摘要
目的既往研究提示直接凝血酶抑制剂抗凝治疗可有效预防冠状动脉球囊成形术后再狭窄，尚无研究探讨其在椎动脉支架术后再狭窄的预防作用。探讨直接凝血酶抑制剂抗凝治疗对椎动脉支架术后再狭窄发生的影响。方法采用前瞻性随机对照的单中心临床试验研究方法，选取自2010年8月至2011年12月南京军区南京总医院收治的适合行椎动脉支架置入术的患者，并利用区组随机分组方法分为直接凝血酶抑制剂抗凝治疗组及对照组。直接凝血酶抑制剂抗凝治疗组连续接受直接凝血酶抑制剂（术前2d及术后3d）抗凝治疗，对照组不进行抗凝治疗，2组其余药物治疗相同。直接凝血酶抑制剂抗凝治疗组患者抗凝期间监测凝血功能。临床随访时间点分别为术后1、3、6、9个月；数字减影血管造影复查在术后6-9个月住院进行。主要终点事件为支架内再狭窄，所有数据均录入南京卒中注册系统。结果研究期间共有57例患者入组研究（直接凝血酶抑制剂抗凝治疗组27例、对照组30例），直接凝血酶抑制剂抗凝治疗组目标血管重建率在数值上低于对照组，但差异无统计学意义（3．7％us13．3％，P=0．356）。术后复查，直接凝血酶抑制剂抗凝治疗组再狭窄率明显低于对照组，差异有统计学意义（7．4％us30．0％，P=0．031）。围手术期间和随访9个月2组次要终点事件发生率均无明显差异，其中包括再狭窄率（7．4％us30．0％，P=0．031）、目标位置重建（3．7％us13．3％，P=0．356）、死亡（0粥3．3％，P〉0．999）、复发率中或TIA（0us6．7％，P=0．492）以及心血管事件发生率（3．7％us0，P=0．474）。结论在行椎动脉支架置入术的患者中，直接凝血酶抑制剂抗凝治疗不增加出血等不良事件，可有效预防椎动脉支架术后再狭窄的发生。
Objective Previous studies have suggested that direct thrombin inhibitor may be effective in preventing restenosis after coronary balloon angioplasty, but no studies investigate it＇s function of preventing restenosis after vertebral artery stenting. To inves-tigate the effect of direct thrombin inhibitor on restenosis after vertebral artery stenting. Methods A single-center, prospective, ran-domized, controlled pilot study was designed. We included patients who met the criteria of performing stenting from August 2010 to De-cember 2011. All patients were randomly assigned into the direct thrombin inhibitor group and the control group. In the direct thrombin in-hibitor group, all patients were treated with intravenous argatroban 10mg twice dally for 5 days, while the control group was black control All patients underwent follow-up 4 times （ 1 month, 3 months, 6 months,9 months） after stenting were adopted. And DAS follow-up was done at 6 -9 months. The primary endpoint was defined as the occurrence of in-stent restenosis. All data were recorded in Nanjing Stroke Registry Projects. Results In our study, none patient in direct thrombin inhibitor group occurred bleeding events, allergic reactions or liver dys- function during the perioperative period. During the follow-up, the restenosis rate of direct thrombin inhibitor group was significantly lower thancontrol group （7. 4% vs 30. 0%, P = O. 031 ）. Whereas, no statistical difference was found in the incidence of target vessel revascularization （3.7% vs 13.3%, P =0. 356）. There was no difference on the incidence of secondary events including recurrent stroke or TIA （0% vs 6. 7% ,P = 0.492）, cardiovascular events and death （3.7% vs 0% ,P=0.474） during the perioperative and 9 months followed-up between groups. ConclusionDirect thrombin inhibitor is safe and effective in preventing restenosis after veitebral artery stenting.
出处
《医学研究生学报》
CAS
北大核心
2014年第3期250-253,共4页
Journal of Medical Postgraduates
基金
国家自然科学基金(81000501)
南京军区南京总医院科研基金(2012003)
