Carbamazepine相關不良反應之回溯性研究
A Retrospective Study of Adverse Drug Reactions Associated with Carbamazepine
Date Issued
2004
Date
2004
Author(s)
Wang, Tseng-Hui
DOI
zh-TW
Abstract
There were 212 cases of carbamazepine (CBZ) related adverse reactions reported to National Reporting Center of Adverse Drug Reactions in Taiwan from 1999 to 2003. There were 38 patients of CBZ-related severe adverse reactions applied for drug relief fund from 1999-2002, in which 19 of them obtained compensation. The number received reimbursement with CBZ-related severe adverse reactions is the highest one among the applications. However, the incidence of CBZ-related severe adverse reactions in Taiwan is still not known yet. It is important to evaluate CBZ-related adverse drug reactions (ADRs). The purpose of this study is to analyze the incidence rate, types and risk factors of CBZ-related adverse drug reactions (ADRs) based on a retrospective study of a medical center.
In the study, 277 patients who were prescribed for CBZ for the first time in outpatient setting of National Taiwan University Hospital during May 2002 to July 2002 were included. There were 84 patients developed 115 ADRs after administration of CBZ. Among the 115 ADRs, 35 ADRs (30.4%) were type A reactions, 76 ADRs (66.1%) were type B reactions, and the other 4 ADRs were unknown. In terms of severity of ADRs, 6 cases (5.2%) were severe, 41 cases (35.6%) were moderate and 68 cases (59.1%) were mild. The causality analysis of CBZ-related events: ten cases (8.7%) were probable, 104 cases (90.4%) were possible, and one case (0.9%) was doubtful. The onset day of ADR occurred was from the day of administration to the 203th day after administration, and the mean of onset day was 26.2 days after administration. Base on ADR classification, the incidence of neurological ADR and dermatological ADR are 25.2% and 14.8%, respectively. Discontinuing the usage of CBZ was the most common (55.7%) management when an ADR occurred.
It is found that high mean daily dose in adults, history of herpes zoster infection, older than 60 years old and children under age of 10 were the risk factors in developing ADR. There was significant difference (p= 0.01) between patients with ADR and patients without ADR in patients with a history of AV-block related arrhythmia. But there was not significant difference between patients with ADR and without ADR in the history of bone marrow suppression. It should be warned that it is not suitable to take CBZ with precautions or contraindications. It should be careful as prescribing CBZ to patients with underlying AV-block related arrhythmia and to elderly patients.
The results of the incidence of ADR are comparatable with the data reported in literatures. It was observed that one patient developed the Stevens- Johnson syndrome and some developed the cardiovascular ADRs in this study. None of were fatal, indicated ADRs observed a good management as ADRs developed. Medical health providers should be aware of the safety profile of CBZ and provide proper informations to patients using of CBZ.
Subjects
不良反應
carbamazepine
Type
text
File(s)![Thumbnail Image]()
Loading...
Name
ntu-93-R90451007-1.pdf
Size
23.31 KB
Format
Adobe PDF
Checksum
(MD5):010619d8620d6b66289881d2a32e0c5a