Peschen M, Thimm C, Weyl A, Weiss J M, Kurz H, Augustin M, Simon J C, Schöpf E, Vanscheidt W
Department of Dermatology, University of Freiburg, Germany.
Vasa. 1998 May;27(2):89-93.
Aim of this placebo-controlled clinical study was to examine the expression pattern of coagulation factor XIIIa in patients with chronic venous leg ulcers and the impact of a 10 day topical factor XIII treatment on ulcer healing, leg ulcer size and radius reduction.
24 patients were stratified into two groups, each consisting of 12 patients, with leg ulcers > 1.000 mm2, or < 1.000 mm2. Four patients of each study group were assigned to the control group (n = 8). All leg ulcers were treated by topical application of non-adhering dressings and compression therapy. Patients of the treatment group (n = 16) were treated by additional topical treatment off factor XIII twice daily for ten days. Immunohistochemical staining of leg ulcer specimens before and after treatment (day 10) was performed in all patients.
The immunohistochemical staining of factor XIIIa in all specimens before and after therapy showed no significant increase in the expression of factor XIIIa. Comparison of the leg ulcer size, radius and daily radius reduction in the treatment and control group showed no significant differences in values of patients with leg ulcers > 1.000 mm2. However, a decreased leg ulcer size and radius was found in patients of the treatment group with more acute leg ulcers < 1.000 mm2 in contrast to patients with larger leg ulcers (daily ulcer radius reduction from day 0-10; 0.31 mm versus 0.13 mm, p < 0.015).
These results indicate that locally applied factor XIII promotes especially wound healing of more acute smaller venous leg ulcers. Since immunohistochemical staining of factor XIIIa showed no significant differences before and after therapy, we propose that factor XIII is inactivated rapidly after local application on venous leg ulcers.
本安慰剂对照临床研究的目的是检测慢性下肢静脉溃疡患者凝血因子XIIIa的表达模式，以及为期10天的局部应用因子XIII治疗对溃疡愈合、下肢溃疡大小及半径缩小的影响。
24例患者被分为两组，每组12例，下肢溃疡面积>1000mm²或<1000mm²。每个研究组的4例患者被分配至对照组（n = 8）。所有下肢溃疡均采用非粘性敷料局部应用及加压治疗。治疗组（n = 16）患者额外接受局部应用因子XIII治疗，每日两次，共10天。所有患者均在治疗前（第1天）和治疗后（第10天）对下肢溃疡标本进行免疫组织化学染色。
治疗前后所有标本中因子XIIIa的免疫组织化学染色显示因子XIIIa的表达无显著增加。治疗组和对照组下肢溃疡大小、半径及每日半径缩小情况的比较显示，下肢溃疡面积>1000mm²的患者各项数值无显著差异。然而，与溃疡面积较大的患者相比，治疗组中溃疡面积<1000mm²的急性下肢溃疡患者的下肢溃疡大小和半径有所减小（第0 - 10天每日溃疡半径缩小；0.31mm对0.13mm，p < 0.015）。
这些结果表明，局部应用因子XIII尤其能促进急性较小的下肢静脉溃疡的伤口愈合。由于因子XIIIa的免疫组织化学染色在治疗前后无显著差异，我们推测因子XIII在局部应用于下肢静脉溃疡后迅速失活。
