Myers M W, Jick H
The Boston Collaborative Drug Surveillance Program, Boston University Medical Center, Lexington, MA 02173, USA.
Br J Clin Pharmacol. 1998 Sep;46(3):251-3. doi: 10.1046/j.1365-2125.1998.00772.x.
To estimate the risk of idiopathic acute liver disease among users of terfenadine.
We conducted a population-based cohort study based on the General Practice Research Database (GPRD) in the U.K. All persons who received at least one prescription for terfenadine during the period 1991 through 1995 were eligible for the study. Among these patients we identified all those with a diagnosis of a liver disorder requiring hospitalization or referral to a consultant within 60 days of a prior prescription for terfenadine. We obtained clinical records, including hospital discharge summaries, consultant reports and relevant laboratory results in order to identify a potentially drug-inducible liver illness.
From a cohort of 210683 recipients of terfenadine, we found only three cases of acute liver disease where a causal connection to terfenadine could not be ruled out, yielding a risk estimate of 1.4/100000 users (95% CI 0.5, 4.2) and 0.5/100000 prescriptions (95% CI 0.2, 1.4). All cases were receiving a concomitant hepatotoxic drug and all had a full recovery.
The use of terfenadine is rarely associated with idiopathic acute liver disease.
评估特非那定使用者发生特发性急性肝病的风险。
我们基于英国全科医学研究数据库（GPRD）开展了一项基于人群的队列研究。所有在1991年至1995年期间至少接受过一次特非那定处方的人都符合该研究条件。在这些患者中，我们确定了所有在之前开具特非那定处方后60天内被诊断患有需要住院治疗或转诊给专科医生的肝脏疾病的患者。我们获取了临床记录，包括医院出院小结、专科医生报告和相关实验室检查结果，以确定可能由药物引起的肝病。
在210683名特非那定接受者队列中，我们仅发现3例急性肝病病例，其中无法排除与特非那定的因果关系，风险估计为每100000名使用者中有1.4例（95%可信区间0.5，4.2），每100000张处方中有0.5例（95%可信区间0.2，1.4）。所有病例均同时使用了肝毒性药物，且均完全康复。
特非那定的使用很少与特发性急性肝病相关。
