• Title/Summary/Keyword: cardiac safety

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Characteristics of Heart Rate Variability Among Adults with Metabolic Syndrome (대사증후군 집단의 심박동수 변이의 특징)

  • Yeo, Do Hwan;Kim, Jeong Il;Kang, Dong Mug;Kim, Jeong Yeon;Cho, Jung Hin;Kim, Won;Lim, Seong Kyeon;Woo, Jong-Min
    • Korean Journal of Biological Psychiatry
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    • v.15 no.3
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    • pp.186-193
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    • 2008
  • Objectives : The authors tried to investigate the characteristics of Heart Rate Variability(HRV) among the subjects with metabolic syndrome for testing the possibility of clinical application of HRV in evaluating metabolic syndrome. Methods : We examined the difference of the means of HRV between 122 subjects of metabolic syndrome and 1057 healthy controls using T-test, and the change of means in HRV according to increasing risk factors of metabolic syndrome. Using multiple regression analysis, we examined the association of HRV with the risk factors of metabolic syndrome. Results : The HRV indices including SDNN(Standard Deviation of all normal NN intervals), RMSSD(the square Root of the Mean Squared Differences of successive all normal NN interval), TP(Total Power), LF(Low Freuency), and HF(High Frequency) were significantly lower in the metabolic syndrome group than in the normal control group, and the means of all HRV indices except LF/HF were decreased consistently according to increasing risk factors of metabolic syndrome. The fasting glucose, triglyceride, and waist circumference were dependent factors that contributed significantly to the change of HRV. Conclusion : These findings suggest metabolic syndrome adversely affects cardiac autonomic system and HRV could be a useful method for evaluating metabolic syndrome.

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Development and evaluation of next-generation cardiotoxicity assay based on embryonic stem cell-derived cardiomyocytes

  • Ryu, Bokyeong;Choi, Seong Woo;Lee, Seul-Gi;Jeong, Young-Hoon;Kim, Ukjin;Kim, Jin;Jung, Cho-Rok;Chung, Hyung-Min;Park, Jae-Hak;Kim, C-Yoon
    • BMB Reports
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    • v.53 no.8
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    • pp.437-441
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    • 2020
  • In accordance with requirements of the ICH S7B safety pharmacology guidelines, numerous next-generation cardiotoxicity studies using human stem cell-derived cardiomyocytes (CMs) are being conducted globally. Although several stem cell-derived CMs are being developed for commercialization, there is insufficient research to verify if these CMs can replace animal experiments. In this study, in vitro high-efficiency CMs derived from human embryonic stem cells (hESC-CMs) were compared with Sprague-Dawley rats as in vivo experimental animals, and primary cultured in vitro rat-CMs for cardiotoxicity tests. In vivo rats were administrated with two consecutive injections of 100 mg/kg isoproterenol, 15 mg/kg doxorubicin, or 100 mg/kg nifedipine, while in vitro rat-CMs and hESC-CMs were treated with 5 μM isoproterenol, 5 μM doxorubicin, and 50 μM nifedipine. We have verified the equivalence of hESC-CMs assessments over various molecular biological markers, morphological analysis. Also, we have identified the advantages of hESC-CMs, which can distinguish between species variability, over electrophysiological analysis of ion channels against cardiac damage. Our findings demonstrate the possibility and advantage of high-efficiency hESC-CMs as next-generation cardiotoxicity assessment.

A Study on Cardiotoxicity of DA-125, a New Anticancer Antibiotic (새로운 항암성 항생물질 DA-125의 심장독성에 대한 평가)

  • ;;;;;Toshihiko Watanabe
    • Biomolecules & Therapeutics
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    • v.1 no.1
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    • pp.9-19
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    • 1993
  • DA-125, a new anthracycline antibiotic, showed antitumor activity against animal tumors and human tumors. Therefore we studied the cardiotoxic potential of DA-125 in hamsters and rats as a part of safety research, and compared it with that of doxorubicin(DXR). In acute cardiotoxicity test model used hamsters DA-125 was administered intravenously at a dose of 6, 9, 12 mg/kg, and DXR at 3 mg/kg was given. The electrocardiogram(ECG) of hamsters was recorded for 30 minutes after administration. The DA-125 caused slight ECG alterations at a dose of 6 mg/kg. At a dose of 12 mg/kg DA-125 induced moderate to remarkable changes in ECG like decrease of heart rate, widening of PR interval and 07 interval, and A-V block in 3 out of 5 animals. The severity of ECG alteration at 12 mg/kg of DA-125 was similar to that at 3mg/kg of DXR and these changes caused by DA-125 and DXR recovered within 10 minutes after injection. In chronic cardiotoxicity test model used rats, DA-125 was administered intravenously once a week for three weeks at a dose of 6, 9mg/kg and DXR was given at a dose of 6mg/kg. Electrocardiogram was recorded every week from the start of administration to 2 weeks after the last administration and the animals were sacrificed for histological heart examination at 1 week or 2 weeks after the last administration. DA-125 did not cause any abnormal changes in ECG and in histological heart examination due to administration, but DXR caused widening of ST segment, QRS complex, and QT interval from 1 week after administration and these changes were continued to necropsy. These alterations in ECG were accompanied by cardiac histological lesions such as vacuolation in myocardiac cells, interstitial edema and necrosis of myocytes. These results suggest that DA-125 is less cardiotoxic than DXR.

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Effects of Painless Delivery on Hemodynamic Changes of Parturients with Epidural Analgesia (경막외진통을 이용한 무통분만이 임산부의 혈역학 변동에 미치는 영향)

  • Lee, Sang-Ha;Jang, Young-Ho;Cheun, Jae-Kyu
    • The Korean Journal of Pain
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    • v.9 no.1
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    • pp.63-68
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    • 1996
  • Background; Epidural analgesia for controlling labor pain has recently gained world-wide popularity. However, many patients scheduled for continuous epidural analgesia voice concern over harmful effects to their fetus and other possible complications such as hemodynamic changes, back pain and neurologic sequelae etc. The aim of this study was to evaluate the hemodynamic changes with and without epidural block as a measure to determine the safety of epidural analgesia during labor and delivery. Methods: Twenty healthy subjects were divided equally into two groups(Group 1 without epidural block, and Group 2 with epidural block) and serial hemodynamic measurements were taken in all subjects with transcutaneous impedence cardiography. The epidural catheter was inserted at the level of $L_{3,4}$ in Group 2 and analgesia was maintained using 0.25% bupivacaine mixed with fentanyl. Results: Cardiac output increased slightly with cervical dilatation in both groups, but no significant differences were found between the two groups. Similarly, no significant differences were found in blood pressures between the two groups. Stroke volume and end-diastolic volume indices were slightly decreased in group 1 and slightly increased in group 2. However, there were no significant differences between the two groups. The ejection fraction was nearly constant and ranging 56~59%. Conclusion: We concluded epidural analgesia for labor and delivery is a safe technique for the parturients since results indicated no significant differences in hemodynamic changes, as compared to the control group.

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Immediate Postoperative Care in the General Thoracic Ward Is Safe for Low-risk Patients after Lobectomy for Lung Cancer

  • Park, Seong-Yong;Park, In-Kyu;Hwang, Yoo-Hwa;Byun, Chun-Sung;Bae, Mi-Kyung;Lee, Chang-Young
    • Journal of Chest Surgery
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    • v.44 no.3
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    • pp.229-235
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    • 2011
  • Background: Following major lung resection, patients have routinely been monitored in the intensive care unit (ICU). Recently, however, patients are increasingly being placed in a general thoracic ward (GTW). We investigated the safety and efficacy of the GTW care after lobectomy for lung cancer. Materials and Methods: 316 patients who had undergone lobectomy for lung cancer were reviewed. These patients were divided into two groups: 275 patients were cared for in the ICU while 41 patients were care for in the GTW immediately post-operation. After propensity score matching, postoperative complications and hospital costs were analyzed. Risk factors for early complications were analyzed with the whole cohort. Results: Early complications (until the end of the first postoperative day) occurred in 11 (3.5%) patients. Late complications occurred in 42 patients (13.3%). After propensity score matching, the incidence of early complications, late complications, and mortality were not different between the two groups. The mean expense was higher in the ICU group. Risk factors for early complications were cardiac comorbidities and low expected forced expiratory volume in one second. The location of postoperative care had no influence on outcome. Conclusion: Immediate postoperative care after lobectomy for lung cancer in a GTW was safe and cost-effective without compromising outcomes in low-risk patients.

Analysis of an External Stimulator's Impact on the Heart (체외 전기자극기가 심장에 미치는 영향의 분석 및 평가)

  • Kim, Mun-Soo;Choe, Seung-Wook
    • Transactions of the Korean Society of Mechanical Engineers B
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    • v.35 no.11
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    • pp.1213-1217
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    • 2011
  • Electric stimulators are used for various treatments, such as for pain relief and to improve rehabilitation in and out of the hospital. However, if the stimulation pulse affects the patient's heart, it can cause critical cardiac disorders such as arrhythmia or ventricular fibrillation. As a result, it must be ensured that the transmission length of the stimulation pulse does not exceed the proper range in the design of an electric stimulator. Furthermore, every anticipated risk factor must be monitored in in-vitro and in-vivo experiments. A new stimulator was designed to supply continuous 0.001 J stimulation pulses at a rate of 60 pulses per second. To evaluate the safety of the new electric stimulator and to measure its energy transfer and pulse transmission length, we built a conduction model that was filled with saline and measured the electric field at various positions in response to real stimulations. In an animal experiment with two pigs, heart disorders were induced by applying electric stimulation to tissues near the heart. These heart disorders were different from the result obtained with 9 V DC stimulation.

General Pharmacology of LB71350, a New HIV-1 Pretense Inhibitor

  • Kim, Hee-Jin;Oh, Jeng-In;Park, Hee-Dong;Kang, Ju-Seop;Ko, Hyun-Chul;Lee, Chang-Ho
    • Biomolecules & Therapeutics
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    • v.7 no.3
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    • pp.271-277
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    • 1999
  • Safety evaluation of LB71350, a new HIV-1 protease inhibitor, was performed in mice, rats and dogs. For the general behavior of mice, LB71350 at an oral dose of 200 mg/kg did not show any significant effects on muscle tone and locomotor activity. In terms of central nervous system, at oral doses of 200 mg/kg and 1000 mg/kg, LB71350 inhibited acetic acid-induced pain response approximately 41% and 83% of control. respectively. At oral doses of 200 mg/kg and 500 mg/kg, it reduced the rectal body temperature in rats. Pentylenetetrazole-induced seizure in mice was slightly potentiated by oral administration of LB71350 at doses ranging from 200 mg/kg to 1000 mg/Ag. Single or five day treatment of LB71350 doubled the hexobarbital- induced sleeping time in mice at oral doses ranging from 50 mg/kg to 500 mg/kg. It did not cause any effects on gastric secretion and acidity in rat at oral doses of 200 mg/kg and 1000 mg/kg and also it did not change intestinal motility in mice up to 1000 mg/kg. Blood coagulation indices such as prothrombin time (PT), activated partial thromboplastin time (aPTT), and thrombin time (TT) in rats were not affected by the treatment of LB71350 up to 500 mg/kg. LB71350 caused no significant effects on the cardiac output, stroke volume, heart rate, and mean blood pressure when infused intravenously to the anesthetized rats and dogs. Taken together, LB71350 at high oral doses caused significant pharmacological effects on the central nervous system and the hexobarbital-induced sleeping time.

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Comparison of Inpatient and Outpatient Preoperative Factors and Postoperative Outcomes in 2-Level Cervical Disc Arthroplasty

  • Hill, Patrick;Vaishnav, Avani;Kushwaha, Blake;McAnany, Steven;Albert, Todd;Gang, Catherine Himo;Qureshi, Sheeraz
    • Neurospine
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    • v.15 no.4
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    • pp.376-382
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    • 2018
  • Objective: The purpose of this study was to evaluate factors associated with inpatient admission following 2-level cervical disc arthroplasty (CDA). A secondary aim was to compare outcomes between those treated on an inpatient versus outpatient basis. Methods: Using data from the American College of Surgeons National Surgical Quality Improvement Program database, multivariate logistic regression analysis was used to assess the independent effect of each variable on inpatient or outpatient selection for surgery. Statistical significance was defined by p-values <0.05. The factors considered were age, sex, body mass index (BMI), smoking status, American Society of Anesthesiologists physical status classification, and comorbidities including hypertension, diabetes, history of dyspnea or chronic obstructive pulmonary disease, previous cardiac intervention or surgery, steroid usage, and history of bleeding. In addition, whether the operation was performed by an orthopedic or neurosurgical specialist was analyzed. Results: The number of 2-level CDA procedures increased from 6 cases reported in 2014 to 142 in 2016, although a statistically significant increase in the number of outpatient cases performed was not seen (p=0.2). The factors found to be significantly associated with inpatient status following surgery were BMI (p=0.019) and diabetes mellitus requiring insulin (p=0.043). There were no significant differences in complication and readmission rates between the inpatient and outpatient groups. Conclusion: Patients undergoing inpatient 2-level CDA had significantly higher rates of obesity and diabetes requiring insulin than did patients undergoing the same procedure in the outpatient setting. With no difference in complication or readmission rates, 2-level CDA may be considered safe in the outpatient setting in appropriately selected patients.

Propofol with and without Midazolam for Diagnostic Upper Gastrointestinal Endoscopies in Children

  • Akbulut, Ulas Emre;Kartal, Seyfi;Dogan, Ufuk;Akcali, Gulgun Elif;Kalayci, Serap;Kirci, Hulya
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.22 no.3
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    • pp.217-224
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    • 2019
  • Purpose: Various publications on the use of sedation and anesthesia for diagnostic procedures in children have demonstrated that no ideal agent is available. Although propofol has been widely used for sedation during esophagogastroduodenoscopy in children, adverse events including hypoxia and hypotension, are concerns in propofol-based sedation. Propofol is used in combination with other sedatives in order to reduce potential complications. We aimed to analyze whether the administration of midazolam would improve the safety and efficacy of propofol-based sedation in diagnostic esophagogastroduodenoscopies in children. Methods: We retrospectively reviewed the hospital records of children who underwent diagnostic esophagogastroduodenoscopies during a 30-month period. Demographic characteristics, vital signs, medication dosages, induction times, sedation times, recovery times, and any complications observed, were examined. Results: Baseline characteristics did not differ between the midazolam-propofol and propofol alone groups. No differences were observed between the two groups in terms of induction times, sedation times, recovery times, or the proportion of satisfactory endoscopist responses. No major procedural complications, such as cardiac arrest, apnea, or laryngospasm, occurred in any case. However, minor complications developed in 22 patients (10.7%), 17 (16.2%) in the midazolam-propofol group and five (5.0%) in the propofol alone group (p=0.010). Conclusion: The sedation protocol with propofol was safe and efficient. The administration of midazolam provided no additional benefit in propofol-based sedation.

East Asian Traditional Medicine Treatment for Patients after Heart Valve Replacements: A Systematic Review with Meta-Analysis (심장판막 치환술 후 한의학적 치료에 대한 체계적 문헌고찰 및 메타분석)

  • Ahn, Mu-hyeok;Kim, Ji-ho;Shin, Bong-jin;Kwon, Jung-nam
    • The Journal of Internal Korean Medicine
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    • v.43 no.4
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    • pp.720-737
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    • 2022
  • Objectives: To compare the effectiveness and safety of East Asian traditional medicine treatments (EATMT) versus conventional management in patients following heart valve replacement surgery. Methods: We searched several databases, including the Korean Studies Information Service System, PubMed, China National Knowledge Infrastructure, and Citation Information by NII. The search range included randomized controlled trials from each first issue until June 27, 2021. Two review authors independently extracted the data. We assessed the risk of systematic errors by evaluating risk domains using the "Risk of bias" tool. Results: We included 5 trials in the review. In the EATMT, the investigators reported significant improvements in reshaping of the heart structure: left ventricular end diastolic diameter (MD -4.43, 95% CI -6.06 to -2.79; 130 participants; 2 studies; high evidence). Comparisons with usual care revealed a significant decrease in gastrointestinal complications rate (OR 0.30, 95% CI 0.20 to 0.47; 503 participants; 2 studies; high evidence). We assessed 4 studies as having a low risk of bias and 1 study as having a high risk of bias. Conclusion: This systematic review suggests that East Asian traditional medicine interventions may be effective in preventing and alleviating complications, but we found evidence of important trade-offs between known benefits and known adverse effects in cardiac dysfunction and inflammation following heart valve replacement. Consequently, additional high-quality studies should be conducted.