• Title/Summary/Keyword: clinical efficacy

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Humoral immune response to SARS-CoV-2 mRNA vaccines is associated with choice of vaccine and systemic adverse reactions

  • Hanna Klingel;Alexander Kruttgen;Matthias Imohl;Michael Kleines
    • Clinical and Experimental Vaccine Research
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    • v.12 no.1
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    • pp.60-69
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    • 2023
  • Purpose: Although the fast development of safe and effective messenger RNA (mRNA) vaccines against severe acute respiratory syndrome coronavirus 2 has been a success, waning humoral immunity has led to the recommendation of booster immunization. However, knowledge of the humoral immune response to different booster strategies and the association with adverse reactions is limited. Materials and Methods: We investigated adverse reactions and anti-spike protein immunoglobulin G (IgG) concentrations among health care workers who received primary immunization with mRNA-1273 and booster immunization with mRNA-1273 or BNT162b2. Results: Adverse reactions were reported by 85.1% after the first dose, 94.7% after the second dose, 87.5% after a third dose of BNT162b2, and 86.0% after a third dose of mRNA-1273. They lasted for a median of 1.8, 2.0, 2.5, and 1.8 days, respectively; 6.4%, 43.6%, and 21.0% of the participants were unable to work after the first, second, and third vaccination, respectively, which should be considered when scheduling vaccinations among essential workers. Booster immunization induced a 13.75-fold (interquartile range, 9.30-24.47) increase of anti-spike protein IgG concentrations with significantly higher concentrations after homologous compared to heterologous vaccination. We found an association between fever, chills, and arthralgia after the second vaccination and anti-spike protein IgG concentrations indicating a linkage between adverse reactions, inflammation, and humoral immune response. Conclusion: Further investigations should focus on the possible advantages of homologous and heterologous booster vaccinations and their capability of stimulating memory B-cells. Additionally, understanding inflammatory processes induced by mRNA vaccines might help to improve reactogenicity while maintaining immunogenicity and efficacy.

Baseline Serum Interleukin-6 Levels Predict the Response of Patients with Advanced Non-small Cell Lung Cancer to PD-1/PD-L1 Inhibitors

  • Da Hyun Kang;Cheol-Kyu Park;Chaeuk Chung;In-Jae Oh;Young-Chul Kim;Dongil Park;Jinhyun Kim;Gye Cheol Kwon;Insun Kwon;Pureum Sun;Eui-Cheol Shin;Jeong Eun Lee
    • IMMUNE NETWORK
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    • v.20 no.3
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    • pp.27.1-27.11
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    • 2020
  • Although various studies on predictive markers in the use of PD-1/PD-L1 inhibitors are in progress, only PD-L1 expression levels in tumor tissues are currently used. In the present study, we investigated whether baseline serum levels of IL-6 can predict the treatment response of patients with advanced non-small cell lung cancer (NSCLC) treated with PD-1/PD-L1 inhibitors. In our cohort of 125 NSCLC patients, the objective response rate (ORR) and disease control rate (DCR) were significantly higher in those with low IL-6 (<13.1 pg/ml) than those with high IL-6 (ORR 33.9% vs. 11.1%, p=0.003; DCR 80.6% vs. 34.9%, p<0.001). The median progression-free survival was 6.3 months (95% confidence interval [CI], 3.9-8.7) in the low IL-6 group, significantly longer than in the high IL-6 group (1.9 months, 95% CI, 1.6-2.2, p<0.001). The median overall survival in the low IL-6 group was significantly longer than in the high IL-6 group (not reached vs. 7.4 months, 95% CI, 4.8-10.0). Thus, baseline serum IL-6 levels could be a potential biomarker for predicting the efficacy and survival benefit of PD-1/PD-L1 inhibitors in NSCLC.

Coil-Protected Technique for Liquid Embolization in Neurovascular Malformations

  • Keun Young Park;Jin Woo Kim;Byung Moon Kim;Dong Joon Kim;Joonho Chung;Chang Ki Jang;Jun-Hwee Kim
    • Korean Journal of Radiology
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    • v.20 no.8
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    • pp.1285-1292
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    • 2019
  • Objective: To evaluate the safety and efficacy of the coil-protected technique for liquid embolization in neurovascular malformations. Materials and Methods: Twenty-two patients who underwent coil-protected liquid embolization for symptomatic cranial (n = 13) and spinal (n = 9) arteriovenous fistula (AVF) or arteriovenous malformations (AVMs) were identified. A total of 36 target feeder vessels were embolized with N-butyl cyanoacrylate and/or Onyx (Medtronic). This technique was used to promote delivery of a sufficient amount of liquid embolic agent into the target shunt or nidus in cases where tortuous feeding arteries preclude a microcatheter wedging techniqu and/or to prevent reflux of the liquid embolic agent in cases with a short safety margin. The procedure was considered technically successful if the target lesion was sufficiently filled with liquid embolic agent without unintentional reflux. Angiographic and clinical outcomes were retrospectively evaluated. Results: Technical success was achieved for all 36 target feeders. Post-embolization angiographies revealed complete occlusion in 16 patients and near-complete and partial occlusion in three patients each. There were no treatment-related complications. Of the six patients who showed near-complete or partial occlusion, five received additional treatments: two received stereotactic radiosurgery for cerebral AVM, two underwent surgical removal of cerebral AVM, and one underwent additional embolization by direct puncture for a mandibular AVM. Finally, all patients showed complete (n = 19) or near-complete (n = 3) occlusion of the target AVF or AVM on follow-up angiographies. The presenting neurological symptoms improved completely in 15 patients (68.2%) and partially in seven patients (31.8%). Conclusion: The coil-protected technique is a safe and effective method for liquid embolization, especially in patients with various neurovascular shunts or malformations who could not be successfully treated with conventional techniques.

Hybrid argon plasma coagulation in Barrett's esophagus: a systematic review and meta-analysis

  • Sagar N. Shah;Nabil El Hage Chehade;Amirali Tavangar;Alyssa Choi;Marc Monachese;Kenneth J. Chang;Jason B. Samarasena
    • Clinical Endoscopy
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    • v.56 no.1
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    • pp.38-49
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    • 2023
  • Background/Aims: Patients with Barrett's esophagus are at increased risk of developing esophageal adenocarcinoma. Endoscopic therapies aim to eradicate dysplastic and metaplastic tissues. Hybrid argon plasma coagulation (hybrid-APC) utilizes submucosal fluid injection to create a protective cushion prior to ablation that shields the submucosa from injury. We performed a pooled meta-analysis to evaluate the safety and efficacy of hybrid-APC. Methods: We conducted a systematic search of major electronic databases in April 2022. Studies that included patients with dysplastic and non-dysplastic Barrett's esophagus undergoing treatment with hybrid-APC were eligible for inclusion. Outcome measures included complete remission of intestinal metaplasia (CR-IM), stricture formation, serious adverse events, and number of sessions necessary to achieve CR-IM. Results: Overall pooled CR-IM rate for patients undergoing hybrid-APC was 90.8% (95% confidence interval [CI], 0.872-0.939; I2=0%). Pooled stricture rate was 2.0% (95% CI, 0.005-0.042; I2=0%). Overall serious adverse event rate was 2.7% (95% CI, 0.007-0.055; I2=0%). Conclusions: Results of the current meta-analysis suggest that hybrid-APC is associated with high rates of CR-IM and a favorable safety profile. Interpretation of these results is limited by the inclusion of retrospective cohort and case series data. Randomized controlled trials that standardize treatment and outcome evaluation protocols are necessary to understand how this treatment option is comparable to the current standards of care.

Efficacy of endoscopy under general anesthesia for the detection of synchronous lesions in oro-hypopharyngeal cancer

  • Yoichiro Ono;Kenshi Yao;Yasuhiro Takaki;Satoshi Ishikawa;Kentaro Imamura;Akihiro Koga;Kensei Ohtsu;Takao Kanemitsu;Masaki Miyaoka;Takashi Hisabe;Toshiharu Ueki;Atsuko Ota;Hiroshi Tanabe;Seiji Haraoka;Satoshi Nimura;Akinori Iwashita;Susumu Sato;Rumie Wakasaki
    • Clinical Endoscopy
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    • v.56 no.3
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    • pp.315-324
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    • 2023
  • Background/Aims: Image-enhanced endoscopy can detect superficial oro-hypopharyngeal squamous cell carcinoma; however, reliable endoscopy of the pharyngeal region is challenging. Endoscopy under general anesthesia during transoral surgery occasionally reveals multiple synchronous lesions that remained undetected on preoperative endoscopy. Therefore, we aimed to determine the lesion detection capability of endoscopy under general anesthesia for superficial oro-hypopharyngeal squamous cell carcinoma. Methods: This retrospective study included 63 patients who underwent transoral surgery for superficial oropharyngeal squamous cell carcinoma between April 2005 and December 2020. The primary endpoint was to compare the lesion detection capabilities of preoperative endoscopy and endoscopy under general anesthesia. Other endpoints included the comparison of clinicopathological findings between lesions detected using preoperative endoscopy and those newly detected using endoscopy under general anesthesia. Results: Fifty-eight patients (85 lesions) were analyzed. The mean number of lesions per patient detected was 1.17 for preoperative endoscopy and 1.47 for endoscopy under general anesthesia. Endoscopy under general anesthesia helped detect more lesions than preoperative endoscopy did (p<0.001). The lesions that were newly detected on endoscopy under general anesthesia were small and characterized by few changes in color and surface ruggedness. Conclusions: Endoscopy under general anesthesia for superficial squamous cell carcinoma is helpful for detecting multiple synchronous lesions.

Usefulness of a new polyvinyl alcohol hydrogel (PVA-H)-based simulator for endoscopic submucosal dissection training: a pilot study

  • Dong Seok Lee;Gin Hyug Lee;Sang Gyun Kim;Kook Lae Lee;Ji Won Kim;Ji Bong Jeong;Yong Jin Jung;Hyoun Woo Kang
    • Clinical Endoscopy
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    • v.56 no.5
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    • pp.604-612
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    • 2023
  • Background/Aims: We developed a new endoscopic submucosal dissection (ESD) simulator and evaluated its efficacy and realism for use training endoscopists. Methods: An ESD simulator was constructed using polyvinyl alcohol hydrogel sheets and compared to a previous ESD simulator. Between March 1, 2020, and December 30, 2021, eight expert endoscopists from three different centers analyzed the procedure-related factors of the simulator. Five trainees performed gastric ESD exercises under the guidance of these experts. Results: Although the two ESD simulators provided overall favorable outcomes in terms of ESD-related factors, the new simulator had several benefits, including better marking of the target lesion's limits (p<0.001) and overall handling (p<0.001). Trainees tested the usefulness of the new ESD simulator. The complete resection rate improved after 3 ESD training sessions (9 procedures), and the perforation rate decreased after 4 sessions (12 procedures). Conclusions: We have developed a new ESD simulator that can help beginners achieve a high level of technical experience before performing real-time ESD procedures in patients.

Thread-Embedding TThread-Embedding Therapy for Depression, Anxiety, and Dementia: A Systematic Reviewherapy for Depression, Anxiety, and Dementia: A Systematic Review (우울, 불안, 치매 환자에 대한 매선 치료: 체계적 문헌 고찰)

  • Jun-Hee Cho;So-Hyeon Park;Bo-Kyung Kim;Jung-Hwa Lim
    • Journal of Oriental Neuropsychiatry
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    • v.35 no.1
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    • pp.37-68
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    • 2024
  • Objectives: This study aimed to systematically review thread-embedding treatment studies for depression, anxiety, and dementia and examine the effectiveness and safety of thread-embedding treatment. Methods: Ten domestic and international search databases were used for study selection, including CNKI, PubMed, CENTRAL, EMBASE, CINAHL, AMED, PsycArticles, RISS, OASIS, and KCI. We included studies that presented diagnostic or appropriate criteria for depression, anxiety, and dementia, and randomized control studies using thread-embedding therapy. We searched papers published until October 10, 2023. Results: Twenty-one studies were selected, of which 11 studies were conducted on depression, nine on dementia, and one on anxiety disorders. The most commonly used acupoint for depression was Gansu (BL18), whereas zusanli (ST36) and fenglong (ST40) were used for dementia. The most commonly used type of thread was 1-0 United States pharmacopeia (USP) and 1 cm for depression and 2-0 USP and 1 cm for dementia. The treatment period for most of the studies was once every 2 weeks and for 8 weeks. Among the included studies, 17 showed significant improvements in depression scales, such as Hamilton depression rating scale and Self rating depression scale, activities of daily living scales, and cognitive function scales, such as Hasegawa dementia scale and Mini-mental state examination. Six studies reported adverse events, and no studies reported significant adverse events. Two studies reported follow-ups. Conclusions: This study presents limited evidence for the effectiveness and safety of thread-embedding therapy for depression, anxiety, and dementia. Well-designed studies are needed to review the clinical efficacy and safety of thread-embedding therapy in the future.

Renal Artery Embolization Using a New Liquid Embolic Material Obtained by Partial Hydrolysis of Polyvinyl Acetate (Embol): Initial Experience in Six Patients

  • Sung Il Park;Do Yun Lee;Jong Yoon Won;Sangsoo Park
    • Korean Journal of Radiology
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    • v.1 no.3
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    • pp.121-126
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    • 2000
  • Objective: To evaluate the therapeutic efficacy of a new liquid embolic material, Embol, in embolization of the renal artery. Materials and Methods: Embol is a new embolic material obtained by partial hydrolysis of polyvinyl acetate mixed in absolute ethanol and Iopromide 370 and manufactured by Schering Korea, Kyonggido, Korea. Six patients who underwent embolization of the renal artery using Embol were evaluated. Four were male and two were female and their ages ranged from 11 to 70 (mean, 53) years. Clinical and radiologic diagnoses referred for renal artery embolization were renal cell carcinoma (n = 3), renal angiomyolipoma (n = 2) and pseudoaneurysm of the renal artery (n = 1). After selective renal angiography, Embol was injected through various catheters, either with or without a balloon occlusion catheter. Changes in symptoms and blood chemistry which may have been related to renal artery embolization with Embol were analyzed. Results: The six patients showed immediate total occlusion of their renal vascular lesions. One of the three in whom renal cell carcinoma was embolized with Embol underwent radical nephrectomy, and the specimen thus obtained revealed 40% tumor necrosis. In the two patients with angiomyolipomas, the tumors decreased in size and abdominal pain subsided. Bleeding from pseudoaneurysm of the renal artery was successfully controlled. Four patients showed symptoms of post-embolization syndrome, and one of these also showed increased levels of blood urea nitrogen and creatinine. One patient experienced transient hypertension. Conclusion: Embol is easy to use, its radiopacity is adequate and it is a safe and effective embolic material which provides immediate and total occlusion of renal vascular lesions.

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A Systematic Review on the Use of SBAR in Communication for Domestic Nursing Students (국내 간호대학생의 SBAR를 이용한 의사소통에 대한 체계적 고찰)

  • Mi-Jin Lee;Hwa-Young Kim
    • The Journal of the Convergence on Culture Technology
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    • v.10 no.1
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    • pp.171-182
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    • 2024
  • The purpose of the study was to review the evidence of effects of SBAR for communication in domestic nursing students. Four databases were searched for articles publised until June 2023 that databases include RISS, KISS, DBpia & KCI. Key word used for search include 'nursing students,' 'nursing,' 'SBAR,' 'communication.' Of 57 papers searched, seventeen studies were selected for data analysis. Studies evaluated outcomes including communication clarity, communication competence, communication confidence, critical thinking ability, self-efficacy, reporting confidence, clinical judgment, and communication satisfaction that most studies reported positive effects while some figures were not statistically significant. Accordingly, we intend to analyze the characteristics and contents of communication interventions using SBAR, evaluate their effectiveness, and use them as evidence for future follow-up research on communication interventions using SBAR.

Enhancement of preimplantation mouse embryo development with optimized in vitro culture dish via stabilization of medium osmolarity

  • Hyejin Yoon;Jongwoo Lee;Inyoung Kang;Kyoo Wan Choi;Jaewang Lee;Jin Hyun Jun
    • Clinical and Experimental Reproductive Medicine
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    • v.50 no.4
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    • pp.244-252
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    • 2023
  • Objective: We evaluated the efficacy of the newly developed optimized in vitro culture (OIVC) dish for cultivating preimplantation mouse embryos. This dish minimizes the need for mineral oil and incorporates microwells, providing a stable culture environment and enabling independent monitoring of individual embryos. Methods: Mouse pronuclear (PN) zygotes and two-cell-stage embryos were collected at 18 and 46 hours after human chorionic gonadotropin injection, respectively. These were cultured for 120 hours using potassium simplex optimized medium (KSOM) to reach the blastocyst stage. The embryos were randomly allocated into three groups, each cultured in one of three dishes: a 60-mm culture dish, a microdrop dish, and an OIVC dish that we developed. Results: The OIVC dish effectively maintained the osmolarity of the KSOM culture medium over a 5-day period using only 2 mL of mineral oil. This contrasts with the significant osmolarity increase observed in the 60-mm culture dish. Additionally, the OIVC dish exhibited higher blastulation rates from two-cell embryos (100%) relative to the other dish types. Moreover, blastocysts derived from both PN zygotes and two-cell embryos in the OIVC dish group demonstrated significantly elevated mean cell numbers. Conclusion: Use of the OIVC dish markedly increased the number of cells in blastocysts derived from the in vitro culture of preimplantation mouse embryos. The capacity of this dish to maintain medium osmolarity with minimal mineral oil usage represents a breakthrough that may advance embryo culture techniques for various mammals, including human in vitro fertilization and embryo transfer programs.