不同剂量利伐沙班治疗进展性脑卒中临床疗效的对比研究

Comparative Study for Clinical Effect on Progressive Stroke between Low-dose and High-dose Rivaroxaban

目的比较不同剂量利伐沙班治疗进展性脑卒中(PS)的临床疗效。方法选取2014年5月—2016年5月在云南省交通中心医院就诊的PS患者107例,采用随机数字表法分为低剂量组52例和高剂量组55例。在对症治疗基础上,低剂量组患者给予利伐沙班10 mg/d治疗,高剂量组患者给予利伐沙班20 mg/d治疗;两组患者均连续治疗15 d。比较两组患者临床疗效,治疗前及治疗后7、15 d美国国立卫生研究院卒中量表(NIHSS)评分和血清炎性因子水平,观察两组患者治疗期间不良反应发生情况。结果两组患者临床疗效比较,差异无统计学意义(P>0.05)。两组患者治疗前和治疗后7 d NIHSS评分比较,差异无统计学意义(P>0.05);高剂量组患者治疗后15 d NIHSS评分低于低剂量组(P<0.05)。两组患者治疗前和治疗后7 d血清超敏C反应蛋白(hs-CRP)、肿瘤坏死因子α(TNF-α)、白介素6(IL-6)水平比较,差异无统计学意义(P>0.05);高剂量组患者治疗后15 d血清hs-CRP、TNF-α、IL-6水平低于低剂量组(P<0.05)。治疗期间,两组患者出血事件发生率和不良反应发生率比较,差异无统计学意义(P>0.05)。结论高、低剂量利伐沙班治疗PS的临床疗效相当,但高剂量利伐沙班能更有效地改善患者神经功能,缓解炎症,且未增加不良反应发生风险。

Objective To compare the clinical effect on progressive stroke between low -dose and high -dose rivaroxaban. Methods A total of 107 patients with progressive stroke were selected in the Transportation Centeral Hospital of Yunnan Province from May 2014 to May 2016, and they were divided into A group （n =52） and B group （n =55） according to random number table. Based on conventional treatment, patients of A group received low - dose rivaroxaban （ 10 mg/d） , while patients of B group received high -dose rivaroxaban （20 mg/d） ; both groups continuously treated for 15 days. Clinical effect, NIHSS score and serum inflammatory cytokines levels before treatment, after 7 and 15 days of treatment, and incidence of adverse reactions during the treatment were compared between the two groups. Results No statistically significant differences of clinical effect was found between the two groups （P 〉 0.05 ）. No statistically significant differences of NIHSS score was found between the two groups before treatment or after 7 days of treatment （ P 〉 0. 05 ）, while NIHSS of B group was statistically significantly lower than that of A group after 15 days of treatment （ P 〈 0. 05 ）. No statistically significant differences of hs-CRP, TNF-α or IL-6 was found between the two groups before treatment or after 7 days of treatment （P 〉 0. 05）, while serum levels of hs-CRP, TNF-α and IL-6 of B group were statistically significantly lower than those of A group after 15 days of treatment （ P 〈 0. 05 ）. No statistically significant differences of incidence of bleeding events or adverse reactions was found between the two groups during the treatment （ P 〉 0. 05 ）. Conclusion Low - dose and high - dose rivaroxaban have similar clinical effect in treating progressive stroke, but high -dose rivaroxaban can more effectively improve the neurological function, relive the inflammatory state, without increasing the risk of adverse reactions.