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目的:判定抗结核药物引起的严重肝毒性反应的发生频率及发生急性肝功能衰竭或死亡的预报指标。方法﹕西班牙肺科学会成员对1997-2001年18家医院的资料进行回顾性研究。严重肝毒性反应界定为,无临床症状者转氨酶有10倍升高或胆汁郁滞参数3倍增加;有肝炎症状者则为肝功能参数增加或发生肝功能衰竭。采用logistic 回归分析计算比值比(OR)及其95%可信区间(CI)研究其预报因素。结果﹕3510 例中共有166 例发生肝毒性反应,其中90 例(2.56%)为活动性结核病治疗所致。11 例(10.3%)发生急性肝功能衰竭,其中3 例进行了肝移植。总体病死率为4.7%(5 例,其中3 例与饮酒或肝毒性药物有关)。预后不良的预报指标为总胆红素>2mg/dl(OR=9.4 , 95%CI : 1.0-85.5) 及血清肌肝>1.5mg/dl(OR=32.1,95%CI:2.4-424.6)。结论﹕抗结核药物引起的严重肝毒性反应死亡率较高。必须进行经常性的临床检查及临床实验室观察以预防其发生。
OBJECTIVE: To determine the frequency of severe hepatotoxic reactions caused by anti-TB drugs and predictors of acute liver failure or death. METHODS: Members of the Spanish Lung Association retrospectively reviewed data from 18 hospitals from 1997 to 2001. Severe hepatotoxicity was defined as a 10-fold increase in aminotransferases or a 3-fold increase in bile-stasis parameters without clinical symptoms; an increase in liver function parameters or liver failure with hepatitis symptoms. Logistic regression analysis was used to calculate the odds ratio (OR) and its 95% confidence interval (CI) to study its predictors. Results: A total of 166 out of 3510 patients developed hepatotoxicity, of which 90 (2.56%) were caused by active TB. Eleven patients (10.3%) developed acute liver failure and 3 of them underwent liver transplantation. The overall case fatality rate was 4.7% (5 cases, 3 of which were related to alcohol or hepatotoxic drugs). The prognostic indicators of poor prognosis were total bilirubin> 2 mg / dl (OR = 9.4, 95% CI: 1.0-85.5) and serum muscular liver> 1.5 mg / dl (OR = 32.1, 95% CI: 2.4-424.6). Conclusion: The mortality of severe hepatotoxicity caused by anti-TB drugs is high. Regular clinical examination and clinical laboratory observations must be performed to prevent its occurrence.