低温球囊治疗下肢动脉狭窄与闭塞的初步临床研究

The clinical application of cryoplasty for lower extremity arterial occlusive disease

目的观察低温球囊治疗下肢动脉狭窄、闭塞的近期疗效及安全性。方法纳入25例下肢动脉狭窄、闭塞的患者（共27条动脉），按随机数字表分为低温球囊组及普通球囊组，分别行下肢动脉球囊成形术。低温球囊组10例，病变长度（6．7±0．9）cm，狭窄程度（914-6）％，Fontaine分级Ⅱ级7例、Ⅲ级3例，按泛大西洋介入学会协议（TASC）分型A型8例、B型2例，踝肱指数（ABI）0．46±0．07；普通球囊组15例，病变长度（6．5±0．7）cm，狭窄程度（89±7）％，Fontaine分级，Ⅱ级13例、Ⅲ级2例；TASC分型，A型13例、B型2例，AB10．48±0．08，两组患者一般临床症状和体征比较差异无统计学意义（P〉0．05）。按Rutherford治疗后肢体状态7级评估法，评估术后临床变化。采用重复测量方差分析比较两组术后2d及30d疗效。结果低温球囊组10例技术成功，术中未发生血管壁损伤，术后30d临床症状显著改善8例，中度改善2例；AB10．84±0．04；狭窄程度（29±4）％。普通球囊组15例技术操作均成功，其中1例发生血管壁夹层，术后30d临床症状显著改善13例，中度改善2例；AB10．84±0．05；狭窄程度（32±4）％。两组术前与术后的ABI（P〈0．01）、狭窄程度（P〈0．01）差异均有统计学意义；两组之间的ABI（P=0．20）、狭窄程度（P=0．55）差异无统计学意义。结论低温球囊治疗下肢动脉狭窄闭塞安全并具有较好的近期疗效。

Objective To observe the short term efficacy and safety of cryoplasty in treatment of lower extremity arterial occlusive disease. Methods Twenty five patients （27 limbs ） scheduled for lower extremity artery balloon angioplasty were randomized to cryoplasty [ group CRYO, 10 patients with 8 male, age （76± 8 ） years ] or conventional balloon angioplasty [ group COBA, 15 patients with 13 male, age （68± 4） years]. In CRYO group, the average lesion length and stenosis were （6.7 ±0.9） cm and, （91 ± 6） % , respectively. The average ankle-brachial index （ABI） was 0. 46 ± 0. 07 before treatment. According to Fontaine clinical stages, 7 patients （7/10） in this group were staged Ⅱ and the other 3 （3/10） were staged Ⅲ. According to Trans Atlantic Inter Society Consensus （TASC） , 8 patients （8/10） were classified as TASC type A and the other 2 （2/10） were TASC type B. In COBA group, the average lesion length and stenosis were （6. 5 ± 0. 7 ） cm and （ 89 ± 7 ） %, respectively. The average ABI was 0.48 ± 0. 08 before treatment. According to Fontaine clinical stages, 13 patients （13/15） were staged Ⅱ and the other 2（2/15） were staged Ⅲ. And, according to TACS, 13 patients （13/15） were classified as TASC type A and the other 2 （2/15） were TASC type B. The clinical symptoms and signs had no significant difference between the two groups （ P 〉 0. 05 ）. Clinical status was evaluated according to Rutherford classification. The clinical efficacy on the 2nd and 30 th day after the operation was compared using analysis of variance with repeated measurements. Results Technical success was achieved in all patients both in CRYO group （10/10） and in COBA group （15/15）. None patient in CRYO group occurred postoperative complication. One patient in COBA group （1/15） occurred vessel wall dissection. In CRYO group, clinical status were remarkably improved in 8 patients （8/10） and moderately improved in 2 patients （2/10） ; while, in COBA group, they were remarkably improved in 13 patients （13/15） and moderately improved in 2 patients （2/15）. The average ABI was 0. 84 ±0. 04 in group CRYO and 0. 84 ±. 05 in group COBA （P =0. 20）.The average stenosis was （29 ± 4） % in group CRYO and （32± 4） % in group COBA （ P = 0. 55 ）. No significant difference was detected between the two groups. Both the average ABI and stenosis presented statistically significant difference between pre-operation and post-operation in both groups （P 〈 0. 01, respectively）. Conclusions Cryoplasty is safe for the treatment of lower extremity arterial occlusive disease, which showed a good short-term resuh in this research.