Zakharova N O, Bulgakova S V, Katorkin S E, Melnikov M A, Treneva E V, Nikolaeva A V
Samara state medical university, 165 b, Karl Marx pr., Samara, 443079, Russian Federation;
Adv Gerontol. 2017;30(6):917-924.
The effectiveness of the inclusion of sulodexide in the pharmacotherapy of complex treatment of patients (n=52) elderly and senile with a combination of chronic diseases of the veins complicated by refractory trophic ulcers of the lower extremities, and type 2 diabetes mellitus was studied. Patients were randomly randomized in the 1st (n=26) and the 2nd (n=26) groups, the statistical differences between them in age (t1-2=0,2, p1-2=0,833), sex (χ21-2=0,008, p1-2=0,991), nosology (χ21-2=0,004, р1-2=0,993); the anamnesis of chronic diseases of veins (t1-2=0,14, p1-2=0,893); duration of trophic ulcers (t1-2=0,21, p1-2=0,827); planimetric parameters of trophic ulcers (t1-2=0,18, p1-2=0,865) were not recorded. Patients of the 1st group received treatment with sulodexide according to the standard schedule for 50 days. The primary outcome of the study is the complete closure of the trophic ulcer after 1 month. Secondary outcomes are epithelization after 2 months and dynamic planimetric indices within 12 months. The effectiveness of the use of sulodexide was assessed according to the VCSS scale, dynamic changes in the malleolar volume and changes in planimetric parameters. A statistically significant improvement in the overall VSCC score was observed in both the 1st (p=0,002) and the 2nd (p=0,0016) groups in all study outcomes. At the same time, a statistically significant improvement in the VSCC scores was more pronounced in the 1st group (p<0,05). After 2 and 6 months, a statistically significant decrease in the malleolar volume of the affected lower extremity was recorded both in the 1st (t=4,17, p=0,001) and in the 2nd (t=2,4, p=0,37) groups. Clinically and statistically significant decrease in malleolar volume was more pronounced in the 1st group (p<0,05). After 30 days, trophic ulcers were closed in 9 (34,6%) cases in the 1st group and in 5 (19,2%) patients in the 2nd group (p<0,05). On day 60 epithelization was achieved in 22 (84,6%) and 12 (46,1%) patients, respectively. The time of complete epithelization in patients of the 1st and the 2nd groups was 51,2±1,6 and 78,4±2,6 days (p<0,05). The conclusion is made that sulodexide is an effective and pathogenetically grounded pharmacological preparation for the treatment of patients of elderly and senile age with chronic clinical disease C6 of clinical class and type 2 diabetes mellitus.
研究了舒洛地昔纳入药物治疗对患有慢性静脉疾病合并难治性下肢营养性溃疡及2型糖尿病的老年和高龄患者(n = 52)进行综合治疗的有效性。患者被随机分为第1组(n = 26)和第2组(n = 26),两组在年龄(t1 - 2 = 0.2,p1 - 2 = 0.833)、性别(χ21 - 2 = 0.008,p1 - 2 = 0.991)、疾病分类(χ21 - 2 = 0.004,р1 - 2 = 0.993)、静脉慢性病病史(t1 - 2 = 0.14,p1 - 2 = 0.893)、营养性溃疡持续时间(t1 - 2 = 0.21,p1 - 2 = 0.827)、营养性溃疡的平面测量参数(t1 - 2 = 0.18,p1 - 2 = 0.865)方面未记录到统计学差异。第1组患者按照标准方案接受舒洛地昔治疗50天。该研究的主要结局是1个月后营养性溃疡完全愈合。次要结局是2个月后上皮化以及12个月内的动态平面测量指标。根据VCSS量表、踝周体积的动态变化和平面测量参数的变化评估舒洛地昔的使用效果。在所有研究结局中,第1组(p = 0.002)和第2组(p = 0.0016)的总体VSCC评分均有统计学显著改善。同时,第1组的VSCC评分改善在统计学上更显著(p < 0.05)。2个月和6个月后,第1组(t = 4.17,p = 0.001)和第2组(t = 2.4,p = 0.37)患侧下肢的踝周体积均有统计学显著下降。第1组踝周体积在临床和统计学上的显著下降更明显(p < 0.05)。30天后,第1组9例(34.6%)患者的营养性溃疡愈合,第2组5例(19.2%)患者的营养性溃疡愈合(p < 0.05)。60天时,第1组22例(84.6%)和第2组12例(46.1%)患者实现上皮化。第1组和第2组患者完全上皮化的时间分别为51.2±1.6天和78.4±2.6天(p < 0.05)。得出的结论是,舒洛地昔是一种有效且基于发病机制的药物制剂,可用于治疗患有临床分级为C6的慢性疾病及2型糖尿病的老年和高龄患者。