Seth Avinash Kumar, Misra Ambikanandan, Umrigar Dipak, Vora Nipul
Pharmacy Department, Faculty of Engineering & Technology, M.S. University, Vadodara, India.
Med Sci Monit. 2003 Jul;9(7):PI93-8.
Acyclovir (ACY) is effective in the treatment of herpes simplex (HSV-1) & (HSV-2) but has systemic toxic effects if given orally or intravenously. ACY has not been used to treat the disease topically due to poor drug penetration into skin. A novel 1% liposomal ACY topical gel in a 5% Hydroxypropylmethyl cellulose (HPMC) K4M gel base has been developed and clinically evaluated in HSV-1 and HSV-2 patients.
MATERIAL/METHODS: 26 patients suffering from recurrent mild facial (HSV-1) and genital (HSV-2) infections (HSV-1: 4F, 6M, age 21-34 years; HSV-2: 16M, age 24-40 years) were subjected to double blind clinical evaluation. Plain ACY gel (PAG) and Liposomal ACY gel (LAG) were clinically evaluated by application five times daily on herpetic lesions for up to eight weeks.
A significant increase in the average percent improvement of lesion healing was observed in HSV-1 and HSV-2 patients after 2-3 weeks treatment with LAG, as well as a significant decrease in side effects associate with ACY, such as itching and burning in both HSV-1 and HSV-2, and burning micturation in HSV-2.
The results demonstrate that a five-fold reduction in the ACY content in liposomal gel is sufficient for the complete healing of herpetic lesions in HSV-1 and HSV-2 infection. The increased duration of topical therapy may be acceptable for patients suffering from mild herpetic lesions because of the advantage of avoiding systemic and local side effects
阿昔洛韦(ACY)对单纯疱疹病毒1型(HSV - 1)和2型(HSV - 2)感染有效,但口服或静脉给药会产生全身毒性作用。由于药物对皮肤的渗透性差,ACY尚未用于局部治疗该疾病。一种新型的1%脂质体阿昔洛韦局部凝胶,以5%羟丙基甲基纤维素(HPMC)K4M凝胶为基质,已研发成功并在HSV - 1和HSV - 2感染患者中进行了临床评估。
材料/方法:26例复发性轻度面部(HSV - 1)和生殖器(HSV - 2)感染患者(HSV - 1:4名女性,6名男性,年龄21 - 34岁;HSV - 2:16名男性,年龄24 - 40岁)接受了双盲临床评估。普通阿昔洛韦凝胶(PAG)和脂质体阿昔洛韦凝胶(LAG)通过每日在疱疹性损害处涂抹5次,持续长达8周进行临床评估。
用LAG治疗2 - 3周后,HSV - 1和HSV - 2患者的皮损愈合平均改善百分比显著增加,同时与ACY相关的副作用也显著减少,如HSV - 1和HSV - 2患者的瘙痒和烧灼感,以及HSV - 2患者的尿痛。
结果表明,脂质体凝胶中ACY含量降低五倍就足以使HSV - 1和HSV - 2感染的疱疹性损害完全愈合。对于患有轻度疱疹性损害的患者,延长局部治疗时间可能是可以接受的,因为这样具有避免全身和局部副作用的优点