• Title/Summary/Keyword: Adverse Event

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Bronchoesophageal fistula in a patient with Crohn's disease receiving anti-tumor necrosis factor therapy

  • Kyunghwan Oh;Kee Don Choi;Hyeong Ryul Kim;Tae Sun Shim;Byong Duk Ye;Suk-Kyun Yang;Sang Hyoung Park
    • Clinical Endoscopy
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    • v.56 no.2
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    • pp.239-244
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    • 2023
  • Tuberculosis is an adverse event in patients with Crohn's disease receiving anti-tumor necrosis factor (TNF) therapy. However, tuberculosis presenting as a bronchoesophageal fistula (BEF) is rare. We report a case of tuberculosis and BEF in a patient with Crohn's disease who received anti-TNF therapy. A 33-year-old Korean woman developed fever and cough 2 months after initiation of anti-TNF therapy. And the symptoms persisted for 1 months, so she visited the emergency room. Chest computed tomography was performed upon visiting the emergency room, which showed BEF with aspiration pneumonia. Esophagogastroduodenoscopy with biopsy and endobronchial ultrasound with transbronchial needle aspiration confirmed that the cause of BEF was tuberculosis. Anti-tuberculosis medications were administered, and esophageal stent insertion through endoscopy was performed to manage the BEF. However, the patient's condition did not improve; therefore, fistulectomy with primary closure was performed. After fistulectomy, the anastomosis site healing was delayed due to severe inflammation, a second esophageal stent and gastrostomy tube were inserted. Nine months after the diagnosis, the fistula disappeared without recurrence, and the esophageal stent and gastrostomy tube were removed.

Prophylactic Cranial Irradiation for Acute Lymphoblastic Leukemia in Childhood (소아 급성 림프모구성 백혈병의 예방적 전뇌 방사선조사)

  • Kim, In-Ah;Choi, Ihl-Bhong;Kang, Ki-Mun;Shinn, Kyung-Sub;Kim, Hack-Ki
    • Radiation Oncology Journal
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    • v.14 no.2
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    • pp.137-147
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    • 1996
  • Purpose : This report is the result f retrospective analysis for children who received prophylactic cranial irradiation combined with intrathecal chemotherapy. Materials and Methods : Ninety children with ALL who had got bone marrow remission after induction chemotherapy received PCI. All but 3 children were treated with a dose of 1800 cGy as a standard regimen. While the PCI was given, all patients received intrathecal chemotherapy. Results : Nine of 90 patients experienced CNS relapse during the duration of follow-up ranged from 36 to 96 months (median 60 months). Three children experienced BM relapse prior to CNS relapse. Therefore, CNS relapse rate as the first adverse event was $6.7\%$. Median time interval of CNS relapse was 16 months from the first day of hematologic complete remission. Eighty-nine percent of patients who had CNS relapse were associated with hematologic relapse. and $78\%$ of CNS relpase occurred during maintenance chemotherapy (on-therapy relapse). The CNS RFS at 2 and 5 years are $68\%$ and $42\%$, respectively with median of 43 months. The Prognostic factors affecting CNS RFS are initial WBC count (cut-off point of 50,000/ul), FAB subtype and CALGB risk criteria. The DFS at 2 and 5 years are 61 and $39\%$, respectively with median of 34 months. The prognostic factors affecting DFS are initial WBC count (cut-off point of 50,000/ul), FAB subtype, POG and CALGB risk criteria. Conclusions : In our study, $6.7\%$ of CNS relapse rate as a first adverse event was comparable with other studies. Various risk criteria was based on age at diagnosis and initial WBC count such as POG and CALGB criteria, had prognostic significance for CNS RFS and DFS. Prospective randomized trial according to prognostic subgroup based on risk criteria and systematic study about neuropsychologic function for long term survivors, are essential to determine the most effective and least toxic form of CNS prophylaxis.

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Xeliri Plus Bevacizumab Compared with Folfiri Plus Bevacizumab as First-Line Setting in Patients with Metastatic Colorectal Cancer: Experiences at Two-Institutions

  • Uygun, Kazim;Bilici, Ahmet;Kaya, Serap;Ustaalioglu, Bala Basak Oven;Yildiz, Ramazan;Temiz, Suleyman;Seker, Mesut;Aksu, Gorkem;Cabuk, Devrim;Gumus, Mahmut
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.4
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    • pp.2283-2288
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    • 2013
  • Background: Efficacy of chemotherapy plus bevacizumab has been shown in patients with metastatic colorectal cancer (mCRC) compared with chemotherapy alone. The aim of the present study was to evaluate the efficacy and safety of FOLFIRI or XELIRI regimens in combination with bevacizumab for mCRC patients in a first-line setting. Materials and Methods: A total of 132 patients with previously untreated and histologically confirmed mCRC were included. They were treated with either FOLFIRI-Bevacizumab (Bev) or XELIRI-Bev according to physician preference. The efficacy and safety of the two regimens were compared. Results: Between 2006 and 2010, 68 patients were treated with the XELIRI-Bev regimen, while the remaining 64 patients received the FOLFIRI-Bev regimen. The median age was 58.5 years (53.6 years in the FOLFIRI-Bev and 59.7 years in the XELIRI-Bev arm, p=0.01). Objective response rate was 51.6% for FOLFIRI-Bev versus 41.2% for XELIRI-Bev (p=0.38). At the median follow-up of 24.5 months, the median progression-free survival (PFS) was not different between two groups (14.2 months in FOLFIRI-Bev vs. not reached in the XELIRI-Bev, p=0.30). However, median overall survival time for the FOLFIRI-Bev arm was better than that for patients treated with XELIRIBev, but these differences was not statistically significant (37.8 months vs. 28.7 months, respectively, p=0.58). Most commonly reported grade 3-4 toxicities (FOLFIRI-Bev vs XELIRI-Bev) were nausea/vomiting (7.8% vs. 14.7%, p=0.27), diarrhea (10.9% vs 22.1%, p=0.10), hand-foot syndrome (0% vs 8.8%, p=0.02) and neutropenia (18.7% vs 27.9%, p=0.22). Conclusion: Our results showed that FOLFIRI-Bev and XELIRI-Bev regimens were similarly effective treatments in a first-line setting for patients with untreated mCRC, with manageable adverse event profiles.

Effect of caspases and RANKL induced by heavy force in orthodontic root resorption

  • Minato, Yukari;Yamaguchi, Masaru;Shimizu, Mami;Kikuta, Jun;Hikida, Takuji;Hikida, Momoko;Suemitsu, Masaaki;Kuyama, Kayo;Kasai, Kazutaka
    • The korean journal of orthodontics
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    • v.48 no.4
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    • pp.253-261
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    • 2018
  • Objective: Orthodontic root resorption (ORR) due to orthodontic tooth movement is a difficult treatment-related adverse event. Caspases are important effector molecules for apoptosis. At present, little is known about the mechanisms underlying ORR and apoptosis in the cementum. The aim of the present in vivo study was to investigate the expression of tartrate-resistant acid phosphatase (TRAP), caspase 3, caspase 8, and receptor activator of nuclear factor kappa-B ligand (RANKL) in the cementum in response to a heavy or an optimum orthodontic force. Methods: The maxillary molars of male Wistar rats were subjected to an orthodontic force of 10 g or 50 g using a closed coil spring. The rats were sacrificed each experimental period on days 1, 3, 5, and 7 after orthodontic force application. And the rats were subjected to histopathological and immunohistochemical analyses. Results: On day 7 for the 50-g group, hematoxylin and eosin staining revealed numerous root resorption lacunae with odontoclasts on the root, while immunohistochemistry showed increased TRAP- and RANKL-positive cells. Caspase 3- and caspase 8-positive cells were increased on the cementum surfaces in the 50-g group on days 3 and 5. Moreover, the number of caspase 3- and caspase 8-positive cells and RANKL-positive cells was significantly higher in the 50-g group than in the 10-g group. Conclusions: In our rat model, ORR occurred after apoptosis was induced in the cementum by a heavy orthodontic force. These findings suggest that apoptosis of cementoblasts is involved in ORR.

Intravenous Iron Supplementation in Korean Children on Chronic Dialysis (한국 만성 투석 소아 환자에서 정맥용 철분 제제 투여에 관한 연구)

  • Cho, Hee-Yeon;Hahn, Hye-Won;Ha, Il-Soo;Cheong, Hae-Il;Choi, Yong
    • Childhood Kidney Diseases
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    • v.13 no.2
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    • pp.197-206
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    • 2009
  • Purpose : Limited information is available on experiences of intravenous iron treatment in children. In this study, iron sucrose was administered intravenously to determine its effect, the factors predicting outcome, and safety in children on chronic dialysis. Methods : Twenty-one children whose serum ferritin levels were less than 100 ng/mL or transferrin saturations (TSAT) were less than 20% were enrolled. In 12 children on peritoneal dialysis (PD), the drug was infused intravenously as 200 mg/$m^2$ ($\leq$200 mg) at week 0, 2, 4, and 6. In 9 children on hemodialysis (HD), it was given intravenously as 8 weekly doses of 3 mg/kg ($\leq$100 mg) through week 0-7. Results : After treatment, serum ferritin levels increased significantly in both groups, and TSAT rose significantly in PD group. However, hemoglobin level did not rise significantly in both groups. Children with baseline hemoglobin less than 10 g/dL or baseline TSAT less than 20% showed significantly higher rise of hemoglobin after intravenous iron treatment. To the contrary, those with higher baseline hemoglobin and TSAT levels displayed higher rise in serum ferritin after the treatment. Although no serious adverse event occurred, TSAT levels exceeding 50% were noted in 6 patients in PD group. Conclusion : This suggests that 3 mg/kg/week of intravenous iron sucrose can be used safely in children on chronic HD, but 200 mg/$m^2$ every other week may incur excessive TSAT level in some patients on chronic PD.

Randomized, Double-blind, Placebo-controlled Trial of the Effects of Polycan, β-glucan Originating from Aureobasidium Pullulans, on Bone Biomarkers in Healthy Women

  • Kim, Jong Dae;Park, Mi Yeon;Kim, Joo Wan;Kim, Ki Young;Cho, Hyung Rae;Choi, In Soon;Choi, Jae Suk;Ku, Sae Kwang;Park, Soo-Jin
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.29 no.4
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    • pp.330-336
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    • 2015
  • Polycan originating from Aureobasidium pullulans is mostly composed of β-1, 3/1, 6 glucans and possesses an anti-osteoporotic effect. We conducted a randomized, double-blind, placebo-controlled trial to examine the efficacy and safety of the polycan on bone biochemical markers in healthy perimenopausal women. Sixty subjects were randomly allocated to 2 groups-group 1 received 400 mg of polycan and group 2 received placebo-these were administered once daily for 28 days. Fasting blood and urine samples were collected at baseline and 4 weeks after treatment. The primary outcome was change in osteocalcin (OSC) and bone-specific alkaline phosphatase (BALP). Changes in calcium (Ca), phosphorus (P), C-telopeptide of collagen cross-links (CTx), N-telopeptide of collagen cross-links (NTx), and deoxypyridinoline (DPYR) were the secondary outcomes. A safety assessment was performed using adverse event (AE) and laboratory data. After 4 weeks of polycan treatment, OSC, DPYR, and BALP levels changed (P < 0.05) significantly from baseline in both groups. However, no significant differences were observed in any markers between the 2 groups, except for P (P < 0.05). Interestingly, group 2 showed a significant increase in CTx (65.2%, P < 0.05), while CTx in group 1 slightly increased (17.2%). Both groups showed no significant differences in AE. Although 4 weeks of polycan treatment did not have a statistically significant effect on bone metabolism biomarkers, increases in CTx were modestly inhibited by polycan. Further studies in a large population and longer treatment periods are needed to confirm the effect of polycan on bone turnover.

The Effects of MERS(Middle East Respiratory Syndrome) Event on the Psychosocial Wellbeing of Healthcare Workers and the Public with the Mediating Effect of Resilience (메르스(Middle East Respiratory Syndrome)사태에 따른 병원종사자와 일반인의 스트레스 정도가 사회심리적 건강에 미치는 영향과 회복탄력성의 매개효과)

  • Kwon, Hyuk-Min;Kim, Tae-Hyung;Choi, Mal-Rye;Kim, Byoung-Jo;Kim, Hyoung-Wook;Song, Ok-Sun;Eun, Hun-Jeong
    • Korean Journal of Psychosomatic Medicine
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    • v.25 no.2
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    • pp.111-119
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    • 2017
  • Objectives : The purpose of this study is to investigate the effects of stress on psychosocial wellbeing at the time of an outbreak of Middle East respiratory syndrome(MERS) and to investigate the effect of resilience as a mediator on the relationship between stress and psychosocial wellbeing. Methods : Perceived Stress Scale, Psychosocial Wellbeing Index Short Form, and the Conner-Davidson Resilience Scale was implemented for 156 medical persons who worked at the hospital in which exposure to MERS cases had been confirmed and 127 ordinary people. We conducted a Pearson correlation coefficient and a hierarchical multiple regression to confirm the effect of stress on psychosocial wellbeing and the mediating effect of resilience between stress and psychosocial wellbeing. Results : The higher the perceived stress, the lower the psychosocial wellbeing in both healthcare workers and the public. The higher the perceived stress, the lower the resilience and the research results showed that there was a partially mediating effect of resilience in the relationship between stress and psychosocial wellbeing. Conclusions : This study demonstrated that the degree of individual resilience can indirectly give a positive effect on the psychosocial wellbeing when people under the stress by MERS shows adverse effects on psychosocial wellbeing. This suggests that clinical intervention and psychosocial approach aiming at strengthening resilience is important to maintain mental health during crisis development.

The Effect of CYP2D6/3A5 Genotypes on Plasma Concentrations of Haloperidol after Adjunctive Treatment of Aripiprazole

  • Shim, Joo-Cheol;Ahn, Jung-Mi;Jung, Do-Un;Kong, Bo-Geum;Kang, Jae-Wook;Liu, Kwang-Hyeon;Shin, Jae-Gook
    • Korean Journal of Biological Psychiatry
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    • v.18 no.2
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    • pp.95-100
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    • 2011
  • Objectives To evaluate the drug interactions between aripiprazole and haloperidol, authors investigated plasma concentrations of those drugs by genotypes. Method Fifty six patients with a confirmed Diagnostic and Statistical Manual of Mental Disorders 4th edition diagnosis of schizophrenia were enrolled in this eight-week, double blind, placebo-controlled study. Twenty-eight patients received adjunctive aripiprazole treatment and twenty-eight patients received placebo while being maintained on haloperidol treatment. Aripiprazole was dosed at 15 mg/day for the first 4 weeks, and then 30 mg for the next 4 weeks. The haloperidol dose remained fixed throughout the study. Plasma concentrations of haloperidol and aripiprazole were measured by high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) at baseline, week 1, 2, 4 and 8. $^*1$, $^*5$, and $^*10$ B alleles of CYP2D6 and $^*1$ and $^*3$ alleles of CYP3A5 were determined. The Student's T-test, Pearson's Chi-square test, Wilcoxon Rank Sum test and Logistic Regression analysis were used for data analysis. All tests were two-tailed and significance was defined as an alpha < 0.05. Results In the frequency of CYP2D6 genotype, $^*1/^*10$ B type was most frequent (36.5%) and $^*1/^*1$ (30.8%), $^*10B/^*10B$ (17.3%) types followed. In the frequency of CYP3A5 genotype, $^*3/^*3$ type was found in 63.5% of subjects, and $^*1/^*3$ type and $^*1/^*1$ were 30.8% and 5.8% respectively. The plasma levels of haloperidol and its metabolites did not demonstrate significant time effects and time-group interactions after adjunctive treatment of aripiprazole. The genotypes of CYP2D6 and 3A5 did not affect the plasma concentration of haloperidol in this trial. No serious adverse event was found after adding aripiprazole to haloperidol. Conclusion No significant drug interaction was found between haloperidol and aripiprazole. Genotypes of CYP2D6 and 3A5 did not affect the concentration of haloperidol after adding aripiprazole.

Laparoscopic Retroperitoneal Nephroureterectomy is a Safe and Adherent Modality for Obese Patients with Upper Urinary Tract Urothelial Carcinoma

  • Matsumoto, Kazumasa;Hirayama, Takahiro;Kobayashi, Kentaro;Hirano, Syuhei;Nishi, Morihiro;Ishii, Daisuke;Tabata, Ken-ichi;Fujita, Tetsuo;Iwamura, Masatugu
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.8
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    • pp.3223-3227
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    • 2015
  • Objective: We evaluated the association of body mass index (BMI) with perioperative outcomes in patients who underwent laparoscopic or open radical nephroureterectomy. Materials and Methods: This retrospective single-center study included 113 patients who had been diagnosed with upper urinary tract cancer from January 1998 to June 2013 and were treated with laparoscopic nephroureterectomy (Lap group, n=60) or open nephroureterectomy (Open group, n=53). Laparoscopic nephroureterectomy was performed via a retroperitoneal approach following an open partial cystectomy. The two surgical groups were stratified into a normal-BMI group (<25) and a high-BMI group ($BMI{\geq}25$). The high-BMI group included 27 patients: 13 in the Lap group and 14 in the Open group. Results: Estimated blood loss (EBL) in the Lap group was much lower than that in the Open group irrespective of BMI (p<0.01). Operative time was significantly prolonged in normal-BMI patients in the Lap group compared to those in the Open group (p=0.03), but there was no difference in operative time between the Open and Lap groups among the high-BMI patients. Multivariate logistic regression analysis of the data for all the cohorts revealed that the open procedure was a significant risk factor for high EBL (p<0.0001, hazard ratio 8.02). Normal BMI was an independent predictor for low EBL (p=0.01, hazard ratio 0.25). There was no significant risk factor for operative time in multivariate analysis. There were no differences in blood transfusion rates or adverse event rates between the two surgical groups. Conclusions: Laparoscopic radical nephroureterectomy via a retroperitoneal approach can be safely performed with significantly reduced EBL even in obese patients with upper urinary tract cancer.

High-dose chemotherapy and autologous peripheral blood stem cell transplantation in the treatment of children and adolescents with Ewing sarcoma family of tumors

  • Seo, Juhee;Kim, Dong Ho;Lim, Jung Sub;Koh, Jae-Soo;Yoo, Ji Young;Kong, Chang-Bae;Song, Won Seok;Cho, Wan Hyeong;Jeon, Dae-Geun;Lee, Soo-Yong;Lee, Jun Ah
    • Clinical and Experimental Pediatrics
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    • v.56 no.9
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    • pp.401-406
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    • 2013
  • Purpose: We performed a pilot study to determine the benefit of high-dose chemotherapy and autologous peripheral blood stem cell transplantation (HDCT/autoPBSCT) for patients with Ewing sarcoma family of tumors. Methods: We retrospectively analyzed the data of patients who received HDCT/autoPBSCT at Korea Cancer Center Hospital. Patients with relapsed, metastatic, or centrally located tumors were eligible for the study. Results: A total of 9 patients (3 male, 6 female), with a median age at HDCT/autoPBSCT of 13.4 years (range, 7.1 to 28.2 years), were included in this study. Patients underwent conventional chemotherapy and local control either by surgery or radiation therapy, and had achieved complete response (CR, n=7), partial response (n=1), or stable disease (n=1) prior to HDCT/autoPBSCT. There was no transplant-related mortality. However, the median duration of overall survival and event-free survival after HDCT/autoPBSCT were 13.3 months (range, 5.3 to 44.5 months) and 6.2 months (range, 2.1 to 44.5 months), respectively. At present, 4 patients are alive and 5 patients who experienced adverse events (2 metastasis, 2 local recur, and 1 progressive disease) survived for a median time of 2.8 months (range, 0.1 to 10.7 months). The 2-year survival after HDCT/autoPBSCT was $44.4%{\pm}16.6%$ and disease status at the time of HDCT/autoPBSCT tended to influence survival ($57.1%{\pm}18.7%$ of cases with CR vs. 0% of cases with non-CR, P=0.07). Conclusion: Disease status at HDCT/autoPBSCT tended to influence survival. Further studies are necessary to define the role of HDCT/autoPBSCT and to identify subgroup of patients who might benefit from this investigational treatment.