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外用2%酮色林软膏治疗静脉性溃疡的双盲安慰剂对照研究。

Double-blind placebo-controlled study with topical 2% ketanserin ointment in the treatment of venous ulcers.

作者信息

Roelens P

出版信息

Dermatologica. 1989;178(2):98-102. doi: 10.1159/000248400.

DOI:10.1159/000248400
PMID:2647535
Abstract

Previous animal and human data have shown that ketanserin, the first specific serotonin2 antagonist, may have beneficial effects on peripheral vascular diseases and on the healing of ulcers. In this double-blind study a 2% ketanserin ointment in a polyethylene glycol base was used to treat 23 patients with venous ulcers (13 ketanserin, 10 placebo). Classical wound care measures were maintained in both groups; therefore, conventional ulcer therapy (with placebo in a polyethylene glycol base) was in reality compared with conventional ulcer treatment plus ketanserin. The most important parameter for evaluation in this study was the development of granulation tissue (first sign of successful wound healing). The evolution of granulation was significantly better with ketanserin than with placebo (p less than 0.05, Mann-Whitney U test). According to the investigator's evaluation, ketanserin showed a response in 10 out of 11 patients as opposed to 5 out of 10 placebo patients at the end of the study. This first double-blind placebo-controlled study suggests that topically applied ketanserin promotes the healing of venous ulcers.

摘要

先前的动物和人体数据表明,首个特异性5-羟色胺2拮抗剂酮色林可能对外周血管疾病和溃疡愈合具有有益作用。在这项双盲研究中,一种以聚乙二醇为基质的2%酮色林软膏被用于治疗23例静脉性溃疡患者(13例使用酮色林,10例使用安慰剂)。两组均维持经典的伤口护理措施;因此,实际上是将传统溃疡治疗(使用聚乙二醇基质的安慰剂)与传统溃疡治疗加酮色林进行比较。本研究中最重要的评估参数是肉芽组织的形成(伤口成功愈合的首要迹象)。使用酮色林时肉芽组织的进展明显优于使用安慰剂时(p<0.05,曼-惠特尼U检验)。根据研究者的评估,在研究结束时,11例使用酮色林的患者中有10例有反应,而10例使用安慰剂的患者中只有5例有反应。这项首个双盲安慰剂对照研究表明,局部应用酮色林可促进静脉性溃疡的愈合。

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引用本文的文献

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Effects of ketanserin on hypergranulation tissue formation, infection, and healing of equine lower limb wounds.酮色林对马下肢伤口过度肉芽组织形成、感染及愈合的影响。
Can Vet J. 2004 Feb;45(2):144-9.
2
Chronic Venous Insufficiency.慢性静脉功能不全
Curr Treat Options Cardiovasc Med. 2003 Apr;5(2):109-119. doi: 10.1007/s11936-003-0019-7.
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Ketanserin. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential in hypertension and peripheral vascular disease.酮色林。对其药效学和药代动力学特性以及在高血压和外周血管疾病中的治疗潜力的综述。
Drugs. 1990 Dec;40(6):903-49. doi: 10.2165/00003495-199040060-00010.