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Allogeneic clonal mesenchymal stem cell therapy for refractory graft-versus-host disease to standard treatment: a phase I study

  • Yi, Hyeon Gyu;Yahng, Seung-Ah;Kim, Inho;Lee, Je-Hwan;Min, Chang-Ki;Kim, Jun Hyung;Kim, Chul Soo;Song, Sun U.
    • The Korean Journal of Physiology and Pharmacology
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    • v.20 no.1
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    • pp.63-67
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    • 2016
  • Severe graft-versus-host disease (GVHD) is an often lethal complication of allogeneic hematopoietic stem cell transplantation (HSCT). The safety of clinical-grade mesenchymal stem cells (MSCs) has been validated, but mixed results have been obtained due to heterogeneity of the MSCs. In this phase I study, the safety of bone marrow-derived homogeneous clonal MSCs (cMSCs) isolated by a new subfractionation culturing method was evaluated. cMSCs were produced in a GMP facility and intravenously administered to patients who had refractory GVHD to standard treatment resulting after allogeneic HSCT for hematologic malignancies. After administration of a single dose ($1{\times}10^6cells/kg$), 11 patients were evaluated for cMSC treatment safety and efficacy. During the trial, nine patients had 85 total adverse events and the rate of serious adverse events was 27.3% (3/11 patients). The only one adverse drug reaction related to cMSC administration was grade 2 myalgia in one patient. Treatment response was observed in four patients: one with acute GVHD (partial response) and three with chronic GVHD. The other chronic patients maintained stable disease during the observation period. This study demonstrates single cMSC infusion to have an acceptable safety profile and promising efficacy, suggesting that we can proceed with the next stage of the clinical trial.

Comparison of Periodontology Terminology between South and North Korea (남북한 치주과학 용어의 비교)

  • Kim, Tae-Yeon;Kim, Bum-Su;Kim, Jae-Young;Shim, Sang-Su;Huh, Jin-Young
    • Journal of Periodontal and Implant Science
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    • v.32 no.4
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    • pp.711-719
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    • 2002
  • Background : Terminology is a good index of reflections in conceptional imaginations, trends and technological advances in the field of their own. The purpose of this study is to compare the similarity and difference of terms in periodontology to evaluate the communicability between South and North Korea. These result may be particularly helpful for making glossary, academic communication and social unity at the time of reunion. Methods : This study was carried out by searching northern periodontology terminologies used in literatures published in North Korea and comparing those terms with the southern terms. The standard northen terms were not able to be distinguished, so the terms used frequently were chosen as the standard northern terms. Results : The South and North both use terms that stem from Chinese characters, but this tendency is stronger in the South. The main differences between the South and North are due to the North Korea's effort in converting terms into the native languages. There are also some differences in inscription of foreign language, spelling and spacing, and so on. Conclusion : The terminology using in South and North Korea in the field of periodontology is somewhat different but both side can be capable of communication. Now the basic efforts in both parts must be taken, such as establishing new terms, in order to relieve these differences.

The Case and Implications of Terminology Mapping for Development of Dankook University Hospital EHR-Based MOA CDM (단국대학교병원 EHR 기반 MOA CDM 구축을 위한 용어 매핑 사례와 시사점)

  • Yookyung Boo;Sihyun Song;Jihwan Park;Mi Jung Rho
    • Korea Journal of Hospital Management
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    • v.29 no.1
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    • pp.1-18
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    • 2024
  • Purposes: The Common Data Model(CDM) is very important for multi-institutional research. There are various domestic and international CDM construction cases to actively utilize it. In order to construct a CDM, different terms from each institution must be mapped to standard terms. Therefore, we intend to derive the importance and major issues of terminology mapping and propose a solution in CDM construction. Methodology/Approach: This study conducted terminology mapping between Electronic Health Record(EHR) and MOA CDM for constructing Medical Record Observation & Assessment for Drug Safety(MOA) CDM at Dankook University Hospital in 2022. In the process of terminology mapping, a CDM standard terminology process and method were developed and terminology mapping was performed by applying this. The constructions of CDM mapping terms proceeded in the order of diagnosis, drug, measurement, and treatment_procedure. Findings: We developed mapping guideline for CDM construction and used this for mapping. A total of 670,993 EHR data from Dankook University Hospital(January 1, 2013 to December 31, 2021) were mapped. In the case of diagnosis terminology, 19,413 were completely mapped. Drug terminology mapped 92.1% of 2,795. Measurement terminology mapped 94.5% of 7,254 cases. Treatment and procedure were mapped to 2,181 cases, which are the number of mapping targets. Practical Implications: This study found the importance of constructing MOA CDM for drug side effect monitoring and developed terminology mapping guideline. Our results would be useful for all future researchers who are conducting terminology mapping when constructing CDM.

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Incidence of Venous Thromboembolism after Primary Total Hip Arthroplasty with Mechanical Prophylaxis in Hong Kong Chinese

  • Daniel Wai-Yip Wong;Qunn-Jid Lee;Chi-Kin Lo;Kenneth Wing-Kin Law;Dawn Hei Wong
    • Hip & pelvis
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    • v.36 no.2
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    • pp.108-119
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    • 2024
  • Purpose: The incidence of deep vein thrombosis (DVT) following total hip arthroplasty (THA) without chemoprophylaxis could be as high as 50% in Caucasians. However, according to several subsequent studies, the incidence of venous thromboembolic events (VTE) in Asians was much lower. The routine use of chemoprophylaxis, which could potentially cause increased bleeding, infection, and wound complications, has been questioned in low-incidence populations. The objective of this study is to determine the incidence of VTE after primary THA without chemoprophylaxis in an Asian population using a fast-track rehabilitation protocol and to verify the safety profile for use of 'mechanical prophylaxis alone' in patients with standard risk of VTE. Materials and Methods: This is a retrospective cohort study of 542 Hong Kong Chinese patients who underwent primary THA without chemoprophylaxis. All patients received intermittent pneumatic compression and graduated compression stockings as mechanical prophylaxis. Multimodal pain management was applied in order to facilitate early mobilisation. Routine duplex ultrasonography was performed between the fourth and seventh postoperative day for detection of proximal DVT. Results: All patients were Chinese (mean age, 63.0±11.9 years). Six patients developed proximal DVT (incidence rate, 1.1%). None of the patients had symptomatic or fatal pulmonary embolism. Conclusion: The incidence of VTE after primary THA without chemical prophylaxis can be low in Asian populations when following a fast-track rehabilitation protocol. Mechanical prophylaxis alone can be regarded as a reasonably safe practice in terms of a balanced benefit-to-risk ratio for Asian patients with standard risk of VTE.

Cost-Effectiveness Analysis of Granisetron-Based versus Standard Antiemetic Regimens in Low-Emetogenic Chemotherapy: A Hospital-based Perspective from Malaysia

  • Keat, Chan Huan;Ghani, Norazila Abdul
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.12
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    • pp.7701-7706
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    • 2013
  • Background: In a prospective cohort study of antiemetic therapy conducted in Malaysia, a total of 94 patients received low emetogenic chemotherapy (LEC) with or without granisetron injections as the primary prophylaxis for chemotherapy-induced nausea and vomiting (CINV). This study is a retrospective cost analysis of two antiemetic regimens from the payer perspective. Materials and Methods: This cost evaluation refers to 2011, the year in which the observation was conducted. Direct costs incurred by hospitals including the drug acquisition, materials and time spent for clinical activities from prescribing to dispensing of home medications were evaluated (MYR 1=$0.32 USD). As reported to be significantly different between two regimens (96.1% vs 81.0%; p=0.017), the complete response rate of acute emesis which was defined as a patient successfully treated without any emesis episode within 24 hours after LEC was used as the main indicator for effectiveness. Results: Antiemetic drug acquisition cost per patient was 40.7 times higher for the granisetron-based regimen than for the standard regimen (MYR 64.3 vs 1.58). When both the costs for materials and clinical activities were included, the total cost per patient was 8.68 times higher for the granisetron-based regimen (MYR 73.5 vs 8.47). Considering the complete response rates, the mean cost per successfully treated patient in granisetron group was 7.31 times higher (MYR 76.5 vs 10.5). The incremental cost-effectiveness ratio (ICER) with granisetron-based regimen, relative to the standard regimen, was MYR 430.7. It was found to be most sensitive to the change of antiemetic effects of granisetron-based regimen. Conclusions: While providing a better efficacy in acute emesis control, the low incidence of acute emesis and high ICER makes use of granisetron as primary prophylaxis in LEC controversial.

Development of Nursing Practice Standards of Hemodialysis Care According to Admission Types (내원유형별 혈액투석 간호업무 표준개발)

  • Kim, Min Sun;Kim, Moon Sil;Kim, Jung A;Jeong, Eun Ju;Heo, Eun Hwa;Hong, Hwa Jeong;Shin, Hye Sun;Jeong, Yeo Won
    • Journal of Korean Clinical Nursing Research
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    • v.21 no.3
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    • pp.293-308
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    • 2015
  • Purpose: This study aimed to develop nursing practice standards of hemodialysis care according to admission types. Methods: The standards were developed in four phases. Phase 1: The preliminary standards of hemodialysis care were developed based on literature review and evaluation of professional experts. Phase 2: Content validity was evaluated by 34 professional experts and the standards were modified and revised. Phase 3: Clinical validity was evaluated by 212 hemodialysis nurses. Expert group validated and verified the final outcome. Phase 4: Final standards of hemodialysis care according to admission types were developed. Results: The standard of hemodialysis care for out-patients included 5 standards, 9 contents, 43 nursing activities. The standard for in-patients included 6 standards, 10 contents, 50 nursing activities. The standards for critical patients included 4 standards, 10 contents, 43 nursing activities. There were differences in nursing activities according to admission type. Time required to meet the standards were different according to admission types. Conclusion: The findings of this research demonstrated that the time required for hemodialysis care and appropriate number of nurse would be different according to admission types. Different nursing workload according to admission type of hemodialysis patients need to be considered in allocating nursing manpower.

Quantitative Analysis of MR Image in Cerebral Infarction Period (뇌경색 시기별 MR영상의 정량적 분석)

  • Park, Byeong-Rae;Ha, Kwang;Kim, Hak-Jin;Lee, Seok-Hong;Jeon, Gye-Rok
    • Journal of radiological science and technology
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    • v.23 no.1
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    • pp.39-47
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    • 2000
  • In this study, we showed a comparison and analysis making use of DWI(diffusion weighted image) using early diagnosis of cerebral Infarction and with the classified T2 weighted image, FLAIR images signal intensity for brain infarction period. period of cerebral infarction after the condition of a disease by ischemic stroke. To compare 3 types of image, we performed polynomial warping and affined transform for image matching. Using proposed algorithm, calculated signal intensity difference between T2WI, DWI, FLAIR and DWI. The quantification values between hand made and calculated data are almost the same. We quantified the each period and performed pseudo color mapping by comparing signal intensity each other according to previously obtained hand made data, and compared the result of this paper according to obtained quantified data to that of doctors decision. The examined mean and standard deviation for each brain infarction stage are as follows ; the means and standard deviations of signal intensity difference between DWI and T2WI for each period are $197.7{\pm}6.9$ in hyperacute, $110.2{\pm}5.4$ in acute, and $67.8{\pm}7.2$ in subacute. And the means and standard deviations of signal intensity difference between DWI and FLAIR for each period are $199.8{\pm}7.5$ in hyperacute, $115.3{\pm}8.0$ in acute, and $70.9{\pm}5.8$ in subacute. We can quantificate and decide cerebral infarction period objectively. According to this study, DWI is very exact for early diagnosis. We classified the period of infarction occurrence to analyze the region of disease and normal region in DW, T2WI, FLAIR images.

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The Adoptions and Use of Electronic Nursing Records in Korean Hospitals: Findings of a Nationwide Survey (국내 전자간호기록 개발 및 실무적용 현황 조사)

  • Cho, Insook;Choi, Won Ja;Choi, Woan Heui;Kim, Min Kyeong
    • Journal of Korean Clinical Nursing Research
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    • v.19 no.3
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    • pp.345-356
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    • 2013
  • Purpose: To provide clear estimates of the adoption and use of electronic nursing records (ENRs) with standard terminology in Korea and identification of the scope and use as well as perceived or potential benefits of ENRs. Methods: A survey was done of 733 hospitals at three levels: tertiary advanced hospitals, general hospitals, and community hospitals. After performing a literature review a modified version of an existing survey tool was used for 2 months in 2012. The collected information related to EHR functionality and coverage of nursing documentation and nursing process, application of standard terminology, and perceived satisfaction and benefits of ENRs. Results: The response rate was 39.4% (289/733), and 202 hospitals (70.1%, 95% CI64.8~75.5%) of the respondents had ENR systems (82.5% of tertiary hospitals, 66.7% of general hospitals, and 70.1% of community hospitals). Out of these hospitals less than 10% had ENRs fully covering nursing documentation. The adoption rate of standard terminology was 55%, and hospital satisfaction with ENRs was 70%. But personalized care was identified as needing improvement in ENRs. Conclusion: The ENR adoption rate was high but there are many potential opportunities for improving ENR systems in terms of the data standardization and personalized care.

Comparison of dexmedetomidine alone with dexmedetomidine and fentanyl during awake fiberoptic intubation in patients with difficult airway: a randomized clinical trial

  • Acharya, Ranjita;Sriramka, Bhavna;Koushik, Priyangshu
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.22 no.5
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    • pp.349-356
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    • 2022
  • Background: Awake fiberoptic intubation (AFOI) is the procedure of choice for securing the airway in patients with a difficult airway when undergoing surgeries under general anesthesia. An ideal drug would not only provide conscious sedation but also maintain spontaneous ventilation, smooth intubation conditions, and stable hemodynamics. We compared the effects of dexmedetomidine alone and dexmedetomidine in combination with fentanyl at a dose lower than the standard dose for achieving conscious sedation during AFOI in difficult airway patients undergoing oral cancer and dental surgeries. Methods: We included 68 adult patients undergoing AFOI. The patients were randomized in two groups, wherein Group D received intravenous dexmedetomidine 1 ㎍/kg and Group DF received dexmedetomidine 0.5 ㎍/kg and fentanyl 1 ㎍/kg. The outcomes measured were airway obstruction score, intubation scores, fiberoptic intubation comfort score, sedation score, and hemodynamic variables. Results: Low-dose dexmedetomidine with fentanyl showed similar results as those with the standard dose of dexmedetomidine in terms of airway obstruction, vocal cord movement, degree of cough, degree of limb movements, and intubation comfort. However, the sedation achieved and incidence of hypotension and bradycardia were higher in Group D than in Group DF. Conclusions: A low dose of dexmedetomidine-fentanyl provides satisfactory intubation conditions as those with a standard dose of dexmedetomidine in AFOI, thereby avoiding bradycardia, hypotension, and sedation.

Clinical Effect of Traditional Chinese Medicine Shenhuang Granule in Critically Ill Patients with COVID-19: A Single-Centered, Retrospective, Observational Study

  • Feng, Jun;Fang, Bangjiang;Zhou, Daixing;Wang, Junshuai;Zou, Dengxiu;Yu, Gang;Fen, Yikuan;Peng, Dan;Hu, Jifa;Zhan, Daqian
    • Journal of Microbiology and Biotechnology
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    • v.31 no.3
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    • pp.380-386
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    • 2021
  • The coronavirus disease 2019 (COVID-19) pandemic has become a public health emergency of global concern. In China, traditional Chinese medicine has been widely administered to COVID-19 patients without sufficient evidence. To evaluate the efficacy of Shenhuang Granule (SHG) for treating critically ill patients with COVID-19, we included in this study 118 patients who were admitted to the ICU of Tongji Hospital between January 28, 2020 and March 28, 2020. Among these patients, 33 (27.9%) received standard care plus SHG (treatment group) and 85 (72.1%) received standard care alone (control group). Enrolled patients had a median (IQR) age of 68 (57-75) years, and most (79 [67.1%]) were men. At end point of this study, 83 (70.3%) had died in ICU, 29 (24.5%) had been discharged from ICU, and 6 patients (5.2%) were still in ICU. Compared with control group, mortality was significantly lower in treatment group (45.4% vs. 80%, p < .001). Patients in treatment group were less likely to develop acute respiratory distress syndrome (ARDS) (12 [36.3%] vs. 54 [63.5%], p = 0.012) and cardiac injury (5 [15.1%] vs. 32 [37.6%], p = 0.026), and less likely to receive mechanical ventilation (22 [66.7%] vs. 72 [84.7%], p = 0.028) than those in control group. The median time from ICU admission to discharge was shorter in treatment group (32 [20-73] days vs. 76 [63-79] days, p = 0.0074). These findings suggest that SHG treatment as a complementary therapy might be effective for critically ill adults with COVID-19 and warrant further clinical trials.