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目的:根据国内临床应用替米沙坦引起药品不良反应(ADR)的文献,考察替米沙坦的安全性。方法:通过中国医院知识仓库(CHKD)、万方数据库、中文科技期刊数据库(维普)收集2004～2008年国内临床资料进行汇总、分析。结果:临床应用替米沙坦的1 197例患者共发生ADR 95例(7.94%),涉及神经系统、心血管系统、消化系统、肌肉骨骼系统等6个系统。口服40mg·d~(-1)给药和80 mg·d~(-1)给药ADR发生率分别为5.29%(31/586)和8.96%(42/469),因ADR被迫停药共1例(0.08%)。结论:替米沙坦安全性好,不良反应发生率低,且耐受性良好,一般不需中断治疗,推荐以40 mg·d~(-1)为给药剂量。临床使用中,应特别注意替米沙坦神经系统和心血管系统方面的ADR,密切关注血钾水平和体位性低血压。
OBJECTIVE: To investigate the safety of telmisartan according to the literature of domestic clinical application of telmisartan-induced adverse drug reaction (ADR). Methods: The domestic clinical data from 2004 to 2008 were collected and analyzed by CHKD, Wanfang and Chinese Science and Technology Database (VIP). RESULTS: A total of 1 197 patients with telmisartan were enrolled in this study. A total of 95 ADR cases (7.94%) were involved. Six systems involved the nervous system, cardiovascular system, digestive system and musculoskeletal system. The incidence of ADR was 5.29% (31/586) and 8.96% (42/469) respectively after oral administration of 40 mg · d -1 and 80 mg · d -1. ADR was discontinued A total of 1 cases (0.08%). Conclusion: telmisartan is safe, the incidence of adverse reactions is low, and the tolerability is good. Generally, it is recommended to discontinue treatment. The dose of 40 mg · d ~ (-1) is recommended. In clinical use, particular attention should be given to ADR in the neurological and cardiovascular systems of telmisartan, paying close attention to serum potassium levels and orthostatic hypotension.