• Title/Summary/Keyword: efficacy rate

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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.

Effectiveness of Acupotomy for Migraine: A Systematic Review (편두통의 침도 치료에 대한 체계적 문헌고찰)

  • Seok-Hee Jeon;Soo-Min Jeong;Jeong-Cheol Shin
    • Korean Journal of Acupuncture
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    • v.40 no.3
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    • pp.62-78
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    • 2023
  • Objectives : This study aims to assess the impact of acupotomy on migraine through an examination of clinical studies conducted since 2015. Methods : We conducted a comprehensive search for randomized controlled trials (RCTs) and non-randomized controlled trials (nRCTs) related to acupotomy treatment for migraine, utilizing five Korean online databases (OASIS, Science ON, DBPIA, KISS, RISS), as well as four foreign online databases (CNKI, PubMed, EMBASE, Cochrane Library). We identified a total of 10 relevant studies for analysis. Participants characteristics, treatment points, combination treatments, treatment cycles or frequencies, evaluation indices, efficacy, and adverse events were analyzed. The risk of bias in the 10 RCTs was assessed using the Revised Cochrane risk-of-bias tool for randomized trials (RoB 2.0). Results : A total of 931 participants were included in 10 studies. In the intervention group, the average duration of migraine morbidity ranged from 15.5±4.5 months to 15.9±4.2 years. Six studies based their diagnoses on the International Classification of Headache Disorders (ICHD), while five studies relied on Chinese diagnostic criteria. All studies specified the treatment area as the region exhibiting tenderness or induration on the head and neck. Treatment cycles ranged from a minimum of 2 days to a maximum of 1 week, with the number of days per treatment course varied from 5 days to 4 weeks. The diameter of acupuncture needles used varied between 0.3 mm and 1 mm. Of the eight studies specifying needle length, the shortest was 20 mm, and the longest was 40 mm. A total of eight evaluation indices were employed, with total efficacy rate (TER) and visual analogue scale (VAS) being the most frequently used. Statistically, all intervention groups showed more significant results compared to the control groups. Adverse events were reported in only two studies within the intervention group. Overall, the risk of bias assessment for the selected RCTs ranged from 'some concerns' to 'high risk of bias.' Conclusions : This study showed that acupotomy treatments for migraine were effective.

The Optimal Tumor Mutational Burden Cutoff Value as a Novel Marker for Predicting the Efficacy of Programmed Cell Death-1 Checkpoint Inhibitors in Advanced Gastric Cancer

  • Jae Yeon Jang;Youngkyung Jeon ;Sun Young Jeong ;Sung Hee Lim ;Won Ki Kang;Jeeyun Lee ;Seung Tae Kim
    • Journal of Gastric Cancer
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    • v.23 no.3
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    • pp.476-486
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    • 2023
  • Purpose: The optimal tumor mutational burden (TMB) value for predicting treatment response to programmed cell death-1 (PD-1) checkpoint inhibitors in advanced gastric cancer (AGC) remains unclear. We aimed to investigate the optimal TMB cutoff value that could predict the efficacy of PD-1 checkpoint inhibitors in AGC. Materials and Methods: Patients with AGC who received pembrolizumab or nivolumab between October 1, 2020, and July 27, 2021, at Samsung Medical Center in Korea were retrospectively analyzed. The TMB levels were measured using a next-generation sequencing assay. Based on receiver operating characteristic curve analysis, the TMB cutoff value was determined. Results: A total 53 patients were analyzed. The TMB cutoff value for predicting the overall response rate (ORR) to PD-1 checkpoint inhibitors was defined as 13.31 mutations per megabase (mt/Mb) with 56% sensitivity and 95% specificity. Based on this definition, 7 (13.2%) patients were TMB-high (TMB-H). The ORR differed between the TMB-low (TMB-L) and TMB-H (8.7% vs. 71.4%, P=0.001). The progression-free survival and overall survival (OS) for 53 patients were 1.93 (95% confidence interval [CI], 1.600-2.268) and 4.26 months (95% CI, 2.992-5.532). The median OS was longer in the TMB-H (20.8 months; 95% CI, 2.292-39.281) than in the TMB-L (3.31 months; 95% CI, 1.604-5.019; P=0.049). Conclusions: The TMB cutoff value for predicting treatment response in AGC patients who received PD-1 checkpoint inhibitor monotherapy as salvage treatment was 13.31 mt/Mb. When applying the programmed death ligand-1 status to TMB-H, patients who would benefit from PD-1 checkpoint inhibitors can be selected.

Efficacy and safety of losartan in childhood immunoglobulin A nephropathy: a prospective multicenter study

  • Hyesun Hyun;Yo Han Ahn;Eujin Park;Hyun Jin Choi;Kyoung Hee Han;Jung Won Lee;Su Young Kim;Eun Mi Yang;Jin Soon Suh;Jae Il Shin;Min Hyun Cho;Ja Wook Koo;Kee Hyuck Kim;Hye Won Park;Il Soo Ha;Hae Il Cheong;Hee Gyung Kang;Seong Heon Kim
    • Childhood Kidney Diseases
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    • v.27 no.2
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    • pp.97-104
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    • 2023
  • Purpose: Angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers (ARBs) are frequently employed to counteract the detrimental effects of proteinuria on glomerular diseases. However, the effects of ARBs remain poorly examined in pediatric patients with immunoglobulin A (IgA) nephropathy. Herein, we evaluated the efficacy and safety of losartan, an ARB, in pediatric IgA nephropathy with proteinuria. Methods: This prospective, single-arm, multicenter study included children with IgA nephropathy exhibiting proteinuria. Changes in proteinuria, blood pressure, and kidney function were prospectively evaluated before and 4 and 24 weeks after losartan administration. The primary endpoint was the difference in proteinuria between baseline and 24 weeks. Results: In total, 29 patients were enrolled and received losartan treatment. The full analysis set included 28 patients who received losartan at least once and had pre- and post-urinary protein to creatinine ratio measurements (n=28). The per-protocol analysis group included 22 patients who completed all scheduled visits without any serious violations during the study period. In both groups, the mean log (urine protein to creatinine ratio) value decreased significantly at 6 months. After 24 weeks, the urinary protein to creatinine ratio decreased by more than 50% in approximately 40% of the patients. The glomerular filtration rate was not significantly altered during the observation period. Conclusions: Losartan decreased proteinuria without decreasing kidney function in patients with IgA nephropathy over 24 weeks. Losartan could be safely employed to reduce proteinuria in this patient population. ClinicalTrials.gov trial registration (NCT0223277)

No-Touch vs. Conventional Radiofrequency Ablation Using Twin Internally Cooled Wet Electrodes for Small Hepatocellular Carcinomas: A Randomized Prospective Comparative Study

  • Yun Seok Suh;Jae Won Choi;Jeong Hee Yoon;Dong Ho Lee;Yoon Jun Kim;Jeong Hoon Lee;Su Jong Yu;Eun Ju Cho;Jung Hwan Yoon;Jeong Min Lee
    • Korean Journal of Radiology
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    • v.22 no.12
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    • pp.1974-1984
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    • 2021
  • Objective: This study aimed to compare the efficacy between no-touch (NT) radiofrequency ablation (RFA) and conventional RFA using twin internally cooled wet (TICW) electrodes in the bipolar mode for the treatment of small hepatocellular carcinomas (HCC). Materials and Methods: In this single-center, two-arm, parallel-group, prospective randomized controlled study, we performed a 1:1 random allocation of eligible patients with HCCs to receive NT-RFA or conventional RFA between October 2016 and September 2018. The primary endpoint was the cumulative local tumor progression (LTP) rate after RFA. Secondary endpoints included technical conversion rates of NT-RFA, intrahepatic distance recurrence, extrahepatic metastasis, technical parameters, technical efficacy, and rates of complications. Cumulative LTP rates were analyzed using Kaplan-Meier analysis and the Cox proportional hazard regression model. Considering conversion cases from NT-RFA to conventional RFA, intention-to-treat and as-treated analyses were performed. Results: Enrolled patients were randomly assigned to the NT-RFA group (37 patients with 38 HCCs) or the conventional RFA group (36 patients with 38 HCCs). Among the NT-RFA group patients, conversion to conventional RFA occurred in four patients (10.8%, 4/37). According to intention-to-treat analysis, both 1- and 3-year cumulative LTP rates were 5.6%, in the NT-RFA group, and they were 11.8% and 21.3%, respectively, in the conventional RFA group (p = 0.073, log-rank). In the as-treated analysis, LTP rates at 1 year and 3 years were 0% and 0%, respectively, in the NT-RFA group sand 15.6% and 24.5%, respectively, in the conventional RFA group (p = 0.004, log-rank). In as-treated analysis using multivariable Cox regression analysis, RFA type was the only significant predictive factor for LTP (hazard ratio = 0.061 with conventional RFA as the reference, 95% confidence interval = 0.000-0.497; p = 0.004). There were no significant differences in the procedure characteristics between the two groups. No procedure-related deaths or major complications were observed. Conclusion: NT-RFA using TICW electrodes in bipolar mode demonstrated significantly lower cumulative LTP rates than conventional RFA for small HCCs, which warrants a larger study for further confirmation.

Radiofrequency Ablation Using a Separable Clustered Electrode for the Treatment of Hepatocellular Carcinomas: A Randomized Controlled Trial of a Dual-Switching Monopolar Mode Versus a Single-Switching Monopolar Mode

  • Jae Won Choi;Jeong Min Lee;Dong Ho Lee;Jung-Hwan Yoon;Yoon Jun Kim;Jeong-Hoon Lee;Su Jong Yu;Eun Ju Cho
    • Korean Journal of Radiology
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    • v.22 no.2
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    • pp.179-188
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    • 2021
  • Objective: This study aimed to prospectively compare the efficacy, safety, and mid-term outcomes of dual-switching monopolar (DSM) radiofrequency ablation (RFA) to those of conventional single-switching monopolar (SSM) RFA in the treatment of hepatocellular carcinoma (HCC). Materials and Methods: This single-center, two-arm, parallel-group, randomized controlled study was approved by the Institutional Review Board. Written informed consent was obtained from all patients upon enrollment. A total of 80 patients with 94 HCC nodules were randomized into either the DSM-RFA group or SSM-RFA group in a 1:1 ratio, using a blocked randomization method (block size 2). The primary endpoint was the minimum diameter of the ablation zone per unit time. The secondary endpoints included other technical parameters, complication rate, technique efficacy, and 2-year clinical outcomes. Results: Significantly higher ablation energy per unit time was delivered to the DSM-RFA group than to the SSM-RFA group (1.7 ± 0.2 kcal/min vs. 1.2 ± 0.3 kcal/min; p < 0.001). However, no significant differences were observed between the two groups for the analyzed variables, including primary endpoint, regarding size of the ablation zone and ablation time. Major complication rates were 4.9% in the DSM-RFA group and 2.6% in the SSM-RFA group (p = 1.000). The 2-year local tumor progression (LTP) rates of the HCC nodules treated using DSM-RFA and SSM-RFA were 8.5% and 4.7%, respectively (p = 0.316). The 2-year LTP-free survival rates of patients in the DSM-RFA and SSM-RFA groups were 90.0% and 94.4%, respectively (p = 0.331), and the 2-year recurrence-free survival rates were 54.9% and 75.7%, respectively (p = 0.265). Conclusion: Although DSM-RFA using a separable clustered electrode delivers higher ablation energy than SSM-RFA, its effectiveness failed to show superiority over SSM-RFA in the treatment of HCC.

Efficacy and Safety of the Safe Triangular Working Zone Approach in Percutaneous Vertebroplasty for Spinal Metastasis

  • Bi Cong Yan;Yan Feng Fan;Qing Hua Tian;Tao Wang;Zhi Long Huang;Hong Mei Song;Ying Li;Lei Jiao;Chun Gen Wu
    • Korean Journal of Radiology
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    • v.23 no.9
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    • pp.901-910
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    • 2022
  • Objective: This study aimed to assess the technical feasibility, efficacy, and safety of the safe triangular working zone (STWZ) approach applied in percutaneous vertebroplasty (PV) for spinal metastases involving the posterior part of the vertebral body. Materials and Methods: We prospectively enrolled 87 patients who underwent PV for spinal metastasis involving the posterior part of the vertebral body, with or without the STWZ approach, from January 2019 to April 2022. Forty-nine patients (27 females and 22 males; mean age ± standard deviation [SD], 57.2 ± 11.6 years; age range, 31-76 years) were included in group A (with STWZ approach), accounting for 54 vertebrae. Thirty-eight patients (18 females and 20 males; 59.1 ± 10.9 years; 29-81 years) were included in group B (without STWZ approach), accounting for 57 vertebrae. Patient demographics, procedure-related variables, and pain relief as assessed using the visual analog scale (VAS) were collected at different time points. Tumor recurrence in the vertebrae after PV was analyzed using Kaplan-Meier curves. Results: The STWZ approach was successful from T1 to L5 without severe complications. Cement filling was satisfactory in 47/54 (87.0%) and 25/57 (43.9%) vertebrae in groups A and B, respectively (p < 0.001). Cement leakage was not significantly different between groups A and B (p = 1.000). Mean VAS score ± SD before and 1 week and 1, 3, 6, 9, and 12 months after PV were 7.6 ± 1.8, 4.2 ± 2.0, 2.7 ± 1.9, 1.9 ± 1.5, 1.7 ± 1.4, 1.7 ± 1.1, and 1.6 ± 1.3, respectively, in group A and 7.2 ± 1.7, 4.0 ± 1.3, 3.4 ± 1.6, 2.4 ± 1.2, 1.8 ± 1.0, 1.4 ± 0.5, and 1.7 ± 0.9, respectively, in group B. Kaplan-Meier analysis showed a lower tumor recurrence rate in group A than in group B (p = 0.001). Conclusion: The STWZ approach may represent a new, safe, alternative/auxiliary approach to target the posterior part of the vertebral body in the PV for spinal metastases.

Efficacy and Safety of Ultrasound-Guided Radiofrequency Ablation for Primary Hyperparathyroidism: A Prospective Study

  • Hui-hui Chai;Yu Zhao;Zeng Zeng;Rui-zhong Ye;Qiao-hong Hu;Hong-feng He;Jung Hwan Baek;Cheng-zhong Peng
    • Korean Journal of Radiology
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    • v.23 no.5
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    • pp.555-565
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    • 2022
  • Objective: To assess the efficacy and safety of ultrasound (US)-guided radiofrequency ablation (RFA) in patients with primary hyperparathyroidism (PHPT). Materials and Methods: This prospective study enrolled 39 participants (14 male, 25 female; mean age, 59.5 ± 15.3 [range, 18-87] years) between September 1, 2018, and January 31, 2021. All participants had parathyroid lesions causing PHPT, proven biochemically and through imaging. The imaging features of the PHPT nodules, including the shape, margin, size, composition, and location, were evaluated before treatment. Serum intact parathyroid hormone, calcium, and phosphorus levels; parathyroid nodule volume; and PHPT-related symptoms were recorded before and after treatment. We calculated the technical success, biochemical cure, and clinical cure rates for these patients. Complications were evaluated during and after the ablation. Results: Complete ablation was achieved in 38 of the 39 nodules in the 39 enrolled participants. All the patients were treated in one session. The technical success rate was 97.4% (38/39). The mean follow-up duration was 13.2 ± 4.6 (range, 6.0-24.9) months. At 6 and 12 months post-RFA, the biochemical cure rates were 82.1% (32/39) and 84.4% (27/32), respectively, and the clinical cure rates were 100% (39/39) and 96.9% (31/32), respectively. Only 2.6% (1/39) of the patients had recurrent PHPT. At 1, 3, 6, and 12 months after technically successful RFA, 44.7% (17/38), 34.3% (12/35), 15.8% (6/38), and 12.5% (4/32) of participants, respectively, had elevated eucalcemic parathyroid hormone levels. Recurrent laryngeal nerve paralysis occurred in 5.1% (2/39) of the patients, who recovered spontaneously within 1-3 months. Conclusion: US-guided RFA was effective and safe for PHPT patients. RFA may be an alternative treatment tool for patients who cannot tolerate or refuse to undergo surgery.

Effects of GV1001 on Language Dysfunction in Patients With Moderate-to-Severe Alzheimer's Disease: Post Hoc Analysis of Severe Impairment Battery Subscales

  • Hyuk Sung Kwon;Seong-Ho Koh;Seong Hye Choi;Jee Hyang Jeong;Hae Ri Na;Chan Nyoung Lee;YoungSoon Yang;Ae Young Lee;Jae-Hong Lee;Kyung Won Park;Hyun Jeong Han;Byeong C. Kim;Jinse Park;Jee-Young Lee;Kyu-Yong Lee;Sangjae Kim
    • Dementia and Neurocognitive Disorders
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    • v.22 no.3
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    • pp.100-108
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    • 2023
  • Background and Purpose: The efficacy and safety of GV1001 have been demonstrated in patients with moderate-to-severe Alzheimer's disease (AD). In this study, we aimed to further demonstrate the effectiveness of GV1001 using subscales of the Severe Impairment Battery (SIB), which is a validated measure to assess cognitive function in patients with moderate-to-severe AD. Methods: We performed a post hoc analysis of data from a 6 month, multicenter, phase 2, randomized, double-blind, placebo-controlled trial with GV1001 (ClinicalTrials.gov, NCT03184467). Patients were randomized to receive either GV1001 or a placebo for 24 weeks. In the current study, nine subscales of SIB-social interaction, memory, orientation, language, attention, praxis, visuospatial ability, construction, and orientation to name-were compared between the treatment (GV1001 1.12 mg) and placebo groups at weeks 12 and 24. The safety endpoints for these patients were also determined based on adverse events. Results: In addition to the considerable beneficial effect of GV1001 on the SIB total score, GV1001 1.12 mg showed the most significant effect on language function at 24 weeks compared to placebo in both the full analysis set (FAS) and per-protocol set (PPS) (p=0.017 and p=0.011, respectively). The rate of adverse events did not differ significantly between the 2 groups. Conclusions: Patients with moderate-to-severe AD receiving GV1001 had greater language benefits than those receiving placebo, as measured using the SIB language subscale.

The effect of learning motivation of learners who have experienced university part-time registration system on learner characteristics, learning satisfaction, and intention to continue participation (대학의 시간등록제 학습을 경험한 학습자의 학습동기가 학습자특성, 학습만족, 참여지속의도에 미치는 영향)

  • Lee Sang-woo;Oh Hyun-sung
    • The Journal of the Convergence on Culture Technology
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    • v.10 no.3
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    • pp.915-922
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    • 2024
  • Currently, in Korea, there is a growing interest in improving the learning ability of the education target group due to the low birth rate and aging population. The dilemma of a shrinking population ultimately causes the burden of having to come up with a plan to efficiently maximize the use of available population resources. Accordingly, this study explores the impact of learning motivation (activity-oriented motivation, learning-oriented motivation) on learner characteristics (learning value, learning efficacy) and learning satisfaction, and as a result, intention to continue participating in lifelong learning (recommendation intention, relationship continuation intention). As a results of the analysis, it shows that learning motivation had a significant effect on learning satisfaction, and the emotions formed in this way had a positive effect on recommendation intention and relationship continuation intention. In addition, the results show that learning-oriented motivation had a significant effect on both learning satisfaction and learner characteristics, but that learning efficacy had no effect on recommendation intention. This study is significant in that it presents the basis for an educational system based on relationship maintenance and learner characteristics by considering the learner's orientation, individual achievement direction, recommendation intention, and relationship continuation intention.