Chun, Ji Young
(Department of Pediatrics, Samsung Medical Center, Sungkyunkwan University School of Medicine)
,
Kang, Ben
(Department of Pediatrics, Samsung Medical Center, Sungkyunkwan University School of Medicine)
,
Lee, Yoo Min
(Department of Pediatrics, Samsung Medical Center, Sungkyunkwan University School of Medicine)
,
Lee, Soo Youn
(Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine)
,
Kim, Mi Jin
(Department of Pediatrics, Ilsan Paik Hospital, Inje University College of Medicine)
,
Choe, Yon Ho
(Department of Pediatrics, Samsung Medical Center, Sungkyunkwan University School of Medicine)
Purpose: This study was aimed to evaluate the frequency and course of adverse events associated with azathioprine treatment in Korean pediatric patients with inflammatory bowel disease. Methods: Total of 174 pediatric patients (age range, 1 to 19 years) with inflammatory bowel disease who received a...
Purpose: This study was aimed to evaluate the frequency and course of adverse events associated with azathioprine treatment in Korean pediatric patients with inflammatory bowel disease. Methods: Total of 174 pediatric patients (age range, 1 to 19 years) with inflammatory bowel disease who received azathioprine in order to maintain remission at Samsung Medical Center (Seoul, Korea) from January 2002 through December 2012 were included in this study. Medical records of these subjects were retrospectively reviewed regarding the development of adverse events associated with azathioprine treatment. Results: Ninety-eight patients (56.3%) of 174 patients experienced 136 episodes of adverse events, requiring dose reduction in 31 patients (17.8%), and discontinuation in 18 patients (10.3%). The mean dose of azathioprine that had been initially administered was $1.32{\pm}0.42$ mg/kg/day. Among the adverse reactions, bone marrow suppression developed in 47 patients (27.0%), requiring dose reduction in 22 patients (12.6%) and discontinuation in 8 patients (4.6%). Other adverse events that occurred were gastrointestinal disturbance (15.5%), hair loss (12.1%), pancreatitis (7.5%), arthralgia (6.9%), hepatotoxicity (2.9%), skin rash/allergic reactions (2.9%), headache/dizziness (2.3%), sepsis (0.6%), and oral mucositis (0.6%). Conclusion: Bone marrow suppression, especially leukopenia was most commonly associated with azathioprine treatment in Korean pediatric inflammatory bowel disease patients. Close observation for possible adverse events is required in this population with inflammatory bowel diseases who are under treatment with azathioprine.
Purpose: This study was aimed to evaluate the frequency and course of adverse events associated with azathioprine treatment in Korean pediatric patients with inflammatory bowel disease. Methods: Total of 174 pediatric patients (age range, 1 to 19 years) with inflammatory bowel disease who received azathioprine in order to maintain remission at Samsung Medical Center (Seoul, Korea) from January 2002 through December 2012 were included in this study. Medical records of these subjects were retrospectively reviewed regarding the development of adverse events associated with azathioprine treatment. Results: Ninety-eight patients (56.3%) of 174 patients experienced 136 episodes of adverse events, requiring dose reduction in 31 patients (17.8%), and discontinuation in 18 patients (10.3%). The mean dose of azathioprine that had been initially administered was $1.32{\pm}0.42$ mg/kg/day. Among the adverse reactions, bone marrow suppression developed in 47 patients (27.0%), requiring dose reduction in 22 patients (12.6%) and discontinuation in 8 patients (4.6%). Other adverse events that occurred were gastrointestinal disturbance (15.5%), hair loss (12.1%), pancreatitis (7.5%), arthralgia (6.9%), hepatotoxicity (2.9%), skin rash/allergic reactions (2.9%), headache/dizziness (2.3%), sepsis (0.6%), and oral mucositis (0.6%). Conclusion: Bone marrow suppression, especially leukopenia was most commonly associated with azathioprine treatment in Korean pediatric inflammatory bowel disease patients. Close observation for possible adverse events is required in this population with inflammatory bowel diseases who are under treatment with azathioprine.
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문제 정의
However, studies among pediatric population are scarce, and there have been no reported studies among Korean pediatric patients. Therefore, the aim of this study was to evaluate adverse events associated with AZA in Korean children and adolescents with IBD.
This study is the first to describe adverse drug reactions associated with AZA in Korean pediatric patients with IBD. The present results show higher incidence and different distribution of adverse drug reactions compared with previous reports conducted in Caucasian patients.
제안 방법
Patients were required to visit the outpatient clinic at least once per month before remission of the disease, and once every 2 to 3 months after remission was obtained. Laboratory tests were conducted in order to monitor disease activity and adverse drug reactions at each visit.
Medical records of the subjects were retrospectively reviewed to obtain clinical and laboratory data regarding adverse events associated with AZA treatment. Myelosuppression was defined as a decrease of any one of the following cells of the hematologic system; leukocytes, neutrophils, and platelets.
Neutropenia occurred 7 days after treatment with AZA and drug doses were reduced to 1 mg/kg/day. The initial laboratory test at admission showed pancytopenia, with a white blood cell count of 1,700/mm3, an absolute neutrophil count of 70/mm3, hemoglobin of 11.7 g/dL, and a platelet count of 45,000/mm3. Despite discontinuation of treatment with AZA, pancytopenia worsened and high fever continued.
The main limitation of this study is that this study was retrospectively conduted under a small study scale at a single center. Another limitation is that possible drug interactions between AZA and other co-administrated drugs were not analyzed in this study.
대상 데이터
A 15-year-old boy who had been diagnosed with CD was admitted with complaints of high fever and oral lesions for 2 days. Treatment with AZA had been initiated 1 month before with a dose of 2.
Patients aging from 1 to 19 years who had been diagnosesd as CD or UC at Samsung Medical Center (Seoul, Korea) from January 2002 to December 2012, and had been followed up for at least 6 months were initially included in this study. Among these patients, those who had received treatment with AZA were the ultimate study subjects in this study.
성능/효과
5%). Considering the results of our study and these studies, bone marrow suppresion was more frequently observed in East Asians compared to Caucasians, similar to the studies in adults.
In conclusion, bone marrow suppression, especially leukopenia was the most commonly associated adverse drug reaction associated with AZA treatment in Korean pediatric IBD patients, and therefore close observation for possible adverse events is required in this population. Further studies in order to determine the underlying mechanisms related to the higher occurrence of bone marrow suppression in this population are required in the future.
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