• Title/Summary/Keyword: Adverse events

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Comparison of Radial Artery and Saphenous Vein Composite Y Grafts during Off-pump Coronary Artery Bypass

  • Wi, Jin-Hong;Joo, Hyun-Chel;Youn, Young-Nam;Song, Suk-Won;Kim, Tae Hoon;Yoo, Kyung-Jong
    • Journal of Chest Surgery
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    • 제46권4호
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    • pp.265-273
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    • 2013
  • Background: The safety and efficacy of arterial composite grafts for total arterial revascularization have been demonstrated. The saphenous vein (SV) is a widely used graft because of its accessibility, sufficient length, and ease of manipulation. Our aim was to compare mid-term outcomes of saphenous vein Y-grafts with radial artery Y-grafts joined by anastomosis to the left internal thoracic artery. Materials and Methods: Records of off-pump coronary artery bypass grafting with composite Y-grafts based on the left internal thoracic artery technique in 552 patients were analyzed retrospectively. After propensity score matching, 79 radial arterial (RA) composite grafts (RA group) and 79 saphenous vein composite grafts (SV group) were compared. The duration of mean follow-up was $24.6{\pm}14.6$ months (range, 1 to 55 months). Results: There were no differences in surgical mortality, all-cause mortality, or morbidity among the groups. Rates of 4-year survival were 91.7% and 96.3% in the RA and SV groups, respectively (p=0.519). The coronary reintervention-free survival rate and freedom from major adverse cardiovascular or cerebrovascular events were similar in the two groups (p=0.685, p=0.564). Conclusion: Construction of composite Y-grafts using the radial artery or saphenous vein showed similar mid-term results. Long-term follow-up and randomized trials will be needed to confirm our present conclusions.

External Application of Herbal Medicines for Acne Vulgaris: A Systematic Review and Meta Analysis

  • Sung, Soo-Hyun;Choi, Gwang-Ho;Lee, Nam-Woo;Shin, Byung-Cheul
    • 대한약침학회지
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    • 제23권1호
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    • pp.8-17
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    • 2020
  • Aim of the study: The objective of this systematic review is to critically evaluate the evidence of the effectiveness and safety of external application of herbal medicines (EAHM) for acne vurgalis (AV). Methods: English, Chinese and Korean language databases were searched up to May 2018. Randomized clinical trials (RCTs) that reported the effects of EAHM for AV were included and analysed. Results: A total of 10 randomized trials with 656 AV patients were identified. A meta-analysis of two RCTs indicated that EAHM had a significant effect on improving primary outcome 'global assessment' compared with placebo (mean difference (MD) = -2.62, confidence interval (CI) = -4.84 to -0.40, p = 0.02). Furthermore, data extracted from two RCTs showed that EAHM significantly reduce primary outcome 'inflammatory lesion count of acne' (MD = -1.25, CI = -1.68 to -0.83, p < 0.00001) and 'non-inflammatory lesion count of acne' (MD = -1.32, CI = -1.75 to -0.90, p < 0.00001). No significant difference was observed between groups in secondary outcome 'sebum of skin' (MD = -0.21, CI = -0.53 to 0.11, p = 0.20) and 'patient-reported changes in symptom' (relative risk (RR) = 2.56, CI = 0.43 to 15.22, p = 0.30). No severe adverse events (AEs) were found and no treatment was stopped due to AEs of EAHM. Conclusions: EAHM seems to have affirmative effects, but quality of evidence, and non-standardized use of EAHM make our conclusion weak. Our suggestion is rigorously designed RCTs and standardization of EAHM are required in the future.

NF-κB 조절을 통한 오매추출물의 항염효과 및 작용기작에 관한 연구 (Study on the Anti-inflammatory Effect and Mechanism of Prunus mume Extract Regarding NF-κB)

  • 서원상;오한나;박우정;엄상용;이대우;강상모
    • KSBB Journal
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    • 제29권1호
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    • pp.50-57
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    • 2014
  • NF-${\kappa}B$ is a transcriptional factor which is involved in many biological processes including immunity, inflammation, and cell survival. Many investigators studied on the mechanism involved in activation of NF-${\kappa}B$ signalling pathway via ubiquitination and degradation of $I{\kappa}B$ regarding skin disease. Some specific molecules including Akt, MEK, p38 MAP Kinase, Stat3, et al. represent convergence points and key regulatory proteins in signaling pathways controlling cellular events such as growth and differentiation, energy homeostasis, and the response to stress and inflammation. Ultraviolet (UV) irradiation has many adverse effects on skin, including inflammation, alteration in the extracellular matrix, cellular senescence, apoptosis and skin cancer. Prunus mume, a naturally derived plant extract, has beneficial biological activities as blood fluidity improvement, anti-fatigue action, antioxidative and free radical scavenging activities, inhibiting the motility of Helicobacter pyolri. Previous reports on various beneficial function prompted us to investigate UVB-induced or other immunostimulated biological marker regarding P. mume extract. P. mume extract suppresses UVB-induced cyclooxygenase-2 (COX-2) expression in mouse skin epidermal JB6 P+ cells. The activation of activator protein-1 and nuclear factor-${\kappa}B$ induced by UVB was dose-dependently inhibited by P. mume extract treatment. This results suggest that P. mume extracts might be used as a potential agents for protection of inflammation or UVB induced skin damage.

Complications associated with intravenous midazolam and fentanyl sedation in patients undergoing minor oral surgery

  • Saiso, Krittika;Adnonla, Pornnarin;Munsil, Jitpisut;Apipan, Benjamas;Rummasak, Duangdee;Wongsirichat, Natthamet
    • Journal of Dental Anesthesia and Pain Medicine
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    • 제17권3호
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    • pp.199-204
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    • 2017
  • Background: Anxiety control remains an important concern in dental practice. We evaluated the incidence, nature, and sequelae of complications during and after minor oral surgeries performed under intravenous midazolam and fentanyl sedation using the titration technique. Method: The medical records of patients who had undergone minor oral surgeries under moderate intravenous midazolam and fentanyl sedation at our institution between January 1, 2015 and December 31, 2015 were retrospectively evaluated. Age, sex, body mass index, medical history, American Society of Anesthesiologists (ASA) classification, indications for sedation, amount of sedative used, surgical duration, and recovery time were evaluated for all patients. Results: In total, 107 patients aged 9-84 years were included. ASA class I and class II were observed for 56.1% and 43.9% patients, respectively. Complications associated with sedation occurred in 11 (10.2%) patients. There were no serious adverse events. Oxygen saturation reached 95% during the procedure in six patients; this was successfully managed by stimulating the patients to take a deep breath. Two patients exhibited deep sedation and one exhibited paradoxical excitement. After the procedure, one patient experienced nausea without vomiting and one exhibited a prolonged recovery time. The surgical procedures were completed in all patients. Obesity was found to be significantly associated with sedation-related complications. Conclusion: Our results suggest that complications associated with intravenous midazolam and fentanyl sedation using the titration technique for minor oral surgeries are mostly minor and can be successfully managed with no prolonged sequelae.

Ginseng for Reducing the Blood Pressure in Patients with Hypertension: A Systematic Review and Meta-Analysis

  • Hur, Myung-Haeng;Lee, Myeong-Soo;Yang, Hye-Jeong;Kim, Chan;Bae, Ik-Lyul;Ernst, Edzard
    • Journal of Ginseng Research
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    • 제34권4호
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    • pp.342-347
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    • 2010
  • Ginseng is one of the most-widely used herbal remedies. This systematic review evaluates the current evidence for its use in the reducing blood pressure (BP) in patients with hypertension. Systematic searches of 12 electronic databases were conducted without language restrictions. All randomized clinical trials (RCTs) of ginseng as a treatment for hypertension were candidates for inclusion. Methodological quality was assessed using the Cochrane risk of bias. Five RCTs met the inclusion criteria. The risk of bias was low in most of the trials. Four of the included RCTs compared the effectiveness of ginseng to placebo. The meta-analysis of these data failed to show a statistically significant acute effect on systolic BP (SBP) or diastolic BP (DBP). However, subgroup analyses showed beneficial effects of Korean red ginseng (KRG) on both SBP (n=54, mean difference [MD], -6.52; 95% confidence interval [CI], -9.99 to -3.04; p=0.0002) and DBP (n=54, MD, -5.21; 95% CI, -7.90 to -2.51; p=0.0001). Two RCTs tested the long-term effects of ginseng for BP for 24hours. One of these trials failed to show any benefits of KRG compared to no treatment, and the other failed to show superior effects of North American ginseng compared to placebo. Adverse events with ginseng were none in one trial or not assessed. Collectively, these RCTs provide limited evidence for the acute effectiveness of KRG in the treatment of high BP. The total number of RCTs included in the analysis and the total sample size were insufficient to draw definitive conclusions. More rigorous studies are warranted.

갈근강황추출물의 갱년기 증상 개선에 대한 유효성 및 안전성 평가 (Efficacy and Safety of Extract Obtained from Pueraria thunbergiana Bentham and Curcuma longa L. on the Improvement of the Menopausal Symptoms)

  • 안하영;허다희;김용재;차민석;이동녕;김형준
    • 대한한방부인과학회지
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    • 제33권4호
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    • pp.75-92
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    • 2020
  • Objectives: This clinical trial is performed to investigate the effect of improving the menopausal symptoms and the safety of extract obtained from Pueraria thunbergiana Bentham and Curcuma longa L. in menopausal women Methods: This study was randomized, double blinded, placebo-controlled clinical trial. 110 women with menopausal symptoms were assigned to treatment group (n=55) and control group (n=55). The results of this study were evaluated through changes in Kupperman Index score, Menopause-specific Quality of Life Questionnaire (MENQOL) score, degree of hot flashes and sweating, Body Mass Index(BMI), laboratory test results including female hormones. Results: In the treatment group compared to before baseline, there was significant difference in the Kupperman Index total score, score of each item in the Kupperman Index, MENQOL total score, hot flush and sweating visual analogue scale (VAS), hot flush score, and hot flush duration at one time. However, there was also a significant change compared to baseline in the control group, there was no significant difference between the treatment group and the control group. There was no significant change in female hormone levels in both group, and there were no adverse events associated with the clinical trial product. Conclusions: This clinical trial showed that extract obtained from Pueraria thunbergiana Bentham and Curcuma longa L. was helpful in improving menopausal symptoms in menopausal women without significant side effects.

위암 한약제제 임상시험 가이드라인 개발을 위한 한약제제 무작위배정 대조군 임상시험 고찰 (Analysis of Existing Guidelines and Randomized, Controlled, Clinical Trials for Development of [Guideline of Clinical Trial with Herbal Medicinal Product for gastric cancer])

  • 한가진;성신;김성수;김진성;박재우
    • 대한한의학회지
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    • 제38권3호
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    • pp.124-142
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    • 2017
  • Objectives: This study aimed to learn what should be considered in [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer)] by analyzing the existing guidelines and clinical trials. Methods: The development committee searched guidelines for herbal medicinal product or gastric cancer developed already. Then, clinical trials for gastric cancer using herbal medicine were searched. The searched trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparator, outcomes and trial design. Then, we compared the results of analysis with the regulations and guidelines of Ministry of Food and Drug Safety to suggest the issue that we will have to consider when making the [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer]. Results: As a result, few guidelines for anti-tumor agent and clinical trial with herbal medicinal product were searched in the national institution homepage. In addition, 10 articles were searched by using the combination following search term; 'stomach neoplasm', 'herbal medicine', 'Medicine, Korean traditional', 'Medicine, Chinese Traditional', 'TCM', 'TKM', 'trial'. Most trials included gastric cancer participants with medical history of operation. The type of intervention was various such as decoction, granules, and fluid of intravenous injection. Comparators were diverse such as placebo, conventional treatment including chemotherapy and nutritional supplement. The most frequently used outcome for efficacy was quality of life. Besides, the symptom score, tumor response, and survival rate were used. Safety was investigated by recording adverse events. Conclusion: We found out some issue by reviewing the existing guidelines and comparing it with clinical trials for gastric cancer and herbal medicinal products. These results will be utilized for developing [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer].

자가면역 혈소판감소성 자반병과 관련된 항인지질 증후군 1례 (A Case of Antiphospholipid Syndrome Associated with Autoimmune Thrombocytopenic Purpura)

  • 남윤성;이우식;박찬;윤태기;차광열
    • Clinical and Experimental Reproductive Medicine
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    • 제26권2호
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    • pp.265-269
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    • 1999
  • Thrombocytopenic patients without detectable bound antiplatelet antibody should be diagnosed with idiopathic thrombocytopenic purpura (ITP) if no other cause of their decreased platelet count could be found. More recently the term "autoimmune thrombocytopenic purpura (ATP) has supplanted ITP since the disease is related to the production of autoantibodies against one's own platelets. This entity should not be confused with isoimmune thrombocytopenic purpura (also called alloimmune thrombocytopenic purpura). In this cases maternal antiplatelet antibodies directed against the PLA 1 antigen on the fetal platelets causes severe fetal and neonatal thrombocytopenia in a situation analogous to Rheusus disease. Antibodies to the negatively charged phospholipids, lupus anticoagulant, and anticardiolipin have been linked to adverse pregnancy events. Pregnant women possessing these antibodies have an increased risk of spontaneous abortion, stillbirths, intrauterine fetal growth retardation, preterm birth, and arterial and venous thrombosis. Antiphospholipid antibodies decrease or may even disappear between pregnancies only to recur with increased activity in a subsequent pregnancy and lead to loss. We have experienced a case of antiphospholipid syndrome associated with autoimmune thrombocytopenic purpura in patient with recurrent spontaneous abortion. So we report this case with a brief review of literatures.

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국내 노인 심부전 환자에서의 잠재적으로 부적절한 약물사용 현황에 대한 연구 (Assessment of Potentially Inappropriate Medication Use in Korean Elderly Patients with Chronic Heart Failure)

  • 배민경;이인향;윤정현
    • 한국임상약학회지
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    • 제24권2호
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    • pp.115-125
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    • 2014
  • Purpose: The purpose of the present study was to assess the incidence of the potentially inappropriate medication (PIM) use in Korean elderly patients with heart failure, and to evaluate factors that influence PIM use. Method: Korean National Health Insurance claims database between January 2009 and December 2009 was used. Using 2012 updated Beers criteria, PIM use in heart failure patients aged 65 years or older was examined. Result: The incidence of PIM use in elderly heart failure patients was higher than in overall elderly patients. Among the 12,759 elderly patients with heart failure, 46.2% of study subjects were prescribed PIM(s) at least once. The number of PIM per 10 medications that patients received per patient was 1.53. The most commonly used PIMs in elderly heart failure patients were benzodiazepines (30.9%), non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2 inhibitors (16.3%), digoxin (9.9%), and spironolactone (9.0%). Women (odds ratio, 1.20; 95% CI, 1.17-1.24), medical aid (odds ratio, 1.11; 95% CI, 1.08-1.13), and long-term facilities (odds ratio, 2.69; 95% CI, 2.44-2.96) were revealed to be important factors associated with PIM use. In addition, patient's age also seems to influence PIM use. Conclusion: Elderly heart failure patients are at a greater risk for adverse drug events attributed by inappropriate medication use. Efforts to increase awareness of PIM use in elderly heart failure patients are needed. In addition, various comprehensive strategies and policies to identify and prevent PIM use should be established nationwide.

강직성 척추염의 침 치료에 대한 최근 연구동향 분석: China National Knowledge Infrastructure 검색을 중심으로 (Acupuncture Treatment for Ankylosing Spondylitis Using China National Knowledge Infrastructure: A Literature Review)

  • 유재은;권용수;김효준;박주언;김국범;이희원;배준효
    • 한방재활의학과학회지
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    • 제30권4호
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    • pp.79-88
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    • 2020
  • Objectives This study was performed to research the trends of Chinese acupuncture treatment for ankylosing spondylitis (AS). Methods We searched clinical studies about Chinese acupuncture treatment for AS through China National Knowledge Infrastructure. We analyzed the characteristics of selected studies according to research design, sample size, publication year, treatment methods, evaluation criteria and adverse events. Results 16 studies published from 2015 to 2020 were selected. They consisted of 11 randomized controlled trials and 5 case reports. In these studies, several types of acupuncture treatments were performed and especially there were many treatments that applied thermal stimulation of needles. The most commonly used evaluation criteria was effective rate. Conclusions This study showed that acupuncture treatment could be effective for AS. It suggested that various studies should be conducted to provide reliable evidence about acupuncture treatment for AS in Korea.