• 제목/요약/키워드: adverse event

검색결과 282건 처리시간 0.029초

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

  • 조희연;한혜원;하일수;정해일;최용
    • Childhood Kidney Diseases
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    • 제13권2호
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    • pp.197-206
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    • 2009
  • 목적 : 소아에서 정맥용 철분 제제 투여에 대해서는 활용할 수 있는 연구 결과가 제한되어 있다. 이번 연구에서는 만성 투석 환아에게 정맥용 철분 수크로즈 제제를 투여함에 있어서 효과 및 결과 예측 인자, 안정성을 확인해 보고자 한다. 방법 : 혈청 페리틴 농도가 100 ng/mL 이하이거나 트랜스페린 포화도가 20% 이하인 21명의 만성 투석 환자가 선정되었다. 12명의 복막 투석 환자에게 철분 수크로즈를 체표면적당 200 mg의 용량으로 2주 간격으로 4회 투여하였고, 9명의 혈액 투석 환자에게 동일한 제제를 체중당 3 mg의 용량으로 일주일 간격으로 8회 투여하였다. 결과 : 치료 후 혈청 페리틴 농도는 양측 환자에서 유의한 상승을 보였고 복막 투석 환자에서는 트랜스페린 포화도가 유의한 상승을 보였다. 그러나 혈색소 수치는 양측 환자에서 모두 의미 있는 상승을 보이지는 않았다. 기저 혈색소 수치가 10 g/dL 이하이거나 기저 트랜스페린 포화도가 20% 이하인 환자는 정맥용 철분 제제 투여 후 의미있는 혈색소 상승을 보였다. 대조적으로 기저 혈색소 수치와 트랜스페린 포화도가 높았던 환자들은 치료 후 혈청 페리틴 수치의 상승을 보였다. 심각한 부작용은 없었으나 치료하는 과정에서 6명의 복막 투석 환자에서 50% 이상의 트랜스페린 포화도를 보였다. 결론 : 본 연구에서 혈액 투석 환아에서 일주일 간격으로 체중당 3 mg의 철분제제의 정맥 투여는 안전하게 사용될 수 있음을 확인할 수 있었던 반면, 복막 투석 환자에서 격주 간격으로 체표면적당 200 mg의 철분제제의 정맥 투여는 과도한 트랜스페린 포화도를 보일 수 있다.

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
    • 동의생리병리학회지
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    • 제29권4호
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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.

메르스(Middle East Respiratory Syndrome)사태에 따른 병원종사자와 일반인의 스트레스 정도가 사회심리적 건강에 미치는 영향과 회복탄력성의 매개효과 (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)

  • 권혁민;김태형;최말례;김병조;김형욱;송옥선;은헌정
    • 정신신체의학
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    • 제25권2호
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    • pp.111-119
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    • 2017
  • 연구목적 본 연구는 메르스(Middle East Respiratory Syndrome, MERS(Middle East Respiratory Syndrome, 이하 MERS) 사태 발생 당시에 받은 스트레스가 사회심리적 건강에 미치는 영향을 알아보고, 회복탄력성이 매개효과로서 사회심리적 건강에 영향을 주는지를 알아보고자 하였다. 방 법 MERS가 발생한 병원의 병원종사자 156명과 일반인 127명을 대상으로 스트레스 자각척도, 사회심리적 건강측정 도구, 코너-데이비슨 리질리언스 척도를 시행하였다. 스트레스가 사회심리적 건강에 미치는 영향 및 회복탄력성의 매개효과를 확인하기 위해 피어슨 상관관계분석과 위계적 다중회귀분석을 실시하였다. 결 과 병원종사자와 일반인 모두에서 지각된 스트레스가 높을수록 사회 심리적 건강이 좋지 않음을 보였고, 지각된 스트레스가 높을수록 낮은 회복탄력성을 나타냈으며, 스트레스와 사회심리적 건강 사이의 관계에서 회복탄력성이 부분 매개를 하는 것으로 나타났다. 결 론 본 연구는 MERS 사태로 인해 받은 스트레스가 사회심리적 건강에 영향을 미침에 있어서 개인의 회복탄력성의 정도가 간접적으로 사회심리적 건강에 긍정적 효과를 끼칠 수 있고, 회복탄력성 강화를 목표로 한 임상적 개입 및 사회심리적 접근방법이 위기 발생시 정신건강을 유지하는데 중요함을 시사한다.

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
    • 생물정신의학
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    • 제18권2호
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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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    • 제16권8호
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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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    • 제56권9호
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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.

A Clinical Trial to Assess the Efficacy of Acupuncture on Hot Flashes in Postmenopausal Women;Focusing on the comparison of the effects of Traditional Korean medical acupuncture (TKMA) and Minimal Acupuncture (MA)

  • Kim, Dong-Il;Roh, Jin-Ju;Choi, Min-Sun;Lee, Seung-Deok;Roh, Ju-Won;Yoon, Sang-Ho;Ahn, Hong-Yup;Oh, Dal-Seok;Choi, Sun-Mi
    • 대한한의학회지
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    • 제28권4호
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    • pp.74-85
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    • 2007
  • Objective : In this study we wanted to confirm if proper stimulation and de-Qi of traditional Korean medical acupuncture could increase hot flash relief efficacy. Design : A randomized controlled, single blind study. We used two modalities of acupuncture, one with optimal stimulation [Study group; Korean medical acupuncture (TKMA)] and one with minimal stimulation [Control group; Minimal acupuncture (MA)]. Same acupoints [PC6(內關), HT8(少府), HT7(神門), LI4(合谷), ST36(足三里), SP6(三陰交), Ren4(關元)] were used in both groups. Fifty-two patients were treated twice a week for 8 weeks, and follow up was done after 4 weeks from the last treatment. Patients were checked hot flash VAS (visual analog scale), frequency and duration every time they visited. Results : Hot flash relief efficacy by 100mm hot flash VAS was obvious in both groups. Hot flash VAS scores of study group were smaller than the scores of control group at the early stage (3rd, $4^{th}$ and $8^{th}$ visit), but there wasn't a remarkable difference between study and control group at the end of the trial. Besides, diminution of hot flash VAS was faster and more even in the study group than control group by visualization using 'Box plot'. We compared frequency and duration of hot flash, 100mm sweating, palpitation, sleep disturbance VAS, and Kupperman Index, MENQOL, Patient's global assessment score. Both groups showed definite decrease from the baseline, but the difference was not statistically significant. There wasn't any adverse event. Hot flash relief efficacy was kept in most patients after 4 weeks' follow-up. Conclusion : Acupoint combination by Traditional Korean medical theory is effective on hot flashes and hot flash relief efficacy was faster and more even in optimal stimulation than minimal stimulation.

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Efficacy and Safety of Miniscalpel Acupuncture on Knee Osteoarthritis - A randomized controlled pilot trial -

  • Jun, Seungah;Lee, Jung Hee;Gong, Han Mi;Choi, Seong Hun;Bo, Min Hwang;Kang, Mi Suk;Lee, Geon-Mok;Lee, Hyun-Jong;Kim, Jae Soo
    • 대한약침학회지
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    • 제21권3호
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    • pp.151-158
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    • 2018
  • Objectives: We investigated the efficacy and safety of miniscalpel acupuncture (MA) for knee osteoarthritis (KOA) in an assessor-blinded randomized controlled pilot trial; this would provide information for a large-scale randomized controlled trial. Methods: Participants (n = 24) were recruited and randomly allocated to the MA group (experimental) or acupuncture group (control). The MA group received treatment once a week for 3 weeks (total of 3 treatments), while the acupuncture group received treatment two times per week for 3 weeks (total of 6 treatments). The primary outcome was pain as assessed by a visual analogue scale (VAS). The secondary outcomes (intensity of current pain, stiffness, and physical function) were assessed using the short-form McGill Pain Questionnaire (SF-MPQ) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Assessments were performed at baseline, 1, 2, and 3 during treatment and at week 5 (2 weeks after the end of treatment). Results: Of the 24 participants, 23 completed the study. Both groups showed significant improvements in VAS, SF-MPQ, and WOMAC. However, there were no significant differences between the MA and acupuncture groups. No serious adverse event occurred and blood test results were within normal limits. Conclusion: Our results suggest that although both MA and acupuncture provide similar effects with regard to pain control in patients with KOA, MA may be more effective in providing pain relief because the same relief was obtained with fewer treatments. A large-scale clinical study is warranted to further clarify these findings.

The Ratio of Descending Aortic Enhancement to Main Pulmonary Artery Enhancement Measured on Pulmonary CT Angiography as a Finding to Predict Poor Outcome in Patients with Massive or Submassive Pulmonary Embolism

  • Park, Chi-Young;Yoo, Seung-Min;Rho, Ji-Young;Ji, Young-Geon;Lee, Hwa-Yeon
    • Tuberculosis and Respiratory Diseases
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    • 제72권4호
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    • pp.352-359
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    • 2012
  • Background: The purpose of this study was to evaluate whether measuring the ratio of descending aortic enhancement (DAE) to main pulmonary artery enhancement (MPAE) on pulmonary computed tomography angiography (PCTA) can predict poor outcome in patients with acute massive or submassive pulmonary embolism (PE). Methods: We retrospectively, reviewed computed tomgraphy findings and charts of 37 patients with acute PE and right ventricular dysfunction. We divided the enrolled patients into 3 groups; group Ia (n=8), comprised of patients with major adverse event (MAE); group Ib (n=5), consisted of those with PE-related MAE; and group II (n=29), those without MAE. We analyzed the right ventricular diameter (RVD)/left ventricular diameter (LVD) and DAE/MPAE on PCTA. Results: For observer 1, RVD/LVD in group Ia ($1.9{\pm}0.36$ vs. $1.44{\pm}0.38$, p=0.009) and group Ib ($1.87{\pm}0.37$ vs. $1.44{\pm}0.38$, p=0.044) were significantly higher than that of group II. For observer 2, RVD/LVD in group Ia ($1.71{\pm}0.18$ vs. $1.41{\pm}0.47$, p=0.027) was significantly greater than that of group II, but RVD/LVD of group Ib was not ($1.68{\pm}0.2$ vs. $1.41{\pm}0.47$, p=0.093). For both observers, there was a significant difference of DAE/MPAE between group Ib and group II ($0.32{\pm}0.15$ vs. $0.64{\pm}0.24$, p=0.005; $0.34{\pm}0.16$ vs. $0.64{\pm}0.22$, p=0.004), but no significant difference of DAE/MPAE between group Ia and group II ($0.51{\pm}0.3$ vs. $0.64{\pm}0.24$, p=0.268; $0.53{\pm}0.29$ vs. $0.64{\pm}0.22$, p=0.302). Intra-class correlation coefficient (ICC) for the measurement of DAE/MPAE (ICC=0.97) was higher than that of RVD/LVD (ICC=0.74). Conclusion: DAE/MPAE measured on PCTA may predict PE-related poor outcomes in patients with massive or submassive PE with an excellent inter-observer agreement.

Effect of a Proton Pump Inhibitor on Tumor Bleeding Prevention in Unresectable Gastric Cancer Patients: a Double-Blind, Randomized, Placebo-Controlled Trial

  • Kim, Young-Il;Kim, Mi-Jung;Park, Sook Ryun;Kim, Hark Kyun;Cho, Soo-Jeong;Lee, Jong Yeul;Kim, Chan Gyoo;Kim, Gwang Ha;Park, Moo In;Nam, Byung-Ho;Park, Young Iee;Choi, Il Ju
    • Journal of Gastric Cancer
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    • 제17권2호
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    • pp.120-131
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    • 2017
  • Purpose: Tumor bleeding is a major complication in inoperable gastric cancer. The study aim was to investigate the effects of proton pump inhibitor (PPI) treatment for the prevention of gastric tumor bleeding. Materials and Methods: This study was a prospective double-blind, randomized, placebo-controlled trial. Patients with inoperable gastric cancer were randomly assigned to receive oral lansoprazole (30 mg) or placebo daily. The primary endpoint was the occurrence of tumor bleeding, and the secondary endpoints were transfusion requirement and overall survival (OS). Results: This study initially planned to enroll 394 patients, but prematurely ended due to low recruitment rate. Overall, 127 patients were included in the analyses: 64 in the lansoprazole group and 63 in the placebo group. During the median follow-up of 6.4 months, tumor bleeding rates were 7.8% and 9.5%, in the lansoprazole and placebo groups, respectively, with the cumulative bleeding incidence not statistically different between the groups (P=0.515, Gray's test). However, during the initial 4 months, 4 placebo-treated patients developed tumor bleeding, whereas there were no bleeding events in the lansoprazole-treated patients (P=0.041, Gray's test). There was no difference in the proportion of patients who required transfusion between the groups. The OS between the lansoprazole (11.7 months) and the placebo (11.0 months) groups was not statistically different (P=0.610). Study drug-related serious adverse event or bleeding-related death did not occur. Conclusions: Treating patients with inoperable gastric cancer with lansoprazole did not significantly reduce the incidence of tumor bleeding. However, further studies are needed to evaluate whether lansoprazole can prevent tumor bleeding during earlier phases of chemotherapy (ClinicalTrial.gov, identifier No. NCT02150447).