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Efficacy and safety of Aethoxysklerol (R) (polidocanol) 0.5%, 1% and 3% in comparison with placebo solution for the treatment of varicose veins of the lower extremities in Chinese patients (ESA-China Study)

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机构: [1]Renji Hospital, Medical College, Shanghai JiaoTong University, No. 174, Shanghai, People’s Republic of China [2]Changhai Hospital, Second Military Medical University, No. 174, Shanghai, People’s Republic of China [3]Chemische Fabrik Kreussler & Co. GmbH, Rheingaustrasse 87–93, Wiesbaden 65203, Germany [4]Westmead Hospital, Woollahra, Sydney, NSW 2025, Australia [5]Beijing Xuan Wu Hospital, Capital Medical University, Beijing, People’s Republic of China
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关键词: C1/C2 varicose veins sclerotherapy polidocanol Chinese population

摘要:
Objectives: To assess efficacy and safety of polidocanol (POL) versus placebo in the treatment of C1 and C2 non-saphenous varicose veins in Chinese patients. Methods: Patients were randomly assigned to POL or placebo. POL 0.5%, 1% and 3% were administered depending on varicose vein type. Response after 12 weeks was defined as Grade 4 or 5 on a digital imaging-based five-point scale (C1 veins) or occlusion and/or absence of reflux >0.5 second (C2 veins). Safety was evaluated with a five-point scale and standard safety assessments. Results: Two hundred and eighty-five patients were treated. POL 0.5%, 1% and 3% were each superior to placebo (P < 0.001); response rates: 87.1% versus 13.6%, 86.4% versus 12.5% and 88.6% versus 4.3%, respectively. Significantly more POL than placebo patients were satisfied/very satisfied with treatment. POL was well tolerated, with mostly symptoms at the injection site reported. Conclusions: Sclerotherapy with POL 0.5%, 1% and 3% was efficacious and safe in Chinese patients.

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出版当年[2011]版:
大类 | 4 区 医学
小类 | 4 区 外周血管病
最新[2023]版:
大类 | 4 区 医学
小类 | 4 区 外周血管病
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出版当年[2010]版:
Q2 PERIPHERAL VASCULAR DISEASE
最新[2023]版:
Q3 PERIPHERAL VASCULAR DISEASE

影响因子: 最新[2023版] 最新五年平均 出版当年[2010版] 出版当年五年平均 出版前一年[2009版] 出版后一年[2011版]

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第一作者机构: [1]Renji Hospital, Medical College, Shanghai JiaoTong University, No. 174, Shanghai, People’s Republic of China
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通讯机构: [3]Chemische Fabrik Kreussler & Co. GmbH, Rheingaustrasse 87–93, Wiesbaden 65203, Germany
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