Vanscheidt W, Ukat A, Horak V, Brüning H, Hunyadi J, Pavlicek R, Emter M, Hartmann A, Bende J, Zwingers Th, Ermuth T, Eberhardt R
Dermatologische Praxisgemeinschaft Freiburg, Freiburg, Germany.
Wound Repair Regen. 2007 May-Jun;15(3):308-15. doi: 10.1111/j.1524-475X.2007.00231.x.
In a multicenter trial, the effect of a commercially available combination of autologous keratinocytes (3-6 x 10(6)/mL) with fibrin sealant (Tissucol Duo S Immuno, Baxter Hyland Immuno) on the healing of recalcitrant venous leg ulcers (duration >3 months) was compared with standard care. The primary endpoint was time to healing, and the secondary endpoint was number of healed ulcers in both groups. Both groups received compression therapy with short-stretch bandages. Forty-four (38.3%) of the 116 patients who had BioSeed-S treatment achieved complete healing of the target ulcer compared with 24 (22.4%) of 109 patients who received standard treatment. The advantage for treatment with BioSeed-S over standard treatment was statistically significant (chi-square test: p=0.0106). Time to complete healing of ulcers: the log-rank test for equality over strata revealed a superiority of treatment with BioSeed-S+compression (median: 176 days) over compression+standard care (median >201 days) (p<0.0001). This study, to date the largest multicenter study with autologous keratinocytes, provides evidence for its efficacy in the treatment of patients with therapy-resistant chronic venous leg ulcers.
在一项多中心试验中，将市售的自体角质形成细胞（3 - 6×10⁶/mL）与纤维蛋白密封剂（Tissucol Duo S Immuno，百特海兰免疫公司）的组合用于治疗顽固性腿部静脉溃疡（病程>3个月）的效果与标准护理进行了比较。主要终点是愈合时间，次要终点是两组中愈合溃疡的数量。两组均接受短拉伸绷带加压治疗。接受BioSeed - S治疗的116例患者中有44例（38.3%）实现了目标溃疡的完全愈合，而接受标准治疗的109例患者中有24例（22.4%）实现了完全愈合。BioSeed - S治疗相对于标准治疗的优势具有统计学意义（卡方检验：p = 0.0106）。溃疡完全愈合的时间：分层对数秩检验显示，BioSeed - S + 加压治疗（中位数：176天）优于加压 + 标准护理（中位数>201天）（p<0.0001）。这项研究是迄今为止关于自体角质形成细胞的最大规模多中心研究，为其在治疗难治性慢性腿部静脉溃疡患者中的疗效提供了证据。
