• Title/Summary/Keyword: Clinical safety

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Recent Research Trends of Acupuncture Treatment for Recurrent Implantation Failure (RIF) Patients in In Vitro Fertilization (체외수정에서 반복 착상 실패(RIF) 환자 침치료 최근 연구 동향)

  • Se-Yeon Cho;Seung-Kyu Kim;Deok-Sang Hwang;Jin-Moo Lee;Jun-Bock Jang;Chang-Hoon Lee
    • The Journal of Korean Obstetrics and Gynecology
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    • v.37 no.2
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    • pp.120-134
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    • 2024
  • Objectives: This research aimed at investigating the trends of acupuncture treatment for Recurrent Implantation Failure (RIF) patients in IVF. Methods: Studies were searched from PubMed, Cochrane Library, EMBASE, CNKI up to April 2024. Terms as 'Implantation failure', 'Recurrent implantation failure', 'Repeated implantation failure', 'RIF' and 'Acupuncture', 'Electroacupuncture', 'Needling' were used. Results: Of 136 screened, 10 studies are selected and analyzed. Studies were conducted using manual acupuncture and electroacupuncture. The results showed that acupuncture (electroacupuncture) treatment for RIF patients is effective in improving clinical pregnancy rate, endometrial blood flow, uterus morphology, endometrium thickness. The most frequently used acupoints were 三陰交 (SP6) and 子宮 (EX-CA1). Conclusions: Included studies showed that acupuncture (electroacupuncture) might have effect on RIF. Further research and meta-analysis should be conducted to verify its therapeutic mechanisms and safety.

A Systematic Review on the Causative Medicines for Stevens-Johnson Syndrome (스티븐스-존슨증후군을 유발하는 주요 의약품별 위험도에 대한 체계적 문헌고찰)

  • Kwon, Kyoung-Eun;Jung, Sun-Young;Jung, Hyun-Joo;Kim, Bong Gi;Park, Byung-Joo
    • Korean Journal of Clinical Pharmacy
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    • v.23 no.4
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    • pp.344-364
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    • 2013
  • Background: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are immune-complex-mediated hypersensitivity reactions that predominantly involve skin and mucous membranes. Despite the low incidence, both are considered medical emergencies as the mortality rate has been estimated at 30-50%. Although as many as half of cases are idiopathic, several drugs have been implicated as main cause of SJS/TEN. This review therefore aimed to identify drugs that were potentially associated with SJS/TEN and compare the relative risk of the medications. Method: A comprehensive search was performed using MEDLINE, EMBASE and 5 Korean databases. We defined study drugs as non-steroidal anti-inflammatory drugs (NSAIDs), antibiotics, antiepileptics, and allopurinol. Only epidemiologic studies investigating associations between the above drugs and drug-induced SJS/TEN were included. Two reviewers independently selected and evaluated candidate papers and extracted odds ratios or incidence rates. Meta-analysis was performed only for drugs that were reported from 4 or more studies. Results: We found 8 case-control studies, 3 cohort studies and 1 RCT. The ranges of adjusted ORs were 0.6-34.0 for NSAIDs, 1.6-302.0 for antiepileptics, 0.3-10.0 for antibiotics and 1.0-187.0 for allopurinol. The drug with the highest incidence of SJS/TEN was carbamazepine (40 persons/1,000 DDD). Conclusion: Finally, the risk was highest in first 8 weeks after onset of treatment in all drugs.

Utilization, Safety, and Related Factors of Illegal Phosphodiesterase Type 5 Inhibitors in South Korean Men (국내 남성에서 포스포디에스테라제 5형 억제제 불법유통 사용현황, 안전성 및 관련 요인)

  • Kim, Bong Gi;Jung, Sun-Young;Kwon, Kyoung-Eun;Park, Byung-Joo
    • Korean Journal of Clinical Pharmacy
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    • v.25 no.1
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    • pp.50-55
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    • 2015
  • Background: Phosphodiesterase Type 5 Inhibitors (PDE5Is), which are prescription drug in South Korea, have been concerned about misuse, overuse and illegal provision of the drugs. This study was performed to investigate utilization and safety of illegal Phosphodiesterase Type 5 Inhibitors (PDE5Is), and related factors among South Korean men. Methods: A questionnaire survey was conducted from May to July in 2013 among 1,500 nationally representative general males using computer-assisted telephone interview (CATI). The questionnaire included the characteristics of population, the characteristics of PDE5Is use, the experience with the use of illegally obtained PDE5Is, and adverse events after PDE5Is use. Results: Among study population, the 1,015 (67.7%) men answered that they have used the illegally obtained PDE5Is. Younger age, single, lower frequency of PDE5Is use in a lifetime was associated with an increased use of illegally obtained PDE5Is. The men experienced adverse events after PDE5Is use is 528 (35.2%). The most common adverse event was mild to moderate hot flashes. Conclusion: We need to enhance awareness about the risk of illegally obtained PDE5Is use, especially in younger men and single. Proactive educations and public relations on safe use of PDE5Is for proper patients are needed.

Safety of Soshihotang Soft Extract after Single Oral Administration in Healthy Male Volunteers, Single Center Study (소시호탕연조엑스의 단회 경구투여 후 안전성 평가에 대한 단일기관 연구)

  • An, Sung-Hu;Park, Kyungtae;Yeom, Seung-Ryong;Kwon, Young-Dal;Cho, Hea-Young
    • Journal of Korean Medicine Rehabilitation
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    • v.30 no.2
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    • pp.153-164
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    • 2020
  • Objectives This study is designed to evaluate the safety of Soshihotang soft extract in healthy male volunteers. Methods 12 healthy male volunteers were recruited and this study was carried out by a single center. Laboratory test results, vital signs of the volunteers were collected to evaluate safety. According to registration order, the 12 subjects were allocated by serial number. To evaluate safety, blood samples were taken and vital signs were checked 4 times-screening, pre administration, post administration and follow up-during the whole trial. The incidence of all adverse effects are shown in percentage. The mean and standard deviation were used to to describe and summarize continuous data. To evalate the effectiveness of the intervention, data of blood tests was analyzed by Wilcoxon signed rank test or paired T-test (p<0.05). Results In the case of red blood cell, hemoglobin, hematocrit, neutrophils, protein, albumin, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, γ-glutamyl transpeptidase values, the normality test result of the variable for the difference value before and after the dosing has a significance level <0.05. But most of values did not deviate from the normal range, and the deviation from the normal range could not be regarded as the significance associated with this clinical trial. And adverse event wasn't observed associated with the clinical trial drug. Conclusions Soshihotang soft extract were considered to be safe for healthy male volunteers.

Acute and Subchronic Inhalation Toxicity of n-Octane in Rats

  • Sung, Jae-Hyuck;Choi, Byung-Gil;Kim, Hyeon-Yeong;Baek, Min-Won;Ryu, Hyun-Youl;Kim, Yong-Soon;Choi, Young-Kuk;Yu, Il-Je;Song, Kyung-Seuk
    • Safety and Health at Work
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    • v.1 no.2
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    • pp.192-200
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    • 2010
  • Objectives: We have investigated the toxic effects of the inhalation of subchronic and acute levels of n-octane. Methods: The rats were exposed to n-octane of 0, 2.34, 11.68 and 23.36 mg/L (n = 5 rats/group/gender) in an acute inhalation test (Organization for Economic Co-operation and Development (OECD) TG 403), or to 0, 0.93, 2.62 and 7.48 mg/L (n = 10 rats/group/gender) for a subchronic inhalation test (OECE TG 413), to establish a national chemical management system consistent with the Globally Harmonized Classification System (GHS). Results: Acutely-exposed rats became lethargic but recovered following discontinuation of inhalation. Other clinical symptoms such as change of body weight and autopsy finds were absent. The LC50 for the acute inhalation toxicity of n-octane was determined to exceed 23.36 mg/L and the GHS category was 'not grouping'. Subchronically-treated rats displayed no significant clinical and histopathological differences from untreated controls; also, target organs were affected hematologically, biochemically and pathologically. Therefore, the no observable adverse effect level was indicated as exceeding 7.48 mg/L and the GHS category was 'not grouping' for the specific target organ toxicity upon repeated exposure. Conclusion: However, n-octane exposure should be controlled to be below the American Conference of Industrial Hygienists recommendation (300 ppm) to prevent inhalation-related adverse health effects of workers.

Safety, efficacy, and onset of a novel botulinum toxin type A (Nabota) for the treatment of glabellar frown lines: a single-arm, prospective, phase 4 clinical study

  • Song, Sinyoung;Lee, Yeon Hoon;Hong, Joon Pio;Oh, Tae Suk
    • Archives of Craniofacial Surgery
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    • v.19 no.3
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    • pp.168-174
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    • 2018
  • Background: Safety, efficacy, and time to onset of effect of botulinum toxin type A is of importance to persons who seek improvement in glabellar frown lines, but this has not been well studied. The aim of this study was to determine the safety, efficacy, and onset of action of a newly developed botulinum toxin type A (Nabota) for the treatment of glabellar frown lines. Methods: This was a single-arm, open-label, and phase 4 clinical study. Forty-two subjects with glabellar lines were treated with five times of intramuscular injection of 0.1 mL (4 U/0.1 mL) for a total of 20 U of Nabota. Efficacy and safety were assessed at 2, 3, 4, 5, and 14 days. Efficacy was assessed by the investigator and it was defined as a 1-point change on a 4-point scale. Results: Improvement in glabellar frown lines at maximum frown was observed in 85.4% of subjects 2 days after administration. Improvement in glabellar lines at rest was observed in 51.2% of subjects 2 days after administration, and the proportion of subjects showing improvement increased with time. No severe adverse events were recorded. Conclusion: Onset of action was observed in the majority of subjects by 2 days after administration of Nabota. In addition, Nabota was found to be safe and effective for the treatment of glabellar frown lines.

Convergence Influences of Nurses' Professional Autonomy and Empathy on Patient Safety Culture (간호사의 전문직 자율성과 공감능력이 환자안전문화에 미치는 융복합적 영향)

  • Lee, Seong-Su;Choi, Hye-Ran
    • Journal of Digital Convergence
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    • v.17 no.2
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    • pp.231-241
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    • 2019
  • This study was a descriptive survey to identify influences of nurses' professional autonomy and empathy on patient safety culture. The participants were 191 nurses working at a general hospital in Seoul. The data were collected using structured questionnaires and analyzed using the SPSS/WIN 24.0 program. Patient safety culture had a significant correlation with nurses' professional autonomy (r=.26, p<.001) and the subscales of empathy, which were perspective-taking (r=.30, p<.001) and empathic concern (r=.27, p<.001). Factors influencing patient safety culture were perspective-taking (${\beta}=.27$, p<.001), professional autonomy (${\beta}=.20$, p=.004), and a total clinical career of over ten years (${\beta}=.17$, p=.012). The results of this study could be the basic data for the development of programs that enhance the professional autonomy and empathy of nurses. In addition, it is necessary to study repeatedly in various groups in the future.

Potential Probiotic Characteristics and Safety Assessment of Lactobacillus rhamnosus SKG34 Isolated from Sumbawa Mare's Milk

  • Sujaya, I Nengah;Suwardana, Gede Ngurah Rsi;Gotoh, Kazuyoshi;Sumardika, I Wayan;Nocianitri, Komang Ayu;Sriwidyani, Ni Putu;Putra, I Wayan Gede Artawan Eka;Sakaguchi, Masakiyo;Fatmawati, Ni Nengah Dwi
    • Microbiology and Biotechnology Letters
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    • v.50 no.1
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    • pp.51-62
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    • 2022
  • Lactobacillus rhamnosus SKG34 (LrSKG34), a potential probiotic strain, was successfully isolated from Sumbawa Mare's milk. Our previous studies showed that the strain is resistant to gastrointestinal conditions, possesses antioxidant activity, and lowers blood cholesterol levels. Further clarification of the potential probiotic characteristics and safety assessment are necessary. This study aimed to evaluate the adhesion of LrSKG34 to Caco-2 cell monolayers and its effect on mucosal integrity in vitro. We also examined the LrSKG34 safety profile based on antimicrobial susceptibility testing, haemolytic activity determination, Caco-2 cell monolayer translocation evaluation, and in vivo investigation of the effect of LrSKG34 on the physiology, biochemical markers, and histopathological appearance of major organs in an animal model. LrSKG34 attached to Caco-2 cell monolayers and maintained mucosal integrity in vitro. The typical resistance of lactobacilli to ciprofloxacin, gentamicin, vancomycin, trimethoprim-sulfamethoxazole, and metronidazole was confirmed for LrSKG34. No haemolytic activity was observed on blood agar plates, and no LrSKG34 translocation was observed in Caco-2 cell monolayers. Administration of LrSKG34 to Sprague-Dawley rats did not adversely affect body weight. No abnormalities in hematological parameters, serum biochemistry levels, or histopathological structures of major organs were observed in LrSKG34-treated rats. Collectively, the results implicate LrSKG34 as a promising and potentially safe probiotic candidate for further development.

Factors Affecting Fall-Prevention Behavior of Long-Term Care Nurses (요양병원 간호사의 낙상예방행위에 미치는 영향요인)

  • Choi, Ju Youn;Lee, Ga Eon;Jun, Hye Jung
    • Korean Journal of Occupational Health Nursing
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    • v.31 no.4
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    • pp.157-166
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    • 2022
  • Purpose: The purpose of this study was to identify factors influencing fall-prevention behaviors of nurses working in long-term care hospitals. Methods: Participants included 147 nurses working in 10 long-term care hospitals in B city. Data were collected from September 20-October 12, 2016. SPSS/WIN 21.0 was used for analysis with t-test, ANOVA, Scheffé test, Pearson correlation coefficients, and multiple regression. Results: It was found that attitude toward fall (r=.29, p<.001) and patient safety culture (r=.25, p=.002) had a significant positive correlation with fall-prevention behaviors of nurses working in long-term care hospitals. The factors influencing fall-prevention behaviors in participants were clinical career and patient safety culture (β=.21, p=.012), contributing to 19% of the total variance in fall- prevention behaviors. Conclusion: The findings showed that systematic delivery of differentiated fall prevention education is preferred to nurse's clinical career as a private factor to improve fall-prevention behaviors of nurses in long term care hospital. Particularly, it is imperative to conduct periodical and practical fall-prevention education for nurses to prevent career discontinuity. An independent report system and open communication system as well as a scheme that can disseminate patient safety culture in individual departments to implement patient direct nursing are required to encourage patient safety culture in organizations.

Safety of Palmultang Soft Extract after Single Oral Administration in Healthy Male Volunteers, Single Center Study (팔물탕연조엑스의 단회 경구 투여 안전성 평가에 관한 연구)

  • Yeong-jin Jeong;Su-Hak Kim;Ji-Sung Lim;Young-Dal Kwon
    • Journal of Korean Medicine Rehabilitation
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    • v.33 no.1
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    • pp.77-85
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    • 2023
  • Objectives This study is designed to evaluate the safety of palmul-tang soft extract in healthy male volunteers. Methods Twelve healthy male volunteers were recruited. And this study was conducted in a single center. As a result of the laboratory test, the safety was evaluated by collecting vital signs of volunteers. Twelve subjects were assigned by serial number according to the registration order. For safety evaluation, blood samples were collected and vital signs were checked four times throughout the test period, including screening, pre-administration, post-administration (after 48 hours) and post-administration (after 7 days). The difference in variables was summarized as the mean±standard deviation. The normality was performed using Kolmogorov-Smirnov and Shapiro-Wilk test. If normality is satisfied, a paired t-test is applied. Otherwise, the Wilcoxon sign rank test, which is a nonparametric method, is applied. The significance was p<0.05. The incidence of all side effects is expressed as a percentage. Results In the case of red blood cell, hemoglobin, and hematocrit values, the result of normality test of variables for the difference value before and after administration is significant level p<0.05. However, all laboratory test values before and after administration did not deviate from the normal range. Also the deviations in the normal range could not be seen as significance related to this clinical trial. And no side effects related to clinical trial drugs were observed. Conclusions The soft extract of palmul-tang was considered safe for healthy male volunteers.