紫杉醇药物涂层球囊治疗冠脉支架内再狭窄的临床研究

Clinical study of drug-coated balloon with Paclitaxel for treatment of coronary in-stent restenosis

目的探讨紫杉醇药物涂层球囊治疗冠脉支架内再狭窄的临床效果。方法选择2015年1月~2016年12月广州医科大学附属第三医院收治的87例冠脉支架内再狭窄患者,按随机数字表法将其分为对照组(43例)和治疗组(44例)。对照组给予药物洗脱支架治疗,治疗组给予紫杉醇药物涂层球囊治疗。观察并比较两组术后1、6、12个月的心血管不良事件发生率及两组术后12个月时的支架内再狭窄发生率。结果治疗组术后心血管不良事件总发生率(6.82%)及术后12个月时支架内再狭窄发生率(6.82%)均明显低于对照组(23.26%、27.91%),差异有统计学意义(χ~2=4.623,P=0.032;χ~2=6.778,P=0.009)。结论紫杉醇药物涂层球囊治疗冠脉支架内再狭窄的临床效果显著,能够明显减少心血管不良事件的发生,可避免再次置入支架,值得临床推广应用。

Objective To explore the clinical efficacy of drug-coated balloon with Paelitaxel for treatment of coronary in-stent restenosis. Methods Eighty-seven patients with coronary in-stent restenosis admitted to the Third Affiliated Hospital of Guangzhou Medical University from January 2015 to December 2016 was divided into control group （43 cases） and treatment group （44 cases） by random number table method. Control group was treated with drug-eluting stent, while treatment group was treated with drug-coated balloon with Paelitaxel. The rate of cardiovascular adverse events after operation for 1, 6, 12 months and the incidence of coronary in-stent restenosis after operation for 12 months of the two groups were observed and compared. Results The total rate of cardiovascular adverse events and the incidence of coronary in-stent restenosis of treatment group （6.82%, 6.82%） were both lower than those of control group （23.26%, 27.91%） after operation for 12 months, the differences were statistically significant （χ^2=4.623, P = 0.032; X^2= 6.778, P = 0.009）. Conclusion The drug-coated balloon with Paelitaxel is effective in the treatment of coronary instent restenosis, it can reduce the incidence of cardiovascular adverse events and avoid placing stents again, it is worthy of promotion and application in clinic.