• Title/Summary/Keyword: Adverse outcomes

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No benefit of hypomethylating agents compared to supportive care for higher risk myelodysplastic syndrome

  • Sohn, Sang Kyun;Moon, Joon Ho;Lee, In Hee;Ahn, Jae Sook;Kim, Hyeoung Joon;Chung, Joo Seop;Shin, Ho Jin;Park, Sung Woo;Lee, Won Sik;Lee, Sang Min;Kim, Hawk;Lee, Ho Sup;Kim, Yang Soo;Cho, Yoon Young;Bae, Sung Hwa;Lee, Ji Hyun;Kim, Sung Hyun;Song, Ik Chan;Kwon, Ji Hyun;Lee, Yoo Jin
    • The Korean journal of internal medicine
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    • v.33 no.6
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    • pp.1194-1202
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    • 2018
  • Background/Aims: This study evaluated the role of hypomethylating agents (HMA) compared to best supportive care (BSC) for patients with high or very-high (H/VH) risk myelodysplastic syndrome (MDS) according to the Revised International Prognostic Scoring System. Methods: A total of 279 H/VH risk MDS patients registered in the Korean MDS Working Party database were retrospectively analyzed. Results: HMA therapy was administered to 205 patients (73.5%), including 31 patients (11.1%) who then received allogeneic hematopoietic cell transplantation (allo-HCT), while 74 patients (26.5%) received BSC or allo-HCT without HMA. The 3-year overall survival (OS) rates were $53.1%{\pm}10.7%$ for allo-HCT with HMA, $75%{\pm}21.7%$ for allo-HCT without HMA, $17.3%{\pm}3.6%$ for HMA, and $20.8%{\pm}6.9%$ for BSC groups (p < 0.001). In the multivariate analysis, only allo-HCT was related with favorable OS (hazard ratio [HR], 0.356; p = 0.002), while very poor cytogenetic risk (HR, 5.696; p = 0.042), age ${\geq}65years$ (HR, 1.578; p = 0.022), Eastern Cooperative Oncology Group performance status (ECOG PS) 2 to 4 (HR, 2.837; p < 0.001), and transformation to acute myeloid leukemia (AML) (HR, 1.901; p = 0.001) all had an adverse effect on OS. Conclusions: For the H/VH risk group, very poor cytogenetic risk, age ${\geq}65years$, ECOG PS 2 to 4, and AML transformation were poor prognostic factors. HMA showed no benefit in terms of OS when compared to BSC. Allo-HCT was the only factor predicting a favorable long-term outcome. The use of HMA therapy did not seem to have an adverse effect on the transplantation outcomes. However, the conclusion of this study should be carefully interpreted and proven by large scale research in the future.

Evolution of Process and Outcome Measures during an Enhanced Recovery after Thoracic Surgery Program

  • Lee, Alex;Seyednejad, Nazgol;Lawati, Yaseen Al;Mattice, Amanda;Anstee, Caitlin;Legacy, Mark;Gilbert, Sebastien;Maziak, Donna E.;Sundaresan, Ramanadhan S.;Villeneuve, Patrick J.;Thompson, Calvin;Seely, Andrew J.E.
    • Journal of Chest Surgery
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    • v.55 no.2
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    • pp.118-125
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    • 2022
  • Background: A time course analysis was undertaken to evaluate how perioperative process-of-care and outcome measures evolved after implementation of an enhanced recovery after thoracic surgery (ERATS) program. Methods: Outcome and process-of-care measures were compared between patients undergoing major elective thoracic surgery during a 9-month pre-ERATS implementation period to those at 1-3, 4-6, and 7-9 months post-ERATS implementation. Outcome measures included length of stay, the 30-day readmission rate, 30-day emergency department visits, and minor and major adverse events. Process measures included first time to activity, out-of-bed, ambulation, fluid diet, diet as tolerated, as well as removal of the first and last chest tube, epidural, patient-controlled analgesia, and Foley and intravenous catheters. Results: In total, 704 patients (352 pre-ERATS, 352 post-ERATS) were included. Mobilization-related process measures, including time to first activity (16.5 vs. 6.8 hours, p<0.001), out-of-bed (17.6 vs. 8.9 hours, p<0.001), and ambulation (32.4 vs. 25.4 hours, p=0.04) saw statistically significant improvements by 1-3 months post-ERATS implementation compared to pre-ERATS. Time to Foley removal improved by 4-6 months post-ERATS (19.5 vs. 18.2 hours, p=0.003). Outcome measures, including the 30-day readmission rate and emergency department visits, steadily decreased post-ERATS. By 7-9 months post-ERATS, both minor (18.2% vs. 7.9%, p=0.009) and major (13.6% vs. 4.4%, p=0.007) adverse events demonstrated statistically significant improvements. Length of stay trended towards improvement from 6.2 days pre-ERATS to 4.8 days by 7-9 months post-ERATS (p=0.06). Conclusion: The adoption of ERATS led to improvements in multiple process-of-care measures, which may collectively and gradually achieve optimization of clinical outcomes.

A Comparative Clinical Study on an Electronic Moxibustion with Acupuncture for Dry Eye Syndrome (건성안 증후군에 대한 전자뜸과 침의 효과 비교 임상연구)

  • Ji-Shik Park;Ji-Hoon Song;Min-Yeong Jung;Jung-Hwa Choi;Soo-Yeon Park
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.36 no.1
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    • pp.64-77
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    • 2023
  • Objectives : Recently, the number of patients with dry eye syndrome has been steadily increasing. However, established treatment for it does not yet exist. This study compared electronic moxibustion with acupuncture for patients with dry eye in terms of efficacy and safety. Methods : This trial was designed as an investigator-initiated, single-blinded, comparative, randomized controlled trial. Thirty patients with dry eye were randomized to the electronic moxibustion treatment group(EMG) or the acupuncture treatment group(AG) in equal proportion. The participants who assigned to the EMG were treated with electronic moxibustion to ten acupoints including both sides of BL2, GB14, TE23, and LI4 for 12 minutes. The participants who were assigned to the AG were treated with acupuncture to the same acupoints for 15 minutes. Over 4 weeks, each intervention was carried out twelve times in total. The primary outcome was the ocular surface disease index(OSDI). The secondary outcomes were the subjective symptoms visual analog scale(VAS), quality of life(QoL), Schirmer I test(SIT), and general assessment. Adverse events and vital signs were also investigated for safety assessment. Results : In intragroup comparisons, both the EMG and the AG significantly improved the OSDI scores, the subjective symptoms VAS scores, the QoL scores, and the SIT results after 4 weeks of the trial. However, there were no statistical differences in intergroup comparisons between the two groups after 4 weeks. The safety of electronic moxibustion and acupuncture was confirmed by no occurrence of serious adverse events. Conclusions : Both electronic moxibustion and acupuncture were effective for dry eye syndrome, and they were safe. Electronic moxibustion and acupuncture can be used for dry eye syndrome as equivalent treatments.

The Effectiveness and Safety of Dokwhalkisaeng-tang Combined with the Medication on Rheumatoid Arthritis: A Study Protocol for Systematic Review and Meta-analysis (류마티스 관절염 치료제와 병용한 독활기생탕의 효과 및 안전성: 체계적 문헌고찰 및 메타분석 프로토콜)

  • Chae, Soo-Yeon;Jung, Chan-Yung;Kim, Joo-Hee;Kim, Eun-Jung;Seo, Byung-Kwan;Hwang, Min-Seop;Park, Seong-Sik;Kim, Kyung-Ho;Yoon, Jong-hwa;Sung, Won-Suk
    • Herbal Formula Science
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    • v.30 no.2
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    • pp.95-100
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    • 2022
  • Objectives : Recent studies reported that Dokwhalkisaeng-tang (DHJST) could relieve the clinical rheumatoid arthritis (RA) symptoms and the level of RA-related blood test. However, evidence-based review on effectiveness and safety of DHJST with medication on RA was not yet provided. Methods : Searching randomized controlled trials on the use of DHJST for RA will be performed using multiple electronic databases, manual search, and contact to author. Studies will be selected according to the pre-defined criteria and collected data on study participants, interventions, control groups, outcome measurements, the results, adverse events, and risk of bias will be summarized. Primary outcome will be the disease activity score (including effective rate, swollen joint count, tender joint count, and morning stiffness), and the secondary outcomes will be RA-related blood test and adverse events. We will use Review Manager software to perform a meta-analysis, Cochrane Collaboration "risk of bias" tool for assessing the risk of bias, and Grades of Recommendation, Assessment, Development and Evaluation for the determination of quality of evidence. Results : We are going to investigate the effectiveness and safety of DHJST with medication for RA. Conclusion : This study will provide reliable evidence on whether DHJST combined with medicine is more effective on RA than medicine monotherapy.

Safety and efficacy of target controlled infusion administration of propofol and remifentanil for moderate sedation in non-hospital dental practice

  • Douglas Lobb;Masoud MiriMoghaddam;Don Macalister;David Chrisp;Graham Shaw;Hollis Lai
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.23 no.1
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    • pp.19-28
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    • 2023
  • Background: Fearful and anxious patients who find dental treatment intolerable without sedative and analgesic support may benefit from moderate sedation. Target controlled infusion (TCI) pumps are superior to bolus injection in maintaining low plasma and effect-site concentration variability, resulting in stable, steady-state drug concentrations. We evaluated the safety and efficacy of moderate sedation with remifentanil and propofol using TCI pumps in non-hospital dental settings. Methods: A prospective chart review was conducted on 101 patients sedated with propofol and remifentanil using TCI pumps. The charts were completed at two oral surgeons and one general dentist's office over 6 months. Hypoxia, hypotension, bradycardia, and over-sedation were considered adverse events and were collected using Tracking and Reporting Outcomes of Procedural Sedation (TROOPS). Furthermore, patient recovery time, sedation length, drug dose, and patient satisfaction questionnaires were used to measure sedation effectiveness. Results: Of the 101 reviewed sedation charts, 54 were of men, and 47 were of women. The mean age of the patients was 40.5 ±18.7 years, and their mean BMI was 25.6 ± 4.4. The patients did not experience hypoxia, bradycardia, and hypotension during the 4694 min of sedation. The average minimum Mean Arterial Pressure (MAP) and heartbeats were 75.1 mmHg and 60.4 bpm, respectively. 98% of patients agreed that the sedation technique met their needs in reducing their anxiety, and 99% agreed that they were satisfied with the sedation 24 hours later. The average sedation time was 46.9 ± 55.6 min, and the average recovery time was 12.4 ± 4.4 min. Remifentanil and propofol had mean initial effect-site concentration doses of 0.96 µ/.ml and 1.0 ng/ml respectively. The overall total amount of drug administered was significantly higher in longer sedation procedures compared to shorter ones, while the infusion rate decreased as the procedural stimulus decreased. Conclusion: According to the results of this study, no patients experienced adverse events during sedation, and all patients were kept at a moderate sedation level for a wide range of sedation times and differing procedures. The results showed that TCI pumps are safe and effective for administering propofol and remifentanil for moderate sedation in dentistry.

CT-Based Leiden Score Outperforms Confirm Score in Predicting Major Adverse Cardiovascular Events for Diabetic Patients with Suspected Coronary Artery Disease

  • Zinuan Liu;Yipu Ding;Guanhua Dou;Xi Wang;Dongkai Shan;Bai He;Jing Jing;Yundai Chen;Junjie Yang
    • Korean Journal of Radiology
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    • v.23 no.10
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    • pp.939-948
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    • 2022
  • Objective: Evidence supports the efficacy of coronary computed tomography angiography (CCTA)-based risk scores in cardiovascular risk stratification of patients with suspected coronary artery disease (CAD). We aimed to compare two CCTA-based risk score algorithms, Leiden and Confirm scores, in patients with diabetes mellitus (DM) and suspected CAD. Materials and Methods: This single-center prospective cohort study consecutively included 1241 DM patients (54.1% male, 60.2 ± 10.4 years) referred for CCTA for suspected CAD in 2015-2017. Leiden and Confirm scores were calculated and stratified as < 5 (reference), 5-20, and > 20 for Leiden and < 14.3 (reference), 14.3-19.5, and > 19.5 for Confirm. Major adverse cardiovascular events (MACE) were defined as the composite outcomes of cardiovascular death, nonfatal myocardial infarction (MI), stroke, and unstable angina requiring hospitalization. The Cox model and Kaplan-Meier method were used to evaluate the effect size of the risk scores on MACE. The area under the curve (AUC) at the median follow-up time was also compared between score algorithms. Results: During a median follow-up of 31 months (interquartile range, 27.6-37.3 months), 131 of MACE were recorded, including 17 cardiovascular deaths, 28 nonfatal MIs, 64 unstable anginas requiring hospitalization, and 22 strokes. An incremental incidence of MACE was observed in both Leiden and Confirm scores, with an increase in the scores (log-rank p < 0.001). In the multivariable analysis, compared with Leiden score < 5, the hazard ratios for Leiden scores of 5-20 and > 20 were 2.37 (95% confidence interval [CI]: 1.53-3.69; p < 0.001) and 4.39 (95% CI: 2.40-8.01; p < 0.001), respectively, while the Confirm score did not demonstrate a statistically significant association with the risk of MACE. The Leiden score showed a greater AUC of 0.840 compared to 0.777 for the Confirm score (p < 0.001). Conclusion: CCTA-based risk score algorithms could be used as reliable cardiovascular risk predictors in patients with DM and suspected CAD, among which the Leiden score outperformed the Confirm score in predicting MACE.

Prostatic Artery Embolization for Lower Urinary Tract Symptoms via Transradial Versus Transfemoral Artery Access: Single-Center Technical Outcomes

  • Ryun Gil;Dong Jae Shim;Doyoung Kim;Dong Hwan Lee;Jung Jun Kim;Jung Whee Lee
    • Korean Journal of Radiology
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    • v.23 no.5
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    • pp.548-554
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    • 2022
  • Objective: To evaluate the safety and feasibility of prostatic artery embolization (PAE) via transradial access (TRA) compared with transfemoral access (TFA). Materials and Methods: This retrospective study included 53 consecutive men with lower urinary tract symptoms (LUTS) who underwent PAE between September 2018 and September 2021. Thirty-one patients (mean age ± standard deviation: 70.6 ± 8.4 years) were treated with TFA, including 14 patients treated before adopting TRA. Since December 2019, TRA has also been attempted with the procedure's selection criteria of patent carpal circulation and a height ≤ 172 cm, with 22 patients treated via TRA (69.1 ± 9.6 years). Parameters of technical success (defined as successful bilateral embolization), clinical success (defined as LUTS improvement), procedural time, radiation dose, and adverse events were compared between the two groups using the Fisher's exact test, independent sample t test, Wilcoxon signed-rank test, or Mann-Whitney test. Results: All patients received at least one-side PAE. Technical success of PAE was achieved in most patients (TRA, 21/22; TFA, 30/31; p > 0.999). No technical problem-related conversion from TRA to TFA occurred. The clinical success rate was 85% (11/13) in patients with TRA, and 89% (16/18) in patients with TFA for follow-up > 2 weeks post-PAE (median, 3 months) (p > 0.999). The median procedure time was similar in both groups (TRA, 81 minutes vs. TFA, 94 minutes; p = 0.570). No significant dose differences were found between the TRA and TFA groups in the dose-area product (median Gycm2, 95 [range, 44-255] for TRA and 84 [34-255] for TFA; p = 0.678) or cumulative air kerma (median mGy, 609 [236-1584] for TRA and 634 [217-1594] for TFA; p = 0.551). No major adverse events occurred in either of the groups. Conclusion: PAE via TRA is a safe and feasible method comparable to conventional TFA. It can be safely implemented by selecting patients with patent carpal circulation and adequate height.

Pharmacoacupuncture for the Treatment of Frozen Shoulder: protocol for a systematic review and meta-analysis

  • Ji-Ho Lee;Hyeon-Sun Park;Sang-Hyeon Park;Dong-Ho Keum;Seo-Hyun Park
    • Journal of Pharmacopuncture
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    • v.27 no.1
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    • pp.14-20
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    • 2024
  • Objectives: Frozen shoulder (FS) is one of the most challenging shoulder disorders for patients and clinicians. Its symptoms mainly include any combination of stiffness, nocturnal pain, and limitation of active and passive glenohumeral joint movement. Conventional treatment options for FS are physical therapy, nonsteroidal anti-inflammatory drugs, injection therapy, and arthroscopic capsular release, but adverse and limited effects continue to present problems. As a result, pharmacoacupuncture (PA) is getting attention as an alternative therapy for patients with FS. PA is a new form of acupuncture treatment in traditional Korean medicine (TKM) that is mainly used for musculoskeletal diseases. It has similarity and specificity compared to corticosteroid injection and hydrodilatation, making it a potential alternative injection therapy for FS. However, no systematic reviews investigating the utilization of PA for FS have been published. Therefore, this review aims to standardize the clinical use of PA for FS and validate its therapeutic effect. Methods: The protocol was registered in Prospero (CRD42023445708) on 18 July 2023. Until Aug. 31, 2023, seven electronic databases will be searched for randomized controlled trials of PA for FS. Authors will be contacted, and manual searches will also be performed. Two reviewers will independently screen and collect data from retrieved articles according to predefined criteria. The primary outcome will be pain intensity, and secondary outcomes will be effective rate, Constant-Murley Score, Shoulder Pain and Disability Index, range of motion, quality of life, and adverse events. Bias and quality of the included trials will be assessed using the Cochrane handbook's risk-of-bias tool for randomized trials. Meta analyses will be conducted using Review Manager V.5.3 software. GRADE will be used to evaluate the level of evidence for each outcome. Results: This systematic review and meta-analysis will be conducted following PRISMA statement. The results will be published in a peer-reviewed journal. Conclusion: This review will provide scientific evidence to support health insurance policy as well as the standardization of PA in clinical practice.

Dioxins and Health: Human Exposure Level and Epidemiologic Evidences of Health Effects (다이옥신과 건강: 인체 노출 수준 및 건강영향에 대한 역학적 연구)

  • Jang, Jae-Yeon;Kwon, Ho-Jang
    • Journal of Preventive Medicine and Public Health
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    • v.36 no.4
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    • pp.303-313
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    • 2003
  • General information is summarized, that is necessary to introduce a scientific assessment of the human health and exposure issue concerning dioxin and dioxin-like compound. Scientific literatures were reviewed to assess the background exposures to the dioxin-like compounds for normal residents. Epidemiologic studies were also reviewed to assess malignant and nonmalignant sweets of dioxins. In 1997, the International Agency for Research on Cancer classified 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) as a human carcinogen, primarily based on occupational cohort studies. The US Environmental Protection Agency made the same decision in it's Draft Dioxin Reassessment. Epidemiologic evidences point to a generalized excess of all cancers, without any pronounced excess at specific sites. Reported non-cancer effects included a range of conditions affecting most systems. Among them, chloracne, elevation in gamma glutamyl transferase(GGT), and alterations in reproductive hormones are related to TCDO, Other adverse outcomes, such as lipid concentrations, diabetes, circulatory and heart diseases, immunologic disorders, neurobehavioral effects, and developmental outcomes require further study before their respective relationships to TCDD can be more definitively assessed.

Initial clinical outcomes of proton beam radiotherapy for hepatocellular carcinoma

  • Yu, Jeong Il;Yoo, Gyu Sang;Cho, Sungkoo;Jung, Sang Hoon;Han, Youngyih;Park, Seyjoon;Lee, Boram;Kang, Wonseok;Sinn, Dong Hyun;Paik, Yong-Han;Gwak, Geum-Youn;Choi, Moon Seok;Lee, Joon Hyeok;Koh, Kwang Cheol;Paik, Seung Woon;Park, Hee Chul
    • Radiation Oncology Journal
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    • v.36 no.1
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    • pp.25-34
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    • 2018
  • Purpose: This study aimed to evaluate the initial outcomes of proton beam therapy (PBT) for hepatocellular carcinoma (HCC) in terms of tumor response and safety. Materials and Methods: HCC patients who were not indicated for standard curative local modalities and who were treated with PBT at Samsung Medical Center from January 2016 to February 2017 were enrolled. Toxicity was scored using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Tumor response was evaluated using modified Response Evaluation Criteria in Solid Tumors (mRECIST). Results: A total of 101 HCC patients treated with PBT were included. Patients were treated with an equivalent dose of $62-92GyE_{10}$. Liver function status was not significantly affected after PBT. Greater than 80% of patients had Child-Pugh class A and albumin-bilirubin (ALBI) grade 1 up to 3-months after PBT. Of 78 patients followed for three months after PBT, infield complete and partial responses were achieved in 54 (69.2%) and 14 (17.9%) patients, respectively. Conclusion: PBT treatment of HCC patients showed a favorable infield complete response rate of 69.2% with acceptable acute toxicity. An additional follow-up study of these patients will be conducted.