• Title/Summary/Keyword: Clinical safety

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Laser-cut-type versus braided-type covered self-expandable metallic stents for distal biliary obstruction caused by pancreatic carcinoma: a retrospective comparative cohort study

  • Koh Kitagawa;Akira Mitoro;Takahiro Ozutsumi;Masanori Furukawa;Yukihisa Fujinaga;Kenichiro Seki;Norihisa Nishimura;Yasuhiko Sawada;Kosuke Kaji;Hideto Kawaratani;Hiroaki Takaya;Kei Moriya;Tadashi Namisaki;Takemi Akahane;Hitoshi Yoshiji
    • Clinical Endoscopy
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    • v.55 no.3
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    • pp.434-442
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    • 2022
  • Background/Aims: Covered self-expandable metallic stents (CMSs) are widely used for malignant distal biliary obstructions (MDBOs) caused by pancreatic carcinoma. This study compared the efficacy and safety of the laser-cut-type and braided-type CMSs. Methods: To palliate MDBOs caused by pancreatic carcinoma, the laser-cut-type CMSs was used from April 2014 to March 2017, and the braided-type CMSs was used from April 2017 to March 2019. The tested self-expandable metallic stents were equipped with different anti-migration systems. Results: In total, 47 patients received CMSs for MDBOs (24 laser-cut type, 23 braided-type). The time to recurrent biliary obstruction (TRBO) was significantly longer in the braided-type CMSs (p=0.0008), and the median time to stent dysfunction or patient death was 141 and 265 days in the laser-cut-type CMSs and braided-type CMSs, respectively (p=0.0023). Stent migration was the major cause of stent dysfunction in both groups, which occurred in 37.5% of the laser-cut-type CMSs and 13.0% of the braided-type CMSs. There were no differences in the survival duration between the groups. Conclusions: The TRBO was significantly longer for the braided-type CMSs with an anti-migration system than for the laser-cut-type. Stent migration tended to be less frequent with the braided-type CMSs than with the laser-cut-type CMSs.

Effect of belimumab in patients with systemic lupus erythematosus treated with low dose or no corticosteroids

  • Yeo-Jin Lee;Soo Min Ahn;Seokchan Hong;Ji-Seon Oh;Chang-Keun Lee;Bin Yoo;Yong-Gil Kim
    • The Korean journal of internal medicine
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    • v.39 no.2
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    • pp.338-346
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    • 2024
  • Background/Aims: Systemic lupus erythematosus (SLE) responder index (SRI)-4 response has been achieved with belimumab treatment in patients with moderate disease activity in cornerstone clinical trials and following studies. However, most studies involved patients treated with a mean prednisolone-equivalent dose of approximately 10 mg/d and focused on the steroid-sparing effect of belimumab. We aimed to identify the effect of belimumab in patients with mild-to-moderate SLE who were treated with low-dose or no corticosteroids. Methods: We retrospectively reviewed the electronic medical records of patients treated with belimumab for at least 6 months between May 2021 and June 2022. The primary endpoint was SRI-4 response at 6 months. Results: Thirty-one patients were included (13 low dose- and 18 steroid non-users). The mean age was 39.2 ± 11.4 years, and 90.3% of patients were female. The baseline Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score was 6.0 (4.0-9.0). The primary endpoint was achieved in 32.3% (10/31) of patients. Significant improvements in anemia, C4 levels, and SELENA-SLEDAI score were observed during treatment. Univariate analysis showed that the baseline SELENA-SLEDAI and arthritis were significantly associated with SRI-4 response at 6 months, and only the SELENA-SLEDAI remained significant (p = 0.014) in multivariate analysis. Conclusions: This cohort study is the first to report the efficacy of belimumab after minimizing the effect of corticosteroids. Belimumab showed efficacy in improving the SELENA-SLEDAI score, anemia, and low C4 in patients who did not receive corticosteroids or received only low doses.

Initial experience with Scepter Mini dual lumen balloon for embolization of cerebrovascular diseases

  • Muhammad U Manzoor;Ibrahim A. Almulhim;Abdullah A. Alrashed;Shorog Althubait;Abdulrahman Y. Alturki;Sultan M. Al-Qahtani
    • Journal of Cerebrovascular and Endovascular Neurosurgery
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    • v.25 no.2
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    • pp.175-181
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    • 2023
  • Objective: Endovascular treatment of cerebrovascular diseases is often challenging due to small caliber, tortuous distal vessels. Several devices and techniques have evolved to overcome these challenges. Recently, a low profile dual lumen microballoon catheter, specifically designed for distal navigation is employed for neurovascular procedures. Due to its recent advent, scarce data is available on clinical utility and safety of Scepter Mini. The aim of this case series is to report our initial experience with Scepter Mini in the management of various cerebrovascular diseases. Methods: All interventional neurovascular cases performed using Scepter Mini between January 2020 till April 2021 were included. Data regarding patient demographics, procedural details and complications was retrospectively collected from patient's electronic medical record and procedure reports. Results: Total twelve embolization procedures were performed in eleven patients, including six brain arteriovenous malformation, two dural arteriovenous fistula, one vein of Galen malformation and three hyper-vascular glomus tumor embolizations. All procedures were successfully performed with adequate penetration of the embolic agent. Complete embolization was performed in six procedures, while intended partial embolization was performed in the rest of procedures. Scepter Mini was solely used in ten procedures, however in the other two embolization procedures it was used as an additional conjunct tool to complete the intended embolization. No balloon related complication was observed in any procedure. Conclusions: Scepter Mini dual lumen microballoon catheter is safe and feasible for delivery of liquid embolic agents for cerebrovascular embolization procedures.

A Review of Etiology, Syndrome Differentiation, and Herbal Medicine of Epilepsy (뇌전증의 병인, 변증, 한약 치료에 대한 고찰 -한국, 일본, 중국 데이터베이스를 중심으로-)

  • Kim Hye Yeon;Kim Tae Hwan;Han Ju Hui;Bang Mi Ran;Chang Gyu Tae;Lee Jin Yong;Kim Hyo In;Lee Donghun;Lee Sun Haeng
    • The Journal of Pediatrics of Korean Medicine
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    • v.38 no.3
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    • pp.66-96
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    • 2024
  • Objectives This study aimed to establish a foundation for research on Korean medicine for epilepsy by analyzing its etiology, syndrome differentiation, and the use of herbal medicines. Methods Articles were extracted from five databases in Korea, Japan, and China: the Oriental Medicine Advanced Searching Integrated System (OASIS), Citation Information by the National Institute of Informatics (CiNii), Chinese National Knowledge Infrastructure (CNKI), Wangfang Database, and Chinese Scientific Journal Database (VIP). The etiology, syndrome differentiation, and herbal medicines used for epilepsy were investigated. Results A total of 64 articles were selected, including seven clinical studies, 16 case reports, and 41 reviews. Epilepsy is a complex disease with various etiologies, and among the five viscera, syndrome differentiation mainly involved the liver, spleen, and kidney, with pathological factors that included phlegm, wind, and blood stasis. Frequently used herbal medicines included Modified Jeongganhwan, Sihogyejitang, Yukgunjatang, and Sihogayonggolmoryotang. Conclusions This study analyzed epilepsy's etiology, syndrome differentiation, and herbal treatments. Further evidence is needed to better understand the efficacy and safety of Korean herbal medicine for treating epilepsy.

Decellularized Matrices for the Treatment of Tissue Defects: from Matrix Origin to Immunological Mechanisms

  • Xinyue Wang;Jiqiang Guo;Qing Yu;Luyao Zhao;Xiang Gao;Li Wang;Meiling Wen;Junrong Yan;Meiwen An;Yang Liu
    • Biomolecules & Therapeutics
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    • v.32 no.5
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    • pp.509-522
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    • 2024
  • Decellularized matrix transplantation has emerged as a promising therapeutic approach for repairing tissue defects, with numerous studies assessing its safety and efficacy in both animal models and clinical settings. The host immune response elicited by decellularized matrix grafts of natural biological origin plays a crucial role in determining the success of tissue repair, influenced by matrix heterogeneity and the inflammatory microenvironment of the wound. However, the specific immunologic mechanisms underlying the interaction between decellularized matrix grafts and the host immune system remain elusive. This article reviews the sources of decellularized matrices, available decellularization techniques, and residual immunogenic components. It focuses on the host immune response following decellularized matrix transplantation, with emphasis on the key mechanisms of Toll-like receptor, T-cell receptor, and TGF-β/SMAD signaling in the stages of post-transplantation immunorecognition, immunomodulation, and tissue repair, respectively. Furthermore, it highlights the innovative roles of TLR10 and miR-29a-3p in improving transplantation outcomes. An in-depth understanding of the molecular mechanisms underlying the host immune response after decellularized matrix transplantation provides new directions for the repair of tissue defects.

The efficacy and safety of transcatheter closure of atrial septal defect with Amplatzer septal occluder in young children less than 3 years of age (3세 미만 심방중격결손 소아에서 Amplatzer 기구 폐쇄술의 안전성 및 효용성)

  • Lee, Soo Hyun;Choi, Deok Young;Kim, Nam Kyun;Choi, Jae Young;Sul, Jun Hee
    • Clinical and Experimental Pediatrics
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    • v.52 no.4
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    • pp.494-498
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    • 2009
  • Purpose : Applicability of transcatheter closure of atrial septal defect (ASD) has been expanded by accumulation of clinical experiences and evolutions of the device. This study was performed to evaluate the safety and efficacy of transcatheter closure of ASD with Amplatzer septal occluder (ASO) in young children less than 3 years of age. Methods : From May 2003 to December 2005, 295 patients underwent transcatheter closure of ASD with ASO in the Severance Cardiovascular Hospital, Yonsei University Health System. Among them, 51 patients less than 3 years of age were enrolled in this study. We investigated procedural success rate, rate of residual shunt, frequency of complications, procedure/fluoroscopy time, and need of modified techniques for device implantation. Results : The median age was 2.1 years and median body weight was 12 kg. Implantation of device was successful in 50 patients (98%). Seven patients (15%) showed a small residual shunt 1 day after the procedure, but complete occlusion had been documented at 6 month follow-up in all patients (100%). The pulmonary to systemic flow ratio (Qp/Qs), peak systolic pulmonary artery pressure, and peak systolic right ventricular pressure had decreased significantly after closure of ASD. There were 2 complications including device embolization (1, 2%) and temporary groin hematoma (1, 2%). Conclusion : Transcatheter closure of ASD with ASO can be performed with satisfactory results and acceptable risk even in young children less than 3 years of age. We could suggest that even in very young children with ASD, there is no need to wait until they grow to a sufficient size for the transcatheter closure.

Comparative Study of Perinatal Outcome and the Incidene of Congenital Anomalies of Babies Born after Intracytoplasmic Sperm Injection (ICSI) and Conventional In-vitro Fertilization (IVF) (고식적 체외수정시술과 난자 세포질내 정자주입술에 의해 태어난 아이의 주산기 결과 및 선천성 기형 발생빈도의 비교 연구)

  • Lim, Jeong-Eun;Yoo, Keun-Jai;Lee, Jong-Pyo;Lee, Moon-Seob;Hyun, Woo-Young;Jun, Jin-Hyun;Hong, Soo-Jeong;Song, Ji-Hong;Song, In-Ok;Paik, Eun-Chan;Choi, Bum-Chae;Son, Il-Pyo;Koong, Mi-Kyoung;Kang, In-Soo;Jun, Jong-Young;Park, In-Sou
    • Clinical and Experimental Reproductive Medicine
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    • v.25 no.3
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    • pp.323-329
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    • 1998
  • The safety of ICSI as a novel procedure of assisted fertilization may be assessed by the health of the baby born. In order to evaluate the safety of ICSI, perinatal outcome and congenital anomaly of the babies born after ICSI were compared with those of babies born after IVF (control group). We analysed the clinical data from the obstetric and pediatric records, including the information obtained through telephone. The results are as follows; Mean gestational age $({\pm}SEM)$ and birth weight in singleton pregnancy were $38.8{\pm}1.9$ weeks and $3209.7{\pm}501.9gm$ in IVF group, $39.0{\pm}2.2$ weeks and $3289.9{\pm}479.5gm$ in ICSI group, respectively. Mean gestational age and birth weight in twins were $36.8{\pm}2.1$ weeks and $2512.8{\pm}468.0gm$ in IVF group, $36.5{\pm}2.8$ weeks and $2492.7{\pm}537.1gm$ in ICSI group. In IVF group, perinatal mortality rates were 8.5 in singletons and 56.6 in twins; for the ICSI singletons and ICSI twins, the perinatal mortality rates were 11.6 and 49.0, respectively. The incidence of congenital malformations was 3.6% (8/224) in IVF group and 2.1% (4/188) in ICSI group, there was no statistical difference (p>0.05, Fisher's exact test). The incidence of major congenital anomalies was 0.9% (2/224; pulmonary artery hypoplasia, renal cystic dysplasia) in IVF group and 1.1% (2/188; holoprosencephaly, Cri du chat syndrome) in ICSI groups (p>0.05, Fisher's exact test). Similarly, there was no significant difference in incidence of minor congenital anormalies 2.7% (6/224) in IVF group and 1.1% (2/188) in ICSI group respectively (p>0.05, Fisher's exact test). In conclusion, there was no difference in the perinatal outcome and the incidence of congenital anomalies between the babies born after ICSI and those after conventional IVF.

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Efficacy and safety of electrolytes-free polyethylene glycol (PEG) 4000 for disimpaction in children with chronic functional constipation (소아 만성 기능성변비 치료에서 전해질이 함유되지 않은 polyethylene glycol (PEG) 4000의 분변박힘 제거효과 및 안전성)

  • Lee, Jeong Hee;Lee, Ran;Bae, Sun Hwan
    • Clinical and Experimental Pediatrics
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    • v.51 no.4
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    • pp.391-395
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    • 2008
  • Purpose : This study was performed evaluate optimal dose for disimpaction, efficacy and safety of PEG 4000 in children with chronic functional constipation. Methods : Eighty six children with chronic functional constipation were enrolled in this prospective study at Konkuk university hospital March, 2003 through August, 2006. Success in disimpaction with PEG 4000 was defined as meeting at least two out of three criteria; resolution of chief complaint, getting easiness of defecation with respect to frequency of bowel movement and hardness of stool based on defecation diary, and decrease in fecal impaction on simple abdominal X-ray test. Adverse effects of PEG 4000 were monitored clinically and biochemically. Results : Eighty three out of 86 children completed the study, and success rate of disimpaction was 99% (82/83). The mean dose of PEG 4000 for disimpaction was $0.93{\pm}0.28g/kg/day$ (0.4-2.0 g/kg/day, Max.: 30 g/day). Frequency of bowel movement increased ($5.02{\pm}2.71/wk$ vs. $11.25{\pm}5.43/wk$) in most children (79/83). Fecal impaction on simple abdominal X-ray test improved with statistical significance in 25 children (P=0.0007). Because of adverse effect of PEG 4000, 3 children did not complete the study; urticaria, severe diarrhea, diarrhea and abdominal pain. One 6-year-old girl who completed the study complained tingling sensation in the hand and foot without laboratory abnormality (4/86, 4.7%). Laboratory test revealed hyperosmolality without clinical symptom in 1 child, and eosinophilia in 6 children. Conclusion : The average safe and effective dose of PEG 4000 for disimpaction was $0.93{\pm}0.28g/kg/day$ (0.4-2.0 g/kg/day, Max : 30 g/day) in children with chronic functional constipation.

The First 20 Cases of Cardiac Surgery Using the da $Vinci^{TM}$ Surgical System: A Single Center Experience (다빈치 수술로봇을 이용한 심장수술 20예 보고 - 단일 기관 보고 -)

  • Je, Hyoung-Gon;Lee, Yong-Jik;Jung, Sung-Ho;Jung, Jae-Seung;Kang, Pil-Je;Choo, Suk-Jung;Song, Hyun;Chung, Cheol-Hyun;Lee, Jae-Won
    • Journal of Chest Surgery
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    • v.41 no.4
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    • pp.423-429
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    • 2008
  • Background: The interest in robotic cardiac surgery has recently grown but there has not been much clinical research reported on this. The aim of this study is to examine our initial experience, since August 2007, with robotic cardiac surgery using the da $Vince^{TM}$ surgical system and to evaluate the feasibility and safety of it. Material and Method: Between August and December 2007, a total of 20 patients underwent robotic cardiac surgery using the da Vinci surgical system. For mitral valve repair (n=11), tricuspid valve repair (n=1), and ASD repair (n=1), cannulation, antegrade cardioplegia and transthoracic aortic cross-clamping were conducted for the right femoral vessels and the right internal jugular vein. For minimally invasive direct CABG (MIDCAB) (n=7), the internal thoracic artery (ITA) was harvested with the da Vinci surgical system. Result: The mean age of the patients was 50.1 (range: $26{\sim}78$) years. Three concomitant Maze procedures and one tricuspid annuloplasty were combined with mitral valve repair. The mean cardiopulmonary bypass time was $208.0{\pm}61.3$ minutes and the aortic cross clamp time was $158.8{\pm}40.6$ minutes. No patients showed more than mild mitral regurgitation after repair and the median hospital stay was 4 days. The robotic-harvested ITA was used for either left ITA (n=6) or bilateral ITA (n=1). The mean harvest time was $43.2{\pm}12.0$ minutes. The harvested ITA showed good flow and it was anastomosed under direct vision after left anterolateral thoracotomy. The patency of all the grafts was 100% (18/18) in MIDCAB. Conclusion: Robotic cardiac surgery using the da Vinci surgical system was variously adapted to areas such as mitral and tricuspid valve repair, ASD repair and ITA harvest for MIDCAB. The early results of the robotic cardiac surgery showed its safety and feasibility. With this primary report, we anticipate that clinical applications and further studies on robotic cardiac surgery using the da Vinci surgical system will be actively conducted in Korea.

Comparison of Clinical Results of Excimer Laser Correction of Myopia and Compound Myopic Astigmatism Using VISX 20/20B $VisionKey^{TM}$ (VISX 20/20B $VisionKey^{TM}$ 엑시머레이저의 version 4.01 software를 이용한 근시교정술 및 근시성난시교정술의 임상성적 비교)

  • Lee, Sang-Bumm;Bae, Sang-Bok
    • Journal of Yeungnam Medical Science
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    • v.17 no.1
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    • pp.55-65
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    • 2000
  • Purpose: To compare the efficacy, predictability, stability and safety of excimer laser photorefracive keratectomy(PRK) for myopia and photoastigmatic refractive keratectomy(PARK) for compound myopic astigmatism. Methods: Two-hundred and three eyes(l18 eyes < -7D spherical equivalent, 85 eyes ${\geq}$ -7D spherical equivalent) received excimer laser correction for compound myopic astigmatism and 152 eyes(116 eyes < -7D, 36 eyes ${\geq}$ -7D) for simple myopia. A VISX 20/20B $VisionKey^{TM}$ excimer laser was used to perform either PARK or PRK. Visual acuity with and without correction, refraction, IOP, corneal haze, and topography were evaluated at 1, 3, 6, and 12 months postoperatively. All patients were followed up for more than 12 months. Results: Postoperative refraction were generally stable after 3 months without significant early overcorrection. At 12 months, 110(94.8%) eyes that underwent PRK and 104(88.1%) eyes that underwent PARK achieved UCVA of 20/30 or better in the group who had lower than -7D correction. For eyes treated with -7D or more, these figures were 31(86.1%) eyes after PRK and 57(67.1%) eyes after PARK. The incidences of within 1D of plano refraction at 1 year follow-up were 97.4% after PRK and 93.2% after PARK in the group who had lower than -7D correction. For eyes treated with -7D or more, these figures were 80.6% after PRK and 70.6% after PARK. Conclusions Myopia with or without astigmatism was successfully treated in most of the eyes using PRK or PARK with VISX 20/20B $VisionKey^{TM}$ excimer laser. The predictability and stability of the postoperative refraction during the first 12 months seem to be quite reliable. Further improvement of excimer laser system and software should increase the clinical outcomes and safety of refractive procedures.

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