• Title/Summary/Keyword: Randomized clinical trial

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Efficacy and Safety of Combination Treatment of Traditional Korean Medicine after Gastric Cancer Surgery: A Systematic Review and Meta-analysis Protocol (위암 수술 후 항암치료를 병행한 한의치료의 유효성 및 안전성: 체계적 문헌고찰 및 메타분석 프로토콜)

  • Jong-hee Kim;Eunbin Kwag;So-jung Park;Donghyun Kim;Soodam Kim;Jihye Park;Hwa-seung Yoo
    • Herbal Formula Science
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    • v.31 no.4
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    • pp.361-371
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    • 2023
  • Objectives : Gastric cancer is a malignant tumor of the digestive tract that not only has a high mortality rate, but also affects quality of life. In Traditional Korean Medicine, acupuncture and herbal medicines can increase the survival rate for Gastric cancer and improve the quality of life. Traditional Korean Medicine treatment played an important role when used alone or in combination with chemotherapy. However, there is still insufficient evidence to support the efficacy and safety of Traditional Korean Medicine in patients undergoing chemotherapy after surgery. Therefore, the purpose of this study is to systematically evaluate the effect of oriental medicine treatment on patients as a complementary therapy for Gastric cancer. Methods : 2 researchers will search using EMBASE, Pubmed, CNKI, Cochrane Library, CiNii, KMBASE, KISS, OASIS, RISS, ScienceON. The search period of the database is from inception until June 2022. This study will include a randomized controlled trial of GC for acupuncture and herbal treatment. Primary outcomes include anti-cancer effects. Secondary outcomes evaluate survival rates and improvements in quality of life. The data uses Review Manager Software 5.4. Results : This study will provide a systematic evaluation by synthesizing the anti-cancer effect, survival rate and quality of life of Gastric cancer when Traditional Korean Medicine is combined with chemotherapy. Conclusion : The conclusion of this study will provide a basis for determining whether Traditional Korean Medicine treatment for Gastric cancer treatment is an effective and safe treatment method in clinical practice.

Identification of an effective and safe bolus dose and lockout time for patient-controlled sedation (PCS) using dexmedetomidine in dental treatments: a randomized clinical trial

  • Seung-Hyun Rhee;Young-Seok Kweon;Dong-Ok Won;Seong-Whan Lee;Kwang-Suk Seo
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.24 no.1
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    • pp.19-35
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    • 2024
  • Background: This study investigated a safe and effective bolus dose and lockout time for patient-controlled sedation (PCS) with dexmedetomidine for dental treatments. The depth of sedation, vital signs, and patient satisfaction were investigated to demonstrate safety. Methods: Thirty patients requiring dental scaling were enrolled and randomly divided into three groups based on bolus doses and lockout times: group 1 (low dose group, bolus dose 0.05 ㎍/kg, 1-minute lockout time), group 2 (middle dose group, 0.1 ㎍/kg, 1-minute), and group 3 (high dose group, 0.2 ㎍/kg, 3-minute) (n = 10 each). ECG, pulse, oxygen saturation, blood pressure, end-tidal CO2, respiratory rate, and bispectral index scores (BIS) were measured and recorded. The study was conducted in two stages: the first involved sedation without dental treatment and the second included sedation with dental scaling. Patients were instructed to press the drug demand button every 10 s, and the process of falling asleep and waking up was repeated 1-5 times. In the second stage, during dental scaling, patients were instructed to press the drug demand button. Loss of responsiveness (LOR) was defined as failure to respond to auditory stimuli six times, determining sleep onset. Patient and dentist satisfaction were assessed before and after experimentation. Results: Thirty patients (22 males) participated in the study. Scaling was performed in 29 patients after excluding one who experienced dizziness during the first stage. The average number of drug administrations until first LOR was significantly lower in group 3 (2.8 times) than groups 1 and 2 (8.0 and 6.5 times, respectively). The time taken to reach the LOR showed no difference between groups. During the second stage, the average time required to reach the LOR during scaling was 583.4 seconds. The effect site concentrations (Ce) was significantly lower in group 1 than groups 2 and 3. In the participant survey on PCS, 8/10 in group 3 reported partial memory loss, whereas 17/20 in groups 1 and 2 recalled the procedure fully or partially. Conclusion: PCS with dexmedetomidine can provide a rapid onset of sedation, safe vital sign management, and minimal side effects, thus facilitating smooth dental sedation.

Neuroimaging Assessment of the Therapeutic Mechanism of Acupuncture and Bee Venom Acupuncture in Patients with Idiopathic Parkinson's Disease: A Double-blind Randomized Controlled Trial

  • Young-Eun Lee;Seung-Yeon Cho;Han-Gyul Lee;Seungwon Kwon;Woo-Sang Jung;Sang-Kwan Moon;Jung-Mi Park;Chang-Nam Ko;Seong-Uk Park
    • The Journal of Korean Medicine
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    • v.44 no.4
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    • pp.104-120
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    • 2023
  • Objectives: The purpose of this study was to explore the therapeutic mechanism of acupuncture and bee venom acupuncture (BVA) in patients with idiopathic Parkinson's disease (IPD) using positron emission tomography (PET) and arterial spin labeling (ASL). Methods: Patients with IPD who received a stable dose of anti-parkinsonian medication for at least 4 weeks were recruited and randomly divided into one of two groups: treatment and control. The treatment group (11 subjects) received acupuncture and BVA at acupoints, and the control group (9 subjects) received sham acupuncture and normal saline injections at non-acupoints, twice per week for 12 weeks. The patients were examined using PET and ASL at baseline and after the 12-week treatment. In addition, age- and sex-matched healthy subjects without neurological symptoms and history were recruited to compare ASL data of patients with IPD. Results: PET results revealed that striatal dopamine transporter binding increased in each group after 12 weeks. Although the change was larger in the treatment group, the difference was not statistically significant. In ASL results, the treatment group exhibited hyperperfusion in specific regions compared with the healthy control group. After 12 weeks' intervention, hyperperfusion regions were recovered only in the treatment group. In contrast, significant changes were not found in hyperperfusion regions in the control group after 12 weeks. Conclusions: Our findings suggest that the therapeutic mechanisms of acupuncture and BVA in IPD are different from placebo and operate by altering dopamine availability and recovering hyperactivity in cerebral blood flow.

Effect of Acupuncture on Nasal Obstruction in Patients with Persistent Allergic Rhinitis: A Randomized Controlled Trial (지속성 알레르기비염의 비폐색에 대한 침치료의 효과: 무작위배정 대조군 연구)

  • Jo, Jeong-Hyo;Hong, Kweon-Eey;Kang, Wee-Chang;Choi, Sun-Mi;Park, Yang-Chun
    • Journal of Acupuncture Research
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    • v.22 no.6
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    • pp.229-239
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    • 2005
  • Objectives : Allergic rhinitis is a prevalent disease. Nasal obstruction is one of the main symptom in allergic rhinitis. It induces sleep disturbances, depression, attention deficit, memory impairments. Acupuncture treatment for rhinitis was mentioned in literature, but there is not enough report that provide evidence by well designed clinical study. The purpose of this research is to examine the effect of acupuncture treatment for nasal obstruction of allergic rhinitis. Methods : In this randomized, single blind, placebo-controlled study, we compared active acupuncture with minimal acupuncture for the treatment of nasal obstruction owing to persistent allergic rhinitis. Acupoints used in active acupuncture group were I120($Y{\hat{o}}nghyang$), GV23($Sangs{\hat{o}}ng$), IL4(Hapkok). Volunteers who satisfied the requirements were enrolled in study. Total nasal volume(NV) and total nasal minimum cross-sectional area(MCA) were measured by acoustic rhinometry before and after treatments(0min, 7.5min, 15min). Results : 101 subjects finished study. There were not difference between two groups on age, sex, weight, height, blood pressure, pulse, respiratory rate, severity of persistent allergic rhinitis, number of positive antigen. After treatment(0min) total NV were significantly increased compared with before treatment in active acupuncture group(p=0.0007) and minimal acupuncture group(p=0.0175). After treatment(15min) total NV of minimal acupuncture group was decreased compared with before treatment(p=0.2560), but total NV of active acupuncture group was maintained increasing in degree of borderline significance(p=0.0871). After treatment(0min) total NV were significantly increased compared with before treatment in active acupuncture group(0.0007) and minimal acupuncture group(p=0.0175). After treatment(Omin) total MCA were significantly increased compared with before treatment in active acupuncture group(p<0.000l) and minimal acupuncture group(p=0.0005). After treatment(15min) total MCA of minimal acupuncture group was decreased compared with before treatment(p=0.6082), but total NV of active acupuncture group was maintained increasing in degree of borderline significance(p=0.0929). Conclusion : Acupuncture treatment reduced nasal obstruction in persistent allergic rhinitis. Further study in the form of long term is needed.

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Effect of Sa-am Acupuncture Method for Chronic Tension-type Headache;A Randomized Controlled Trial (만성 긴장성 두통 환자에 대한 사암침 치료효과의 Pilot 임상연구)

  • Hong, Kwon-Eui;Park, Yang-Chun;Jo, Jeong-Hyo;Jo, Hyun-Gyeong;Jeong, In-Cheol;Kang, Wee-Chang;Lee, Sang-Bong;Choi, Sun-Mi
    • Journal of Acupuncture Research
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    • v.24 no.1
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    • pp.13-28
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    • 2007
  • Objectives : Clinical character of chronic tension-type headache is bilateral, moderate intensity, persistent and chronic, repeating disease and CTTH is a common prevalent disease, but pathophysiology and likely mechanism remain unclear. It impedes subjective quality of life. The purpose of this research is to examine the effect of sa-am acupuncture method for chronic tension-type headache. Methods : In this randomized, single blind, placebo-controlled study, we compared active acupuncture with sham acupuncture for the treatment of chronic tension-type headache. Volunteers who satisfied the requirements were enrolled in study. Evaluation of chronic tension-type headache was measured by VAS and Headache Disability Inventory(HDI), Six point Linkert Scale before and after treatments. Results : 26 subjects finished study. There were not difference between two groups on age, sex, weight, height, blood pressure, pulse, respiratory rate, Byeonjeung, sunrise of treatment. In change of VAS, there were not difference between two groups on before treatment. Before treatment per visit, VAS of 6th and 7th visit were significantly decreased in active acupuncture(each p=0.039, p=0.008) and were not decreased in sham acupuncture. In change of VAS on a withdrawing needling after treatment, VAS of 1st, 2nd, 6th and 7th visit were significantly decreased in active acupuncture (each p=0.001, 0.038, 0.035, 0.008) and VAS of 2nd, 4th and 5th, 6th visit were significantly decreased in sham acupuncture(each p=0.033, 0.032, 0.035, 0.031). In change of VAS on 2hrs after treatment, VAS of 4th and 5th, 6th visit were significantly decreased in active acupuncture(each p=0.014, 0.023, 0.027) and 5th visit were significantly decreased in sham acupuncture(each p=0.004, 0.009). In change of VAS on 4hrs after treatment, VAS of 4th and 5th, 6th visit were significantly decreased in active acupuncture(each p=0.018, 0.011, 0.015) and 5th, 6th visit were significantly decreased in sham acupuncture(each p=0.020, 0.015). In change of VAS on the next day after treatment, VAS of 3th and 4th and 5th, 6th visit were significantly decreased in active acupuncture(each p=0.032, 0.011, 0.005, 0.012) and 4th, 5th visit were significantly decreased in sham acupuncture(each p=0.001, 0.012). In change of VAS according to a current time(before treatment, after a withdrawing needling, 2hrs, 4hrs, the next day), total score of VAS was decreased more active acupuncture group than sham acupuncture group, but there were no statistical significance compared with sham acupuncture group. In change of HDI score, after treatment was decreased than before treatment in two group, but there were no statistical significance compared with two group. In change of Six point Linkert scale score, after treatment was decreased than before treatment in two group on 6th, 7th visit(active acupuncture 6th 7th each p=0.002, 0.003, sham acupuncture 6th 7th each 0.003, 0.009), but there were no statistical significance compared with tow group. Conclusion : Sa-am acupuncture treatment is effective to improve the symptoms and quality of life in patients with chronic tension-type headache.

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Effect of Beraprost Sodium in Patients with Chronic Obstructive Pulmonary Disease (만성폐쇄성폐질환 환자에서 Beraprost sodium의 효과에 대한 연구: 이중 맹검 무작위 임상시험)

  • Lee, Sang-Do;Seo, Kwang Won;Lee, Jung Yeon;Huh, Jin Won;Choi, Ik Su;Park, Jae Sun;Shim, Tae Sun;Oh, Yeon-Mok;Park, In Won;Ryu, Wang-Seong;Choi, Byoung Whui
    • Tuberculosis and Respiratory Diseases
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    • v.57 no.4
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    • pp.320-328
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    • 2004
  • Background : Pulmonary vascular changes which occur early in the course of chronic obstructive pulmonary disease (COPD) are prevalent manifestation and later cause pulmonary hypertension, which is a bad prognostic factor in COPD. Beraprost sodium (BPS), an orally active prostacyclin analogue, has been shown to improve survival in patients with primary pulmonary hypertension. This study investigated the effect of BPS in the patients with COPD. Methods : This is a double-blind randomized placebo-controlled, two center clinical trial. Twenty one consecutive patients with COPD were enrolled from June 2003 to June 2004 (patients treated with BPS for 3 months, BPS group, n=11; those with placebo, placebo group, n=10). The baseline demographic, pulmonary function and hemodynamic data were not significantly different between two groups. Results : On echocardiographic examination, trans tricuspid valve pressure gradient has decreased significantly after 3 months with beraprost in the BPS group [17.7(${\pm}11.4$) to 8.2(${\pm}8.9$) mm Hg, p-value<0.05], while there was no significant change in the control group. Six-minute walking distance has decreased in the control group and increased in the BPS group, but there was no statistical significance. Conclusion : In patients with COPD oral administration of BPS reduced the pulmonary arterial pressure. The clinical significance of this finding, that is improving symptoms and natural course of the disease, needs further study.

Effect of surfactant lavage in severe meconium aspiration syndrome (중증 태변 흡인 증후군에서 인공 폐표면활성제 세정요법의 효과에 관한 비교 연구)

  • Lee, Soon Min;Kim, He Min;Jeon, Ji Hyun;Park, Min Soo;Park, Kook In;Namgung, Ran;Lee, Chul
    • Clinical and Experimental Pediatrics
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    • v.51 no.4
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    • pp.367-371
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    • 2008
  • Purpose : The surfactant dysfunction may play an important role in meconium aspiration syndrome (MAS). We aim to evaluate the effect of surfactant lavage in the treatment of term infants with MAS. Methods : The medical records of 15 neonates with severe MAS admitted at Yongdong Severance Hospital from 2005 to 2007 were reviewed and analyzed. Seven infants with severe MAS necessitating mechanical ventilation underwent tracheobronchial lavage with 20 mL/kg of diluted (5.3 mg phospholipid/mL) surfactant saline suspension ($Newfactan^{(R)}$). Data regarding clinical outcomes was assessed by comparison with 8 control infants with equally severe MAS retrospectively. Results : In the lavage group, radiological improvement was evident after 6 hours of treatment. The duration of artificial ventilation and duration of hospital day were also significantly shorten in the lavage group compared with the control group. The mean oxygen index, mean ventilation index improved significantly within the first 6 hours after treatment. No differences were found in the incidence of major complications and mortality between the two groups. Conclusion : The surfactant lavage seems to be an effective and safe method for treatment of severe MAS. A multicenter, large scaled randomized controlled trial is needed for further study.

The Effects of Weighted Vest During Task-Oriented Training on Gross Motor Performance and Balance Abilities of Children With Spastic Diplegia : A Randomized Clinical Trial Study (경직형 양마비 아동의 과제지향훈련 시 무게조끼 적용이 대동작 수행력과 균형 능력에 미치는 영향: 무작위배정 위약비교 연구)

  • Kwon, Hae-Yeon
    • The Journal of Korean Academy of Sensory Integration
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    • v.15 no.2
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    • pp.46-65
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    • 2017
  • Objective : The purpose of this research is to find clinical effects of application of weighted vest during task-oriented training focused on gross motor performance and balance abilities of children with spastic diplegia. Methods : 34 subjects were divided by simple random sampling into two groups; experimental group (male : 9, female : 8, average age : 8.12) and placebo group (male : 9, female : 9, average age : 7.53). Both two groups underwent to 40 minute intervention, twice a week for 12 weeks. The intervention was task-oriented training focused on facilitating closed kinematic chain and multi-joint functional movement pattern. During the training, the experimental group received loaded-resistance weighted vest and placebo group also received weighted vest but without loaded-resistance. Participants in both groups underwent 8 to 10 reps of the task-oriented training and there were 3 minutes break time between tasks. There were pre-test of gross motor performance and balance abilities, and two times of post-tests were performed upon 6 weeks and 12 weeks after the intervention completed. And in final, an additional follow-up test was performed 12 weeks after the evaluation was finished in order to find any difference between the two groups over time. Results : There was significant difference in Gross Motor Performance Measure (GMPM) between two groups. It is found that average score of the experimental group increased more than the placebo group after 6 weeks and 12 weeks intervention (p<.05). There was significant difference in Pediatric Berg's Balance Scale (PBS) between two groups. It is found that average score of the experimental group increased more than the placebo group after 6 weeks and 12 weeks intervention (p<.05). Conclusion : Based on the results in this study, it is proposed that application of weighted vest into task-oriented training to facilitating closed kinematic chain and multi-joint movement can improve gross motor performance and balance abilities of children with cerebral palsy.

Efficacy and Safety of Red Ginseng on Women's Health Related Quality of Life and Sexual Function (여성의 건강관련 삶의 질과 성기능에 대한 홍삼의 효과 및 안전성 연구)

  • Kim, Dong-II;Choi, Min-Sun;Alm, Hong-Yeop
    • Journal of Ginseng Research
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    • v.33 no.2
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    • pp.115-126
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    • 2009
  • To evaluate the efficacy and safety of red ginseng on women's health-related quality of life (QOL) and sexual function. A randomized, double-blind, placebo-controlled, crossover clinical study was performed. The main efficacy was measured using the Female Sexual Function Index (FSFl) and the 36-Item Short-Form Health Survey (SF-36). Twenty-four healthy, married women aged 30-45 years with FSFl scores below 25 were randomly divided into two groups: the red-ginseng group (N=12) and the placebo group (N=12). During the first six-week period (Study 1), each group was given red ginseng or placebo twice a day. Before the start of the second six-week period (Study 2), a crossover design was chosen with a two-week break (washout period). Interchanging the two groups after the washout period, red ginseng and placebo were given to each group. The outcomes were measured before and after each six-week period. Overall, 23 participants completed the study. In Study 1, the changes relative to the baseline in the FSFl total score were 22.50% and 22.99% for red ginseng and placebo, respectively. In Study 2, the relative changes were 8.14% for red ginseng and 6.29% for placebo. The results showed a greater improving trend in Study 1 with respect to all of the participants' sexual functions, but no significant difference was found between the groups (P=0.9567). After taking red ginseng, all the participants exhibited an improving trend in the desire domain of FSFl, but no significant difference was shown. In the measurement of SF-36, no significant difference was likewise shown. After taking red ginseng, though, all the participants exhibited an improving trend in the physical functioning (PF) domain of SF-36, with no significant difference. Moreover, there was no significant adverse event related to red ginseng. The QOL and sexual function of the study participants in the red-ginseng group were mostly improved, but no statistically significant effect of red ginseng was shown. It is supposed that this result was partly due to the affirmative impression of red ginseng in Korea. Thus, it is anticipated that a long-term clinical trial will show a significant effect of red ginseng on the QOL and sexual function.

Effect of Magnesium Administration on Preventing Arrhythmias after Coronary Artery Bypass Graft (관상동맥 우회술 후 마그네슘 투여가 심 부정맥을 예방하는 효과)

  • Kim, Jun-Hyun;Song, Hyun;Kim, Yong-Hee;Lee, Eun-Sang;Lee, Jay-Won;Song, Myung-Kun
    • Journal of Chest Surgery
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    • v.31 no.4
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    • pp.339-345
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    • 1998
  • Arrhythmias are common after cardiac surgery and are multifactorial. Intravenous magnesium administration reduces the frequency of ventricular arrhythmias in patient with symptomatic heart failure or acute myocardial infarction. This study was designed to evaluate the role of magnesium in preventing PVCs(premature ventricular contractions) occurred frequently after coronary artery bypass graft(CABG). 50 consecutive patients were prospectively entered into a randomized trial to determine the efficacy of postoperative magnesium therapy on the incidence of cardiac arrhythmias after elective coronary artery bypass graft. The patients underwent coronary angiography, echocardiography, electrocardiography and clinical laboratory study preoperatively. Continuous electrocardiographic monitoring was done and magnesium level was checked 0, 3, 6, 12, 18, 24, 36, 48, 60 and 72 hours postoperatively. Study group of 25 patients were given 4g of magnesium continuously over the first 24 hours and then 2g/24hours from 25 to 72 hours. The clinical characteristics of both groups were similar(p<0.05). The preoperative mean serum magnesium concentration was similar in both study group, 1.59mg/dl and control group, 1.71mg/dl. The mean postoperative serum magnesium concentration in study group elevated significantly over postoperative 12hours through 36hours(p<0.05). The postoperative mean serum magnesium concentration in control group declined and remained significantly depressed over immediate postoperation through 72hours. The mean serum magnesium concentration was significantly greater in the study group compared with the control group over postoperative 3hours through 72hours(p<0.05). There was a significant decrease in the incidence of arrhythmias such as PVCs(p<0.01) which might jeopardize hemodynamics. There were no recognized adverse effects of magnesium Administration. In conclusion, prophylactic magnesium administration seems to lessen the incidence and severity of rrhythmias after coponary artery bypass graft.

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