Wozniak G, Dapper F, Alemany J
Department of Cardiovascular Surgery, Justus-Liebig-University, Giessen, Germany.
Semin Thromb Hemost. 1996;22(5):445-50. doi: 10.1055/s-2007-999044.
The therapy concept of topical factor XIII application was developed on the basis of clinical and experimental investigations on improvement of wound healing, as well as on the morphological and pathophysiological topical site of venous ulcers. Topical treatment with factor XIII is special with regard to mode of application as well as efficacy, since a lot of other medications used for local wound treatment contain a fibrinolytic component. In the last 32 months, 23 inpatients (17 female, 6 male) averaging 62.9 +/- 14.1 years and suffering ulcerative leg disease were treated with topically applied factor XIII. The average period of distal venous ulcer in these patients was 3.3 +/- 2.04 years. The extent of the ulcer surface ranged between 2.5 x 3.0 cm (minimum) and 18.5 x 8.0 cm (maximum). All patients had been in medical consultation for several years. The venous ulcers were based upon a "postthrombotic syndrome" in 15 patients. Six patients were suffering from ulcerations due to arterial and venous mixed disease, and there were 2 patients with ulcerations of unknown etiology. In 5 patients, 2 with unknown etiology and 3 with arterial and venous mixed disease, local treatment with factor XIII was discontinued after 4 weeks because there was definitely no improvement in wound healing. Additionally, 3 patients with ulcerations due to arterial and venous mixed disease were treated for a maximum of 6 weeks with only moderate improvement in healing. Twelve of the 15 patients (79.3%) with extended, chronic ulceration on the basis of a postthrombotic syndrome showed such a distinct improvement of topical site after an average of only 3.15 +/- 1.14 weeks that they were released for further ambulatory treatment. Three patients had to be treated for a maximum period of 6 weeks, also with distinct improvement in wound healing. Apart from a wound surface reduction and a clinically documentable improvement of granulation tendency, there was a marked reduction of secretion and bleeding tendency within the ulcer area observed in all patients. None of the patients showed any systemic or local allergic reactions.
局部应用凝血因子 XIII 的治疗理念是基于改善伤口愈合的临床和实验研究，以及静脉性溃疡的形态学和病理生理学局部情况而形成的。凝血因子 XIII 的局部治疗在应用方式和疗效方面都很特殊，因为许多用于局部伤口治疗的其他药物都含有纤溶成分。在过去的 32 个月里，对 23 名平均年龄为 62.9±14.1 岁、患有溃疡性腿部疾病的住院患者（17 名女性，6 名男性）进行了局部应用凝血因子 XIII 的治疗。这些患者远端静脉溃疡的平均病程为 3.3±2.04 年。溃疡表面面积范围在 2.5×3.0 厘米（最小）至 18.5×8.0 厘米（最大）之间。所有患者都已就医数年。15 名患者的静脉性溃疡是由“血栓形成后综合征”引起的。6 名患者患有动静脉混合性疾病导致的溃疡，还有 2 名患者溃疡病因不明。在 5 名患者中，2 名病因不明，3 名患有动静脉混合性疾病，由于伤口愈合绝对没有改善，4 周后停止了凝血因子 XIII 的局部治疗。此外，3 名患有动静脉混合性疾病溃疡的患者接受了最长为期 6 周的治疗，愈合仅略有改善。15 名因血栓形成后综合征导致广泛慢性溃疡的患者中有 12 名（79.3%），平均仅 3.15±1.14 周后局部情况就有明显改善，从而可以出院接受进一步的门诊治疗。3 名患者最长接受了 6 周的治疗，伤口愈合也有明显改善。除了伤口表面缩小和临床上可记录的肉芽形成趋势改善外，所有患者溃疡区域的分泌物和出血倾向都有明显减少。没有患者出现任何全身或局部过敏反应。
