Khemis A, Duteil L, Tillet Y, Dereure O, Ortonne J-P
Service de Dermatologie Hôpital L'Archet 2, Nice Cedex 3, France.
J Eur Acad Dermatol Venereol. 2014 Sep;28(9):1158-64. doi: 10.1111/jdv.12228. Epub 2013 Sep 7.
Topical or systemic antiviral drugs reduce the duration of genital herpes recurrences but may not always alleviate functional symptoms.
To assess the efficacy and safety of oxygenated glycerol triesters-based CS21 barrier genital gel(®) vs. topical aciclovir and placebo (vehicle) in resolving functional symptoms and in healing of genital herpes recurrences.
A prospective randomized controlled, investigator-blinded trial of CS21 barrier genital gel(®) vs. topical aciclovir (reference treatment) and placebo (vehicle) was designed. The primary endpoint was the cumulative score of four herpes-related functional symptoms (pain, burning, itching and tingling sensations). Secondary endpoints included objective skin changes (erythema, papules, vesicles, oedema, erosion/ulceration, crusts), time to heal, local tolerance and overall acceptability of the treatment as reported by a self-administered questionnaire.
Overall, 61 patients were included. CS 21 barrier genital gel(®) was significantly more efficient than topical aciclovir and vehicle for subjective symptoms and pain relief in genital herpes recurrences; additionally, time to heal was significantly shorter with CS 21 than with vehicle, whereas no significantly difference was observed between patients receiving topical aciclovir and vehicle. The treatments under investigation were well tolerated and the adverse events were comparable in the three treatment groups.
Overall, these results support the interest of using of CS 21 barrier genital gel(®) in symptomatic genital herpes recurrences. Accordingly, this product offers a valuable alternative in topical management of recurrent genital herpes.
局部或全身使用抗病毒药物可缩短生殖器疱疹复发的持续时间，但可能无法始终缓解功能性症状。
评估基于含氧甘油三酯的CS21屏障生殖器凝胶（®）与局部使用阿昔洛韦和安慰剂（赋形剂）相比，在解决功能性症状以及治愈生殖器疱疹复发方面的疗效和安全性。
设计了一项前瞻性随机对照、研究者盲法试验，比较CS21屏障生殖器凝胶（®）与局部使用阿昔洛韦（对照治疗）和安慰剂（赋形剂）。主要终点是四种疱疹相关功能性症状（疼痛、烧灼感、瘙痒和刺痛感）的累积评分。次要终点包括客观皮肤变化（红斑、丘疹、水疱、水肿、糜烂/溃疡、结痂）、愈合时间、局部耐受性以及通过自我填写问卷报告的治疗总体可接受性。
总共纳入了61名患者。在生殖器疱疹复发的主观症状和疼痛缓解方面，CS 21屏障生殖器凝胶（®）比局部使用阿昔洛韦和赋形剂显著更有效；此外，CS 21组的愈合时间比赋形剂组显著更短，而接受局部使用阿昔洛韦和赋形剂的患者之间未观察到显著差异。所研究的治疗耐受性良好，三个治疗组的不良事件相当。
总体而言，这些结果支持在有症状的生殖器疱疹复发中使用CS 21屏障生殖器凝胶（®）。因此，该产品为复发性生殖器疱疹的局部治疗提供了一种有价值的替代方法。
