候选杀微生物剂SPL7013凝胶应用于阴茎时安全性的随机对照试验。
A randomized controlled trial of the safety of candidate microbicide SPL7013 gel when applied to the penis.
作者信息
Chen Marcus Y, Millwood Iona Y, Wand Handan, Poynten Mary, Law Matthew, Kaldor John M, Wesselingh Steve, Price Clare F, Clark Laura J, Paull Jeremy R A, Fairley Christopher K
机构信息
Melbourne Sexual Health Centre, The Alfred Hospital, and School of Population Health, University of Melbourne, Melbourne, Australia.
出版信息
J Acquir Immune Defic Syndr. 2009 Apr 1;50(4):375-80. doi: 10.1097/QAI.0b013e318198a7e6.
OBJECTIVES
To determine the safety of the candidate vaginal microbicide SPL7013 gel (VivaGel) when applied to the penis.
METHODS
A randomized, double-blind, placebo-controlled study. Thirty-six healthy men (18 circumcised, 18 uncircumcised) were randomized in a 2:1 ratio and treated with 3% SPL7013 gel (n = 24) or placebo gel (n = 12), applied once daily for 7 days. Genital toxicity was determined by interview, diary, and examination.
RESULTS
There were 10 genital adverse events (AEs) in 6 men (25%) receiving SPL7013 gel and 5 genital AEs in 4 men (33%) receiving the placebo that were possibly or probably related to the study product (difference of -8%, 95% confidence interval: -40% to 23%, P = 0.70). The most common genital AEs were genital pruritus and application site erythema. All genital AEs were mild (grade 1), and all but 1 in the placebo group were transient. Analysis of vital signs, nongenital AEs, and laboratory results indicated no safety or tolerability issues with SPL7013 gel, irrespective of circumcision status. There was no detectable absorption of SPL7013 into the plasma.
CONCLUSIONS
Three percent SPL7013 gel was safe and well tolerated, and comparable with placebo, when administered to the penis of both circumcised and uncircumcised men once daily for 7 days, with no evidence of systemic absorption or toxicity.
目的
确定候选阴道杀微生物剂SPL7013凝胶（VivaGel）应用于阴茎时的安全性。
方法
一项随机、双盲、安慰剂对照研究。36名健康男性（18名包皮环切者，18名未包皮环切者）按2:1比例随机分组，分别接受3% SPL7013凝胶（n = 24）或安慰剂凝胶（n = 12）治疗，每日应用1次，共7天。通过访谈、日记和检查确定生殖器毒性。
结果
接受SPL7013凝胶治疗的6名男性（25%）出现10例生殖器不良事件（AE），接受安慰剂治疗的4名男性（33%）出现5例生殖器AE，这些事件可能或很可能与研究产品有关（差异为-8%，95%置信区间：-40%至23%，P = 0.70）。最常见的生殖器AE是生殖器瘙痒和用药部位红斑。所有生殖器AE均为轻度（1级），安慰剂组除1例之外均为短暂性。生命体征、非生殖器AE和实验室检查结果分析表明，无论包皮环切状态如何，SPL7013凝胶均无安全性或耐受性问题。血浆中未检测到SPL7013的吸收。
结论
对于包皮环切和未包皮环切男性，每日1次、连续7天在阴茎上涂抹3% SPL7013凝胶是安全且耐受性良好的，与安慰剂相当，没有全身吸收或毒性的证据。
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