2018—2019年南京医科大学附属老年医院利伐沙班治疗老年非瓣膜性房颤的合理性分析和不良反应研究

目的 分析南京医科大学附属老年医院治疗的非瓣膜性房颤患者给予利伐沙班的临床合理性与不良反应发生的规律和特点。方法 选取南京医科大学附属老年医院2018年1月—2019年12月使用利伐沙班的103例病例作为研究对象，参照其说明书和相关指南进行合理性分析，对出血相关不良反应发生率、发生时间和临床表现、凝血指标等进行分析统计。结果 103例病例中，剂量不足62例（60.19%）、严重肾功能不全用药5例（4.85%）、联合用药不合理2例（1.94%）和活动性出血用药2例（1.94%）。共随访78例资料完整患者，发生出血相关不良反应的有14例，不良反应发生率为17.95%。不良反应主要表现在皮下血瘀、瘀斑4例（5.13%），消化道出血2例（2.56%），泌尿道出血2例（2.56%）。所收集不良反应中发生时间最短的3 d，最长的128 d。随口服利伐沙班剂量增加，标准剂量与低剂量相比出血事件发生率呈上升趋势，但差异无统计学意义，两组栓塞事件发生率无统计学意义。与服药前相比凝血酶时间（TT）、活化部分凝血活酶时间（APTT）、国际标准化比值（INR）明显升高，D-二聚体（D-D）明显降低，差异具有统计学意义（P<0.05）。结论 本院老年房颤患者应用利伐沙班存在不合理情况，其中剂量不足和严重肾功能不全所占比例较大。临床工作中多数老年房颤患者服用利伐沙班10 mg/d，在降低出血事件的同时需要进一步研究证实其有效性。

Rationality analysis and adverse reaction study of rivaroxaban in treatment of elderly patients with non-valvular atrial fibrillation in Geriatric Hospital of Nanjing Medical University from 2018 to 2019

Objective To analyze the rationality and characteristics of adverse reactions after application of rivaroxaban with nonvalvular atrial fibrillation over 75 years old in Geriatric Hospital of Nanjing Medical University. Methods A total of 103 patients who used rivaroxaban in the Geriatric Hospital of Nanjing Medical University from January 2018 to December 2019 were selected as study subjects. The rationality analysis was carried out by referring to the instructions and relevant guidelines, and the incidence, occurrence time, clinical manifestations, and coagulation indicators of bleeding related adverse reactions were analyzed and statistically analyzed. Results There were 62 (60.19%) patients with insufficient dose, 5 (4.85%) patients severe renal insufficiency, 2(1.94%) patients with unreasonable combination, and 2 (1.94%) patients with active bleeding. A total of 78 patients with complete data were followed up, 14 case of patients had bleeding related adverse reactions, and the incidence of adverse reactions was 17.95%. The adverse reactions were mainly manifested in 4 cases (5.13%) of subcutaneous blood stasis and stasis syndrome, 2 cases (2.56%) of gastrointestinal bleeding, and 2 cases (2.56%) of urinary tract bleeding. The shortest time of adverse reactions was 3 days, and the longest was 128 days. The incidence of bleeding events increased with the increase of oral rivaroxaban dose compared with the low dose, but the difference was not statistically significant, and there was no statistically significant difference in the incidence of embolization events between the two groups. After treatment, TT, APTT and INR were significantly increased, but D-D was significantly decreased, with statistically significant differences (P<0.05). Conclusion The unreasonable situation exists in the application of rivaroxaban in elderly patients with atrial fibrillation, among which the dosage is insufficient and the proportion of severe renal insufficiency is large. In clinical work, most elderly patients with atrial fibrillation take rivaroxaban at 10 mg/d, and further studies are needed to confirm its effectiveness in reducing bleeding events.