目的 分析南京醫(yī)科大學(xué)附屬老年醫(yī)院治療的非瓣膜性房顫患者給予利伐沙班的臨床合理性與不良反應(yīng)發(fā)生的規(guī)律和特點(diǎn)。方法 選取南京醫(yī)科大學(xué)附屬老年醫(yī)院2018年1月—2019年12月使用利伐沙班的103例病例作為研究對(duì)象，參照其說明書和相關(guān)指南進(jìn)行合理性分析，對(duì)出血相關(guān)不良反應(yīng)發(fā)生率、發(fā)生時(shí)間和臨床表現(xiàn)、凝血指標(biāo)等進(jìn)行分析統(tǒng)計(jì)。結(jié)果 103例病例中，劑量不足62例（60.19%）、嚴(yán)重腎功能不全用藥5例（4.85%）、聯(lián)合用藥不合理2例（1.94%）和活動(dòng)性出血用藥2例（1.94%）。共隨訪78例資料完整患者，發(fā)生出血相關(guān)不良反應(yīng)的有14例，不良反應(yīng)發(fā)生率為17.95%。不良反應(yīng)主要表現(xiàn)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%）。所收集不良反應(yīng)中發(fā)生時(shí)間最短的3 d，最長的128 d。隨口服利伐沙班劑量增加，標(biāo)準(zhǔn)劑量與低劑量相比出血事件發(fā)生率呈上升趨勢(shì)，但差異無統(tǒng)計(jì)學(xué)意義，兩組栓塞事件發(fā)生率無統(tǒng)計(jì)學(xué)意義。與服藥前相比凝血酶時(shí)間（TT）、活化部分凝血活酶時(shí)間（APTT）、國際標(biāo)準(zhǔn)化比值（INR）明顯升高，D-二聚體（D-D）明顯降低，差異具有統(tǒng)計(jì)學(xué)意義（P<0.05）。結(jié)論 本院老年房顫患者應(yīng)用利伐沙班存在不合理情況，其中劑量不足和嚴(yán)重腎功能不全所占比例較大。臨床工作中多數(shù)老年房顫患者服用利伐沙班10 mg/d，在降低出血事件的同時(shí)需要進(jìn)一步研究證實(shí)其有效性。

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.

R972

南京藥學(xué)會(huì)-常州四藥醫(yī)院藥學(xué)科研基金項(xiàng)目（2017YX016）；江蘇省藥學(xué)會(huì)—奧賽康醫(yī)院藥學(xué)基金項(xiàng)目（A201710）