從民國89 年12 月起共有23 位病人因慢性危急性下肢缺血病人，接受人類血管內皮生長因子165 質體肌肉注射的基因治療。其中3 位病人因二個患肢都有問題，隨後也接受注射，因此共有26 個患肢接受基因治療。治療劑量由400 (g（N=2）、800 (g（N=5）、1,200 (g（N=4）、1,600 (g（N=7）至2,000 g（N=8），4 週後相同劑量再注射至患部下肢肌肉內，踝／撓動脈壓力指數由0.58 ± 0.04 增加到0.72 ± 0.04，血清VEGF濃度由24.6 ± 6.1 pg/ml 增加到61.7 ± 10.9 pg/ml，又核磁共振血管攝影也有20 患肢改善血流。症狀改善方面，26 患肢的疼痛有21 患肢獲得改善，而潰瘍的改善則有72 ﹪。其中有3 患肢因傷口感染，接受截肢處理，又併發症方面，只有6 例發生輕微的下肢水腫。本研究顯示以人類血管內皮生長因子165 質體，對華人慢性危急性下肢缺血病人施予肌肉注射是安全、可行及有效的。

We enrolled 23 patients with chronic critical leg ischemia from December 2000 to month?year? to investigate the safety and efficacy of intramuscular vascular endothelial growth factor genetherapy. Both limbs were involved and were treated in 3 patients. In total, there were 26 treatedlimbs. A therapeutic dose of either 400 g (n = 2) , 800 g (n = 5) , 1200 g (n = 4) , 1600 g (n = 7) ,or 2000 g (n = 8) was injected directly into the muscles of the ischemic limb. The same dose wasinjected 4 weeks later. The ankle-brachial index significantly improved from 0.58 ± 0.04 to 0.72 ±0.04. Plasma levels of VEGF increased significantly form 24.6 ± 6.1 to 61.7 ± 10.8 pg/ml. Magneticresonance angiography showed qualitative evidence of improved distal flow in 20 limbs. Restingpain was relived or markedly improved in 21 limbs. Ischemic ulcers healed or markedly improvedin 72% of the treated limbs. Amputation was performed in 3 limbs because of wound infection.Complications were limited to mild leg edema in 6 limbs. Our study demonstrated thatintramuscular vascular endothelial growth factor gene therapy for ethnic Chinese (i.e.,Taiwanese?) patients with chronic critical leg ischemia is safe, feasible, and effective.