• 제목/요약/키워드: randomized clinical

검색결과 2,003건 처리시간 0.031초

Ki67 Index Is the Most Powerful Factor for Predicting the Recurrence in Atypical Meningioma : Retrospective Analysis of 99 Patients in Two Institutes

  • Lee, Sang Hyuk;Lee, Eun Hee;Sung, Kyoung Su;Kim, Dae Cheol;Kim, Young Zoon;Song, Young Jin
    • Journal of Korean Neurosurgical Society
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    • 제65권4호
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    • pp.558-571
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    • 2022
  • Objective : The primary objective of this study was to identify predicting factors for local control (LC) of atypical meningioma, and we validated them with comparing the predicting factors for recurrence-free survival (RFS). We also examined the rate of LC after surgical resection with or without adjuvant treatment and RFS. Methods : Clinical and radiological records of patients with atypical meningiomas diagnosed at two institutes from January 2000 to December 2018 were reviewed retrospectively. Histopathological features were also reviewed using formalin-fixed paraffin embedded samples from pathological archives. Results : Of the 99 atypical meningiomas eligible for analysis, 36 (36.4%) recurred during the follow-up period (mean, 83.3 months; range, 12-232 months). The rate of 3-year LC and 5-year LC was 80.8% and 74.7%, respectively. The mean time-to-recurrence was 49.4 months (range, 12-150). The mean RFS was 149.3 months (95% confidence interval, 128.8-169.8 months) during the mean follow-up duration of 83.3 months (range, 12-232 months). Multivariate analysis using Cox proportional-hazard regression model showed that the extent of resection (hazard ratio [HR], 4.761; p=0.013), Ki67 index (HR, 8.541; p=0.004), mitotic index (HR, 3.275; p=0.044), and tumor size (HR, 3.228; p=0.041) were independently associated with LC. These factors were also statistically associated with RFS. In terms of radiotherapy after surgical resection, the recurrence was not prevented by immediate radiotherapy because of the strong effect of proliferative index on recurrence. Conclusion : The present study suggests that the extent of resection, proliferative index (according to Ki67 expression) and mitotic index, and tumor size are associated with recurrence of atypical meningiomas. However, our results should be further validated through prospective and randomized clinical trials to overcome the inborn bias of retrospective nature of the study design.

Addition of 2 mg dexamethasone to improve the anesthetic efficacy of 2% lidocaine with 1:80,000 epinephrine administered for inferior alveolar nerve block to patients with symptomatic irreversible pulpitis in the mandibular molars: a randomized double-blind clinical trial

  • Aggarwal, Vivek;Ahmad, Tanveer;Singla, Mamta;Gupta, Alpa;Saatchi, Masoud;Hasija, Mukesh;Meena, Babita;Kumar, Umesh
    • Journal of Dental Anesthesia and Pain Medicine
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    • 제22권4호
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    • pp.305-314
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    • 2022
  • Introduction: This clinical trial aimed to evaluate the anesthetic effect of the addition of 2 mg (4 mg/ml) of dexamethasone to 2% lidocaine (plain or with 1:80,000 epinephrine). The solutions were injected for a primary inferior alveolar nerve block (IANB) to provide mandibular anesthesia for the endodontic treatment of mandibular molars with symptomatic irreversible pulpitis. Methods: In a double-blinded setup, 124 patients randomly received either of the following injections: 2% lidocaine with 1:80,000 epinephrine, 2% lidocaine with 1:80,000 epinephrine mixed with 2 mg dexamethasone, or plain 2% lidocaine mixed with 2 mg dexamethasone, which were injected as a primary IANB. Ten minutes after injection, patients with profound lip numbness underwent electric and thermal pulp sensibility tests. Patients who responded positively to the tests were categorized as "failed" anesthesia and received supplemental anesthesia. The remaining patients underwent endodontic treatment using a rubber dam. Anesthetic success was defined as "no pain or faint/weak/mild pain" during endodontic access preparation and instrumentation (HP visual analog scale score < 55 mm). The effect of the anesthetic solutions on the maximum change in heart rate was also evaluated. The Pearson chi-square test at 5% and 1% significance was used to analyze anesthetic success rates. Results: The 2% lidocaine with 1:80,000 epinephrine, 2% lidocaine with 1:80,000 epinephrine mixed with 2 mg dexamethasone, and plain 2% lidocaine mixed with 2 mg dexamethasone groups had anesthetic success rates of 34%, 59%, and 29%, respectively. The addition of dexamethasone resulted in significantly better results (P < 0.001, 𝛘2 = 9.07, df = 2). Conclusions: The addition of dexamethasone to 2% lidocaine with epinephrine, administered as an IANB, can improve the anesthetic success rates during the endodontic management of symptomatic mandibular molars with irreversible pulpitis.

간호·간병통합서비스 병동에서의 환자참여 침상인계 프로토콜 적용 효과 (The Effect of Patient-Engaged Bedside Handoffs Protocol in Comprehensive Care Units)

  • 이보영;박경진;임재현;송아름;연미향;송현주;전도진;백규원;장주영;최수정
    • 임상간호연구
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    • 제28권3호
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    • pp.223-232
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    • 2022
  • Purpose: The purpose of this study was to apply patient-engaged bedside handoffs in comprehensive care units, and to evaluate the effects of bedsides to nurses and patients. Methods: This study employed a cluster randomized cross-over design.Electrical Medical Record (EMR)-based handoffs and patient-engaged bedside handoffs were alternatively applied to 104 patients, who were assigned to a total of 30 clusters (nursing handoff teams) in 4 comprehensive care units at the S medical center in Seoul, and the patients evaluated each type of handoffs. A total of 139 nurses were also participated in the same units and evaluated each type of handoffs. Data were analyzed using t-test, Wilcoxon rank sum test, ANOVA, and Kruskal-Walls test. Results: The patient's satisfaction of the patient-engaged bedside handoffs was higher than that of the EMR-based handoffs (Z=-5.16, p<.001). On the other hand, the nurse's satisfaction of the patient-engaged bedside handoffs was significantly lower than that of the EMR-based handoffs (t=13.21, p<.001). There were no differences in length of the reporting time between two types of handoffs (t=-0.48, p=.634). Conclusion: Patient satisfaction with the patient-engaged bedside handoffs was higher than that of EMR-based handoffs, and nurses' satisfaction with the patient-engaged bedside handoffs was significantly lower than that of EMR-based handoffs. Future studies are needed regarding the impacts of patient-engaged bedside handoffs on the quality of healthcare by identifying the benefits of the handoffs.

Randomized clinical trial to evaluate the efficacy and safety of two types of sandblasted with large-grit and acid-etched surface implants with different surface roughness

  • Jeon, Jun-Hyung;Kim, Min-Joong;Yun, Pil-Young;Jo, Deuk-Won;Kim, Young-Kyun
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • 제48권4호
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    • pp.225-231
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    • 2022
  • Objectives: This study aims to evaluate the efficacy and safety of two types of sandblasted with large-grit and acid-etched (SLA) surface implants with different surface roughness. Patients and Methods: This study was conducted based on a clinical record review of 55 patients (mean age, 53.00 years). A total of 80 SLA surface implants was placed. Among the 80 implants, 38 implants placed in 29 subjects had surface roughness (Ra) of 3.09 ㎛ (test group, TG), while the other 42 implants placed in 31 subjects had a surface roughness (Ra) of 2.50 ㎛ (control group, CG). A comparison was made of implant primary/secondary stability; success and survival rates; marginal bone loss; and soft tissue assessment including probing pocket depth (PPD), plaque index (PI), gingival index (GI), and bleeding on probing (BOP) between the groups at 1 year after implant placement. Results: Among the implants that were initially registered, 1 from the TG and 4 from the CG dropped out, leaving 37 implants in the TG and 38 implants in the CG to be traced and analyzed. Although 1 TG case showed unstable primary stability, all cases showed stable secondary stability. Success and survival rates at 1 year after implant placement were 100% in both groups. Marginal bone loss was 0.07 mm and 0.00 mm for the TG and CG, respectively, but the difference was not significant. Among the several parameters for evaluation of soft tissue, the TG showed lower PI at 1 year after implant placement (TG=0.00, CG=0.29; P=0.0004), while the remaining categories showed no significant difference between the groups. Conclusion: This study shows that the two types of SLA implants with different surface roughness have no difference in efficacy or safety. Therefore, both of the implants can be used safely and with promising outcomes.

전립선비대증에 대한 열민구(熱敏灸)의 효과에 관한 체계적 문헌 고찰 (A Systematic Review of effect on Heat-sensitive Moxibustion for Benign Prostatic Hyperplasia)

  • 김민석;주홍민;김민화;박선영;윤영주;박성하
    • 대한한의학회지
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    • 제42권3호
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    • pp.153-164
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    • 2021
  • Objectives: The aim of this study is to investigate the effect of Heat-sensitive Moxibustion on Benign Prostatic Hyperplasia Methods: We searched articles from Academic Journals(CAJ) online databases, Oriental Medicine Advanced Searching Integrated System (OASIS), Searching key words were '前列腺增生', '熱敏灸' and '열민구', '전립선비대'. The search range included randomized controlled trials (RCTs). Among the articles published to 2020, 10 articles were found. After review the title, abstract and original, 3 articles were selected finally to rule out treatment combined with completely different treatments. Result: The Heat-sensitive moxibustion at acupoints in the treatment of Benign prostatic hyperplasia were significantly superior to control group after treatment in the symptoms of patients, IPSS, QOL, PVR and Qmax(P<0.05). The Heat-sensitive moxibustion can significantly reduce the incidence of temporary urinary incontinence after Transurethral resection of the prostate(TURP) and improve life quality and satisfaction of patients(P<0.05). The individualized desensitization saturated time and amount of Heat-sensitive moxibustion is superior effective to general amount and time of traditional moxibustion in the total effective rate, IPSS, Ru and Qmax(P<0.01) for Benign prostatic hyperplasia. Conclusion: Heat sensitive moxibustion directly transfer heat to the source of a disease. So it can be considered as a good treatment for Benign prostate hypertrophy. It was also shown a better effect on BPH compared to traditional moxibustion, According to the thermo principles of tumor, if the tumor cell's death temperature of 43℃ is reached, that can cause tumor degeneration. Therefore I think Heat sensitive moxibustion can be applied to various tumor disease. The results of this study could be applied to clinical treatment of BPH. However, additional large-scale clinical researches should be conducted.

아킬레스 건병증의 한의학적 치료에 대한 국내외 연구 동향 분석 (A Narrative Review of the Korean Medicine Treatments for Achilles Tendinopathy)

  • 윤경영;황동욱;배인수;윤준흠;이유진;장원석;유상준;이도훈;강동협;손자연;양석규;조현우
    • 한방재활의학과학회지
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    • 제32권4호
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    • pp.33-45
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    • 2022
  • Objectives The purpose of this review was to investigate clinical treatment trends of Achilles tendinopathy. Methods Clinical studies about Korean medicine treatments on Achilles tendinopathy were searched in 5 databases. The included studies were classified according to the authors, published years, study designs, purposes of study, methods, interventions outcome measures and adverse event. Results In 23 studies, total number of patients were 1,135. The included studies consist of 14 randomized controlled trials (RCT), 5 non-RCT, 2 retrospective study and 2 case reports. Patients were conducted with 9 kinds of treatment, which is acupuncture, electro-acupuncture, pharmacopuncture, acupotomy, moxibustion, cupping, Chuna, herbal medicine, physiotherapy. Most studies used visual analogue scale as primary outcome. Conclusions Based on the results of the collected studies, the use of Korean medicine treatment on Achilles tendinopathy seem to be effective. Despite the large number of RCTs, the level of research cannot be guaranteed, so it is considered that more rigorous researches are needed in future studies.

천왕보심단(天王補心丹)∘쌀발효추출물(GABAːgamma-aminobutyric acid 30%) 복합물의 항(抗)스트레스에 대한 유효성 연구ː무작위 배정 및 이중맹검 (Study on the Anti-stress Effect of Chenwangbosim-Dan Extract∘Fermented Rice Extract (GABA ː gamma-aminobutyric acid 30%) Complex : A double-blind, randomized, placebo-controlled study)

  • 홍초영;서상권;나승곤;조호성;이미경;진무현;노석선;주영승
    • 대한본초학회지
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    • 제38권2호
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    • pp.1-7
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    • 2023
  • Objectives : From this study, we sight to identify Anti-stress effect of Chenwangbosim-Dan (Tianwangbuxin-Dan) Extract∘Fermented Rice Extract (GABA : gamma-aminobutyric acid 30%) Complex Methods : In order to measure the degree of functional evaluation of tension relief due to stress, it was evaluated whether the psychological indicators VAS(Visual Analog Scale) and POMS(Profile Of Mood State) were improved. Which is generally used for stress measurement and has a high frequency of clinical use. All clinical trial subjects were required to take the drug once a day at 9 ± 30 min in the morning for 2 weeks. Results : After intake, the group that Chenwangbosim-Dan(Tianwangbuxin-Dan) Extract∘Fermented Rice Extract (GABA : gamma-aminobutyric acid 30%) Complex had a statistically significant improvement effect compared to before intake due to an improved 30.81% of the VAS scores. The POMS-T score improved 54.13%, the POMS-V score improved 117.5% and the POMS-F score improved 59%, which had a statistically significant effect compared to Placebo group (p<0.001). There is a significant difference between two group, so even considering the placebo effect, the anti stress effect was confirmed in the Chenwangbosim-Dan (Tianwangbuxin-Dan) Extract∘Fermented Rice Extract (GABA : gamma-aminobutyric acid 30%) Complex intake group. Conclusions : The above results showed that the Chenwangbosim-Dan(Tianwangbuxin-Dan) Extract∘Fermented Rice Extract (GABA : gamma-aminobutyric acid 30%) Complex had an anti-stress effect. Therefore, it is expected to be developed as a safe and comfortable mental care health functional food that can reduce the risk of drug abuse.

이상지질혈증에 대한 택사탕(澤瀉湯)의 효과 : 체계적 문헌 고찰 및 메타 분석 (The Effect of Taeksa-tang for Dyslipidemia: A Systematic Review and Meta-Analysis)

  • 이영서;허태영;김경민
    • 대한한방내과학회지
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    • 제44권3호
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    • pp.485-505
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    • 2023
  • Objective: The purpose of this study is to assess the effectiveness and safety of using Taeksa-tang for dyslipidemia through a systematic review and meta-analysis of randomized controlled trials (RCTs). Methods: The search was conducted using keywords such as "dyslipidemia", "hyperlipidemia", "taeksa tang", "zexie tang", and "takusha to" in 12 databases (Pubmed, Cochrane, Embase, ScienceDirect, CNKI, Wanfang, CiNii, RISS, KISS, ScienceON, OASIS, and DBpia) on April 13, 2023. There were no limits on the publication period and language. Cochrane's risk of bias (RoB) was used to evaluate the quality of the studies. A meta-analysis was conducted according to the outcome measurements such as total effective rate (TER), total cholesterol (TC), triglyceride (TG), HDL-cholesterol (HDL-C), LDL-cholesterol (LDL-C), and adverse effects, using the Review Manager web. Results: A total of 9 RCTs were selected. In evaluating the RoB, 2 studies mentioning the random sequence generation, 1 study conducting double blindness, and 8 studies without missing values were evaluated as low risk, while 1 study without mentioning the random sequence generation was evaluated as high risk. All other parts were evaluated as unclear risk. The treatment group (Taeksa-tang or Taeksa-tang-gagam) showed more statistically significant effects compared to the control group (Western medicine or Chinese patent medicine) in TER (RR : 1.24, 95% CI 1.15 to 1.34, P<0.00001), TC (MD : -1.12, 95% CI -1.68 to -0.56, P<0.0001), TG (MD : -1.08, 95% CI -1.65 to -0.51, P=0.0002), HDL-C (MD : 0.63, 95% CI 0.34 to 0.93, P<0.0001), LDL-C (MD : -0.81, 95% CI -1.10 to -0.53, P<0.00001). In addition, the treatment group showed lower adverse effects compared to the control group (RR : 0.30, 95% CI 0.12 to 0.74, P=0.008). Conclusion: This study suggests that Taeksa-tang is effective and safe to use for treating dyslipidemia. However, due to the low quality of the included studies, more clinical studies need to be conducted in the future to increase the possibility of clinical use.

Imaging of Facial Nerve With 3D-DESS-WE-MRI Before Parotidectomy: Impact on Surgical Outcomes

  • Han-Sin Jeong;Yikyung Kim;Hyung-Jin Kim;Hak Jung, Kim;Eun-hye Kim;Sook-young Woo;Man Ki Chung;Young-Ik Son
    • Korean Journal of Radiology
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    • 제24권9호
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    • pp.860-870
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    • 2023
  • Objective: The intra-parotid facial nerve (FN) can be visualized using three-dimensional double-echo steady-state water-excitation sequence magnetic resonance imaging (3D-DESS-WE-MRI). However, the clinical impact of FN imaging using 3D-DESS-WE-MRI before parotidectomy has not yet been explored. We compared the clinical outcomes of parotidectomy in patients with and without preoperative 3D-DESS-WE-MRI. Materials and Methods: This prospective, non-randomized, single-institution study included 296 adult patients who underwent parotidectomy for parotid tumors, excluding superficial and mobile tumors. Preoperative evaluation with 3D-DESS-WE-MRI was performed in 122 patients, and not performed in 174 patients. FN visibility and tumor location relative to FN on 3D-DESS-WE-MRI were evaluated in 120 patients. Rates of FN palsy (FNP) and operation times were compared between patients with and without 3D-DESS-WE-MRI; propensity score matching (PSM) and inverse probability of treatment weighting (IPTW) were used to adjust for surgical and tumor factors. Results: The main trunk, temporofacial branch, and cervicofacial branch of the intra-parotid FN were identified using 3D-DESS-WE-MRI in approximately 97.5% (117/120), 44.2% (53/120), and 25.0% (30/120) of cases, respectively. The tumor location relative to FN, as assessed on magnetic resonance imaging, concurred with surgical findings in 90.8% (109/120) of cases. Rates of temporary and permanent FNP did not vary between patients with and without 3D-DESS-WE-MRI according to PSM (odds ratio, 2.29 [95% confidence interval {CI} 0.64-8.25] and 2.02 [95% CI: 0.32-12.90], respectively) and IPTW (odds ratio, 1.76 [95% CI: 0.19-16.75] and 1.94 [95% CI: 0.20-18.49], respectively). Conversely, operation time for surgical identification of FN was significantly shorter with 3D-DESS-WE-MRI (median, 25 vs. 35 min for PSM and 25 vs. 30 min for IPTW, P < 0.001). Conclusion: Preoperative FN imaging with 3D-DESS-WE-MRI facilitated anatomical identification of FN and its relationship to the tumor during parotidectomy. This modality reduced operation time for FN identification, but did not significantly affect postoperative FNP rates.

Comparison of Statin With Ezetimibe Combination Therapy Versus Statin Monotherapy for Primary Prevention in Middle-Aged Adults

  • Jung-Joon Cha;Soon Jun Hong;Subin Lim;Ju Hyeon Kim;Hyung Joon Joo;Jae Hyoung Park;Cheol Woong Yu;Do-Sun Lim;Jang Young Kim;Jin-Ok Jeong;Jeong-Hun Shin;Chi Young Shim;Jong-Young Lee;Young-Hyo Lim;Sung Ha Park;Eun Joo Cho;Hasung Kim;Jungkuk Lee;Ki-Chul Sung;Korean Vascular Society
    • Korean Circulation Journal
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    • 제54권9호
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    • pp.534-544
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    • 2024
  • Background and Objectives: Lipid lowering therapy is essential to reduce the risk of major cardiovascular events; however, limited evidence exists regarding the use of statin with ezetimibe as primary prevention strategy for middle-aged adults. We aimed to investigate the impact of single pill combination therapy on clinical outcomes in relatively healthy middle-aged patients when compared with statin monotherapy. Methods: Using the Korean National Health Insurance Service database, a propensity score match analysis was performed for baseline characteristics of 92,156 patients categorized into combination therapy (n=46,078) and statin monotherapy (n=46,078) groups. Primary outcome was composite outcomes, including death, coronary artery disease, and ischemic stroke. And secondary outcome was all-cause death. The mean follow-up duration was 2.9±0.3 years. Results: The 3-year composite outcomes of all-cause death, coronary artery disease, and ischemic stroke demonstrated no significant difference between the 2 groups (10.3% vs. 10.1%; hazard ratio [HR], 1.022; 95% confidence interval [CI], 0.980-1.064; p=0.309). Meanwhile, the 3-year all-cause death rate was lower in the combination therapy group than in the statin monotherapy group (0.2% vs. 0.4%; p<0.001), with a significant HR of 0.595 (95% CI, 0.460-0.769; p<0.001). Single pill combination therapy exhibited consistently lower mortality rates across various subgroups. Conclusions: Compared to the statin monotherapy, the combination therapy for primary prevention showed no difference in composite outcomes but may reduce mortality risk in relatively healthy middle-aged patients. However, since the study was observational, further randomized clinical trials are needed to confirm these findings.