Koblik T, Sieradzki J, Sendur R, Biernat J, Czarnobilski K, Gryz E, Pawlik W, Szczudlik A, Gaddi A
Clinic of Metabolic Diseases, Jagiellonian University, Krakow, Poland.
J Diabetes Complications. 2001 Mar-Apr;15(2):69-74. doi: 10.1016/s1056-8727(00)00134-3.
To assess the efficacy of insulin plus sulodexide (a mixture of 80% heparin-like substances and 20% dermatan sulphate) on diabetic ulcers, and its influence on foot skin microcirculation and diabetic neuropathy.
Two groups of diabetic patients, suffering from severe neuropathy and ulceration, were randomly assigned to insulin (I) plus sulodexide (S) (n=12) or insulin plus placebo (P) (n=6) therapy, for 10 weeks. Laser Doppler assessment of foot skin flow (LDF), at rest and 30 or 60 s after arterial occlusion, and nerve conduction tests (sensorial evoked and motoric conduction potentials) have been evaluated in both groups.
Postischaemic flow was 2.5 times shorter in ulcerated vs. non-ulcerated feet in diabetic patients. A significant increase in flows after 30 and 60 s ischaemia was detected in both groups at the end of therapy (IS group, ulcerated foot, LDF=60 s: from 99.1+/-14.3 to 218.6+/-28.6 PU, P<.001. IP group=from 110.5+/-13.0 to 164.8+/-15.4 PU, P<.05). The length of reactive hyperaemia was higher in IS vs. IP group (IS: from 30.3+/-2.9 to 43.9+/-2.2 s, P<.001; IP: from 28.7+/-3.0 to 33.3+/-3.3 s, ns). Ninety-two percent of ulcers heals in a mean time of 46.4 days (IS group) vs. 83% and 63.0 days, respectively, in IP group. Nerve conduction studies have not demonstrated within- and between-group differences.
Sulodexide and insulin improve the postischaemic skin flow in ulcerated feet, without affecting nerve conduction tests. The effect of sulodexide results additive to insulin; it is clinically relevant, in the view of the possibility of reducing the time needed to completely heal ulcers. The ultimate validation of these preliminary results requires extensive trials.
评估胰岛素联合舒洛地希（一种由80%类肝素物质与20%硫酸皮肤素组成的混合物）治疗糖尿病溃疡的疗效，以及其对足部皮肤微循环和糖尿病神经病变的影响。
将两组患有严重神经病变和溃疡的糖尿病患者随机分为胰岛素（I）联合舒洛地希（S）组（n = 12）或胰岛素联合安慰剂（P）组（n = 6），治疗10周。对两组患者在静息状态下以及动脉闭塞后30秒或60秒时进行足部皮肤血流的激光多普勒评估（LDF），并进行神经传导测试（感觉诱发电位和运动传导电位）。
糖尿病患者中，溃疡足部的缺血后血流较非溃疡足部缩短2.5倍。治疗结束时，两组在缺血30秒和60秒后的血流均显著增加（IS组，溃疡足部，LDF = 60秒：从99.1±14.3增至218.6±28.6灌注单位，P <.001。IP组：从110.5±13.0增至164.8±15.4灌注单位，P <.05）。IS组的反应性充血时长高于IP组（IS组：从30.3±2.9增至43.9±2.2秒，P <.001；IP组：从28.7±3.0增至33.3±3.3秒，无显著差异）。IS组92%的溃疡在平均46.4天内愈合，而IP组分别为83%和63.0天。神经传导研究未显示组内和组间差异。
舒洛地希和胰岛素可改善溃疡足部的缺血后皮肤血流，且不影响神经传导测试。舒洛地希的作用与胰岛素具有相加性；鉴于其有可能缩短溃疡完全愈合所需时间，具有临床相关性。这些初步结果的最终验证需要进行广泛试验。
