• Title/Summary/Keyword: Adverse outcomes

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Comparison of Two pMDIs in Adult Asthmatics: A Randomized Double-Blind Double-Dummy Clinical Trial

  • Nam, Tae-Hyun;Kang, Sung-Yoon;Lee, Sang Min;Kim, Tae-Bum;Lee, Sang Pyo
    • Tuberculosis and Respiratory Diseases
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    • v.85 no.1
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    • pp.25-36
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    • 2022
  • Background: Only a few studies directly compared the therapeutic efficacy and safety of two pressurized metered-dose inhalers (pMDIs) in asthma. We analyzed the asthma treatment outcomes, safety, and patient preferences using formoterol/beclomethasone (FORM/BDP), a pMDI with extra-fine particles, compared with formoterol/budesonide (FORM/BUD), another pMDI with non-extra-fine particles. Methods: In this randomized, double-blind, double-dummy parallel group study, 40 adult asthmatics were randomized to FORM/BDP group (n=18; active FORM/BDP and placebo FORM/BUD) or FORM/BUD group (n=22; active FORM/BUD and placebo FORM/BDP). During the two visits (baseline and end of 8-week treatment), subjects were asked to answer questionnaires including asthma control test (ACT), asthma control questionnaires (ACQ), and Quality of Life Questionnaire for Adult Korean Asthmatics (QLQAKA). Lung function, compliance with inhaler, and inhaler-handling skills were also assessed. Results: Ten subjects in the FORM/BDP group and 14 in the FORM/BUD group completed follow-up visits. ACT, ACQ, QLQAKA (a primary outcome), and adverse events did not differ between two groups. We found that the increase in forced expiratory volume in 1 second/forced vital capacity and forced expiratory flow at 25% to 75% of the pulmonary volume in the FORM/BDP group was higher than in the FORM/BUD group. Regarding preference, subjects responded that the flume velocity of FORM/BDP was higher, but more adequate than that of FORM/BUD. They also answered that FORM/BDP reached the trachea and bronchus and irritated them significantly more than FORM/BUD. Conclusion: The use of pMDI with extra-fine particles may relieve small airway obstruction more than the one with non-extra-fine particles despite no significant differences in overall treatment outcomes. Some asthmatics have a misconception about the adequacy of high flume velocity of pMDIs.

A Case Report of Traditional Korean Medicine-Based Integrative Oncology of Recurrent Cervical Cancer (재발된 자궁경부암 환자의 한의 기반 통합 암 치료에 대한 증례보고)

  • Joo, Han-eum;Park, Ji-hye;Song, Si-yeon;Cho, Young-min;Park, So-jeong;Yoo, Hwa-seung
    • The Journal of Internal Korean Medicine
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    • v.43 no.4
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    • pp.751-760
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    • 2022
  • Objective: To show a decrease in tumor recurrence and improvement in quality of life in patients with recurrent cervical cancer. Method: A 58-year-old female patient diagnosed with recurrent cervical cancer in February 2021 was treated for 14 months with integrative cancer treatment (ICT) to decrease the tumor size and improve chemotherapy-induced peripheral neuropathy (CIPN) and nausea. The patient underwent chemotherapy or concomitant chemoradiation therapy (CCRT) with ICT. Radiologic outcomes were assessed by abdomen & pelvis computed tomography (CT), magnetic resonance imaging (MRI), and positron emission tomography-computed tomography (PET-CT) based on the Response Evaluation Criteria in Solid Tumors (RECIST) protocol. Clinical outcomes were assessed by the National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE), Eastern Cooperative Oncology Group (ECOG), and a numeric rating scale (NRS). Result: During the 14 months of treatment, the size and metabolic activity of the recurrent tumor decreased and underwent partial remission based on RECIST. The NRS scores for CIPN and nausea were improved, and the ECOG score improved from grade 2 to 1. No serious side effects of grade 3 or higher were noted on the NCI-CTCAE test. Conclusion: This case suggests that ICT may have a synergetic effect with chemotherapy or radiotherapy for recurrent cervical cancer.

Efficacy and Safety of Cheong-A-Won Gagambang (JCE003) on Knee Osteoarthritis: Randomized Controlled Pilot Trial

  • Kong, Haejin;Kang, Jaehui;Lee, Hyun
    • Journal of Acupuncture Research
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    • v.39 no.3
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    • pp.202-212
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    • 2022
  • Background: The aim of this study was to evaluate the effectiveness and safety of Cheong-A-Won Gagambang (JCE003) treatment for degenerative knee osteoarthritis. Methods: This was a single-center, randomized, double-blind, placebo-controlled pilot clinical trial. There were 36 adults with degenerative knee osteoarthritis who were randomly allocated into JCE003 1,000 mg, JCE003 2,000 mg, or the placebo group (in a 1:1:1 ratio). The participants received 12 weeks of treatment and had scheduled tests every 6 weeks. The primary outcomes were measured using the Korean Western Ontario and McMaster Universities scale, and the secondary outcomes were measured using the visual analog scale, European quality of life-5-dimensions, patient global impression of change, C-reactive protein, and erythrocyte sedimentation rate. Changes between baseline scores and scores following study completion were analyzed. Results: There were 29 participants whose data were analyzed in this study. The change of Korean Western Ontario and McMaster Universities, visual analog scale, European quality of life-5-dimensions scores showed significant improvement in the JCE003 1,000 mg group. The change of patient global impression of change was significantly improved in the placebo group. There were 14 adverse events, but there was no clinically significant relationship with the intake of JCE003 compared with the placebo. Conclusion: Taking JCE003 may be effective at improving knee pain in patients with degenerative knee osteoarthritis and appears to be safe. Based on this study, the concentration and feasibility of the test group may be used when conducting a large-scale clinical trial of degenerative knee osteoarthritis in the future.

Effects of Neuromuscular Electrical Stimulation on Muscle Wasting with Cancer Patient: Study Protocol for a Systematic Review (신경근전기자극치료가 암환자의 근육 손실에 미치는 영향: 체계적 문헌고찰을 위한 프로토콜)

  • Eun Soo Park;Jong Hee Kim;Soo Dam Kim;Dong Hyun Kim;Min Seok Oh;Eun Jung Lee;Hwa Seung Yoo
    • Journal of Korean Medicine Rehabilitation
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    • v.33 no.2
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    • pp.49-55
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    • 2023
  • Objectives The purpose of this study is to analyze randomized controlled trials about neuromuscular electrical stimulation for muscle wasting with cancer patient and evaluate it's motor functionality effect. Methods Studies will be searched from 7 online databases (PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure [CNKI], Korean studies Information Service System [KISS], Research Information Sharing Service [RISS], Oriental Medicine Advanced Searching Integrated System [OASIS]). Participants will be cancer patients with muscle loss, regardless of cause, gender, race or age, interventions will be neuromuscular electrical stimulation. Other treatments than interventions will be the control group and the main outcome will be reviewed by motor functionality effect. Results Randomized controlled trials about neuromuscular electrical stimulation for muscle wasting should be included in the study. Primary outcomes include motor functionality effect. Secondary outcomes evaluate adverse event. The data uses Review Manager Software 5.4. Conclusions The conclusion of this study will provide a basis for determining whether neuromuscular electrical stimulation treatment for muscle wasting with cancer patient treatment is an effective and safe treatment method in clinical practice.

Impact of Controlling Nutritional Status score on short-term outcomes after carotid endarterectomy: a retrospective cohort study

  • Hee Won Son;Gyeongseok Yu;Seung Jun Lee;Jimi Oh
    • Journal of Yeungnam Medical Science
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    • v.40 no.3
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    • pp.259-267
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    • 2023
  • Background: Malnutrition and impaired immune responses significantly affect the clinical outcomes of patients with atherosclerotic stenosis. The Controlling Nutritional Status (CONUT) score has recently been utilized to evaluate perioperative immunonutritional status. This study aimed to evaluate the relationship between immunonutritional status, indexed by CONUT score, and postoperative complications in patients undergoing carotid endarterectomy (CEA). Methods: We retrospectively evaluated 188 patients who underwent elective CEA between January 2010 and December 2019. The preoperative CONUT score was calculated as the sum of the serum albumin concentration, total cholesterol level, and total lymphocyte count. The primary outcome was postoperative complications within 30 days after CEA, including major adverse cardiovascular events, pulmonary complications, stroke, renal failure, sepsis, wounds, and gastrointestinal complications. Cox proportional hazards regression analysis was used to estimate the factors associated with postoperative complications during the 30-day follow-up period. Results: Twenty-five patients (13.3%) had at least one major complication. The incidence of postoperative complications was identified more frequently in the high CONUT group (12 of 27, 44.4% vs. 13 of 161, 8.1%; p<0.001). Multivariate analyses showed that a high preoperative CONUT score was independently associated with 30-day postoperative complications (hazard ratio, 5.98; 95% confidence interval, 2.56-13.97; p<0.001). Conclusion: Our results showed that the CONUT score, a simple and readily available parameter using only objective laboratory values, is independently associated with early postoperative complications.

Effectiveness of Acupuncture and Acupotomy for Trigger Finger: A Systematic Review and Meta-Analysis

  • Hae-Won Hong;Myung-In Jeong;Hyun-Il Jo;Sun-Ho Lee;Ka-Hyun Kim;Sung-Won Choi;Jae-Won Park;Ji-Su Ha
    • Journal of Acupuncture Research
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    • v.40 no.2
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    • pp.111-128
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    • 2023
  • Trigger finger is a common cause of hand disability that results in finger catching, clicking, or locking. Conventional treatment options such as medication, injection, and surgery have limitations. Studies have indicated that acupuncture and acupotomy can be effective in treating trigger finger. However, no review regarding these treatment modalities has been published yet. This review included randomized controlled trials published until January 2023, investigating acupuncture-related interventions. The primary outcomes of interest included the effectiveness rate (ER) and pain intensity, measured using a visual analog scale (VAS) and Numerical Rating Scale (NRS), and secondary outcomes were the Quinnell grade (QG) and recurrence rate (RR). Adverse events (AEs) have also been reported wherever available. Overall, 19 studies were included, and results demonstrated that arcedge acupuncture improved the ER and QG and reduced NRS, and acupuncture was effective in reducing VAS. Compared with conventional surgery, acupotomy alone improved the ER and QG and lowered VAS and RR, with relatively fewer AEs. Acupotomy add-on treatment was more effective than conventional treatment; however, careful interpretation is needed for VAS. Acupotomy add-on treatment was more effective than acupotomy alone. However, the overall results must be interpreted with caution because of study quality, small sample size, and heterogeneity of the results.

Clinical outcomes and characteristics of acute myocardial infarction patients with developing fever after percutaneous coronary intervention

  • Jae-Geun Lee;Yeekyoung Ko;Joon Hyouk Choi;Jeong Rae Yoo;Misun Kim;Ki Yung Boo;Jong Wook Beom;Song-Yi Kim;Seung-Jae Joo
    • Journal of Medicine and Life Science
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    • v.19 no.2
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    • pp.46-56
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    • 2022
  • The incidence of fever complicating percutaneous coronary intervention (PCI) is rare. However, little is known regarding the cause of fever after PCI. Therefore, this study aimed to determine the clinical characteristics of patients with acute myocardial infarction (AMI), with or without fever, after PCI. We enrolled a total of 926 AMI patients who underwent PCI. Body temperature (BT) was measured every 4 hours or 8 hours for 5 days after PCI. Patients were divided into two groups according to BT as follows: BT<37.7℃ (no-fever group) and BT ≥37.7℃ (fever group). The 2 years clinical outcomes were compared subsequently. Fever after PCI was associated with higher incidence of major adverse cardiac events (MACE) (hazard ratio [HR], 1.56; 95% confidence interval [CI], 1.07-2.28; P=0.021), all-cause death (HR, 2.32; 95% CI, 1.18-4.45; P=0.014), cardiac death (CD) (HR, 2.57; 95% CI, 1.02-6.76; P=0.049), and any revascularization (HR, 1.69; 95% CI, 1.02-2.81; P=0.044) than without fever. In women, prior chronic kidney disease, lower left ventricular (LV) ejection fraction, higher LV wall motion score index, white blood cell count, peak creatine kinase-myocardial band level, and longer PCI duration were associated with fever after PCI. Procedures such as an intra-aortic balloon pump, extracorporeal membrane oxygenation, continuous renal replacement therapy, central and arterial line insertion, and cardiopulmonary resuscitation were related to fever after PCI. Fever after PCI in patients with AMI was associated with a higher incidence of MACE, all-cause death, CD, and any revascularization at the 2 years mark than in those without fever.

A Case Report on the Improvement of Cancer Pain in a Patient with Metastatic Non-Small Cell Lung Cancer Through Herbal Medicine-based Integrative Cancer Treatment with Chemotherapy (항암화학요법과 병행한 한의기반 통합암치료를 통한 전이성 비소세포폐암 환자의 암성 통증 호전 증례보고)

  • Young-min Cho;Jae-ho Yang;Han-eum Joo;So-jeong Park;Ji-hye Park;Hwa-seung Yoo
    • The Journal of Internal Korean Medicine
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    • v.44 no.3
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    • pp.594-601
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    • 2023
  • Objective: To demonstrate an improvement in metastatic cancer pain and a decrease in tumor size in a patient with non-small cell lung cancer. Method: A 53-year-old female patient diagnosed with metastatic non-small cell lung cancer in August 2022 underwent integrative cancer treatment (ICT) for two months to decrease the tumor size and improve back pain from bone metastasis. The patient underwent chemotherapy with ICT. Radiologic outcomes were assessed by chest, abdomen, and pelvis computed tomography based on the Response Evaluation Criteria in Solid Tumors (RECIST) protocol. Clinical outcomes were assessed using National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE), Eastern Cooperative Oncology Group (ECOG), and a numeric rating scale (NRS). Result: During the two months of treatment, the NRS scores for back pain were improved, and the ECOG score improved from grade 2 to 1. The size and metabolic activity of the primary lung tumor decreased and underwent partial remission based on RECIST. No serious side effects of grade 3 or higher were noted on the NCI-CTCAE test. Conclusion: This case suggests that ICT may have a therapeutic effect for cancer pain and a synergetic effect with chemotherapy for metastatic non-small cell lung cancer.

Prothrombin Complex Concentrate versus Fresh Frozen Plasma in Adult Patients Undergoing Cardiac Surgery: A Systematic Review and Meta-Analysis

  • Patricia Viana;Jessica Hoffmann Relvas;Marina Persson;Thamiris Dias Delfino Cabral;Jorge Eduardo Persson;Jessica Sales de Oliveira;Paulo Bonow;Camila Veronica Souza Freire;Sara Amaral
    • Journal of Chest Surgery
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    • v.57 no.1
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    • pp.25-35
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    • 2024
  • Background: Prothrombin complex concentrate (PCC) and fresh frozen plasma (FFP) are commonly used to manage bleeding in patients during cardiac surgery. However, the relative efficacy and safety of these 2 strategies remain uncertain. Methods: MEDLINE, Embase, and Cochrane were searched for studies comparing PCC and FFP in patients who underwent cardiac surgery complicated by bleeding. Review Manager (RevMan) ver. 5.4 (Nordic Cochrane Centre, The Cochrane Collaboration) was used for statistical analysis. Binary and continuous outcomes were compared using pooled risk ratios and mean differences, respectively. The meta-analysis protocol was registered in the International Prospective Register of Systematic Reviews under protocol number CRD42022379144. Results: We included 8 studies with 1,500 patients, of whom 613 (40.9%) received PCC. The mean follow-up period ranged from 28 to 90 days. The PCC group had significantly lower chest tube drainage at 24 hours (mean difference [MD], -148.50 mL; 95% CI, -253.02 to -43.99 mL; p=0.005; I2 =42%). Fewer units of red blood cells (RBCs) were transfused within the first 24 hours (MD, -1.02 units; 95% CI, -1.81 to -0.24 units; p=0.01; I2 =56%), and fewer patients required RBC transfusion within the first 24 hours (risk ratio, 0.85; 95% CI, 0.78-0.93; p<0.007; I2 =45%) in the PCC group. There were no statistically significant differences in secondary outcomes. Nonetheless, a subgroup analysis of randomized controlled trials failed to corroborate the results obtained from the main analysis. Conclusion: Our findings suggest that PCC can be effective, without increased adverse events, when compared with FFP in patients undergoing cardiac surgery complicated by bleeding.

Is It Safe to Preserve Left Atrial Appendage During Maze Procedure?

  • Kyungsub Song;Woo Sung Jang;Namhee Park;Yun Seok Kim;Jae Bum Kim
    • Korean Circulation Journal
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    • v.53 no.8
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    • pp.566-577
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    • 2023
  • Background and Objectives: The left atrial appendage (LAA) can contribute significantly to LA mechanical contraction. Nevertheless, the preventive effect of LAA occlusion during the maze procedure against cerebral infarction remains controversial. In this study, we compared the surgical, cardiac hemodynamic, and neurologic outcomes between LAA preservation and occlusion performed during the maze procedure. Methods: Between January 2015 and August 2021, 252 patients underwent the maze procedure using cryoablation at our medical center. After excluding patients according to our exclusion criteria (i.e., mechanical prosthesis implantation, preexisting LAA thrombus), LAA was preserved in 113 patients (non-occlusion group) and occluded in 75 patients (occlusion group). Outcomes were compared using propensity score matching (PSM). Results: PSM did not reveal significant intergroup differences in baseline characteristics between the non-occlusion (n=53) and occlusion (n=53) groups. During a median follow-up of 44 months, 2 patients in the non-occlusion group (3.8%) experienced ischemic strokes. There was no significant difference in the rate of freedom from stroke (p=0.19) and major adverse cardiac events (p=0.43) between the 2 groups. Through echocardiography at 1-year follow-up, a statistically significant difference in LA mechanical contraction was observed between the non-occlusion group and occlusion group (24 of 33 [72.7%] vs. 18 of 37 [48.6%], respectively; p=0.04). Conclusions: In this study, preservation of the LAA during the maze procedure resulted in better LA function than LAA occlusion, with similar rates of stroke.