氯吡格雷用于动脉粥样硬化血栓栓塞性疾病的安全性和耐受性观察

The Safety and Tolerability of Clopidogrel Used in Patients with Atherosclerosis

目的观察氯吡格雷对动脉粥样硬化血栓栓塞性疾病病人的安全性和耐受性。方法入选21岁～75岁有动脉粥样硬化病变的病人共20例，且病情稳定在1个月以上。服用氯吡格雷75mg／d，持续12周，观察其服药依从性、血压、心率、肝肾功能、血尿粪常规的变化及不良事件的发生情况。结果入选时尿红细胞、大便隐血均为阴性，收缩压（133．6±19．8）mmHg，舒张压（82．4±9.6）mmHg，心率（73．2±7．9）／min；血红蛋白（135．7±9．2）g／L，白细胞（6．3±0．98）×10^9／L，中性粒细胞0.62±0．03，血小板（203.4±40．0）×10^9／L；尿素氮6．1mmol／L±1．4mmol／L，肌酐82．3μmol／L±16．2μmol／L；谷丙转氨酶30．4U/L±11．2U／L，谷草转氨酶27．9U／L±6＋3U／L。1例受试者因皮疹退出研究，另19例完成12周随访，服药依从性为95．0％。在2周、4周、8周、12周时随访血压、心率、肝肾功能指标等，较入选时均无统计学意义，未见任何白细胞或中性粒细胞显著下降。12周随访时2例病人出现尿红细胞阳性；未见大便隐血者；无脑出血、消化道出血等严重出血事件发生，1例病人出现皮下淤斑．3例病人出现轻至中度过敏反应。结论氯吡格雷用于动脉粥样硬化血栓栓塞性疾病病人耐受性好，且较为安全。

Objective To study the safety and tolerability of clopidogrel for atherosclerosis. Methods Twenty patients （pts） with atherosclerosis and stable condition more than 1 month were enrolled. All subjects were prescribed clopidogrel 75mg per day for 12 weeks. The blood pressure, heart rate, hepatic and renal function, routine test of blood and urine, compliance of drug taking and all incidence of adverse effect were collected. Results The baseline tests showed that all pts were negative in urine test. Nineteen pts were followed up for 12 weeks. The compliance of drug taking was 95.0 %. All the parameters such as SBP, DBP, HR , Hb, WBC, PLT, BUN, Cr, ALT and AST did not changed at 2, 4, 8 and 12 week compared with the baseline results. There was no severe adverse effect. Conclusion Clopidogrel was a safe and tolerable drug for atherosclerosis.