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)
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
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.
J Zhang,Z Jing,D E Schliephake,et al.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)[J].PHLEBOLOGY.2012,27(4):184-190.doi:10.1258/phleb.2011.010094.
APA:
J Zhang,Z Jing,D E Schliephake,J Otto,G M Malouf&Y-Q Gu.(2012).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).PHLEBOLOGY,27,(4)
MLA:
J Zhang,et al."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)".PHLEBOLOGY 27..4(2012):184-190