• Title/Summary/Keyword: Non-clinical outcomes

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Efficacy and Safety of Long-Term Administration of Esomeprazole in Japanese Pediatric Patients Aged 1-14 Years with Chronic Gastric Acid-Related Disease

  • Masaaki Mori;Yoshiko Nakayama;Shigeo Nishimata;Tadafumi Yokoyama;Ryo Matsuoka;Reiko Hatori;Masaki Shimizu;Katsuhiro Arai;Yuri Etani;Tsuyoshi Sogo;Tomoko Ishizu;Masahiro Nii;Ryosuke Nakashima;Toshiaki Shimizu
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.27 no.5
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    • pp.274-285
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    • 2024
  • Purpose: To evaluate prolonged esomeprazole use in Japanese pediatric patients for reflux esophagitis (RE) maintenance therapy and prevention of gastric (GU) and/or duodenal ulcers (DU) while using non-steroidal anti-inflammatory drugs (NSAIDs) or low-dose aspirin (LDA). Methods: This multicenter, open-label, parallel-group, phase III study (NCT03553563) included patients who were administered esomeprazole according to body weight (10 mg/day [Groups 1 and 3] and up to 20 mg/day [Groups 2 and 4] for patients weighing 10-20 kg and ≥20 kg, respectively). Efficacy outcomes for Groups 1 and 2 (maintenance therapy for healed RE) and Groups 3 and 4 (prevention of long-term NSAID/LDA use-associated GU/DU) were the presence/absence of RE relapse and GU/DU recurrence, respectively. Results: Esomeprazole as maintenance therapy was associated with a low RE recurrence rate, independent of body weight or dosage. Recurrence rates of RE were 0.0% and 5.3% for Groups 1 and 2, respectively. In patients previously diagnosed with GU and/or DU due to long-term NSAID/LDA use, the recurrence rates of GU/DU during weeks 0-32 were 11.1% and 0.0% in Groups 3 and 4, respectively. Conclusion: Long-term use of 10- or 20-mg, once-daily esomeprazole demonstrated a favorable benefit-risk balance in preventing RE and suppressing recurrence of GU and/or DU secondary to NSAID or LDA therapy in Japanese pediatric patients. No new safety concerns were identified. Esomeprazole may be a viable option for managing RE and preventing GU and DU in Japanese pediatric patients.

Characteristics and outcomes of patients with septic shock who transferred to the emergency department in tertiary referral center: multicenter, retrospective, observational study (상급종합병원 및 종합병원 응급실로 전원된 패혈성 쇼크 환자의 특성과 예후: 다기관 후향적 관찰연구)

  • Kim, Min Gyun;Shin, Tae Gun;Jo, Ik Joon;Kim, Won Young;Ryoo, Seung Mok;Chung, Sung Phil;Beom, Jin Ho;Choi, Sung-Hyuk;Kim, Kyuseok;Jo, You Hwan;Kang, Gu Hyun;Suh, Gil Joon;Shin, Jonghwan;Lim, Tae Ho;Han, Kap Su;Hwang, Sung Yeon;Korean Shock Society (KoSS)
    • Journal of The Korean Society of Emergency Medicine
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    • v.29 no.5
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    • pp.465-473
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    • 2018
  • Objective: We evaluated the clinical characteristics and prognoses of patients with septic shock who transferred to the emergency department (ED) in a tertiary referral center. Methods: This study was performed using a prospective, multi-center registry of septic shock, with the participation of 11 tertiary referral centers in the Korean Shock Society between October 2015 and February 2017. We classified the patients as a transferred group who transferred from other hospitals after meeting the inclusion criteria upon ED arrival and a non-transferred group who presented directly to the ED. Primary outcome was hospital mortality. We conducted multiple logistic regression analysis to assess variables related to in-hospital mortality. Results: A total of 2,098 patients were included, and we assigned 717 patients to the transferred group and 1,381 patients to the non-transferred group. The initial Sequential Organ Failure Assessment score was higher in the transferred group than the non-transferred group (6; interquartile range [IQR], 4-9 vs. 6; IQR, 4-8; P<0.001). Mechanical ventilator (29% vs. 21%, P<0.001) and renal replacement therapy (12% vs. 9%, P=0.034) within 24 hours after ED arrival were more frequently applied in the transferred group than the non-transferred group. Overall hospital mortality was 22% and there was no significant difference between transferred and non-transferred groups (23% vs. 22%, P=0.820). Multivariable analysis showed an odds ratio for in-hospital mortality of 1.00 (95% confidence interval, 0.78-1.28; P=0.999) for the transferred group compared with the non-transferred group. Conclusion: The transferred group showed higher severity and needed more organ support procedures than the non-transferred group. However, inter-hospital transfer did not affect in-hospital mortality.

A Study on the Changes in Ventilator Care Rate and Outcome of Very Low Birth Weight Infants During Last Four Years (최근 4년간 극소 저출생 체중아의 인공 호흡기 치료율과 경과 변화에 관한 연구)

  • Jung, Byun Kyung;Kim, Yeoung Ju;Lee, Sang Geel
    • Clinical and Experimental Pediatrics
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    • v.46 no.11
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    • pp.1073-1079
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    • 2003
  • Purpose : Recently there has been a decrease in ventilator care rate and duration of very low birth weight infants(VLBWI) in Fatima Hospital. The aims of this study were to survey the frequency and duration of ventilation in VLBWI and to develop a non-invasive neonatal intensive care unit (NICU) policy. Methods : We performed a retrospective study of 284 newborn of infants less than 1,500 gm admitted to NICU and discharged from January 1998 to December 2001. Patients were intubated or applied continuous positive airway pressure(CPAP) via nasal prong immediately after presenting signs of respiratory distress. We analyzed epidemiologic data to study the changes in ventilator care rate, duration and outcome of ventilator care groups. Results : Of 284 newborn infants, 146 required invasive management, such as endotracheal intubation and assisted ventilation. The characteristics, the severity of clinical symptoms and laboratory findings in ventilator care groups at birth showed no significant differences. The annual proportion of infants requiring assisted ventilation decreased according to increasing gestational age. The median duration of ventilation decreased markedly from 6.0 days in 1998 to 2.7 days in 2001. Final complications and outcomes in ventilator care groups showed no significant differences. Conclusion : Our study shows a significant reduction in the invasiveness of the treatment of VLBW infants, which was not associated with an increased mortality or morbidity. A non-invasive strategy for the VLBW infant with minimal to moderate respiratory distress after birth in NICU is better than immediate invasive management. Non-invasive nasal CPAP is a simpler and safer method than invasive assisted ventilation.

Clinical Outcomes of Thoracic Sympathicotomy for Palmar Hyperhidrosis (수부 다한증에서 흉부교감신경 절제술의 성적)

  • Lee, Jang-Hoon;Lee, Jung-Cheul
    • Journal of Chest Surgery
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    • v.41 no.1
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    • pp.89-94
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    • 2008
  • Background: Thoracoscopic R3 sympathicotomy can effectively treat palmar hyperhidrosis. Here, we evaluated post-operative outcomes of patients receiving a thoracoscopic R3 sympathicotomy due to palmar hyperhidrosis. Material and Method: From January 2001 to December 2006, 225 patients were treated with a R3 sympathicotomy, and follow up was completed for 200 patients, with an average follow up period of 51.7 ($11{\sim}80$) months. We measured postoperative hand sweating according to four grades; dry (grade 1), proper (grade 2), light sweating (grade 3), heavy sweating (grade 4) and evaluated patient satisfaction using 4 grades: very good (grade 0), good (grade1), regular (grade 2), and deficient (grade 3). Result: There were no differences in clinical parameters between the compensatory sweating group and the non-compensatory sweating group. There was a 83.5% compensatory sweating rate. The degree of compensatory sweating related to the patient's body mass index and was influenced by the season, environmental temperature, and emotional stress. Conclusion: The satisfaction rate was 61.5%, and the degree of satisfaction related to the development of compensatory sweating. Therefore, reducing compensatory sweating would increase patient satisfaction with R3 sympathicotomies.

Treat-to-Target Strategy for Asian Patients with Early Rheumatoid Arthritis: Result of a Multicenter Trial in Korea

  • Song, Jason Jungsik;Song, Yeong Wook;Bae, Sang Cheol;Cha, Hoon-Suk;Choe, Jung-Yoon;Choi, Sung Jae;Kim, Hyun Ah;Kim, Jinseok;Kim, Sung-Soo;Lee, Choong-Ki;Lee, Jisoo;Lee, Sang-Heon;Lee, Shin-Seok;Lee, Soo-Kon;Lee, Sung Won;Park, Sung-Hwan;Park, Won;Shim, Seung Cheol;Suh, Chang-Hee;Yoo, Bin;Yoo, Dae-Hyun;Yoo, Wan-Hee
    • Journal of Korean Medical Science
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    • v.33 no.52
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    • pp.346.1-346.11
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    • 2018
  • Background: To evaluate the therapeutic benefits of the treat-to-target (T2T) strategy for Asian patients with early rheumatoid arthritis (RA) in Korea. Methods: In a 1-year, multicenter, open-label strategy trial, 346 patients with early RA were recruited from 20 institutions across Korea and stratified into 2 groups, depending on whether they were recruited by rheumatologists who have adopted the T2T strategy (T2T group) or by rheumatologists who provided usual care (non-T2T group). Data regarding demographics, rheumatoid factor titer, anti-cyclic citrullinated peptide antibody titer, disease activity score of 28 joints (DAS28), and Korean Health Assessment Questionnaire (KHAQ) score were obtained at baseline and after 1 year of treatment. In the T2T group, the prescription for disease-modifying antirheumatic drugs was tailored to the predefined treatment target in each patient, namely remission (DAS28 < 2.6) or low disease activity (LDA) ($2.6{\leq}DAS28$ < 3.2). Results: Data were available for 163 T2T patients and 162 non-T2T patients. At the end of the study period, clinical outcomes were better in the T2T group than in the non-T2T group (LDA or remission, 59.5% vs. 35.8%; P < 0.001; remission, 43.6% vs. 19.8%; P < 0.001). Compared with non-T2T, T2T was also associated with higher rate of good European League Against Rheumatism response (63.0% vs. 39.8%; P < 0.001), improved KHAQ scores (-0.38 vs. -0.13; P = 0.008), and higher frequency of follow-up visits (5.0 vs. 2.0 visits/year; P < 0.001). Conclusion: In Asian patients with early RA, T2T improves disease activity and physical function. Setting a pre-defined treatment target in terms of DAS28 is recommended.

Internal Fixation of Proximal Humerus Fracture with Polyaxial Angular Stable Locking Compression Plate in Patients Older Than 65 Years (65세 이상의 상완골 근위부 골절 환자에서 다축 각안정 잠김 압박 금속판을 이용한 내고정술)

  • Lee, Ki-Won;Choi, Young-Joon;Ahn, Hyung-Sun;Kim, Chung-Hwan;Hwang, Jae-Kwang;Kang, Jeong-Ho;Choo, Han-Ho;Park, Jun-Seok;Kim, Tae-Kyung
    • Clinics in Shoulder and Elbow
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    • v.15 no.1
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    • pp.25-31
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    • 2012
  • Purpose: The clinical and radiographic outcomes of the internal fixation, which were executed on patients over the age of 65 with proximal humerus fracture by using a polyaxial angular stable locking compression plate (Non-Contact-Bridging proximal humerus plate, Zimmer, Switzerland, NCB), were evaluated. Materials and Methods: Thirty two patients over the age of 65 among the proximal humerus fracture treated with NCB plate, between August 2007 and January 2011, were chosen as the subjects. The average age of patients was 71 years, and the average postoperative follow-up period was 11.5 months. The fractures included 14 two-part and 18 three-part fractures. The clinical results were evaluated, using the visual analog scale (VAS) score and the Constant score. The radiological results were evaluated by time to union and Paavolainen method, which measures the neck shaft angle. Results: At the last follow-up examination, the mean VAS score was 3 points and the mean Constant score was 64.5 points, with bone union achieved after the average of 16.2 weeks following the surgery in all the cases. The mean neck shaft angle was 125.9 and 24 cases had good results, while 8 cases had fair results by Paavolainen method, at the last follow-up. There were 1 case of delayed union and cerclage wire failure, and 3 cases of subacromial impingement. There were no complications, such as loss of reduction, nonunion, screw loosening, or avascular necrosis of the humeral head. Conclusion: Internal fixation, using a NCB plate, was considered to be an effective surgical method in treating proximal humerus fracture in the elderly patients, on whom the fixation of the fracture and maintenance of reduction are difficult.

Comparison of Results Between Immediate Fixation Group and Delayed Reconstruction Group in Displaced Mid-shaft Fractures of the Clavicle (쇄골 전위성 간부 골절에서 조기 고정술 군과 지연 재건술 군 간의 결과 비교)

  • Kim, Doo-Sub;Rah, Jung-Ho;Yoon, Yeo-Seung;Lee, Chang-Ho
    • Clinics in Shoulder and Elbow
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    • v.12 no.1
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    • pp.61-66
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    • 2009
  • Purpose: Several authors have reported excellent results of delayed reconstruction of non-union & malunion in displaced mid-shaft fractures of the clavicle and these results were equal to that of immediate fixation. But direct comparison between these treatments is rare. We evaluated the results between the immediate fixation group and delayed reconstruction group for treating displaced mid-shaft fractures of the clavicle. Materials and Methods: We studied the results of 18 cases with immediate fixation of displaced mid-shaft fractures of the clavicle and 15 cases with delayed reconstruction of non-union & malunion after conservative management, and these cases were seen from March 2000 to February, 2006. The final postoperative outcome was analyzed according to the clinical outcomes with using the Constant score and the radiological findings of bony union. Results: The constant score was low in the delayed reconstruction group compare to that of the immediate fixation group (p value=0.045). For the pain score & the activities of daily living score, a statistically significant difference was seen between the two groups (p<0.05), but not for the range of motion score & the power score (p>0.05). Radiological findings of bony union were seen for both groups at an average of 8.8 weeks for the immediate fixation group and at an average of 9.8 weeks for the delayed reconstruction group. Conclusion: Though the delayed reconstruction group was shown good clinical and radiological results, the immediate fixation group had a significantly better pain score, a better activities of daily living score and a better Constant score. It is important to choose the initial treatment option for displaced mid-shaft fractures of the clavicle after sufficient explanation to patients about the merits and demerits between these two treatment options.

Clinical Outcomes of Oral Squamous Cell Carcinoma Patients Treated in National Cancer Center for Last 10 years (최근 10년간 국립암센터에서 치료받은 구강 편평상피세포암종 환자의 치료성적 연구)

  • Jo, Sae-Hyung;Kim, Tae-Woon;Choung, Han-Wool;Park, Sung-Won;Park, Joo-Yong;Choi, Sung-Weon
    • Maxillofacial Plastic and Reconstructive Surgery
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    • v.32 no.6
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    • pp.544-550
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    • 2010
  • Purpose: The result of all malignant neoplasms including oral cancer is decided by long-term prognosis. However, until now, there are only a few reports about long-term prognosis of cancer secluded in the oral cavity. So, we investigated all patients that visited our clinic for oral squamous cell carcinoma (SCCa) for the last 10 years. From this survey, we hope to find important factors that influence prognosis of the disease. Patients and Methods: A retrospective study was performed for patients that visited the oral oncology clinic for oral cancers from Jan. 2001 to Feb. 2010. We selected the patients that were diagnosed with SCCa and received curative treatment. In these patients, we investigated basic epidemiology, smoking history, body mass index, recurrence rate, treatment methods, pathologic data and 5-yr survival rate. Results: There was a total of 185 patients (115 males, 70 females and mean age: 57.3 years) that visited the oral oncology clinic for oral SCCa. Areas of primary lesion were tongue (105 cases, 57%), lower gum (19 cases, 10%), floor of mouth (16 caess, 8%), retromolar trigone (12 cases, 6.5%), and buccal cheek (11 cases, 6%). Other involved areas were upper gum, palate, lip, and salivary glands-of 1 case each. The overall 5-year survival rate was 63.7%. The factors that influenced prognosis of the disease were stage of the disease, status of differentiation, recurrence, metastasis of cervical lymph node and age. Conclusion: The factors that influence prognosis of disease are stage of the disease, status of differentiation, recurrence, metastasis of cervical lymph node and age. To point out a current trend, the mean age of patients that developed oral cancer was lower than that of before. Secondly, the prevalence of oral cancer in non-smoker are on the rise. Thus, further studies on etiology and epidemiology should be done.

Effect of leukocyte alteration on treatment outcomes following preoperative chemoradiotherapy in patients with rectal cancer

  • Kim, Tae Gyu;Park, Won;Choi, Doo Ho;Park, Hee Chul;Kim, Seok-Hyung;Cho, Yong Beom;Yun, Seong Hyen;Kim, Hee Cheol;Lee, Woo Yong;Lee, Jeeyun;Park, Joon Oh;Park, Young Suk
    • Radiation Oncology Journal
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    • v.35 no.3
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    • pp.217-226
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    • 2017
  • Purpose: Hematotoxicity following anti-cancer treatment is known to be related to treatment efficacy in several malignancies. The purpose of this study was to examine the hematologic parameters related to the tumor response and survival in patients treated with curative surgery following preoperative chemoradiotherapy (CRT) for rectal cancer. Materials and Methods: Four hundred eighteen patients with rectal cancer who underwent preoperative CRT and curative surgery were analyzed, retrospectively. The main clinical factors and blood cell counts before and after CRT were investigated with respect to their relationships with tumor downstaging and patient survival. Results: The post-CRT leukocyte count was significantly different between the tumor downstaging group and the non-downstaging group (median, 4740/uL vs. 5130/uL; p = 0.013). Multivariate analysis showed that histological grade, circumferential extent, and post-CRT leukocyte count were related to tumor downstaging. In addition, histological grade, post-CRT leukocyte count, and tumor downstaging were related to disease-free survival. The 5-year disease-free survival and overall survival in patients with post-CRT leukocyte count ${\leq}3730/uL$, which is the cut-off value derived from the receiver operation characteristic (ROC) curve analysis, were significantly higher than those with higher counts (88.0% vs. 71.6%, p = 0.001; 94.4% vs. 84.1%, p = 0.024). Conclusion: Post-CRT leukocyte count of ${\leq}3730/uL$ could be regarded as a good prognostic factor for tumor response and survival in rectal cancer patients treated with preoperative CRT.

Surgical Experience of Infratentorial Meningiomas : Clinical Series at a Single Institution during the 20-Year Period

  • Jung, Min-Ho;Moon, Kyung-Sub;Lee, Kyung-Hwa;Jang, Woo-Youl;Jung, Tae-Young;Jung, Shin
    • Journal of Korean Neurosurgical Society
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    • v.55 no.6
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    • pp.321-330
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    • 2014
  • Objective : Based on surgical outcomes of patients with infratentorial meningiomas surgically treated at our institution, we analyzed the predictors for surgical resection, recurrence, complication, and survival. Methods : Of surgically treated 782 patients with intracranial meningioma, 158 (20.2%) consecutive cases of infratentorial location operated on between April 1993 and May 2013 at out institute were reviewed retrospectively. The patients had a median age of 57.1 years (range, 16-77 years), a female predominance of 79.7%, and a mean follow-up duration of 48.4 months (range, 0.8-242.2 months). Results : Gross total resection (Simpson's grade I & II) was achieved in 81.6% (129/158) of patients. Non-skull base location was an independent factor for complete resection. The recurrence rate was 13.3% (21/158) and the 5-, 10-, and 15-year recurrence rates were 8.2%, 12.0%, and 13.3%, respectively. Benign pathology, postoperative KPS over than 90, low peritumoral edema, and complete resection were significantly associated with longer recurrence-free survival rate. The 5-, 10-, and 15-year survival rates were 96.2%, 94.9%, and 94.9%, respectively. Benign pathology, postoperative KPS over than 90 and complete resection were significantly associated with a longer survival rate. The permanent complication rate was 13% (21/158). Skull base location and postoperative KPS less than 90 were independent factors for the occurrence of permanent complication. Conclusion : Our experience shows that infratentorial meningiomas represent a continuing challenge for contemporary neurosurgeons. Various factors are related with resection degree, complications, recurrence and survival.