• Journal of Acupuncture Research
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• v.37 no.2
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• pp.102-109
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• 2020

Background: Due to the aging population in Korea, knee osteoarthritis (KOA) has become an increasingly common condition. Many patients with KOA prefer analgesics, herbal medicines, acupuncture, or exercise, rather than arthroscopic surgery or a knee replacement. Gyebutang (GB) granules are a herbal extract widely used to treat KOA in traditional Korean medicine, but there is insufficient evidence of its efficacy and safety. Methods: A multicenter, randomized, assessor-blinded, 2-armed parallel, controlled clinical trial has been designed to investigate the efficacy and safety of GB combined with acupuncture for the treatment of KOA. There will be 100 patients with KOA enrolled in the study from 3 traditional Korean medicine hospitals. The participants will be randomly allocated to an experimental group (GB and acupuncture) or a control group (celecoxib and acupuncture) in a 1:1 ratio. Both groups will receive acupuncture treatment once a week for 6 weeks; one group will receive GB and the other will receive celecoxib for the same duration. Results: The primary outcome will be the change of knee osteoarthritic pain, based on scores on a 100 mm visual analog scale. The secondary outcomes will be scores on a numeric rating scale, the Western Ontario and McMaster Universities osteoarthritis index, patient global assessment, European quality of life 5-dimension 5-level scale, and adverse events. Conclusion: The results of this study will provide evidence of efficacy and safety of GB as a treatment for patients with KOA.

• Korean Journal of Clinical Pharmacy
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• v.22 no.3
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• pp.211-219
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• 2012

Nonsteroidal antiinflammatory drugs (NSAIDs) are used in the treatment of extensive diseases related to various symptoms; inflammation, pain and fever. NSAIDs work by blocking prostaglandin synthesis, but adverse drug events (ADEs) have been increasing dramatically such as gastrointestinal bleeding, perforation and stenosis, a kind of serious ADEs. Therefore, NSAID-related ulcer complication guidelines have been announced containing various risk factors and symptoms. Thus, this study aims to evaluate of NSAID usage and appropriateness for prevention of NSAID-related ulcer complication based on American journal of gastroenterology (AJG) guideline 2009. Further, the study suggests Korean guideline for prevention of NSAID-related ulcer compared to AJG guideline. For this study, data was collected through electronic medical record (EMR) at Seoul national university of Bundang hospital. The primary end point was a composite of NSAID-related ulcer risk factor, types of NSAIDs, co-prescribed NSAID ulcer prevention drugs and NSAID-related ulcer after taking NSAID. The risk factors include over 65 years, high dose NSAID, previous ulcer history and taking drugs (e.g. aspirin, anticoagulant and steroid) causing ulcer. If a patient has 3 or 4 factors, that patient was classified high risk group. And if 1 or 2 factors that patient was classified moderate risk group. The patient who has no risk factor was in low risk group. I studied 8,120 patients who received NSAID from 1 January 2009 to 31 December 2009. High risk group was 16(0.2%), moderate risk group was 4,364(53.7%), and low risk group was 3,740(46.1%). The results show that high risk group should be prescribed COX-2 inhibitors with ulcer prevention drugs, and moderate or low risk group need traditional NSAIDs with ulcer prevention drugs. This may be different with 2009 AJG guideline because AJG guideline suggested taking COX-2 inhibitor alone in moderate group or taking traditional NSAID alone in low risk group could get higher ulcer complication. The results indicated that choosing preventive drug is important in case that how many risk factors the patients have. The proper drugs would be helpful for safe and effective NSAID usage in each patient group.

• Journal of the Korean Association of Oral and Maxillofacial Surgeons
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• v.30 no.2
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• pp.143-149
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• 2004

Background: Some clinical trials have reported that a new analgesic combination of tramadol and acetaminophen provides good efficacy in various pain models. For the more clinical uses of this agent, comparisons about the onset of analgesia and analgesic efficacy in the acute state of pain with the other drugs known as strong analgesics were needed. Purpose: The goal of this study was to compare the times to onset of analgesia and the other analgesic efficacy of 75 mg tramadol/650 mg acetaminophen and 20 mg codeine/500 mg acetaminophen/400 mg ibuprofen in the treatment of acute pain after oral surgery. Patients and Methods: Using a randomized, single-dose, parallel-group, single-center, and active-controlled test design, this clinical study compared the times to onset of analgesia using a two-stopwatch technique and the other analgesic efficacy of the single-dose tramadol/acetaminophen and codeine/acetaminophen/ibuprofen. These were assessed in 128 healthy subjects with pain from oral surgical procedures involving extraction of one or more impacted third molars requiring bone removal. From the time of pain development, the times to onset of perceptible and meaningful pain relief, pain intensity, pain relief, an overall assessment, and adverse events of the study medications were recorded for 6 hours. Results: The demographic distribution and baseline pain data in the two groups were statistically similar. The median times to onset of perceptible pain relief were 21.0 and 24.4 minutes in the tramadol/acetaminophen and codeine/acetaminophen/ibuprofen groups respectively and those to onset of meaningful pain relief were 56.4 and 57.3 minutes, which were statistically similar. The other efficacy variables such as mean total pain relief (TOTPAR) and the sum of pain intensity differences (SPID) were also similar in the early period after pain development and drug dosing. The safety of tramadol/acetaminophen was well tolerated and very comparable to that of codeine/acetaminophen/ibuprofen. Conclusions: In this acute dental pain model, the onset of analgesia and analgesic efficacy of tramadol/acetaminophen was comparable to that of codeine/acetaminophen/ibuprofen. These results showed that tramadol/acetaminophen was recommendable for fast and effective treatment in the management of postoperative acute pain.

• Journal of Gastric Cancer
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• v.18 no.2
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• pp.118-133
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• 2018

Purpose: Exercise intervention after surgery has been found to improve physical fitness and quality of life (QOL). The purpose of this study was to investigate the feasibility and effects of a postoperative recovery exercise program developed specifically for gastric cancer patients (PREP-GC) undergoing minimally invasive gastrectomy. Materials and Methods: Twenty-four patients treated surgically for early gastric cancer were enrolled in the PREP-GC. The exercise program comprised sessions of In-hospital Exercise (1 week), Home Exercise (1 week), and Fitness Improvement Exercise (8 weeks). Adherence and compliance to PREP-GC were evaluated. In addition, body composition, physical fitness, and QOL were assessed during the preoperative period, after the postoperative recovery (2 weeks after surgery), and upon completing the PREP-GC (10 weeks after surgery). Results: Of the 24 enrolled patients, 20 completed the study without any adverse events related to the PREP-GC. Adherence and compliance rates to the Fitness Improvement Exercise were 79.4% and 99.4%, respectively. Upon completing the PREP-GC, patients also exhibited restored cardiopulmonary function and muscular strength, with improved muscular endurance and flexibility (P<0.05). Compared to those in the preoperative period, no differences were found in symptom scale scores measured using the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) and Quality of Life Questionnaire-Stomach Cancer-Specific Module (QLQ-STO22); however, higher scores for global health status and emotional functioning were observed after completing the PREP-GC (P<0.05). Conclusions: In gastric cancer patients undergoing minimally invasive gastrectomy, PREP-GC was found to be feasible and safe, with high adherence and compliance. Although randomized studies evaluating the benefits of exercise intervention during postoperative recovery are needed, surgeons should encourage patients to participate in systematic exercise intervention programs in the early postoperative period (Registered at the ClinicalTrials.gov, NCT01751880).

• Tuberculosis and Respiratory Diseases
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• v.73 no.6
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• pp.303-311
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• 2012

Background: This study was designed to analyze the efficacy of gefitinib as a second-line therapy, according to the clinical characteristics in Korean patients with non-small-cell lung cancer (NSCLC). Methods: In this Phase IV observational study, we recruited patients, previously failed first-line chemotherapy, who had locally advanced or metastatic NSCLC, and who were found to be either epidermal growth factor receptor (EGFR) mutation-positive or satisfied 2 or more of the 3 characteristics: adenocarcinoma, female, and non-smoker. These patients were administered with gefitinib 250 mg/day, orally. The primary endpoints were to evaluate the objective response rate (ORR) and to determine the relationship of ORRs, depending on each patient's characteristics of modified intent-to-treat population. Results: A total of 138 patients participated in this study. One subject achieved complete response, and 42 subjects achieved partial response (ORR, 31.2%). The subgroup analysis demonstrated that the ORR was significantly higher in patients with EGFR mutation-positive, compared to that of EGFR mutation-negative (45.8% vs. 14.0%, p=0.0004). In a secondary efficacy variable, the median progression-free survival (PFS) was 5.7 months (95% confidence interval, 3.9~8.4 months) and the 6-month PFS and overall survival were 49.6% and 87.9%, respectively. The most common reported adverse events were rash (34.4%), diarrhea (26.6%), pruritus (17.5%), and cough (15.6%). Conclusion: Gefitinib was observed in anti-tumor activity with favorable tolerability profile as a second-line therapy in these selected patients. When looking at EGFR mutation status, EGFR mutation-positive showed strong association with gefitinib by greater response and prolonged PFS, compared with that of EGFR mutation-negative.

• Tuberculosis and Respiratory Diseases
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• v.73 no.3
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• pp.151-161
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• 2012

Background: Adequate assessment and control of sedation play crucial roles in the proper performance of mechanical ventilation. Methods: A total of 30 patients with various pulmonary diseases were prospectively enrolled. The study population was randomized into two groups. The sedation assessment group (SAG) received active protocol-based control of sedation, and in the empiric control group (ECG), the sedation levels were empirically adjusted. Subsequently, daily interruption of sedation (DIS) was conducted in the SAG. Results: In the SAG, the dose of midazolam was significantly reduced by control of sedation (day 1, $1.3{\pm}0.5{\mu}g/kg/min$; day 2, $0.9{\pm}0.4{\mu}g/kg/min$; p<0.01), and was significantly lower than the ECG on day 2 (p<0.01). Likewise, on day 2, sedation levels were significantly lower in the SAG than in the ECG. Significant relationship was found between Ramsay sedation scale and Richmond agitation-sedation scale (RASS; $r_s$=-0.57), Ramsay Sedation Scale and Bispectral Index (BIS; $r_s$=0.77), and RASS and BIS ($r_s$=-0.79). In 10 patients, who didn't require re-sedation after DIS, BIS showed the earliest and most significant changes among the sedation scales. Ventilatory parameters showed significant but less prominent changes, and hemodynamic parameters didn't show significant changes. No seriously adverse events ensued after the implementation of DIS. Conclusion: Active assessment and control of sedation significantly reduced the dosage of sedatives in patients receiving mechanical ventilation. DIS, conducted in limited cases, suggested its potential efficacy and tolerability.

• Korean Journal of Biological Psychiatry
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• v.20 no.1
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• pp.12-20
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• 2013

Objectives We investigated the tolerability, safety, and treatment response to flexible-dose paliperidone ER in patients with non-acute schizophrenia in whom previous antipsychotic drugs were ineffective. Methods This 24-week interim analysis of the 48-week multicenter, prospective, open-label study assessed effectiveness using the Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression-Schizophrenia-Severity (CGI-SCH-S) Scale, Personal and Social Performance (PSP) and Drug Attitude Inventory (DAI). Safety and tolerability were assessed using the Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) and Liverpool University Neuroleptic Side Effect Rating Scale (LUNSERS). Results Effectiveness was assessed in 169 patients. Significant improvement in the PANSS total score was observed by week-1 and continued until week-24. The response rate was 33%. The CGI-SCH-S and PSP total scores significantly improved during 24 weeks ; however, no change occurred in the total DAI. Fifty-nine percent of patients reported adverse events, of which extrapyramidal symptoms were the most frequent (19.0%). The DIEPSS and LUNSERS scores were improved after 24 week. Conclusions Switching to the flexible-dose paliperidone ER from an ineffective antipsychotic drug was safe, tolerable, and showed a good treatment response in Korean patients with schizophrenia.

• The Journal of Internal Korean Medicine
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• v.37 no.1
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• pp.90-108
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• 2016

Objectives: This study aimed to learn what should be considered in the Guidelines of Clinical Trials with Herbal Medicinal Products for Gastroesophageal Reflux Disease (GERD) by analyzing the existing guidelines and clinical trials.Methods: The development committee searched the existing guidelines for herbal medicinal products or GERD. Then, clinical trials related to GERD using herbal medicine were selected. The chosen trials were analyzed in terms of their inclusion and exclusion of participants, intervention, comparators, outcome, and trial design. Then, we compared the results of the analysis according to the regulations and guidelines of the Ministry of Food and Drug Safety to suggest the issues that we will have to consider when developing the Guidelines of Clinical Trials with Herbal Medicinal Products for Gastroesophageal Reflux Disease (GERD).Results: As a result, few guidelines for GERD and clinical trials with herbal medicinal products were located in the national institution homepage. In addition, 8 articles were found using the following combination of search terms: “Gastroesophageal reflux disease”, “GERD”, “herbal medicine”, “herbal therapy”, “Korean Medicine”, “Traditional Chinese Medicine”, and “TCM”. Even though all trials had their own unique research questions, all studies were performed using a randomization method. Most trials included participants with reflux esophagitis, but two trials targeted proton pump inhibitor-refractory GERD. The type of intervention varied, such as decoction, granules, and capsules. Additionally, individualized herbal medicines were used in two studies. Comparators were diverse, such as placebo, Western medicine, and electro-acupuncture. The most frequently used outcome for efficacy was the effectiveness rate. In addition, the outcome for evaluating quality of life, esophageal mucosa and pressure, esophageal acid reflux, and recurrence rates were used. Safety was investigated by recording adverse events and carrying out laboratory tests.Conclusions: We identified some issues by reviewing the existing guidelines and comparing them with clinical trials for GERD and herbal medicinal products. These results will be utilized for developing the Guidelines of Clinical Trials with Herbal Medicinal Products for Gastroesophageal Reflux Disease (GERD).

• Journal of Life Science
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• v.30 no.6
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• pp.570-579
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• 2020

Pre-mRNA splicing is a crucial step for the expression of information encoded in eukaryotic genomes. Alternative splicing occurs when splice sites are differentially recognized and more than one transcript and potentially multiple proteins are generated from the same pre-mRNA. The decision on which splice sites are selected under particular cellular conditions is determined by the interaction of proteins, globally designated as splicing factors, that guide spliceosomal components, and thereby the spliceosome, to their respective splice sites. Abiotic stresses such as heat, cold, salt, drought, and hypoxia markedly alter alternative splicing patterns in plants, and these splicing events implement changes in gene expression for adaptive responses to adverse environments. Alteration of the expression or activity of splicing factors results in alternative splicing under cold, heat, salt, or drought conditions, and alternatively spliced isoforms respond distinctly in several aspects such as expression in different tissues or degradation via nonsense-mediated decay. Spliced isoforms may vary in their subcellular localization or have different biological functions under stress conditions. Despite numerous studies, functional analyses of alternative splicing have been limited to particular abiotic stresses; the molecular mechanism of alternative splicing in abiotic stress response remains uncovered which suggests that further studies are needed in this area.

• Asian Pacific Journal of Cancer Prevention
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• v.13 no.8
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• pp.4187-4190
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• 2012

Aims and Background: To evaluate the efficacy of a combination of aprepitant and conventional antiemetic therapy in patients with advanced or recurrent lung cancer receiving moderately emetogenic chemotherapy (MEC). Methods: Patients with advanced or recurrent lung cancer who were treated with MEC regimens at the Department of Respiratory Medicine, Fukuoka University Hospital, were included and classified into the following groups: control group (treatment: 5-HT3 receptor antagonists + dexamethasone) and aprepitant group (treatment: 5-HT3 receptor antagonists + dexamethasone + aprepitant). The presence or absence of chemotherapy-induced nausea and vomiting (CINV) was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.0; patients with grade 1 or above were considered positive for CINV. Food intake per day, completion of planned chemotherapy, and progression-free survival (PFS) achieved by chemotherapy were investigated. Results: The complete suppression rate of nausea in the aprepitant group was significantly higher than that in the control group (p = 0.0043). Throughout the study, the food intake in the aprepitant group was greater than that in the control group, with the rate being significantly higher, in particular, on day 5 (p = 0.003). The completion rate of planned chemotherapy was also higher in the aprepitant group (p = 0.042). PFS did not differ significantly, but tended to be improved in the aprepitant group. Conclusions: The aprepitant group showed significantly higher complete suppression of nausea, food intake on day 5, and completion of planned chemotherapy than the control group.