Randomized, double-blind, placebo-controlled, dose-ranging study of granulocyte-macrophage colony stimulating factor in patients with chronic venous leg ulcers
Randomized, double-blind, placebo-controlled, dose-ranging study of granulocyte-macrophage colony stimulating factor in patients with chronic venous leg ulcers
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DOI：
10.1046/j.1524-475x.1999.00017.x
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发表时间：
1999-01-01
影响因子：
2.9
通讯作者：
Mendes, M
中科院分区：
文献类型：
--
作者：
da Costa, RM;Jesus, FMR;Mendes, M
慢性下肢静脉溃疡是一种常见病，没有理想的治疗方法。最近的报道表明，粒细胞-巨噬细胞集落刺激因子可用于这些慢性伤口的愈合。因此，我们进行了一项双盲、随机、安慰剂对照的研究，纳入了60名慢性下肢静脉溃疡患者，我们用安慰剂或200或400 μ g粒细胞-巨噬细胞集落刺激因子通过病灶周围注射药物治疗，每周治疗4次。在每次治疗访视时以及纳入方案后第5、9、13和6个月进行观察。安慰剂组和治疗组愈合伤口的数量有显著差异（p = 0.05），第一组21例中有4例（19%）在第13周愈合，而200 μ g组和400 μ g组分别为21例中有12例（57%）和18例中有11例（61%）。只有轻微的副作用归因于治疗，并在6个月的重新观察表明，在此期间，没有治疗的溃疡复发。我们的结论是，粒细胞-巨噬细胞集落刺激因子注射病灶周围可能是一个有用的药物治疗慢性下肢静脉溃疡。
Chronic venous leg ulcers are a common ailment with no ideal treatment. Recent reports have shown granulocyte-macrophage colony stimulating factor to be of use in the healing of these chronic wounds. Therefore, we conducted a double-blind, randomized, placebo-controlled study which enrolled 60 patients with chronic venous leg ulcers, whom we treated with placebo or with 200 or 400 mu g of granulocyte-macrophage colony stimulating factor by perilesional injections of the drug in four weekly treatment episodes. Observations were conducted at each treatment visit, at weeks 5, 9, 13 and six months after the inclusion in the protocol. The number of healed wounds in the placebo and the treated arms were significantly different (p = 0.05), with 4 of 21 (19%) in the first group having healed at week 13, as compared to 12 of 21 (57%) and 11 of 18 (61%), in the 200 mu g and the 400 mu g groups, respectively. There were only minor side-effects attributable to the treatment, and the reobservation at 6 months showed that none of the treated ulcers recurred during that period. We conclude that granulocyte-macrophage colony stimulating factor injected perilesionally may be a useful drug for the treatment of chronic venous leg ulcers.