Venous leg ulcer: A meta-analysis of adjunctive therapy with micronized purified flavonoid fraction

Venous leg ulcer: A meta-analysis of adjunctive therapy with micronized purified flavonoid fraction
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DOI:
10.1016/j.ejvs.2005.04.017
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发表时间:
2005-08-01
影响因子:
5.7
通讯作者:
Ramelet, AA
Ramelet, AA
中科院分区:
医学1区
文献类型:
--
作者:
Coleridge-Smith, P;Lok, C;Ramelet, AA

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Objective.评估口服微粒化纯化类黄酮组分(MPFF)对腿部溃疡愈合的影响。采用MPFF加常规治疗的随机前瞻性研究的荟萃分析:材料与方法确定了5项前瞻性、随机、对照研究,其中723例静脉性溃疡患者在1996年至2001年期间接受了治疗。在两项研究中(N = 309),将MPFF加常规治疗(压迫和局部护理)与常规治疗加安慰剂进行了比较,或在三项研究中(N = 414)与单独常规治疗进行了比较。主要终点是6个月时溃疡完全愈合。在6个月时,接受预防性MPFF治疗的患者的溃疡愈合机会比仅接受常规治疗的患者高32%(RRR:32%; CI:3-70%)。这种差异从第2个月开始存在(RRR:44%; CI,7-94%),并且与较短的愈合时间相关(16 vs 21周; P = 0.0034)。MPFF的主要获益出现在面积在5 - 10 cm 2之间的溃疡亚组(RRR:40%; CI,6-87%)和持续时间为6-12个月的溃疡亚组(RRR:44%; CI,6-97%)。这些结果证实了MPFF治疗加速了静脉溃疡愈合。MPFF可能是一个有用的辅助传统治疗的大和长期的溃疡。
Objective. To assess the effect of oral treatment with micronized purified flavonoid fraction (MPFF) on leg ulcer healing.Design. Meta-analysis of randomised prospective studies using MPFF in addition to conventional treatment.Materials and methods. Five prospective, randomised, controlled studies in which 723 patients with venous ulcers were treated between 1996 and 2001 were identified. Conventional treatment (compression and local care) in addition to MPFF was compared to conventional treatment plus placebo in two studies (N = 309), or with conventional treatment alone in three studies (N = 414). The primary end point was complete ulcer healing at 6 months.Results. At 6 months, the chance of healing ulcer was 32% better in patients treated with adjunctive MPFF than in those managed by conventional therapy alone (RRR: 32%; CI, 3-70%). This difference was present from month 2 (RRR: 44%; CI, 7-94%), and was associated witha shorter time to healing (16 versus 21 weeks; P = 0.0034). The main benefit of MPFF was present in the subgroup of ulcers between 5 and 10 cm 2 in area (RRR: 40%; CI, 6-87%), and those present for 6-12 months duration (RRR: 44%; CI, 6-97%).Conclusion. These results confirm that venous ulcer healing is accelerated by MPFF treatment. MPFF might be a useful adjunct to conventional therapy in large and long standing ulcers.