达比加群酯应用于高龄老年非瓣膜性心房纤颤患者中的安全性评价

The safety evaluation of dabigatran etexilate in senile patients with non-valvular atrial fibrillation

目的 观察达比加群酯在高龄老年非瓣膜性心房纤颤患者中应用的安全性.方法 纳入2013年11月~2014年10月住院或门诊就诊的高龄老年（年龄≥80岁）非瓣膜性房颤患者32例（既往未服用过口服抗凝药物）,给予达比加群酯55 mg 2/日口服,患者服药后2周如未出现消化道不适、出血等情况将达比加群酯调整为110 mg 2/日口服.观察患者服药后1个月、3个月、6个月、12个月的D-二聚体、血红蛋白、肝肾功能等指标的变化,并记录所有患者随访期间有无栓塞、出血、死亡、消化道症状等不良事件发生.结果 与治疗前比较,达比加群酯治疗后D-二聚体有下降趋势,在治疗12个月时D-二聚体的降低与治疗前相比具有统计学意义（P〈0.05）.达比加群酯治疗后血红蛋白、肝肾功能等指标与治疗前比较均无显著性差异（P〉0.05）.所有患者服用达比加群酯后不良反应主要表现为消化不良,共发生7例（21.9%）,1例患者出现轻微头痛,1例患者发生皮下瘀斑.随访期间所有患者无大出血、胃肠道出血、颅内出血等,无心肌梗死、肾脏损害、栓塞等不良事件发生.结论 高龄老年非瓣膜性房颤患者应用达比加群酯110 mg 2/日口服具有良好的安全性,但本研究样本量相对较少,今后需进一步增加样本量及观察时间.

Objective Observe the safety of dabigatran etexilate in senile patients with non-valvular atrialfibrillation. Methods 32 patients （aged≥80） with non-valvular atrial fibrillation （never taking oral antithromboticdrug） from the department or outpatient service during November 2013 to October 2014 were enrolled. Allof patients received dabigatran etexilate 55mg, orally twice a day. After two weeks, if patients do not appeargastrointestinal discomfort and bleeding, the dose of dabigatran etexilate would be adjusted to 110 mg twice a day.After 1 months, 3 months, 6 months and 12 months, D-dimer, hemoglobin, liver and kidney function were observed.Any adverse events such as embolization, bleeding, death and gastrointestinal symptoms were recorded duringfollow-up. Results Compared with the pretreatment, the D- dimer had a tendency to decrease after treatment. Thereduction of D-dimer in the 12 months of treatment was statistically significant （P〈0.05）. There was no significantdifference in hemoglobin, liver and kidney function after treatment （P〉0.05）. After taking dabigatran etexilate,7 patients had indigestion, one patients appeared mild headache, one patient had ecchymosis, and there was noobvious hemorrhage, gastrointestinal bleeding, intracranial hemorrhage, myocardial infarction, liver and kidneydamage, embolism or other adverse incidents. Conclusion Senile patients with non valvular atrial fibrillationpatients with dabigatran etexilate 110 mg twice a day with good security, but the sample size is relatively small. Inthe future, we need to further increase the sample size and the observation time.