2$/d 용량군은 차이가 있었고 250 $\mu\textrm{g}$/$m^2$/d 용량군은 차이가 있었으나 통계적 유의성은 없었다. 비혈구치가 최저치에서 4.000/㎣ 이상으로 회복되는 평균일수와 호중구치가 최저치에서 2.000/㎣ 이상으로 회복되는 평균일수는 세 용량군 모두에서 관찰기어 비해 시험기에서 증가하였다. 고용량 항암약물요법후 중성구 감소에 의한 발열은 rhGM-CSF 비투여기에서 18예. rhGM-CSF 투여기에서 8예 관찰되었다고 발열기간은 각각 5-7일. 2-3일 이었다. 임상 양상은 세 용량군 간 차이가 없었으나, 시험기에서 발열의 발현율이 낮았으며, 발열일 수와 항생제 사용일 수가 짧았다. 결론: 골수억제 조절 효과는 용량에 따른 혈액소견에 미치는 영향, 부작용, 감염의 빈도, 감염발생에 따른 항생제 사용기간 등을 고려하여 그 임상 유효성 평가시, 제 3상 시험에 사용할 권장량 (recommended dose) 은 250 ug/$m^2$/d $\times$ 10d 으로 관찰되었다.

• 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.

• Proceedings of the Korean Society of Applied Pharmacology
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• 1994.04a
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• pp.189-189
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• 1994

Q-35의 일회 및 반복투여 연구결과, 자타학 증상은 단지반복투여 피험자에서 중등도의 두통(1예)과 설사(3예)가 관찰되었으나 이들 설사증례는 장내 세균총 검사상 복감염에 의한 것이 아니었다. Q-35 투여 후 Q-EEG 및 평행기능의 장애 등은 관찰되지 않았으며 임상화학 검사상 반복투여 3예에서 SGOT, SGPT의 경미한 상승을 보였으나 이러한 변화는 정상 범위내에서의 변화이었다. Q-35의 반복투여에 따라 투약 3일에서 8일에 걸처 장내세균총은 일부 호기성 및 혐기성 세균총의 감소를 보였으나 투약종료 10일 후에는 투약전 상태로 회복되었다. Q-35는 투여량의 약 70 % 가 24시간 뇨중으로 배설되었으며 일회 및 반복투여의 결과 용량의존적인 동태양상은 관찰할 수 없었다. 50 mg에서 400 mg까지 일회 투여시 5.6-7.1 시간의 혈장반감기를 보였으며, 반복투여 시험에서는 평균 5.6 $\pm$ 0.7 시간의 반감기를 보였다. Q-35는 타액내로 신속히 이행되었으며 타액내 AUC는 혈장 AUC의 약 75 %에 해당하였고, 식사에 의해 약간의 흡수속도지연(Cmax 0.4 시간지연)과 공복시에 비해 82 %의 상대적 생체이용율을 보였다.

• Clinical and Experimental Pediatrics
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• v.45 no.9
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• pp.1055-1058
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• 2002

뇌종양 치료성적은 점차 향상되고 있지만 백혈병 등 다른 소아암에 비해 향상 속도가 느리다. 하지만, 근래 MRI, PET scan 등 neuro-imaging 기술의 발달, 뇌종양의 분자유전학적 연구, 외과 수술 방법의 진전, 치료방사선요법의 다양화 등 많은 분야에서 꾸준한 발전을 보이고 있다. 그리고 여러 가지 신약개발에 의한 제 1, 제 2상의 약제시험, antiangiogenesis 약제의 임상시험, gene therapy 등의 연구가 활발하게 진행되고 있으므로, 이에 따른 환자의 치료 성적도 향상될 것으로 기대하고 있다. 외국에서는 여러 대학이 함께 참여하여 작성한 공동의 치료 protocol에 의한 치료가 활발하게 진행되어 생존율을 높이는데 반해, 우리나라에서는 아직까지 각 기관의 협조체제가 구축되지 못한 형편이다. 하지만 금년에 처음으로 여러 대학에서 임상각과가 참석하는 한국소아 뇌종양연구회가 탄생되어 우리나라 뇌종양 환아들의 치료 protocol 개발에 기여할 것을 기대하고 있다. 뇌종양 치료 후 생존하는 아이들을 위한 정밀한 추적관찰이 필수사항인데 여기에 소아과 의사들의 역할은 클 것으로 사료된다. 지능장애, 부적절한 대인관계, 사회적응의 어려움, 치료 후 발생한 내분비계통의 후유증 그리고 2차 암의 발생 등의 정확한 진단 및 치료가 소아과 의사들의 몫으로 남는다. 또한, 이러한 장애가 있는 환아들이 사회에 잘 적응하도록 하기 위해서는 재활교육에 대한 사회적인 관심과 그에 적절한 지원제도의 확립이 절실히 요구된다. 이 점에 있어서도 소아과 의사들의 관심과 지원이 필요하다.

• The Korean Journal of Applied Statistics
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• v.21 no.1
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• pp.35-51
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• 2008

Comparative studies in Phase III clinical trials quite often involve two or more equally important endpoints, and one cannot select primary endpoint from them. O'Brien(1984) proposed for continuous endpoints the OLS and GLS statistics as milti-variate test statistics. Pocock et al. (1987) mentioned the possibility of analyzing a mixture of data types, such as quantitative, binary and survival data types, with the OLS and GLS statistics, but the authors did not explore problems in combining several endpoints of different types. Furthermore, they did not perform a simulation study to assess the efficiencies of the OLS and GLS statistics for endpoints of a mixture of data types. In this paper, we propose the combining methods of correlated P-values for the analysis of multiple endpoints, and compare the efficiencies of this method with those of OLS and GLS statistics for a mixture of data types with a simulation study. Among the several methods of combining P-values that are more advantageous than combining of OLS and GLS statistics, method B maintains nominal significance levels and is more efficient, while method F and G have type I error rates that are larger than the specified significance levels, which might occasionally lead to a wrong conclusion.

• Korean Journal of Clinical Pharmacy
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• v.13 no.2
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• pp.97-105
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• 2003

아스코마이신(ascomycin)의 macrolactam 유도체인 피메크로리무스(pimecrolimus; 엘리델 [Elidel], SDZ ASM 981; Novartis Pharma AG, 바젤, 스위스)는 세포선택성을 지닌 염증성 사이토카인(cytokines) 억제제로서 아토피피부염, 알레르기성 접촉피부염, 자극성 접촉피부염 및 판형 건선 등 염증성 피부질환의 치료제로 개발되었다. T세포와 비만세포의 염증성 사이토카인 생산 분비를 억제하고 사전 형성된 염증성 매개물질의 비만 세포 분비를 저해한다. 국소 투여된 피메크로리무스는 알레르기성 접촉피부염(allergic contact dermatitis [ACD]) 돼지 모델에서 고역가 코르티코스테로이드 클로베타졸-17-propionate(corticosteroid clobetasol-17-propionate)와 동등한 효과를 나타낸다. 하지만 피메크로리무스는 클로베타졸과는 달리 피부 위축을 일으키지 않는다. 경구 투여시 피메크로리무스는 마우스와 랫트 ACD 치료에 있어서 타크로림무스(tacrolimus [FK 506])와 동등한 혹은 더 우수한 효과를 나타낸다. 또한 피메크로리무스는 아토피피부염 급성 징후 유사 모델인 저마그네슘 혈증 탈모 랫트(hypomagnesemic hairless rat)의 피부 염증과 소양증을 효과적으로 감소시킨다. 피메크로리무스는 랫트에서 다음과 같은 측면의 전신 면역반응 손상 효과가 타크로리무스 와 비교하여 낮게 평가된다: (1)국소 이식편대 숙주 반응, (2)양(sheep) 적혈구에 대한 항체 형성, (3)신장이식. 시험관내 평가시 돼지 피부를 통한 피메크로리무스 투과 속도가 타크로리무스보다 10배 낮게 측정되므로 생체에서 경피 흡수가 더 적게 될 것으로 판단된다. 상기 자료로 판단컨대 피메크로 리무스는 피부에 대한 항염증 활성이 높을 뿐 아니라 전신 면역반응 손상 부작용이 낮은것으로 사료된다.

• Journal of Chest Surgery
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• v.35 no.4
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• pp.267-273
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• 2002

Background: We performed a phase IV clinical trial to examine the usefulness of a continuous infusion of nicardipine hydrochloride to control hypertension in patients with acute aortic dissection. material and Method: Systolic/diastolic blood pressure, and heart rate were monitored before and after the intravenous administration of nicardipine in 31 patients with aortic diseases. The period of nicardipine administration in each patient was from 3 to 14 days. Efficacy was evaluated by determining the average amount of blood pressure reduction on the 3rd day of drug administration. The dosage of another antihypertensive agent was slowly tapered down, and ultimately replaced by the test drug. Result: 28 patients were diagnosed as acute aortic dissection, 2 patients as rupture of the aortic arch aneurysm, and 1 patient as traumatic aortic rupture. Mean age was 53.9 $\pm$ 14.9(29~89) years, and 21 patients(67.7%) were male. 14 patients(32.3%) had complications associated with underlying aortic disease: aortic insufficiency in 7, hemopericardium in 6, acute renal failure in 1, paraplegia in 1, lower extremity ischemia in 1, and hemothorax in 1. The time needed to reach the target blood pressure was within 15 minutes in 16, from 15 to 30 minutes in 10, from 30 to 45 minutes in 3 and from 45 to 60 minutes in 2, and their baseline average systolic, diastolic, and mean arterial blood pressures(mmHg) were 147$\pm$23, 82.3$\pm$ 18.6, and 104 $\pm$ 18, respectively. Average systolic, diastolic, and mean arterial blood pressures(mmHg) on the third day of nicardipine infusion were 119$\pm$ 12, 69$\pm$9, and 86$\pm$8, and they all showed statistically significant decrease(p<0.05). The average systolic, diastolic, and mean arterial blood pressure(mmHg) after the discontinuation of the nicardipine infusion were 119 $\pm$ 15, 71 $\pm$ 14, and 86$\pm$ 13, respectively. No significant difference was observed between the average pressures measured on the third day and those measured after the discontinuation of the nicardipine infusion, and no definite side effects were observed during the study period. Conclusion: Nicardipine hydrochloride was both effective and safe at controlling blood pressure in patients with acute aortic dissection.

• Restorative Dentistry and Endodontics
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• v.31 no.4
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• pp.269-281
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• 2006

This study evaluated the effectiveness and safety of an experimental bleaching strip (Medison dental whitening strip. Samsung medical Co., Anyang, Korea) containing 2.9% hydrogen peroxide. Twenty-three volunteers used the bleaching strips for one and a half hour daily for 2 weeks. As control group. the same strips in which hydrogen peroxide was not included were used by 24 volunteers with the same protocol. The shade change (${\Delta}E^{*}$, color difference) of twelve anterior teeth was measured using Shade Vision (X-Rite Inc., S.W. Grandville, MI, USA). Chroma Meter (Minolta Co., Ltd. Osaka. Japan) and Vitapan classical shade guide (Vita Zahnfabrik, Germany). The shade change of overall teeth in the experimental group was significantly greater than that in the control group (p < 0.05) and was easily perceivable. The change resulted from the increase of lightness (CIE $L^{*}$ value) and the decrease of redness (CIE $a^{*}$ value) and yellowness (CIE $b^{*}$ value). The shade change of individual tooth was greatest in canine. and smallest in central incisor. The safety of the bleaching strip was also confirmed.

• The Korean Journal of Pharmacology
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• v.11 no.1 s.17
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• pp.33-38
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• 1975

The clinical efficacy of Ethaverine, a peripheral vasodilator, was studied according to a double-blind, non-cross over method in 29 diabetic patients with peripheral arterial diseases. The clinical improvement was assessed from the history of patients including the incidence and frequency of intermitten claudication. Ethaverine, after 4 weeks of therapy, was not effective in improving clinical symptoms compared to placebo. Ethaverine, however, was an efective vasodilator than placebo. The quality of vasodilation induced by Ethaverine, was similar to that of alcohol. A new clinical method of studying peripheral vasodilator was presented. The clinical symptoms of peripheral vascular arterial disease in the lower extrimities include reduced intensity of palpable pulses, coldness, and discoloration of the skin. Intermittent claudication may be present. Pathologic changes in vessel architecture precede the symptoms, and recognition of impending vascular insufficiency is a determining factor in selecting vasodilating therapy or surgical management. Also, post-operative patients who have chronic peripheral vascular arterial disease may be candidates for subsequent vasodilating therapy. Peripheral vasodilators, according to the series of reports, may be indicated in vasospastic peripheral vascular condition rather than an occlusive vascular disease and the vessel responds best when a relatively large vascular beds are involved rather than a small, capillary beds. Recently, the clinical efficacy of peripheral vasodilators have been challanged by many clinical investigators and clinicians. In this study, we have re-evaluated the efficacy of Ethaverine HCl as peripheral vasodilator in patients with vasospastic peripheral arterial disease. Ethaverine is claimed to be two to four times as potent a spasmolytic agent as papaverine in a variety of laboratory and clinical work.