Efficacy of Daflon 500 mg in the treatment of lymphedema (secondary to conventional therapy of breast cancer)
Efficacy of Daflon 500 mg in the treatment of lymphedema (secondary to conventional therapy of breast cancer)
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DOI：
10.1177/000331979704800115
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发表时间：
1997-01-01
期刊：
影响因子：
2.8
通讯作者：
Pillion, G
中科院分区：
文献类型：
--
作者：
Pecking, AP;Fevrier, B;Pillion, G
为了评估一种纯化的微粉化类黄酮组分(Dies；达富隆500 mg*)对乳腺癌治疗后上肢淋巴水肿的活性，进行了一项单中心、随机、双盲、平行分组与安慰剂(PLAC)的试验。包括104名患有淋巴水肿症的妇女；94名完成了研究(46名DIOS，48名PLAC)。对24例有较严重淋巴水肿的患者(10例DIO，14例PLAC)进行了单独的分析。由DIES或PLAC组成的治疗在六个月内每天服用两片。在包裹体和治疗结束时，用~(99m)Tm进行放射性核素淋巴显像。每两个月测量一次上肢体积。在总体人群中，Dies和Plac的参数演变没有差别。在24例淋巴水肿较重的患者中，淋巴显像参数(m+/-SD)如下：DIES组淋巴迁移速度明显高于PLAC组(增量速度cm/min：0.84+/-0.6vs0.14±0.26，P=0.005)。随着时间的推移，DIES组胶体化合物的半衰期明显延长(Delta半衰期=10.3+/-13.07min，P=0.034)，而PLAC组(Delta半衰期=0.53min+/-15.51min，P=0.086)。胶体清晰度随时间的变化在DIES组接近统计学意义(DeltaClearance Mu L/min：2.18+/-3.10，P=0.054)，而PLAC组无统计学意义(0.11+/-2.26，P=0.86)。淋巴水肿量的演变没有发现明显的差异，尽管有倾向于死亡。这可能与体积值的广泛分布和患者数量较少有关。在受更严重淋巴水肿影响的患者中，每天服用两片。淋巴速度的明显提高说明了其已知的淋巴运动活性。更大剂量的进一步研究可以证实该药在治疗继发性淋巴水肿方面的有益活性。
To assess the activity of a purified, micronized, flavonoidic fraction (Dies; Daflon(R) 500 mg*) on upper limb lymphedema occurring after breast cancer therapy, a monocenter, randomized, double-blind, parallel group vs placebo (Plac) trial was carried out.One hundred and four women with lymphedema were included; 94 completed the study (46 Dios, 48 Plac). A subset of 24 patients with more severe lymphedema (10 Dios, 14 Plac) was subjected to a separate analysis. Treatment consisting of Dies or Plac was given two tablets daily over a six-month period. A radionuclide lymphoscintigraphy using technetium-99m was performed at inclusion and at the end of the treatment. The upper limb volume was measured every two months.In the overall population the evolution of parameters was not different between Dies and Plac. In the 24 patients with a more severe lymphedema, the lymphoscintigraphic parameters (m +/- sd) were as follows: lymphatic migration speed was significantly improved by Dies in comparison with Plac (Delta Speed cm/minute: 0.84 +/- 0.6 vs 0.14 + 0.26, P = 0.005). The half-life of the colloidal compound was significantly improved over time in the Dies group (Delta half-life = 10.3 +/- 13.07 minute, P = 0.034) but not in the Plac group (Delta half-life = 0.53 +/- 15.51 minute, P = 0.086). The change over time of colloidal clearance was close to significance in the Dies group (Delta clearance mu L/minute: 2.18 +/- 3.10, P = 0.054) but not in the Plac group (0.11 +/- 2.26, P = 0.86). No significant difference was found for evolution of lymphedema volume, despite a tendency in favor of Dies. This can be related to wide distribution of volume values and small numbers of patients.dose of two tablets/day in patients affected with more severe lymphedema. The clear improvement of the lymphatic speed illustrates its known lymphokinetic activity. Further studies with a higher dosage could confirm the beneficial activity of this drug in secondary lymphedema.