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在肯尼亚内罗毕进行的一项单剂量环丙沙星与红霉素治疗软下疳的随机、双盲、安慰剂对照试验。

A randomized, double-blind, placebo-controlled trial of single-dose ciprofloxacin versus erythromycin for the treatment of chancroid in Nairobi, Kenya.

作者信息

Malonza I M, Tyndall M W, Ndinya-Achola J O, Maclean I, Omar S, MacDonald K S, Perriens J, Orle K, Plummer F A, Ronald A R, Moses S

机构信息

Department of Medical Microbiology, University of Nairobi, Nairobi City Commission, Nairobi, Kenya.

出版信息

J Infect Dis. 1999 Dec;180(6):1886-93. doi: 10.1086/315133.

Abstract

A randomized, double-blind, placebo-controlled clinical trial was conducted in Nairobi, Kenya, to compare single-dose ciprofloxacin with a 7-day course of erythromycin for the treatment of chancroid. In all, 208 men and 37 women presenting with genital ulcers clinically compatible with chancroid were enrolled. Ulcer etiology was determined using culture techniques for chancroid, serology for syphilis, and a multiplex polymerase chain reaction for chancroid, syphilis, and herpes simplex virus (HSV). Ulcer etiology was 31% unmixed chancroid, 23% unmixed syphilis, 16% unmixed HSV, 15% mixed etiology, and 15% unknown. For 111 participants with chancroid, cure rates were 92% with ciprofloxacin and 91% with erythromycin. For all study participants, the treatment failure rate was 15%, mostly related to ulcer etiologies of HSV infection or syphilis, and treatment failure was 3 times more frequent in human immunodeficiency virus-infected subjects than in others, mostly owing to HSV infection. Ciprofloxacin is an effective single-dose treatment for chancroid, but current recommendations for empiric therapy of genital ulcers may result in high treatment failure due to HSV infection.

摘要

在肯尼亚内罗毕进行了一项随机、双盲、安慰剂对照临床试验,以比较单剂量环丙沙星与7天疗程的红霉素治疗软下疳的效果。共有208名男性和37名女性因临床诊断为软下疳的生殖器溃疡而被纳入研究。采用软下疳培养技术、梅毒血清学检测以及软下疳、梅毒和单纯疱疹病毒(HSV)的多重聚合酶链反应来确定溃疡病因。溃疡病因中,单纯软下疳占31%,单纯梅毒占23%,单纯HSV占16%,混合病因占15%,病因不明占15%。对于111名软下疳患者,环丙沙星的治愈率为92%,红霉素的治愈率为91%。对于所有研究参与者,治疗失败率为15%,主要与HSV感染或梅毒的溃疡病因有关,且人类免疫缺陷病毒感染患者的治疗失败率是其他患者的3倍,主要原因是HSV感染。环丙沙星是治疗软下疳的一种有效的单剂量疗法,但目前生殖器溃疡经验性治疗的建议可能会因HSV感染导致高治疗失败率。

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