• Journal of the Korean Academy of Child and Adolescent Psychiatry
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• 제16권2호
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• pp.279-285
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• 2005

목적 : 이 연구에서는 장시간 약물작용이 지속되는 MPH-OROS를 주의력결핍과잉운동장애 아동에게 투여하여 그 효용성과 안전성 및 부모 만족도를 평가하려고 하였다. 방법 : 연구대상은 DSM-IV의 진단기준을 이용하여 임상적으로 ADHD로 진단 받은 569명의 아동으로 하였다. 이미 약물을 복용중이거나 약을 복용한 적이 없는 아동을 대상으로 이전 약물에서 MPH-OROS로 약물을 바꾸거나 처음으로 MPH-OROS를 복용하였다. 증상의 정도는 MPH-OROS 약물 사용 전과 사용 1주 및 3주에 한국어판 Conners 부모용 평가척도를 사용하여 평가하였다. 임상 호전은 Clinical Global Impression Severity of illness(CGI-S)를 사용하여 MPH-OROS 약물 복용 전과 복용 1주 및 3주에 임상가가 평가하였고 Clinical global impression severity of improvement(CGI-I)로 약물 복용 1주 및 3주에 호전 정도를 평가하였다. 약물 복용 3주에는 약물 복용에 따른 부모 만족도를 설문 조사하였다. 결과 : MPH-OROS의 1일 평균 복용량은 기저선 $25.3{\pm}11.2mg$ 1주 $28.9{\pm}12.7mg$, 3주 $31.3{\pm}13.2mg$이었다. 시간에 따라 용량이 유의하게 증가하였고, 성에 따른 차이는 없었다. 전체의 $13\%$가 중도 탈락했으며, 그 원인으로는 부작용이 가장 많았다. CGI-I의 변화는 시간에 따라 유의하게 감소하는 모습을 보였고, 성에 따른 호전 정도의 차이는 나타나지 않았다. CGI-I에 의한 호전평가에서 MPH-OROS 치료 1주에 호전은 $72.3\%$이고 치료 3주에는 $87.4\%$였다. 한국판 Conners부모용 평가척도 합계 점수는 시간에 따라 유의하게 감소하였다. 한 가지 이상의 부작용을 경험하였던 환자는 119명으로 $20.7\%$에 달하였으며, 가장 많은 빈도로 나타난 것은 식욕부진이고, 불면, 두통, 오심의 순이었다. 기존에 속효성 메틸페니데이트를 사용하던 군과 약물을 처음 사용하는 군을 나누어 부작용 빈도를 살펴보았을 때 크게 차이가 나지 않았다. 부모만족도 설문 결과에서 MPH-OROS 약물치료에 대해 $94\%$의 부모는 전반적으로 만족한다고 응답하였다. 또한 부모가 보고하는 MPH-OROS 의 가장 큰 장점은 오후까지 약물효과 지속, 학교생활 및 수업태도, 가정생활 및 숙제, 과잉행동 개선의 순이었다. 결론 : MPH-OROS는 주의력결핍과잉운동장애의 치료에서 효과적이며 충분히 안전하다.

• 대한기관윤리심의기구협의회지
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• 제2권2호
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• pp.37-48
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• 2020

Purpose: The purpose of this study is to assess the operational status and level of understanding among IRB and HRPP staffs at a hospital or a research institute to the HRPP guideline set by the Ministry of Food and Drug Safety (MFDS) and to provide recommendations. Methods: Online survey was distributed among members of Korean Association of IRB (KAIRB) through each IRB office. The result was separated according to topic and descriptive statistics was used for analysis. Result: Survey notification was sent out to 176 institutions and 65 (37.1%) institutions answered the survey by online. Of 65 institutions that answered the survey; 83.1% was hospital, 12.3% was university, 3.1% was medical college, 1.5% was research institution. 23 institutions (25.4%) established independent HRPP offices and 39 institutions (60.0%) did not. 12 institutions (18.5%) had separate IRB and HRPP heads, 21 (32.3%) institutions separated business reporting procedure and person in charge, 12 institutions separated the responsibility of IRB and HRPP among staff, and 45 institutions (69.2%) had audit & non-compliance managers. When asked about the most important basic task for HRPP, 23% answered self-audit. And according to 43.52%, self-audit was also the most by both institutions that operated HRPP and institutions that did not. When basic task performance status was analyzed, on average, the institutions that operated HRPP was 14% higher than institutions that only operated IRB. 9 (13.8%) institutions were evaluated and obtained HRPP accreditation from MFDS and the most common reason for obtaining the accreditation was to be selected as Institution for the education of persons conducting clinical trial (6 institutions). The most common reason for not obtaining HRPP accreditation was because of insufficient staff and limited capacity of the institution (28%). Institutions with and without a plan to be HRPP accredited by MFDS were 20 (37.7%) each. 34 institutions (52.3%) answered HRPP evaluation method and accreditation by MFDS was appropriate while 31 institutions (47.7%) answered otherwise. 36 institutions answered that HRPP evaluation and accreditation by MFDS was credible while 29 institutions (44.5%) answered that HRPP evaluation method and accreditation by MFDS was not credible. Conclusion: 1. MFDS's HRPP accreditation program can facilitate the main objective of HRPP and MFDS's HRPP accreditation program should be encouraged to non-tertiary hospitals by taking small staff size into consideration and issuing accreditation by segregating accreditation. 2. While issuing Institution for the education of persons conducting clinical trial status as a benefit of MFDS's HRPP accreditation program, it can also hinder access to MFDS's HRPP accreditation program. It should also be considered that the non-contact culture during COVID-19 pandemic eliminated time and space limitation for education. 3. For clinical research conducted internally by an institution, internal audit is the most effective and sole method of protecting safety and right of the test subjects and integrity for research in Korea. For this reason, regardless of the size of the institution, an internal audit should be enforced. 4. It is necessary for KAIRB and MFDSto improve HRPP awareness by advocating and educating the concept and necessity of HRPP in clinical research. 5. A new HRPP accreditation system should be setup for all clinical research with human subjects, including Investigational New Drug (IND) application in near future.

• 동의생리병리학회지
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• 제22권6호
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• pp.1611-1620
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• 2008

This clinical research was conducted to test patients with Atopic Dermatitis by external application with Hwangryeonhaedok-Tang in cosmetics. We gave scores to 31 patients who visited the Dept. of Oriental Medical Opthalmology & Otolaryngology & Dermatology of Semyung University Jecheon Oriental Medical Hospital from May 15th, 2008 to June 26th. Fifteen patients were treated with the ointment that contain Hwangryeonhaedok-Tang (experimental group) and sixteen patients were treated with normal ointment that doesn't have Hwangryeonhaedok-Tang (control group) for 4 weeks. We observed change of total IgE, eosinophil count, Skin Temperature, Transepidermal Water Loss(TEWL), Skin Hydration and Skin pH. Also Clinical Index of Atopic Dermatitis(SCORAD Index) and global assesment of efficacy were used to evaluate the effects of Hwangryeonhaedok-Tang. Statistical analysis was performed by using frequency analysis and descriptive analysis. Statistical significance was achieved if the probability was less than 5%(p<0.05). After 4 weeks of external application treatment, SCORAD Index in experimental group was significant statistically decreased compared with control group. After 4 weeks of external application treatment, total IgE of both groups were decreased and eosinophil count in control group was decreased but experimental group was unstatistically decreased. Unstatistically, both groups didn't showed significant effect on Skin Temperature. Transepidermal Water Loss(TEWL) in both groups were increased but experimental group was significant decreased compared with control group. Skin Hydration in experimental group was significant statistically increased compared with control group. Statistically, both groups didn't showed significant effect on Skin pH. Only experimental group showed little increase. After 4 weeks of external application treatment, experimental group showed significant effect on global assesment of efficacy. Considering the above results, we can speculate that cosmetics with Hwangryeonhaedok-Tang has some therapeutical effects in mitigating the symptoms of Atopic Dermatitis.

• 대한임상독성학회지
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• 제11권1호
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• pp.9-18
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• 2013

Purpose: Antidotes for toxicological emergencies can be life-saving. However, there is no nationwide stocking and delivery system for emergency antidotes in Korea. We report on a two-year experience of a nationwide stocking and delivery trial for emergency antidotes at emergency departments in Korea. Methods: An expert panel of clinical toxicologists reviewed and made a list of 15 stocked antidote. These antidotes were purchased or imported from other countries and delivered from 14 antidote stocking hospitals nationwide 24 hours per day, seven days per week. Results: From August 1, 2011 to April 30, 2013, 177 patients with acute poisoning, with a median age of 48.5 years, were administered emergency antidotes. The causes of poisoning were intentional in 52.0% and 88.0% were intentional as a suicide attempt. Regarding clinical severity, using the poisoning severity score, 40.7% of patients had severe to fatal poisoning and 39.0% had moderate poisoning according to clinical severity. The most frequent presenting symptom was neurologic deficit, such as altered mentality (62.7%). alerted mentality (62.7%). Emergency antidotes were administered as follows: methylene blue (49 cases), flumazenil (31), N-acetylcysteine (25), glucagon (17), 100% ethanol (15), cyanide antidote kit (12), anti-venin immunoglobulin (5), pyridoxine (4), hydroxocobalamine (2), and deferoxamine (1). The median time interval from antidote request to delivery at the patient's bedside was 95 minutes (interquartile range 58.8-125.8). Conclusion: Findings of this study demonstrated the possibility of successful operation of the nationwide system of emergency antidotes stocking and delivery in Korea.

• Clinical and Experimental Reproductive Medicine
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• 제19권2호
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• pp.169-174
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• 1992

Previous studies have indicated that immunological factor is responsible for the infertility. We have detected sperm antibodies in ZIFT patients which grouped as fertilization failure (A; n=18) and low fertilization rate (${\leq}50%$)(B; n=20). Patients, however, had normal oocytes and sperms. We collected serum from wives and semen from husbands and donors (fertile sperm), if it was needed. We examined class, binding patterns and amounts of antisperm antibodies(ASA) by direct and indirect immunobead binding assay. In group A, 11 husbands were ASA positive showing 62.2% and 61.1% binding with IgA and IgG, respectively, and two wives were ASA positive showing 70.0% and 71.0% binding with IgA and IgG, respectively. Binding sites were mainly at the head of sperms (84%). In group B, 8 husbands were ASA positive showing 37.5% and 40.0% binding with IgA and IgG, respectively, and two wives were ASA positive showing 41.3% and 42.0% binding with IgA and IgG, respectively. Binding sites were also mainly at the head of sperms (78%). For the treatment of ZIFT patients who had fertilization failure at the first trial, we used albumin fractionation method and dilution method with 30% fetal cord serum (FCS) to reduce the titer of ASA. We used partial zona dissection (P.Z.D.) method for wives who have antisperm antibodies in their serum. According to represented method, we could inhance the fertilization rate to 60.0% by albumin fractionation and 20.0% by P.Z.D., respectively. We concluded that the use of micromanipulation like P.Z.D. or the other sperm processing methods is required to increase a chance of fertilization. This result suggested that it should be a prerequisite to test antisperm antibodies prior to entering assisted reproductive technologies (ART) programs.

• 정신신체의학
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• 제13권2호
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• pp.85-94
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• 2005

연구목적 : 본 전향적 개방형 연구는 섬망에 대한 quetiapine과 haloperidol의 효과와 안전성을 평가하기 위하여 시행되었다. 방법: DSM-lV에 의하여 섬망으로 진단된 40명(quetiapine군 19 : haloperidol군 21)을 대상으로 순차적으로 quetiapine과 haloperidol을 투여하였다. 약물의 1차적 효과를 평가하기 위하여 한국판 섬망 평가 척도를 매일 일주일간 시행하고, 약물에 의한 2차적 효과와 안전성을 평가하기 위해 전반적 임상 인상-심각도, 한국판 간이정신상태검사, 약물에 의한 추체외로 증상 평가 척도를 각각 연구 시작시와 7일째에 시행하였다. 자료의 수집은 2004년 11월부터 2005넌 6월까지 이루어졌다. 결과: 연구 기간 동안 두 군 모두 한국판 섬망 평가 척도의 점수가 유의하게 감소하였으며, 두 군간의 평균 척도점수는 유의한 차이가 없었다. 두 약물에 대한 치료 반응율에서도 유의한 차이가 없었다. 연구 기간 동안 임상적으로 심각하거나 위험한 부작용은 관찰되지 않았다. 결론: 본 연구 결과 섬망의 치료에 있어서 quetiapine은 haloperidol과 대등한 효과와 안전성을 보였다. 기존의 연구에서 haloperidol은 장기 복용시 운동성 부작용을 유발할 가능성이 크다고 알려져 있으므로, 그러한 부작용이 적다고 알려진 quetiapine이 장기간 지속될 수 있는 섬망의 치료에 있어 haloperidol을 대체할 수 있을 것으로 기대된다.

• The Korean Journal of Pain
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• 제34권1호
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• pp.106-113
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• 2021

Background: We aimed to investigate the analgesic efficacy of an erector spinae plane block (ESPB) in immediate breast reconstruction (IBR) with a tissue expander. Methods: Adult women undergoing IBR with a tissue expander after mastectomy were randomly assigned to either intravenous patient-controlled analgesia (IV-PCA) alone (group P) or IV-PCA plus ESPB (group E). The primary outcome was the total amount of opioid consumption during 24 hours postoperatively between the two groups. Secondary outcomes were patient satisfaction, pain score at rest and on shoulder movement using numerical rating scale, incidences of postoperative nausea and vomiting (PONV), and a short form of the brief pain inventory (BPI-SF) at 3 and 6 months after surgery between the groups. Results: Fifty eight patients completed the study. At 24 hours postoperatively, total opioid consumption was significantly less in group E than in group P (285.0 ± 92.0, 95% confidence interval [CI]: 250.1 to 320.0 vs. 223.2 ± 83.4, 95% CI: 191.5 to 254.9, P = 0.005). Intraoperative and cumulative PCA fentanyl consumption at 3, 6, 9, and 24 hours were also less in group E than in group P (P = 0.004, P = 0.048, P = 0.020, P = 0.036, and P < 0.001, respectively). Patient satisfaction was higher in group E (6.9 ± 1.8 vs. 7.8 ± 1.4, P = 0.042). The incidences of PONV was similar. Conclusions: The ESPB decreased postoperative opioid consumption and increased patient satisfaction without significant complications after IBR with a tissue expander after mastectomy.

• 동의신경정신과학회지
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• 제31권1호
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• pp.1-12
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• 2020

Objectives: The purpose of this study was to evaluate the reliability and validity of the instrument on pattern identification for insomnia (PIT-Insomnia) and verify the correlation between PIT-Insomnia and psychological tests. Methods: Two evaluators examined the pattern identification of the participants who met insomnia disorder diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorder, Fifth Edition (DSM-5) and took the Insomnia Severity Index (ISI) score over 15 once manually and twice using the PIT-Insomnia to measure the inter-rater and test-retest reliability. We also conducted the following surveys: the Pittsburgh Sleep Quality Index (PSQI), the Korean version of Beck's depression inventory (K-BDI), the Korean version of the State-Trait Anxiety Inventory (STAI-K), the Korean Symptom checklist-95 (KSCL-95), and the EuroQol-5 dimension (EQ-5D), to measure concurrent validity and correlation between the PTI-Insomnia and psychological tests. Results: 1. The test-retest reliability analysis of the pattern identification results showed moderate agreement, and test-retest reliability analysis of each pattern identification score showed agreements from poor to moderate. 2. The inter-rater reliability analysis of the pattern identification results via manual showed slight agreement, when analysis was performed with calibration, the inter-rater reliability analysis of the pattern identification results via manual showed fair agreement. 3. The concordance analysis between results via manual and the PIT-Insomnia showed poor agreement, when the analysis was performed with calibration, concordance analysis showed fair agreement. 4. The concordance analysis between the PIT-Insomnia and the PSQI showed positive linear correlation. 5. The concordance analysis between the PIT-Insomnia and the PSQI, K-BDI, STAI-K, KSCL-95, and EQ-5D showed that non-interaction between the heart and kidney have positive linear correlation with the K-BDI, anxiety item of KSCL-95, dual deficiency of the heart-spleen have positive linear correlation with somatization item of KSCL-95, paranoia item of KSCL-95, heart deficiency with timidity have positive linear correlation with stress vulnerability item of KSCL-95, parania item of KSCL-95, phlegm-fire harassing the heart have positive linear correlation with K-BDI, paranoia item of KSCL-95, depressed liver qi transforming into fire have positive linear correlation with the anxiety item of KSCL-95, parania item of KSCL-95, all pattern identification have negative linear correlation with EQ-5D. Conclusions: The PIT-Insomnia has moderate agreement of reliability and reflects the severity of insomnia since it has some concurrent validity with the PSQI. There are some correlations between the PTI-Insomnia with specific psychological tests, so we could suggest it can be used appropriately in the clinical situation.

• Archives of Plastic Surgery
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• 제44권6호
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• pp.482-489
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• 2017

Background Polydeoxyribonucleotide (PDRN) is known to have anti-inflammatory and angiogenic effects and to accelerate wound healing. The aim of this study was to investigate whether PDRN could improve peripheral tissue oxygenation and angiogenesis in diabetic foot ulcers. Methods This was a prospective randomized controlled clinical trial. Twenty patients with a non-healing diabetic foot ulcer were randomly distributed into a control group (n=10) and a PDRN group (n=10). Initial surgical debridement and secondary surgical procedures such as a split-thickness skin graft, primary closure, or local flap were performed. Between the initial surgical debridement and secondary surgical procedures, 0.9% normal saline (3 mL) or PDRN was injected for 2 weeks by the intramuscular (1 ampule, 3 mL, 5.625 mg, 5 days per week) and perilesional routes (1 ampule, 3 mL, 5.625 mg, 2 days per week). Transcutaneous oxygen tension ($TcPO_2$) was evaluated using the Periflux System 5000 with $TcPO_2/CO_2$ unit 5040 before the injections and on days 1, 3, 7, 14, and 28 after the start of the injections. A pathologic review (hematoxylin and eosin stain) of the debrided specimens was conducted by a pathologist, and vessel density (average number of vessels per visual field) was calculated. Results Compared with the control group, the PDRN-treated group showed improvements in peripheral tissue oxygenation on day 7 (P<0.01), day 14 (P<0.001), and day 28 (P<0.001). The pathologic review of the specimens from the PDRN group showed increased angiogenesis and improved inflammation compared with the control group. No statistically significant difference was found between the control group and the PDRN group in terms of vessel density (P=0.094). Complete healing was achieved in every patient. Conclusions In this study, PDRN improved peripheral tissue oxygenation. Moreover, PDRN is thought to be effective in improving inflammation and angiogenesis in diabetic foot ulcers.

• Childhood Kidney Diseases
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• 제18권1호
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• pp.18-23
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• 2014

목적: 소아 신장 이식 환자에서 흔히 사용되는 면역 억제제 타크롤리무스는 성별, 연령별, 인종별로 다양한 약동학적 특성이 있음이 알려져 있다. 본 연구는 우리나라 소아신장 이식 환자가 가지는 타크롤리무스의 약동학적 특징을 파악하고 관련되는 인자를 알아보기 위해 시행되었다. 방법: 경북대병원 소아청소년과에서 신장 이식을 시행받고 초기 면역 억제치료로 타크롤리무스가 사용된 환자 9명을 대상으로, 사용된 약 용량과 혈중 최저 농도 등을 후향적으로 조사하였고 이들의 약동학적 특성을 성인 대조군과 비교하였다. 결과: 남아의 평균 약 용량은 여아에 비해 유의하게 높았으나 혈중 최저 농도는 두 군 간에 유의한 차이가 없었고 청소율 또한 남아에서 유의하게 높았다. 12세 이상의 평균 약 용량은 12세 미만에 비해 낮았고 혈중 최저 농도는 높은 경향을 보였으나 유의한 차이는 없었다. 성인은 12세 이상, 미만 모두의 경우 보다 유의하게 약 용량이 적었으나 혈중 최저 농도에서는 유의한 차이가 없었다. 또한, 청소율와 반감기에서도 모두 유의한 차이를 보였다. 결론: 소아 신장 이식에서 사용되는 타크롤리무스는 나이가 어릴수록, 남아의 경우에 좀 더 많은 용량을 투여해야 할 가능성이 있음을 확인할 수 있었다. 우리나라 소아 신장 이식 환자에서 타크롤리무스의 적절한 치료용량을 확인하기 위해서는 이상의 관련인자에 대한 추가적인 전향적인 연구가 필요하다고 사료 된다.