Loxoprofen sodium, a 2-phenylpropionate non-steroidal anti-inflammatory drug (NSAID), has marked analgesic and antipyretic activities and relatively weak gastrointestinal ulcerogenicity. The purpose of the present study was to evaluate the bioequivalence of two loxoprofen sodium tablets, Hana loxoprofen sodium tablet (Hana Pharm. Co., Ltd.) and Dongwha Loxonin$^{(R)}$ tablet (Dongwha Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The in vitro release of loxoprofen from the two loxoprofen sodium formulations was tested using KP IX Apparatus II method with various dissolution media. Twenty four healthy Korean male volunteers, $22.83{\pm}1.862$ years in age and $69.92{\pm}9.14$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ crossover study was employed. After a single tablet containing 60 mg as loxoprofen sodium was orally administered, blood samples were taken at predetermined time intervals and the concentrations of loxoprofen in serum were determined using a online column-switching HPLC method with UV/Vis detection. The dissolution profiles of two formulations were similar in all tested dissolution media. The pharmacokinetic parameters such as $AUC^t$, $C_{max}$ and $T_{max}$ were calculated, and computer programs (Equiv Test and K-BE Test 2002) were utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and un-transformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, Dongwha Loxonin$^{(R)}$ tablet, were 2.03, 2.99 and -9.49% for $AUC_t$, $C_{max}$, and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log0.8 to log1.25 (e.g., log0.9831~log1.0535 and log0.9455~log1.1386 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Hana loxoprofen sodium tablet was bioequivalent to Dongwha Loxonin$^{(R)}$ tablet.
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).
Objectives We investigated the effectiveness and safety when treated in schizophrenics with paliperidone palmitate, a long acting injectable antipsychotic. Methods This was a 24-week open-label study, performed at one center in Korea. The eligible patients with schizophrenia diagnosed by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria were enrolled. Patients received long-acting paliperidone palmitate injection (234 mg, baseline; 156 mg, week 1 ; then once 4 weeks flexible dosing). Effectiveness assessments were measured by the Positive and Negative Syndrome Scale (PANSS), The Clinical Global Impression Severity Scale (CGI-S), The Personal and Social Performance (PSP) at baseline, week 1, every 4 weeks untill 24 weeks or endpoint. Safety assessments were measured by The Extrapyramidal Symptom Rating Scale (ESRS), body weight (BW) and incidence of adverse events. Oral antipsychotics were stopped or tapered off within next 14 days. Results Of 20 patients recruited, 9 patients (45%) completed the study. Paliperidone palmitate produced a significant improvement in PANSS total score from baseline to endpoint. The response rate was 75% [mean change (${\pm}SD$) $-25.9{\pm}14.4$, all p < 0.001]. The CGI-S and PSP total scores significantly improved during 24 weeks (All p < 0.001). Eighty percent of patients reported adverse events and most common adverse events (${\geq}10%$) in paliperidone palmitate were anticholinergic adverse event, extrapyramidal symptoms, weight gain, akathisia, insomnia, headache, agitation, anxiety and GI trouble. ESRS score is not statistically significant, but tends to get better at the end of the study when compared to baseline. Conclusions Our study results demonstrated maintained effectiveness and safety of paliperidone palmitate treatment in schizophrenics. And provides both clinicians and patients with a new choice of treatment that can improve the outcome of long term therapy. Their potential effectiveness and safety should be better addressed by future randomized-controlled trials.
Journal of Physiology & Pathology in Korean Medicine
/
v.21
no.4
/
pp.1034-1038
/
2007
To examine the difference of health-related quality of life (QoL) of obese patients between before and after treatment of Korean traditional medicine. This study was assessed in 18 obese-women (age 29.72${\pm}$7.38) treated by acupuncture and herbal medicine using SF-36 quality of life questionnaire between January and July 2006, a 36 item instrument yielding 8 dimensions (Social functioning, Role limitation-Physical, Role limitation-Emotion, Mental health, Vitality, Bodily pain, and General health) and a total score. Their weight was measured by Inbody 3.0 (Biospace co. Korea). QoL and body composition was assessed twice at baseline (B) and 4 weeks after treatment. Auricular acupuncture and electrical needle stimulation to abdomen, thigh, and arm fat was used twice a week and complex herb formula was prescribed according to their constitution and symptoms for 4 weeks. Herb medication was taken 2 times a day. Respective variables were analyzed with Wilcoxon signed ranks test and the level set for statistical significance was p <0.05. The mean of the body weight (P=0.000;B64,68${\pm}$6.86, 4 WKs 60.47${\pm}$5.69), fat percentage (P=0.000;B33.14${\pm}$4.86, 4 WKs 30.16${\pm}$5.34), body mass index (P=0.000;B25.18${\pm}$2.44, 4 WKs 23.46${\pm}$2.09) and fat weight (P=0.000;B21.66${\pm}$5.06, 4 WKs 18.41${\pm}$4.57) of some obese patients decreased significantly between before and after treatment for 4 weeks. Physical functioning (P=0.48;B27.06${\pm}$3.17, 4 WKs 28.00${\pm}$1.71), Mental health (P=0.01 ;B18.83${\pm}$5.25, 4 WKs 22.00${\pm}$3.73), Vitality (P=0.028;B13.89${\pm}$3.03, 4 WKs 15.44${\pm}$2.53), Bodily pain (P=.0014;B8.84${\pm}$1.75, 4 WKs 10.15${\pm}$1.78), and the total scores (P=0.001;B104.99${\pm}$12.60, 4 WKs 114.58${\pm}$11.11) of SF-36 were increased significantly after treatments. These data show some differences in QoL and BMI between before and after treatment on obesity and suggest that the treatment with acupuncture and herbal medicine have a positive impact on several domains of QoL of some obese patients. Further randomized clinical trials (RCTs) including follow-up are needed to examine whether acupuncture and herb medicine have a positive effect on QoL of treatment group compared with control group.
Objectives : Acute low back pain syndrome causes pain and poor quality of life. There are various studies of SBV (Sweet bee venom) pharmacopuncture, but few have identified the therapeutic effects for patients unable to walk due to acute back pain. This case series report three cases of acute low back pain syndrome treated with SBV pharmacopuncture combined with Korean Medicine (KM) treatments. Methods : Three acute low back pain syndrome patients with no other acute abnormalities in the imaging were treated by KM treatments including SBV pharmacopuncture, acupuncture, cupping, herbal medicine and physical therapy. The improvement of symptoms was evaluated using Numerical rating scale (NRS), Oswestry disability Index (ODI), EuroQol-5 dimension index (EQ-5D) and EuroQol-visual analogue scale (EQ-VAS). Results : Patients who were unable to walk due to acute back pain were able to walk. There were significant improvements of NRS, ODI, EQ-5D and EQ-VAS after treatment. The patients experienced an average 90% decrease in low back pain after inpatient KM treatment for about 8 days. NRS decreased by an average of 78.9%, ODI decreased by an average of 49.4%, and EQ-VAS increased by an average of 92.6%. In the case 1, EQ-5D decreased in all categories, but in the case 2, it decreased in all categories except for pain/discomfort and anxiety/depression, but in the case 3, it decreased in all categories except anxiety/depression. There was no serious side effect after treatment of SBV pharmacopuncture. Conclusions : KM treatments including SBV pharmacopuncture may be effective for acute low back pain syndrome patients. However, randomized controlled trials are needed in the future to confirm the clinical effects of these interventions.
Objective : This systematic review aimed to investigate the impact of transcranial direct current stimulation combined with constraint-induced movement therapy (CIMT) in patients with stroke Methods : PubMed and NDSL databases were employed to review literature published between January 2009 and December 2018. The main search terms were "Transcranial direct current stimulation" or "tDCS," "Constraint-induced movement therapy" or "CIMT," "Upper extremity function," "Upper limb," and "Stroke." Based on the inclusion and exclusion criteria, 6 articles were selected. Furthermore, intervention effects on upper extremity function, activities of daily living, and cortical activity were assessed. Results : The current intensity, application time, and protocol of the CIMT varied the between studies. However, the intervention procedures to perform CIMT immediately after transcranial direct current stimulation was the same. Transcranial direct current stimulation combined with CIMT was effective in improving upper limb function and activities of daily living in patients with stoke and had a significant effect on cerebral cortex activation. Conclusions : This study provides information on transcranial direct current stimulation combined with CIMT for use by clinical therapists. Further studies are needed to standardize the stimulation time, current intensity, and electrode attachment position. Furthermore, randomized controlled trials, including long-term follow up, are needed for larger populations using the most appropriate CIMT protocol.
Objectives: The purpose of this study is to analyse the domestic trends of Traditional Korean Medicine on Hot flush in menopausal women. Methods: We searched six databases and selected relevant papers according to the criteria. Results: 12 papers included case report, literature review, randomized controlled clinical trials (RCTs), Non-RCTs, and retrospective chart analysis study design. 1. The daily diary, Kupperman's Index, Menopause Rating Scale, Menopause-specific Quality of Life Questionnaire, Digital Infrared Thermographic Imaging were used as a measure of the symptoms of hot flush. 2. There were significant correlations between Thermographic images, Pulse energy, Lifestyle Habits, Low frequency power/High frequency power (LF/HF) ratio and certain items of Menopausal Symptoms Measurement. 3. The case report using Er-Xian decoction and Hwangryunhaedoktang-Gamibang showed significant effect. 4. Domestic RCT studies using herbal or acupuncture treatments showed a significant value of 3.4 on average in the quality assessment conducted in the study. However, the number of domestic studies included was five, which is not enough compared to foreign countries. Conclusions: This study examined domestic research trends on hot flushes of menopausal women and found that various evaluation tools and diagnostic methods were applied. It is necessary to conduct various RCT studies in Korea, where the number of studies is insufficient compared to overseas.
Purpose: We aimed to explore whether the prognosis of patients treated with capecitabine and oxaliplatin (XELOX) or S-1 and oxaliplatin (SOX) regimens who received fewer cycles of chemotherapy after D2 radical resection for gastric cancer (GC) would be non-inferior to that of patients who received the standard number of cycles of chemotherapy. Materials and Methods: Data on patients who received XELOX or SOX chemotherapy after undergoing D2 radical resection at Harbin Medical University Cancer Hospital between January 2011 and May 2016 were collected. Results: In patients who received 4, 6, and 8 cycles of chemotherapy, the 5-year overall survival (OS) rates were 59.4%, 64.8%, and 62.7%, respectively. Compared to patients who received 4 cycles of chemotherapy, those who received 6 cycles (hazard ratio [HR], 0.882; 95% confidence interval [CI], 0.599-1.299; P=0.52) or 8 cycles (HR, 0.882; 95% CI, 0.533-1.458; P=0.62) of chemotherapy did not exhibit significantly prolonged OS. The 3-year disease-free survival (DFS) rate of patients who received 4, 6, and 8 cycles of chemotherapy was 62.1%, 67.2%, and 60.8%, respectively. Compared to patients who received 4 cycles of chemotherapy, those who received 6 cycles (HR, 0.835; 95% CI, 0.572-1.221; P=0.35) or 8 cycles (HR, 0.972; 95% CI, 0.606-1.558; P=0.91) of chemotherapy did not show significantly prolonged DFS. However, the 3-year DFS and 5-year OS rates of patients who received 6 cycles of chemotherapy appeared to be superior to those of patients who received 4 and 8 cycles of chemotherapy. Conclusions: For patients with stage III GC, 4 to 6 cycles of XELOX or SOX chemotherapy may be a favorable option. This study provides a rationale for further randomized clinical trials.
We performed a comprehensive meta-analysis on whether Helicobacter pylori (H. pylori) eradication can prevent gastric cancer in individuals with precancerous lesions (chronic atrophic gastritis, intestinal metaplasia, and dysplasia). The studies evaluating the effect of H. pylori eradication on gastric cancer were searched from PubMed, KoreaMed, EMBASE, and Cochrane Library. Subgroup analyses by precancerous lesions, regions and follow-up time were performed. Six randomized clinical trials were included. In the overall population, H. pylori eradication significantly decreased the risk of gastric cancer (risk ratio [RR]=0.56; 95% confidence interval [CI]: 0.41-0.77, p<0.01). Eradication therapy significantly reduced the risk of gastric cancer in Asian and group who followed up more than 10 years (RR=0.51; 95% CI: 0.35-0.73, p<0.01; I2=0%, p=0.46). However, subgroup analysis according to the precancerous lesions did not show any significant results (p>0.05). In the general population especially in Asian population, H. pylori eradication can reduce the risk of gastric cancer. The effect of the eradication treatment is remarkable upon the long-term follow-up. In contrast, there is insufficient evidence whether the eradication should be recommended for the individuals with precancerous lesions.
Burning mouth syndrome (BMS) is a chronic oral disorder of unknown etiology which presents therapeutic challenges. Alpha-lipoic acid (ALA) has been studied as a potential treatment for BMS. The objective of this systematic review and meta-analysis was to evaluate the effectiveness of ALA compared to that of placebo or other interventions in individuals with BMS. Randomized controlled trials (RCT) using ALA to treat BMS were identified from MEDLINE, Cochrane Library, EMBASE, and Web of Science up to February 3, 2021. The assessment of the risk of bias in the included studies was based on the Cochrane guidelines. The primary outcome evaluated was the visual analog scale (VAS) pain intensity. ALA was compared with placebo, clonazepam, gabapentin, pregabalin, ALA plus gabapentin, capsaicin, Biotène®, and laser therapy. Altogether, 137 records were scanned for inclusion/exclusion, and nine RCTs (two unclear and seven at high risk of bias) were included in the qualitative and quantitative analyses, with a total of 594 patients with BMS included in this review. All studies reported an improvement in VAS pain scores ranging from -0.72 to -2.77. Meta-analysis results showed a non-significant reduction in pain intensity for ALA (P = 0.616) compared to that of placebo on a VAS of 0-10. Patients taking ALA were 1.923 times more likely to show an improvement in self-reported BMS symptoms (P = 0.031) than those in the placebo group. Clonazepam and pregabalin showed a significant VAS pain reduction of 4.08 and 4.68 (P < 0.001), respectively, compared to that with ALA. Although ALA intervention provided a non-significant improvement in the pain score and was more likely to produce a reduction in BMS symptoms, the evidence was of low quality. Further research is needed to establish clear guidelines for the use of ALA for BMS treatment.
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