摘要
目的探讨阿加曲班对脑血管支架置人术后支架内再狭窄发生的影响。方法设计一项前瞻性随机对照试验：选取自2010年8月至2011年8月南京军区总医院神经内科收治的适合行脑血管支架置人术的患者110例，按随机数字表法分为阿加曲班组及对照组。阿加曲班组从术前2d到术后3d连续接受20mg阿加曲班静脉滴注治疗，对照组不进行阿加曲班治疗，2组其余药物治疗相同。阿加曲班组患者给药前及用药2h后采血监测凝血功能。对患者在术后1月、3月、6月、9月门诊随访．6-9月住院复查DSA；以支架内再狭窄为主要终点事件，以目标血管重建、脑卒中复发、心血管事件、死亡及出血事件为次要终点事件。结果安全性结果：阿加曲班组患者围手术期间无出血事件、过敏反应及肝功能障碍的发生。有效性结果：（1）阿加曲班组发生支架内再狭窄率（9．3％）明显低于对照组（24％），差异有统计学意义俨0．042）。（2）阿加曲班组目标血管重建率（5．5％）低于对照组（14．5％），但差异无统计学意义（P=-0．202）。（3）围手术期间和术后随访9月2组次要终点事件发生率f脑卒中复发、心血管事件、死亡事件）比较差异均无统计学意义（围手术期：产3．336，P=0．108；X-Z=1．090，P=-0．481）；术后9月：产1．193，P=0．527；产0．003，P=-1．000；产1．090，芦0．481）。结论阿加曲班可安全有效地预防脑血管支架置人术后支架内再狭窄的发生，不增加出血等不良事件。
Objective To investigate the effect ofargatroban on restenosis aftercerebral vascular stenting. Methods A single-center, prospective, randomized, controlled pilot study was designed. One hundred and ten patients, admitted to our hospital from August 2010 to August 2011 and met the criteria of performing stenting, were randomly assigned into argatroban treatment group and control group. In the argatroban treatment group, 20 mg of argatroban was administered intravenously twice daily 2 days before and 3 days after stenting, while the control group was not administered argatroban. Argatroban treatment group received monitoring of blood clotting function before and 2-3 hours after the administration. Outpatient follow-up at 1, 3, 6 and 9 months after stenting was adopted. The cerebrovascular imaging was scheduled to follow up by DAS during 6-9 months after stenting. The primary endpoint was defined as the occurrence of in-stent restenosis, and the secondary endpoints were the target revascularization, stroke recurrence, cardiovascular events, death and bleeding. Results No patient in the argatroban treatment group occurred bleeding, allergic reactions or liver dysfunction during the perioperative period. The restenosis rate of the argatroban treatment group （9.3%） was significantly lower than that of the control group （24%, P=0.042）. Whereas, no statistical difference was found in the incidence of target vessel revascularization （5.5% vs. 14.5%, P=0.202）. The incidence of secondary events, including recurrent stroke or TIA, cardiovascular events and death, during the perioperative period （recurrent stroke or TIA： X^-3.336, P=-0.108; cardiovascular events： A,a=-I.090, P=- 0.481） and 9 months of follow up （recurrent stroke or TIA： XZ=-l. 193, P=-0.527; cardiovascular events： Xz =0.003, P=I. 000 and death： A,-Z=l.090, P=-0.481） between the two groups were not significantly different. Conclusion Argatroban is safe and effective for preventing restenosis in cerebral vascular stenting.
出处
《中华神经医学杂志》
CAS
CSCD
北大核心
2013年第4期381-385,共5页
Chinese Journal of Neuromedicine
基金
国家自然科学基金（81070923）
