Department and Clinic of Vascular, General and Transplantation Surgery, Wroclaw Medical University, Borowska 213, 50-556 Wroclaw, Poland.
Department of Angiology, Hypertension and Diabetology, Wroclaw Medical University, Borowska 213, 50-556 Wroclaw, Poland.
Int J Environ Res Public Health. 2022 Oct 6;19(19):12818. doi: 10.3390/ijerph191912818.
One of the most serious problems in people with diabetes is diabetic foot syndrome. Due to the peripheral location of atherosclerotic lesions in the arterial system of the lower extremities, endovascular treatment plays a dominant role. However, carrying out these procedures is not always possible and does not always bring the expected results. Gene therapy, which stimulates angiogenesis, improves not only the inflow from the proximal limb but also the blood redistribution in individual angiosomes. Due to the encouraging results of sequential treatment consisting of intramuscular injections of VEGF/HGF bicistronic plasmids followed by a month of ANG1 plasmids, we decided to use the described method for the treatment of critical ischemia of the lower limbs in the course of diabetes and, more specifically, in diabetic foot syndrome. Twenty-four patients meeting the inclusion criteria were enrolled in the study. They were randomly divided into two equal groups. The first group of patients was subjected to gene therapy, where the patients received intramuscular injections of pIRES/VEGF165/HGF plasmids and 1 month of ANG-1 plasmids. The remaining patients constituted the control group. Gene therapy was well tolerated by most patients. The wounds healed significantly better in Group 1. The minimal value of ABI increased significantly in Group 1 from 0.44 ± 0.14 (± standard deviation) to 0.47 ± 0.12 (with = 0.028) at the end of the study. There were no significant differences in the control group. In the gene treatment group, PtcO2 increased significantly (from 28.71 ± 10.89 mmHg to 33.9 ± 6.33 mmHg with = 0.001), while in Group 2, no statistically significant changes were found. The observed resting pain decreased significantly in both groups (Group 1 decreased from 6.80 ± 1.48 to 2.10 ± 1.10; < 0.001; the control group decreased from 7.44 ± 1.42 to 3.78 ± 1.64 with < 0.001). In our study, we evaluated the effectiveness of gene therapy with the growth factors described above in patients with CLI in the course of complicated DM. The therapy was shown to be effective with minimal side effects. No serious complications were observed.
糖尿病患者最严重的问题之一是糖尿病足综合征。由于下肢动脉系统的动脉粥样硬化病变位于周围部位，因此腔内治疗起主导作用。然而，并非总是可以进行这些手术，而且并不总是能带来预期的结果。基因治疗刺激血管生成，不仅改善了近端肢体的流入，而且改善了各个血管体的血液再分配。由于连续治疗（包括肌内注射 VEGF/HGF 双顺反子质粒和随后一个月的 ANG1 质粒）的令人鼓舞的结果，我们决定在糖尿病过程中，更具体地在糖尿病足综合征中使用所述方法治疗下肢严重缺血。符合纳入标准的 24 名患者被纳入研究。他们被随机分为两组。第一组患者接受基因治疗，其中患者接受肌内注射 pIRES/VEGF165/HGF 质粒和 1 个月的 ANG-1 质粒。其余患者构成对照组。基因治疗被大多数患者耐受良好。组 1 的伤口愈合明显更好。组 1 的 ABI 最小值从研究结束时的 0.44 ± 0.14（±标准差）显著增加到 0.47 ± 0.12（ = 0.028）。对照组没有显著差异。在基因治疗组中，PtcO2 显著增加（从 28.71 ± 10.89 mmHg 增加到 33.9 ± 6.33 mmHg， = 0.001），而在组 2 中未发现统计学上的显著变化。两组的静息疼痛均明显减轻（组 1 从 6.80 ± 1.48 降至 2.10 ± 1.10； < 0.001；对照组从 7.44 ± 1.42 降至 3.78 ± 1.64， < 0.001）。在我们的研究中，我们评估了上述生长因子的基因治疗在复杂 DM 过程中 CLI 患者中的有效性。该疗法具有最小的副作用，效果显著。未观察到严重并发症。
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