Skóra Jan, Sadakierska-Chudy Anna, Pupka Artur, Bieguss Jan, Barć Piotr, Baczyńska Dagmara, Janczak Dariusz, Zacharska Sylwia, Ugorski Maciej, Dobosz Tadeusz, Szyber Piotr
Akademiia Medyczna we Wrocławiu, Katedra i Klinika Chirurgii Naczyniowej, Ogólnej i Transplantacyjnej.
Pol Merkur Lekarski. 2006 Jun;20(120):655-9.
In the study we assessed the clinical and histological benefits of gene therapy in no-option patients with critical lower limb ischemia.
We administrated VEGF165 (Vascular Endothelial Growth Factor) plasmid to 10 patients. The plasmid was injected intramuscularly into lower limb. In the study we evaluated: clinical outcomes, venous blood VEGF protein concentration before and after (7th, 14th, 28th and 90th day) administration of plasmid. From patients who required amputation we obtained samples of muscles, which were examined histological and by PCR (Polymerase Chain Reaction) for detection of plasmid genes.
Only two patients from the group did not require amputation due to the therapy. In eight patients the operation was essential. Serum VEGF concentration was higher than in healthy controls (p < 0.05). We observed increase of the concentration of the cytokine on the 14th day an decrease on the 90th day after administration of plasmid (p < 0.05). Histological analysis did not reveal any sings of new blood vessels formation in the samples taken from amputated limbs. There was also no signs of expression of plasmid primers in PCR.
The therapy is safe. We did not observe significant improvement in patient's clinical state. The therapy needs further investigations.
在本研究中，我们评估了基因治疗对无可选择的严重下肢缺血患者的临床和组织学益处。
我们对10名患者给予血管内皮生长因子165（VEGF165）质粒。该质粒通过肌肉注射到下肢。在研究中，我们评估了：临床结果、质粒给药前后（第7天、第14天、第28天和第90天）静脉血VEGF蛋白浓度。从需要截肢的患者身上获取肌肉样本，进行组织学检查并通过聚合酶链反应（PCR）检测质粒基因。
该组中只有两名患者因治疗而无需截肢。八名患者必须进行手术。血清VEGF浓度高于健康对照组（p < 0.05）。我们观察到给药后第14天细胞因子浓度升高，第90天降低（p < 0.05）。组织学分析未显示从截肢肢体获取的样本中有任何新血管形成的迹象。PCR中也没有质粒引物表达的迹象。
该治疗是安全的。我们未观察到患者临床状态有显著改善。该治疗需要进一步研究。
