• Title/Summary/Keyword: Adverse events

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Early Clinical Experience in Aortic Valve Replacement Using On-X$^{circledR}$Prosthetic Heart Valve (On-X$^{circledR}$ 기계판막을 이용한 대동맥판 치환술의 조기 임상 경험)

  • 안병희;전준경;류상완;최용선;김병표;홍성범;박종춘;김상형
    • Journal of Chest Surgery
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    • v.36 no.9
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    • pp.651-658
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    • 2003
  • Since the first implanted in September 1997, the use of On-X prosthetic heart valve has been increasing around in the world. This study was designed to assess the feasibility, safety, and the postoperative hemodynamics with this new valve in clinical setting. Material and Method: The current study was carried out on 52 patients undergoing aortic valve replacement with this prosthesis between April 1999 to August 2002 at Chonnam National University Hospital to evaluate the surgical results. 52% of the patients were male and the average age at implant was 50$\pm$13 years. The study followed the guidelines of the AATS/STS. Preoperatively, 32(61.5%) patients were in NYHA functional class III or IV and 2 patients had previous aortic valve surgery. Concomitant cardiac surgery was performed in 71.1%. The implanted valve sizes were 19 mm in 13 patients, 21 mm in 26, 23 mm in 10 and 25 mm in 3, respectively. Mean follow-up was 16.6$\pm$10.5 months (1∼39 months). Echocardiographic assessment was performed pre- and immediate postoperatively, as well as 3, 6, 12 months after surgery, evaluating pressure loss and regression of left ventricular hypertrophy. Result: Mean cardiopulmonary bypass time was 191$\pm$94.7 minutes with an aortic cross-clamp time of 142$\pm$51.7 minutes. There was no early and late mortality, Freedom from adverse events at 1 year in the study were as follows: thromboembolism, 95.6$\pm$6%; bleeding events, 90.2$\pm$4%; paravalvular leakage 92.3$\pm$4%; and overall valve-related morbidity at 1 year was 76.6$\pm$3%. There were no cases of valve thrombosis, prosthetic valve endocarditis and structural or non-structural failure. Left ventricular function at 12 months after surgery (EF=62.7$\pm$9.8%) revealed a statistically significant improvement compared to preoperative investigation (EF=55.8$\pm$15.9%, p=0.006). Left ventricular mass index was 247.3$\pm$122.3 g/$m^2$ on preoperative echocardiographic study, but regressed to 155.5$\pm$58.2 g/$m^2$ at postoperative 1 year (p=0.002). Over the follow-up period a further decrease of peak transvalvular gradients was observed in all patients: 62.5$\pm$38.0 mmHg on preoperative assessment, 18.2$\pm$6.8 mmHg at immediate postoperative period (p < 0.0001), 7.6$\pm$5.09 mmHg (p<0.0001) at 6 month, 18.0$\pm$10.8 mmHg (p<0.0001) at 1 year. Conclusion: The On-X prosthetic heart valve performs satisfactorily in the first 1 year period. Clinical outcome by examining NYHA functional classification revealed especially good results. Effective regression of left ventricular hypertrophy and statistically significant decrease of transvalvular gradient were observed over the first year, but longer-term follow-up of this patient group is needed to establish the expected rates for late valve-related events as well as the long-term clinical efficacy of this valve.

Efficacy and Safety of $Ultracet^{(R)}$ in Ambulatory Patients with Cancer Pain (암환자의 통증치료에 대한 $Ultracet^{(R)}$의 유효성과 안전성)

  • Lee, Hyo-Jin;Jin, Sun-Ah;Yun, Gak-Won;Yang, Yung-Joon;Park, Nam-Whan;Chun, Jae-Min;Park, Nam-Sook;Yun, Hwan-Jung;Jo, Deog-Yeon;Kim, Sam-Yong
    • Journal of Hospice and Palliative Care
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    • v.9 no.2
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    • pp.101-105
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    • 2006
  • Purpose: We aimed to investigate the efficacy and side effects of $Ultracet^{(R)}$ in relieving cancer pain in setting. Methods: Sixty-one cancer patients over 18 years old, who had cancer pain with or without medication, were enrolled. Pain and other variables were evaluated before and after treatment with $Ultracet^{(R)}$ for 2 weeks, using Korean version of Brief Pain Inventory. Results: Of 61 patients with assessable efficacy data, the maximum pain intensity(PI) experienced in a day were $5.18{\pm}1.41\;and\;4.82{\pm}1.94$, before and after treatment with$Ultracet^{(R)}$ respectively (P=0.113). The minimum PI experienced in a day were $1.2{\pm}1.05\;and\;0.87{\pm}1.35$, before and after treatment with $Ultracet^{(R)}$, respectively (P=0.038). The average PI experienced in a day were $3.61{\pm}1.01\;and\;3.15{\pm}1.73$, before and after treatment with $Ultracet^{(R)}$, respectively (P=0.022). The current PI were $3.63{\pm}1.25\;and\;2.85{\pm}1.94$, before and after treatment with $Ultracet^{(R)}$, respectively (P=0.003). Regarding the quality of life, only mood changed for the better in 49 patients who were treated with $Ultracet^{(R)}$ alone ($1.98{\pm}1.73\;and\;1.35{\pm}1.15$, before and after treatment respectively; P=0.046). There were five (8.2%) adverse events associated with $Ultracet^{(R)}$ treatment. Conclusion: $Ultracet^{(R)}$ seems effective and safe in ambulatory patients with cancer pain.

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Clinical Study of Thalidomide Combined with Dexamethasone for the Treatment of Elderly Patients with Newly Diagnosed Multiple Myeloma

  • Chen, Hai-Fei;Li, Zheng-Yang;Tang, Jie-Qing;Shen, Hong-Shi;Cui, Qing-Ya;Ren, Yong-Ya;Qin, Long-Mei;Jin, Ling-Juan;Zhu, Jing-Jing;Wang, Jing;Ding, Jie;Wang, Ke-Yuan;Yu, Zi-Qiang;Wang, Zhao-Yue;Wu, Tian-Qin
    • Asian Pacific Journal of Cancer Prevention
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    • v.13 no.9
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    • pp.4777-4781
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    • 2012
  • Objective: To investigate the relationship between the efficacy and safety of different doses of thalidomide (Thal) plus dexamethasone (Dex) as the initial therapy in elderly patients with newly diagnosed multiple myeloma (MM). Methods: Clinical data of 28 elderly patients with newly diagnosed MM who underwent the TD regimen as the initial therapy were analyzed retrospectively. The patients were divided into two groups according to the maximal sustained dose of Thal: lower dose (group A) and higher dose (group B). The overall response rate (ORR), progression free survival (PFS), overall survival (OS), and adverse events (AES) were compared between the two groups. Results: A total of 28 patients were followed up with a median of 18 months. The ORR was 60.1%. The median response time and PFS were 2.0 and 17.0 months, respectively. The mean sustained dose of Thal in group B was significantly higher than group A (292.9 mg v 180.4 mg, P=0.01). There was no significantly difference in ORR (57.1% v 64.3%, P=1.00) and PFS (9.63months v 17.66 months, P=0.73) between groups A and B. During the follow up, only five patients died (<40%) and, therefore, median OS values were not available. It is estimated, however, that the mean survival time in the two groups was 35.6 and 33.4 months (P>0.05), respectively. All of the patients tolerated the treatment well. The incidence of AES in patients with a grading above 3 in group B was significantly higher than in group A (P=0.033). Conclusions: The TD regimen results in a high response rate and manageable AES as the initial therapy in elderly patients with MM. TD should be considered as the front line regimen for the treatment of elderly patients with MM in areas with financial constraints. The clinical response can be achieved at a low dose Thal with minimal toxicity.

Economic Value of the Sirolimus Eluting Stent($CYPHER^{TM}$) in Treating Acute Coronary Heart Disease (관상동맥질환 치료를 위한 시롤리무스 방출 스텐트 ($CYPHER^{TM}$)의 경제성 분석)

  • Lee, Hoo-Yeon;Park, Eun-Cheol;Park, Ki-Dong;Park, Ji-Eun;Kim, Young;Lee, Sang-Soo;Kang, Hye-Young
    • Journal of Preventive Medicine and Public Health
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    • v.36 no.4
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    • pp.339-348
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    • 2003
  • Objective : To quantify the economic value of the Sirolimus fluting Stent ($CYPHER^{TM}$) in treating acute coronary heart disease (CMD), and to assist in determining an adequate level of reimbursement for $CYPHER^{TM}$ in Korea. Methods : A decision-analytical model, developed by the Belgium Health Economics Disease Management group, was used to investigate the incremental cost-effectiveness of $CYPHER^{TM}$ versus conventional stenting. The time horizon was five years. The probabilities for clinical events at each node of the decision model were obtained from the results of large, randomized, controlled clinical trials. The initial care and follow-up direct medical costs were analyzed. The initial costs consisted of those for the initial procedure and hospitalization, The follow-vp costs included those for routine follow-up treatments, adverse reactions, revascularization and death. Defending on the perspective of the analysis, the costs were defined as insurance covered or total medical costs (=sum of insurance covered and uncovered medical costs). The cost data were obtained from the administrative data of 449 patients that received conventional stenting from five participating Korean hospitals during June 2002. Sensitivity analyses were peformed for discount rates of 3, 5 and 7%. Since the major clinical advantage of $CYPHER^{TM}$ over conventional stenting was the reduction in the revascularization rates, the economic value of $CYPHER^{TM}$, in relation to the direct medical costs of revascularization, were evaluated. If the incremental cost of $CYPHER^{TM}$ per revascularization avoided, compared to conventional stenting, was no higher than that of a revascularization itself, $CYPHER^{TM}$ would be considered as being cost-effective. Therefore, the maximum acceptable level for the reimbursement price of $CYPHER^{TM}$ making the incremental cost-effectiveness ratio equal to the cost of a revascularization was identified. Results : The average weighted initial insurance covered and total medical costs of conventional stenting were about 6,275,000 and 8,058,000 Won, respectively. The average weighted sum of the initial and 5-year follow-up insurance covered and total medical costs of conventional stenting were about 13,659,000 and 17,353,000 Won, respectively. The estimated maximum level of reimbursement price of $CYPHER^{TM}$ from the perspectives of the insurer and society were $4,126,897{\sim}4,325,161$ and $4,939,939{\sim}5,078,181$ Won, respectively. Conclusion : By evaluating the economic value of $CYPHER^{TM}$, as an alternative to conventional stenting, the results of this study are expected to provide a scientific basis for determining the acceptable level of reimbursement for $CYPHER^{TM}$.

Characteristics of Tuberculosis Detected during Chemotherapy for a Solid Tumor (고형암에 대한 항암화학요법 치료 중 병발한 결핵의 특성)

  • Kim, Deog Kyeom;Lee, Sei Won;Kang, Young Ae;Yoon, Young Soon;Yoo, Chul-Gyoo;Kim, Young Whan;Han, Sung Koo;Shim, Young-Soo;Yim, Jae-Joon
    • Tuberculosis and Respiratory Diseases
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    • v.58 no.3
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    • pp.285-290
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    • 2005
  • Background : Some malignancies including lymphoma, head and neck cancer, and lung cancer are believed to be associated with the reactivation of tuberculosis (TB) because cyclic anti-cancer chemotherapy can induce the leukopenia or immunological deterioration. This report describes the clinical characteristics and treatment response of TB that developed during cyclic anti-cancer chemotherapy in patients with a solid tumor. Materials and Methods : From January 1 2000 to July 31 2004, patients with TB diagnosed microbiologically, pathologically, or clinically during anti-cancer chemotherapy in a tertiary hospital were enrolled, and their medical records were reviewed. Patients with the known risk factors for the reactivation of TB were excluded. Results : Twenty-two patients were enrolled and their mean age was 56.5 years (range 21-78). The male to female ratio was 3.4:1 and pulmonary TB was the main variant (20 patients, 90.9%). Gastric cancer (10 patients, 45.4%) and lymphoma (4 patients, 18.2%) were the leading underlying malignancies. The other malignancies included lung cancer, head and neck cancer, breast cancer, cervix cancer, and ovary cancer. Fifteen patients (68.2%) had a healed scar on a simple chest radiograph suggesting a previous TB infection. Among these patients, new TB lesions involved the same lobe or the ipsilateral pleura in 13 patients (87.6%). An isoniazid and rifampicin based regimen were started in all the subjects except for one patient with a hepatic dysfunction. The mean duration of medication was $9.9{\pm}2.4$ months and no adverse events resulting in a regimen change were observed. With the exception of 5 patients who died of the progression of the underlying malignancy, 70.6% (12/17) completed the anti-TB treatment. Conclusion : The clinical characteristics and response to anti-TB treatment for TB that developed during anticancer chemotherapy for a solid tumor were not different from those of patients who developed TB in the general population.

Effect of intravenous deferoxamine in multiply transfused patients (대량 수혈을 받은 환아들에서 정맥 투여한 deferoxamine의 효과)

  • Oh, Sang Min;Kang, Joon Won;Kim, Sun Young
    • Clinical and Experimental Pediatrics
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    • v.50 no.12
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    • pp.1225-1230
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    • 2007
  • Purpose : Multiple transfusions in patients with chronic anemia can result in excessive iron deposition in tissues and organs. Effective iron chelation therapy in chronically transfused patients can only be achieved when iron chelators remove sufficient amounts of iron equivalent to those accumulated in the body from transfusions, thus leading to maintain body iron load at a non-toxic level. This study was retrospectively carried out to investigate the effect of intravenous iron chelation therapy with deferoxamine in patients who have received multiple transfusions. Methods : From March 2005 to January 2007, 15 patients who have received multiple transfusions were included in this study. Transfusion dependent patients were defined as those receiving >1 packed red blood cell (RBC) units/month for at least 6 months. They received intravenous deferoxamine for 7 days (10-30 mg/kg/day, 24 hour continuous infusions). Before and after deferoxamine infusions and 3 months later, we compared serum iron, TIBC, and ferritin in transfusion dependent patients and transfusion independent patients. Results : There were 6 males and 9 females and their age range was 5.6-21.3 (median 8.3) years. Transfusion dependent patients were 7 and 8 were transfusion independent states after stem cell transplantation or chemotherapy. There was no significant change in ferritin level after deferoxamine treatment for the transfusion dependent patients but significant falling of ferritin level was observed for the transfusion independent patients 3 months later compared with baseline ferritin level (P=0.046). Some adverse events were observed but symptoms were mild and tolerable. Conclusion : Seven days of intravenous deferoxamine was safe and effective in transfusion independent patients. In transfusion dependent patients, chelation therapy should be maintained, in order to minimize or prevent iron accumulation and storage in the tissues.

Clinical Effects of Oseltamivir in Children with Influenza in Busan, in the First Half of 2004 (2004년 상반기에 부산 지역 소아에서 유행한 독감에서 Oseltamivir의 치료 효과)

  • Park, Soo Kyoung;Choi, So Young;Kim, Sung Mi;Kim, Gil Heun;Jung, Jin Hwa;Choi, Im Jung;Cho, Kyung Soon
    • Clinical and Experimental Pediatrics
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    • v.48 no.9
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    • pp.976-985
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    • 2005
  • Purpose : Although influenza is one of the most important causes of acute respiratory tract infections in children, effective antiviral therapies are not common and there are only a few clinical studies on treatment of influenza in children. We evaluated the efficacy of oseltamivir in the treatment of naturally aquired influenza in children during the first half of 2004 in Busan. Methods : From January 2004 to June 2004, throat swabs and nasal washes were performed and cultured for the isolation of influenza virus and tested by rapid antigen detection test(QuickVue influenza test) in children with suspected influenza infections. The children who responded positively to the QuickVue influenza test, we divided into two groups : an oseltamivir treatment group and a control group. We compared their clinical symptoms(including fever duration) and diagnosis. The medical records of patients with influenza virus infection were reviewed retrospectively. Results : A total of 621 individuals were suspected of influenza infection. Influenza viruses were isolated in 79(17.2 percent) out of 621 patients examined. QuickVue influenza tests were positive in 181 cases. The treatment group(83 individuals) received oseltamivir twice daily for 5 days, and the control group(99 individuals) were administered only symptom relief medicine. There was no differences between the two groups in clinical diagnosis and symptoms. Oseltamivir treatment reduced the fever duration and other respiratory symptoms. There were no adverse events associated with oseltamivir treatment. Conclusion : Our data suggest that oral oseltamivir treatment reduces the fever duration and other respiratory symptoms of acute influenza without side effects in children.

Comparison of Antidepressants Tolerability in Cancer Patients Referred for Psychiatric Consultation (정신건강의학과 자문 의뢰된 암 환자의 항우울제 내약성 비교 연구)

  • Ko, Eunmi;Park, Jin-Seong;Ha, Juwon;Lim, Sewon;Kim, Tae-Suk;Ha, Jee Hyun;Paik, Jong-Woo;Lee, Boung Chul;Choe, Byeong Moo;Lee, Kang-Joon;Kim, Sung-Wan;Yang, Jong-Chul;Ko, Young-Hoon;Oh, Kang-Seob
    • Korean Journal of Psychosomatic Medicine
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    • v.21 no.1
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    • pp.3-10
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    • 2013
  • Objectives : Many patients diagnosed with cancer suffer from various psychiatric symptoms such as depression, anxiety and insomnia as well as cancer itself. Patients with cancer are more vulnerable to possible adverse events of psychotropic medications. Although antidepressants are widely used among cancer patients, there is little information about tolerability of antidepressants. This study was conducted to compare tolerability of antidepressants in cancer patients referred for psychiatric consultation. Methods : The participants were cancer patients who had been referred to psychiatrist for their psychiatric symptoms. We retrospectively analyzed the data of patients diagnosed with cancer from 9 general hospitals in Korea. The discontinuation rate for a 6 months period after treatment initiation for three antidepressants(Escitalopram, Mirtazapine, Paroxetine) were compared. Results : Antidepressants were prescribed for 96.3% of subjects and Escitalopram 150(47.2%), Mirtazapine 92(28.9%) and Paroxetine 76(23.9%) were prescribed frequently in order There were no significant differences in discontinuation rates among the three antidepressants during the 6 month period after initiation of pharmacotherapy. But there was a difference in discontinuation rates between inpatients versus outpatients(p<0.0001). Conclusions : In a naturalistic setting for the antidepressant treatment for cancer patients, it seems that there are no differences in discontinuation rates among these three antidepressants. It is therefore essential that such interactions are carefully considered when treating patients of antidepressants who already have cancer.

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Immunogenicity and safety of enhanced-inactivated poliovaccine(eIPV) in healthy Korean infants (한국 영아에서 eIPV의 면역원성과 안정성)

  • Kim, Jung Soo;Hong, Young Jin;Kim, Jong Duk;Jang, Young Taek;Kang, Jin Han
    • Clinical and Experimental Pediatrics
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    • v.49 no.8
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    • pp.864-869
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    • 2006
  • Purpose : We evaluated the immunogenicity and safety of eIPV(Imovax $Polio^{(R)}$) in a group of healthy Korean infants on a three-dose primary vaccination. Methods : Eighty one healthy infants aged 8-10 weeks were enrolled, and 79(male 42, female 37) completed the study. Three doses of eIPV were injected intramuscularly at 2, 4 and 6 months of age as of primary vaccination. Most subjects received concomitant vaccines such as DTaP and/or Hib at 2, 4, and 6 months of age. Immediate reactions were monitored for 30 minutes after each injection. Local and systemic events were recorded for 72 hours following each immunization by parents/guardians. Poliovirus specific neutralizing antibodies were measured using enzyme immuno-assay (EIA) at prior to and 1 month after the third dose. An antibody titer of 1:8 or higher was considered seroprotective. Geometric mean titers(GMTs) to each poliovirus type antigen were also measured. Results : One month after the third dose of eIPV, all infants(100 percent) were seroprotective. The geometric mean titers(GMTs) were 1,532(95 percent CI : 1,312-1,788) in type 1 and 835(95 percent CI : 684-1,018) in type 2 and 846(95 percent CI : 692-1,035) in type 3. Overall, local reactions were observed in 10 percent of infants and systemic reactions in 26.2 percent of infants. All reactions were observed within 3 days after vaccination and resolved without treatment. Conclusion : eIPV(Imovax $Polio^{(R)}$) is a well-tolerated and highly immunogenic vaccine. It can be administered either alone or simultaneously with other routine vaccines to Korean infants.

A Study on the Decision Point and a Standard of Judgment under the Duty of Inter-hospital Transfer for Patients of Doctor - Focused on the Trend of Supreme Court's Decisions - (의사의 전원의무(轉院義務) 위반 여부의 판단기준과 전원시점 판단 - 판례의 동향을 중심으로 -)

  • Choi, Hyun-tae
    • The Korean Society of Law and Medicine
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    • v.20 no.1
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    • pp.163-201
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    • 2019
  • Doctor has the duty of an inter-hospital transfer, known as inter-facility or secondary transfer, when the diagnostic and therapeutic facilities required for a patient are not available at the given hospital. Also, the decision to transfer the patient to an another facility is rely on whether ill patient is the benefits of care, including clinical and non-clinical reasons, available at the another facility against the potential risks. Crucial point to note is that issues about 'inter-hospital transfer' is limited to questions occurred in the course of transfer between emergency medicals (facilities). 'emergency medical (facility)' is specified by Medical Law, article 3 and the duty of an inter-hospital transfer includes any possible adverse events, medical or technical, during the transfer. Because each medical facility has an different ability to care for a patient in an emergency condition, coordination between the referring and receiving hospitals' emergency medicals would be important to ensure prompt transfer to the definitive destination avoiding delay at an emergency. Simultaneously, transfer of documents about the transfer process, medical record and investigation reports are important materials for maintaining continuity of medical care. Although the duty of an inter-hospital transfer is recognized as one of duty of doctor and more often than not it occurs, there is constant legal conflict between a doctor and a patient related to the duty of the inter-hospital transfer. Therefore, we need clear and specific legal standard about the inter-hospital transfer. This paper attempts to review the Supreme Court's cases associated to the inter-hospital transfer and to compare opinion of the cases with guideline for an inter-hospital transfer already given. Furthermore, this article is intended to broaden our horizons of understanding the duty of an inter-hospital transfer and I wish this article helps to resolve the settlement and case dealt with the duty of inter-hospital transfer.