巴曲酶预防糖尿病膝下血管病变介入成形术后再狭窄的前瞻性随机对照研究  

Evaluation of batroxobin in preventing vascular restenosis in diabetic patients after infrapopliteal arterial angioplasty:a randomized comparative study

作　　者：薛波[1] 张培蕾[2] 王珏[2] 李明华[2] 赵俊功[2] 朱悦琦[2] 谭华桥[2] 王建波[2] 

机构地区：[1]上海市第六人民医院神经内科,200233 [2]上海市第六人民医院放射介入科,200233

出　　处：《介入放射学杂志》2011年第3期202-206,共5页Journal of Interventional Radiology

摘　　要：目的研究巴曲酶联合阿司匹林与单纯使用阿司匹林相比较,是否有助于预防糖尿病患者膝下血管病变介入成形术后的血管内再狭窄。方法 52例症状性膝下血管闭塞的糖尿病患者,在成功施行血管成形术后,随机分为治疗组(n=26)和对照组(n=26)。治疗组患者接受巴曲酶治疗(5 u/d×6次,隔天应用)。在以12个月为终点的随访过程中,通过下肢血管磁共振成像(MRA)或者血管超声证实治疗血管再发狭窄或者闭塞。临床症状的缓解程度以及踝-臂指数(ABI)在术前、术后,并在随访过程中逐次比较。Kaplan-Meier生存曲线用以评价患者血管的无狭窄率,肢体挽救率和免截肢率。结果 在12个月的随访过程中,成形血管的再狭窄/再闭塞率在治疗组和对照组分别为22.0%和34.5%(P=0.0307);ABI两组相比,术前、术后(P<0.05)和12个月随访时(P=0.0094)时具有明显统计学差异。巴曲酶治疗组和对照组,临床症状改善及组织愈合的患者数分别为23和19例(P=0.0544)。12个月随访结束时,Kaplan-Meier分析表明两组患者成形血管的无再狭窄率分别为74.0%和54.8%;肢体挽救率分别为96.2%和92.3%;无截肢率分别为84.6%和84.6%。结论结果表明应用巴曲酶可以有效的预防膝下血管病变成形术后的再狭窄,提高临床疗效和缓解患者症状,但并不能明显提高患者的肢体挽救率和降低截肢率。Objective To evaluate batroxobin in preventing vascular restenosis in diabetic patients after infrapopliteal arterial angioplasty through comparing the clinical results of the combination use of batroxobin and aspirin with that of simple use of aspirin.Methods After a successful angioplasty,fifty-two diabetic patients with symptomatic infrapopliteal obstructions were randomly divided into the study group（n=26）and the control group（n=26）.Patients in both groups received 100 mg aspirin everyday,but the patients in study group additionally received 5 IU batroxobin intravenous drip every other day for six times.At the end of the follow-up period lasting for 12 months,magnetic resonance angiography（MRA）or Doppler ultrasonic angiography was performed to check the the vessels to see if there was any restenosis or reocclusion.The relief degree of clinical symptoms were observed,and both preoperative and postoperative ankle-brachial index（ABI）were regularly determined and compared.Kaplan-Meier curves were constructed to evaluate restenosis/reocclusion-free rate,limb salvage rate and amputation-free rate.Results During the follow-up period the occurrence of restenosis/reocclusion in study group and control group was 22.0% and 34.5% respectively（P = 0.0307）.Statistically significant difference in ABI existed between two groups both after the procedure（P 〈0.05） and at 12 months after the treatment（P = 0.0094）.Clinical improvement and tissue healing in study group and control group were observed in 23 and 19 patients respectively（P = 0.0544）.Twelve months after angioplasty,Kaplan-Meier analysis showed that the restenosis/reocclusion-free rate,the limb salvage rate and the amputation-free rate for study group were 74.0%,96.2% and 84.6% respectively,while they was 54.8%,92.3% and 84.6% respectively for control group.Conclusion The results of this study indicate that the use of batroxobin can effectively prevent the vascular restenosis or reocclusion after infrapopliteal arterial angioplasty,app

关 键 词：巴曲酶 成形术 再狭窄 再闭塞 膝下动脉 

分 类 号：R587.2[医药卫生—内分泌]