• Journal of Korean Clinical Nursing Research
• /
• v.19 no.1
• /
• pp.152-167
• /
• 2013

Purpose: The purpose of this study was to develop a website-based patient safety culture promotion program that could be implemented by nurses in real work scenarios. Methods: This study was a methodological study. A patient safety culture promotion program, called 'Safe Culture, Save Patients' was developed, based on structuration theory and performance engineering approaches. Results: This program was delivered in the form of a website containing contents about changes in the work environment, information about accidents and the improvement process details, as well as a program for motivation. The program was tested about the validity on contents and usability - a panel of 14 experts confirmed its validity using the contents validity index (CVI), with a resulting S-CVI of .980. Usability was evaluated by 11 nurses, which allowed finalize the program. Conclusion: The 'Safe Culture, Save Patients' program was a valid program that could be applied in clinical practice immediately. The results of this study warrant further studies to evaluate the effects of this patient safety culture promotion program.

• The Korea Journal of Herbology
• /
• v.33 no.4
• /
• pp.53-58
• /
• 2018

Objectives : Kaempferia parviflora Rhizome is black ginger indigenous to Laos and Thailand. It has been used as a folk medicine to improve blood flow and promote vitality and longevity with good health and well being. For these reasons, Kaempferia parviflora Rhizome has been focused on developing it as a food or food supplement. In addition, Kaempferia parviflora Rhizome could be under consideration of new prescription based on its characteristic compounds, polymethoxyflavonoids. However, it needs to be certified as safe before it can be used. Here, a single-oral toxicity test and safety classification was carried out to identity acute information of the toxicity of Kaempferia parviflora Rhizome powder and to make sure of its safety in clinical applications. Methods : Test substance was orally administered to male and female SD-rat at dose levels of 5000 mg/kg to estimate approximate lethal dose(ALD). Based on the acute information of the toxicity, the safety classification was estimated using the HED(human equivalent dose)-based MOS(margin of safety). Results : At 14 days after treatment with test substance. there were no of test substance related with mortalities and clinical signs. In addition, no changes in the body or organ weights and no gross or histopathological findings were observed. Thus, the ALD of Kaempferia parviflora Rhizome powder was considered over 5,000 mg/kg in both female and male mice. Conclusions : Based on the single oral toxicity test using the highest and limit dose, 5,000 mg/kg and the decision guideline for safety classification based on HED-based MOS, it was estimated that Kaempferia parviflora Rhizome powder is classified as "Specified class B" indicating that clinical dose is not limited to patients as safe as food.

• Journal of Korean Clinical Nursing Research
• /
• v.27 no.2
• /
• pp.210-219
• /
• 2021

Purpose: The study was conducted to investigate the correlation between perception of patient safety risk factors, patient safety competency, and safety nursing activities of nurses in hemodialysis units and identify factors affecting patient safety activities. Methods: The participants were 146 nurses from 16 hemodialysis units located in Gyeongsangnam-do. Data were analyzed using descriptive statistics, independent t-test, one-way ANOVA, Pearson correlation coefficient, and multiple regression analysis using the SPSS, version 24.0. Results: The mean safety nursing activity score was 3.47±0.38. safety nursing activities of the participants were significantly correlated with patient safety competency. The characteristics showing significant differences in safety nursing activities were educational level, hospital type, hospital work experience, number of hemodialysis treatment per day, number of hemodialysis treatment per nurse, educational experience of patient safety, presence of a patient safety incident report registration system, and direct registration of patient safety incident report. The multiple regression analysis revealed that the factors influencing safety nursing activities were patient safety incident report, patient safety competency, and number of daily hemodialysis treatment (<5~7 times/day) per nurse (R²=.34). Conclusion: The results of this study suggest that the safety nursing activities of hemodialysis unit nurses should be intensified. In addition, the registration system of patient safety incident report and nurses' competency on patient safety should be improved, and the number of hemodialysis per nurse should be fewer than 7 times per day.

• Journal of Korean Medicine Rehabilitation
• /
• v.27 no.1
• /
• pp.53-65
• /
• 2017

Objectives The purpose of this study is to evaluate the safety of Non-toxic bee venom (BV) and observe VAS change before and after Non-toxic BV treatment in pain patients. Methods We surveyed the clinical practitioners who treated with Non-toxic BV in pain patients who visited the Korean medical clinic. The questionnaire survey was conducted for clinical practitioners who agreed to participate after hearing the explanation for the purpose and characteristics of the questionnaire. Patients in the questionnaires were reviewed based on their medical records from July 1, 2016 to October 28, 2016. Results We received 445 cases and selected 403 cases finally. 2 cases, however, were not able to continue treatment for 3 weeks and were eliminated. Depending on when the pain occurred, we divided the 401 cases into three groups (Acute, Subacute, Chronic group). In all groups, VAS scores were significantly decreased after treatment. Adverse reactions following Non-toxic BV treatment had occurred was 16 cases (3.60%). Except for 3 cases with hives, most of adverse reactions were mild or moderate and were not in need of extra treatment. The total safety of treatment for 3 weeks was mostly safe. The number of cases discontinued treatment was 42 cases (9.44%). Most of these cases, treatment was stopped for personal reason unrelated to the Non-toxic BV treatment. Conclusions These results suggest that the Non-toxic BV treatment has no serious adverse reactions and is a relatively safe treatment. Further studies are needed to prove the efficacy and clinical safety of Non-toxic BV treatment.

• Asian Pacific Journal of Cancer Prevention
• /
• v.17 no.9
• /
• pp.4327-4333
• /
• 2016

Purpose: To systematically review efficacyand safety of robotic gastrectomy (RG) compared with conventional laparoscopic gastrectomy (LG) for gastric carcinoma. Materials and Methods: A systematic literature search was carried out using PubMed, Cochrane Library, CBM, CNKI, WanFang, VIP and other sources like relevant references to obtain comparative studies assessing the effectiveness and safety between RG and LG published between 2013 and 2016. Then the literature was screened and the data were extracted by 2 independent reviewers. The quality of the literature was assessed, and the data analyzed using Stata/SE 14 software. Fixed effects or random effects models wereapplied according to heterogeneity. Results: A total of 12 non-randomized observational clinical studies involving 3,580 patients were included, of which 1,096 had undergone RG and 2,484 had received LG. The results of the meta-analysis showed in terms of effectiveness, RG was associated with less blood loss, less time to first flatus and greater number of harvested lymph nodes, but there were no significant differences in proximal and distal resection margins, compared with LG. In terms of efficiency, RG was associated with shorter hospital stay, but longer operative time. In terms of safety, there were no statistically significant differences in complications, mortality and conversions between RG and LG. Conclusions: RG can achieve comparable or better short-term and radical effects than LG, with respect to effectiveness, efficiency and safety in treatment of gastric carcinoma. Future studies involving RG should focus on decreasing operative time and reducing cost. Moreover, there is a need for randomized controlled trials comparing the two techniques with long-term follow-up.

• Herbal Formula Science
• /
• v.20 no.2
• /
• pp.55-63
• /
• 2012

Objectives : This study was conducted to investigate the safety of Bangpungtongsung-san in rats. Methods : The safety of this prescription on acute toxicity was evaluated by single dose toxicity study. Rats were orally administrated in a single dose of 0 and 2,000 mg/kg(limited dose) Bangpungtongsung-san. There were 7 rats in each groups. All animals were sacrificed after 14 days of treatment. After single administration, mortality, clinical signs, and body weight changes were observed for 14 days. Three parameters(autopsy finding, clinical chemistry, and hematology) were tested on the last day. Results : In this study with rats, Bangpungtongsung-san treatment did not show any acute toxicity. No mortality was noted for 14 days of treatment. There were no adverse effects on clinical signs, body weight changes, and autopsy finding at all treatment groups. The clinical chemistry parameters attesting to liver and kidney functions as well as the hematological parameters were within the normal ranges. Conclusions : It is considered that $LD_{50}$ of Bangpungtongsung-san is over 2,000 mg/kg in oral administration by rats. This finding of the safety of Bangpungtongsung-san is expected to strengthen the position of this prescription as nontoxic medicine.

• Asian Pacific Journal of Cancer Prevention
• /
• v.15 no.17
• /
• pp.7277-7280
• /
• 2014

This analysis was conducted to evaluate the efficacy and safety of carboplatin based chemotherapy in treating pediatric patients with Wilms tumors. Methods: Clinical studies evaluating the efficacy and safety of carboplatin based regimens on response and safety for pediatric patients with Wilms tumors were identified using a predefined search strategy. Pooled response rates (RRs) of treatment were calculated. Results: In carboplatin based regimens, 4 clinical studies which including 127 patients with advanced Wilms tumors were considered eligible for inclusion. With this carboplatin based chemotherapy, 2 clinical studies included carboplatin, ifosfamide and etoposide. Systemic analysis suggested that, in all patients, the pooled PR was 64.5% (82/127) in carboplatin based regimens. Thrombocytopenia and leukocytopenia were the main side effects. No grade III or IV renal or liver toxicity was observed. No treatment related death occurred with carboplatin based treatment. Conclusion: This systemic analysis suggests that carboplatine based regimens are associated with a reasonable response rate and accepted toxicities for treating pediatric patients with Wilms tumors.

• The Journal of Korean Medicine
• /
• v.30 no.3
• /
• pp.79-85
• /
• 2009

Aim : To evaluate the pharmaceutical safety of the herbal formula Myelophil, composed of Astragali Radix and Salviae Radix, via systemic subacute toxicological study using SD rats. Methods : Forty male and 40 female SD rats were fed with Myelophil (5000, 2500 or 1250 mg/10 mL/kg) or distilled water for four weeks. Adverse effects were examined intensively by comparing the differences between normal and drug-administered groups using clinical signs, necropsies, histopathologic findings, hematology, urinalysis, and blood biochemical analysis. Results : No altered clinical symptoms including body weight, diarrhea, anorexia, death, and abnormal necropsy of major organs were observed in male or female rats. No drug-induced abnormalities in histopathological finding, hematological values, urinalysis, and blood biochemical values were found at any doses of Myelophil. Conclusion : Myelophil should be very safe when used in a clinical application with a wide therapeutic index.

• Biomolecules & Therapeutics
• /
• v.17 no.1
• /
• pp.1-11
• /
• 2009

Since the Committee for Proprietary Medicinal Products (CPMP) of the European Union issued in 1997 a "points to consider" document for the assessment of the potential for QT interval prolongation by non-cardiovascular agents to predict drug-induced torsades de pointes (TdP), the QT liability has become the critical safety issue in the development of pharmaceuticals. As TdP is usually linked to delayed cardiac repolarization, international guideline (ICH S7B) has advocated the standard repolarization assays such as in vitro IKr (hERG current) and in vivo QT interval, or in vitro APD (as a follow up) as the best biomarkers for predicting the TdP risk. However, the recent increasing evidence suggests that the currently used above biomarkers and/or assays are not fully predictive for TdP, but also does not address potential new druginduced TdP due to the selective disruption of hERG protein trafficking to the cell membrane or VT and/or VF with QT shortening. There is, therefore, an urgent need for other surrogate markers or assays that can predict the proarrhythmic potential of drug candidate. In this review, we provide an ideal pre-clinical strategy to predict the potentials of QT liability and lethal arrhythmia of the drug candidates with recent issues in this field in mind, not at the expense of discarding therapeutically innovative drugs.

• The Journal of Korean Medicine
• /
• v.38 no.3
• /
• pp.170-184
• /
• 2017

Objectives: The objective of this study was to summarize randomized clinical trials (RCTs) that have assessed efficacy and safety of mahuang and ephedrine on treatment of obesity and to propose better process of study. Methods: NLM Medline (pubmed), the Cochrane library, Scopus, Science Direct, RISS, KISS were systemically searched for clinical trials investigating the efficacy, safety of mahuang and ephedrine on treatment of obesity from 2000 to 2017. Results: 16 RCTs met all the inclusion criteria. In most reports, mahuang and ephedrine significantly reduced body weight, body fat mass. There were no serious adverse events associated with mahuang and ephedrine in all studies. Conclusions: In appropriate dose of mahuang and ephedrine for healthy adult was safe, and weight loss effect of mahuang and ephedrine was better than control group. Improved clinical practice guidelines should be developed for safe use of mahuang and ephedrine.