CAJ | 학술논문

目的：探讨巴曲酶联合阿司匹林预防糖尿病下肢缺血病变介入术后再狭窄的疗效。方法110例症状性血管闭塞的糖尿病患者随机分为实验组50例和对照组60例。实验组患者接受阿司匹林（100 mg/d）联合巴曲酶治疗（5 u/d ×6次，隔天应用），对照组单独应用阿司匹林。以12个月为随访终点，通过下肢磁共振血管成像（MRA）或者血管超声来评估血管再狭窄或者再闭塞的情况。统计踝以上截肢、死亡人数，以及截肢或死亡累积发生率，运用Kaplan-Meier生存曲线来评估保肢率和存活率。结果12个月后，实验组再狭窄发生率为28.9%，对照组为42.8%（P=0.002）。 MRA及血管超声显示膝下动脉（P=0.003）和长度>10 cm（P=0.001）再狭窄发生率高。 Kaplan-Meier生存曲线显示血管成形术12个月后，对照组和实验组保肢/存活率分别为78.2%和93.5%（log-rank检验，P=0.0324）。结论巴曲酶联合阿司匹林可以有效减少血管成形术后再狭窄发生率，尤其针对膝下病变>10 cm者，有着更好的临床疗效，并且可以提高患者的肢体挽救率。
목적：탐토파곡매연합아사필림예방당뇨병하지결혈병변개입술후재협착적료효。방법110례증상성혈관폐새적당뇨병환자수궤분위실험조50례화대조조60례。실험조환자접수아사필림（100 mg/d）연합파곡매치료（5 u/d ×6차，격천응용），대조조단독응용아사필림。이12개월위수방종점，통과하지자공진혈관성상（MRA）혹자혈관초성래평고혈관재협착혹자재폐새적정황。통계과이상절지、사망인수，이급절지혹사망루적발생솔，운용Kaplan-Meier생존곡선래평고보지솔화존활솔。결과12개월후，실험조재협착발생솔위28.9%，대조조위42.8%（P=0.002）。 MRA급혈관초성현시슬하동맥（P=0.003）화장도>10 cm（P=0.001）재협착발생솔고。 Kaplan-Meier생존곡선현시혈관성형술12개월후，대조조화실험조보지/존활솔분별위78.2%화93.5%（log-rank검험，P=0.0324）。결론파곡매연합아사필림가이유효감소혈관성형술후재협착발생솔，우기침대슬하병변>10 cm자，유착경호적림상료효，병차가이제고환자적지체만구솔。
Objective To assess the clinical value of batroxobin plus aspirin therapy in reducing the incidence of arterial re-stenosis or re-occlusion in diabetic patients with lower-limb ischemia after receiving angioplasty. Methods A total of 110 diabetic patients with symptomatic arterial obstructions were randomly divided into study group (n=50) and control group (n=60). Aspirin 100 mg/d plus batroxobin 5 IU every other day for six times was used in patients of the study group, while only aspirin 100 mg/d was used in patients of the control group. The follow-up finishing point was the end of 12 months. The arterial re-stenosis or re-occlusion was evaluated with magnetic resonance angiography (MRA) and/or vascular sonography. Amputation above the ankle, death, and the cumulative rate of amputation or death were determined, and the limb salvage and survival rates were assessed by using Kaplan-Meier analysis method. Results Twelve months after the treatment, the occurrence of restenosis in the study group and the control groups was 42.8%and 28.9% respectively (P = 0.002). MR angiography and color- duplex sonography revealed that the restenosis occurrence was much higher in infrapopliteal artery (P = 0.003) and in longer (length > 10 cm) diseased artery (P = 0.001). Twelve months after angioplasty Kaplan-Meier analysis showed that the limb salvage-survival rates of the study group and the control group were 78.2%and 93.5%respectively (log-rank test, P = 0.032 4). Conclusion Combination use of batroxobin and aspirin can effectively reduce the occurrence of restenosis after arterial angioplasty, and the clinical effect is particularly better for the artery distal to the knee and the artery with longer lesion (length > 10 cm), besides this treatment can also improve limb salvage rate.