• Journal of the Korean Academy of Child and Adolescent Psychiatry
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• v.16 no.2
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• pp.279-285
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• 2005

Objectives : This study was performed to evaluate the efficacy and safety of MPH-OROS and parental satisfaction for treatment of children with ADHD Method : The 569 participants were clinically diagnosed for ADHD using DSM-IV criteria. We switched current medication to MPH-OROS or introduced MPH-OROS for treatment of ADHD. We assessed the clinical global impression severity of illness (CGI-S), the clinical global impression severity of improvement(CGI-I). And the parents of participants measured the Korean version of Conners rating scale at baseline, the 1 st week and the 3rd week after MPH-OROS trial. At the 3rd week, the parents measured the parent satisfaction questionnaire. Results : $13\%$ of participants dropped out because of several causes including side effects. The change of CGI-S was significantly decreased. Using CGI-I, the improvement was $72.3\%$ at the 1st week and $87.4\%$ at the 3rd week. The total score of the Korean version of Conners parent rating scale was significantly decreased. The participants complaining one or more of side effects were 119$(20.7\%)$, and the most common side effect was anorexia. The $94\%$ of parents replied that they were overall satisfied with MPH-OROS trial. Also the advantages of MPH-OROS of parental report were the long duration of the drug, the improvement of schoolwork and attitude, the improvement of home behavior and homework and the improvement of overactivity. Conclusion : MPH-OROS is effective and well-tolerated in actual clinical use for ADHD.

• The Journal of KAIRB
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• v.2 no.2
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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.

• Journal of Physiology & Pathology in Korean Medicine
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• v.22 no.6
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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.

• Journal of The Korean Society of Clinical Toxicology
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• v.11 no.1
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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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• v.19 no.2
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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.

• Korean Journal of Psychosomatic Medicine
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• v.13 no.2
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• pp.85-94
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• 2005

Objectives: This prospective and open-label study was conducted to evaluate the efficacy and safety of quetiapine and haloperidol in patients with delirium. Methods : Fourty patients(19 patients in a quetiapine group : 21 patients in a haloperidol group) with delirium by DSM-IV were treated with flexible doses of open-label qvetiapine and haloperidol. To evaluate the primary efficacy of the medication, scores from the Korean version of Delirium Rating Scale(K-DRS) were assessed every seven days and to evaluate the secondary efficacy and safety, scores from the Clinical Global Impression-Severity, Korean Version of Mini-Mental State Examination, and the Drug-Induced Extrapyramidal Symptoms Scale were assessed at the baseline and the seventh day. Data were gathered from November 2004 to June 2005. Results : K-DRS scores for each group decreased significantly over the study period; however, no significant differences between groups were found. The group-by-time effect was not significant. In addition, there was no significant difference in the frequency of response to drugs between the two groups. No patients reported clinically significant side effects. Conclusion : These data show no significant difference in the efficacy and safety between quetiapine and haloperidol in the treatment of delirium. Since haloperidol has a great possibility of causing a extrapyramidal side effect resulted by previous studies, it is expected that quetiapine, a renowned medication with low side effects, may be a useful alternative agent to haloperidol, the classical antipsy-chotics, in the treatment of delirium.

• The Korean Journal of Pain
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• v.34 no.1
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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.

• Journal of Oriental Neuropsychiatry
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• v.31 no.1
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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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• v.44 no.6
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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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• v.18 no.1
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• pp.18-23
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• 2014

Purpose: The pharmacokinetics of tacrolimus, one of the most widely used immunosuppressive drugs, are known to vary by sex, age, and ethnicity during pediatric transplantation. This study assessed the pharmacokinetic characteristics and associated factors of tacrolimus in Korean children receiving a kidney transplant. Methods: We retrospectively reviewed the pharmacokinetic data (therapeutic dose, trough level, clearance, and half-life) of 9 children who were given tacrolimus as one of their initial immunosuppressive drugs after kidney transplantation. In addition, we compared the findings to data from 10 adult kidney transplant recipients. Results: The mean age of our pediatric patients was 13.9 years, and the maleto- female ratio was 4:5. The mean dose of tacrolimus was $0.19{\pm}0.14$ mg/kg/day. The mean dose of tacrolimus for males was $0.23{\pm}0.12$ mg/kg/day, which was significantly higher than the dose for females ($0.16{\pm}0.14$ mg/kg/day). The trough level was not significantly different between both groups. The clearance rate of tacrolimus for males was also significantly higher than females. Although the dosage of tacrolimus for patients over the age of 12 years was lower ($0.18{\pm}0.13$ vs. $0.21{\pm}0.16$ mg/kg/day) and the trough level was higher ($8.2{\pm}4.5$ vs. $7.2{\pm}4.2$ mg/mL) than that for patients under the age of 12 years, there was no significant difference between them. However, there were significant differences between children and adults in dose, clearance, and half-life of tacrolimus. Conclusion: Out study suggests that the pharmacokinetics of tacrolimus tends to vary with sex and age. Therefore, large-scale prospective studies are required to verify the proper therapeutic dosage of tacrolimus in Korean children.