社團法人臺灣臨床藥學會

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【原著】抗結核藥物致肝毒性與病人疾病相關之研究
Study of Correlation between Antituberculosis Drug-Induced Hepatotoxicity and Patient’s Diseases
肝毒性、抗結核藥物、病人疾病、hepatotoxicity, antitubercular drug, patient’s disease
許永佳Yung-Chia Hsu1,2 、吳信昇Shihn-Sheng Wu2 、蔡斌智Pin-Chin Tsai1 、溫燕霞Yen-Hsia Wen*2
1財團法人義大醫院藥劑部 、2高雄醫學大學藥學系
目的:結核病之藥物治療過程中常發生肝毒性之不良反應,而誘發肝毒性的因素除了與第一線抗結核藥物有關外,是否有其他潛在的因子可能影響抗結核藥物產生肝毒性,目前尚未有一致的定論。本研究目的在於探討病人本身疾病是否為影響發生肝毒性的相關因子。
方法:本研究採回溯性病歷回顧自2007年1月1日至2007年12月31日止為期一年,於南部某區域教學醫院門診或住院被首次診斷感染結核菌並接受抗結核藥物治療之病人,記錄其基本資料、疾病史、社交史、肝功能生化檢驗值等各項資料,並分析發生肝毒性的案例與其相關疾病因子是否具關聯性。
結果:研究結果顯示,符合條件病人共228人,肝毒性發生率為61.0%(139人),高血壓(p=0.027)與肝毒性的發生有顯著性相關。本研究發現發生肝毒性時程主要集中在服藥後第一個月發生,因此針對在服藥後第一個月發生肝毒性與否和病人的疾病因子加以分析:發現高血壓(p=0.008)、糖尿病(p=0.040)與消化性潰瘍(p=0.021)在第1個月就發生肝毒性有顯著性相關。
結論:病人服用抗結核藥物發生肝毒性與病人高血壓疾病因子有顯著性相關。高血壓、糖尿病或消化性潰瘍的病人與肝毒性是否在第一個月發生有顯著性相關。因此建議在首次服用抗結核藥物時,須密切注意患有高血壓、糖尿病或消化性潰瘍的病人在第一個月產生肝毒性的情形。
 
Objective: Hepatotoxicity is an adverse reaction commonly observed during antituberculosis drug treatment. It is well known that the use of first-line antituberculosis drugs can induce hepatotoxicity; however, other potential factors for antituberculosis drug-induced hepatotoxicity have not yet come to a consistent conclusion. The study aimed to assess the role of pre-existing diseases as a risk factor for the development of hepatotoxicity in patients with active tuberculosis receiving antituberculosis drug treatment.
Method: This is an one-year retrospective study from January 1, 2007 to December 31, 2007 reviewing the medical charts of outpatients and inpatients with newly diagnosed tuberculosis and received treatment of antituberculosis drugs in a local teaching hospital. The patient’s basic information, disease history, social history and liver function test results were recorded and analyzed for the correlation between the occurrence of hepatotoxicity and related underlying disease factors in these patients.
Results: The results of the study have shown that a total of 228 patients met the study criteria and that the incidence of hepatotoxicity in these patients is 61.0% (139 patients). Hypertension (p=0.027) is found to be significantly associated with the occurrence of hepatotoxicity. This study demonstrated that hepatotoxicity occurred mainly within the first month of antituberculosis drug treatment. When the correlation of hepatotoxicity developed in the first month of antituberculosis drug treatment and the disease factors of patients were evaluated, it was observed that hypertension (p=0.008), diabetes (p=0.040) and peptic ulcers (p=0.021) were significantly correlated with development of hepatotoxicity in the first month of antituberculosis drug treatment.
Conclusion: The study has shown that development of hepatotoxicity is significantly associated in patients with hypertension, diabetes or peptic ulcer, within the first month of antituberculosis drug treatment. It is therefore recommended that in the treatment-naive patients with underlying diseases such as hypertension, diabetes or peptic ulcer should be closely monitored for development of hepatotoxicity particularly during the first month of drug therapy.

 
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