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Research Article

结合日本HGF基因治疗严重肢体缺血的临床资料分析

卷 20, 期 1, 2020

页: [25 - 35] 页: 11

弟呕挨: 10.2174/1566523220666200516171447

价格: $65

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摘要

目的: 利用编码肝细胞生长因子(HGF)的裸质粒DNA对日本临床试验数据进行综合分析，目的是证明肌内HGF基因治疗严重肢体缺血(CLI)患者的安全性和有效性。 方法: 在大阪大学的单中心公开试验中，对22例CLI患者进行HGF基因转移;39名患者参与一项随机、安慰剂对照、多中心III期试验，10名患者参与一项多中心公开试验;6例CLI患者在多中心开放试验中使用2或3例肌肉注射2或4毫克裸HGF质粒。在初次注射后12周，以视觉模拟评分法(VAS)评估静息疼痛和创面愈合情况。77例患者中有7例(9.09%)因基因转移引起严重不良事件。与接受VEGF治疗的患者相比，只有1例患者出现外周水肿(1.30%)。基因移植后12周，HGF基因治疗组VAS和缺血性溃疡大小综合评价较安慰剂组有显著改善(P=0.020)。 结果: 长期分析显示HGF基因治疗组缺血性溃疡的大小持续下降。此外，与安慰剂组相比，HGF基因治疗组在基线时VAS评分超过50mm(共有27例患者)有提高VAS评分的趋势(P=0.059)，但并不显著。结论:肌肉注射裸HGF质粒可改善无血管内治疗或旁路移植手术等替代治疗的CLI患者静息疼痛，并可显著降低缺血性溃疡的大小。最近，一种HGF基因治疗产品CollategeneTM在日本上市，并获得有条件和有时限的批准，用于治疗CLI患者的缺血性溃疡。进一步的临床试验将为CLI患者提供新的治疗选择。

关键词: 血管再生术

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