Horwitz E, Pisanty S, Czerninski R, Helser M, Eliav E, Touitou E
Department of Pharmaceutics, School of Pharmacy, Faculty of Medicine, The Hebrew University of Jerusalem, Israel.
Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1999 Jun;87(6):700-5. doi: 10.1016/s1079-2104(99)70164-2.
In a 2-armed, double-blind, randomized clinical study, the efficacy in the treatment of recurrent herpes labialis of 5% acyclovir in a novel liposomal carrier (ethosome) was evaluated in comparison with that of a commercial 5% acyclovir cream (Zovirax cream) and that of a drug-free vehicle. Data were based on 61 herpetic episodes in 40 subjects. In a crossover arm in which the 2 active preparations were compared, the time to crusting of lesions was significantly shorter (P < .025) with the ethosomal acyclovir (1.8 days) than with the cream (3.5 days). Time to loss of crust was also significantly shorter (4.2 vs 5.9 days; P < .05). In a parallel arm in which all 3 preparations were compared, the time to crusting with the ethosomal acyclovir (1.6 days) was significantly shorter than the time with the acyclovir cream (4.3 days; P < .02) and the time with the drug-free vehicle (4.8 days; P < .005); in this arm, the shorter time to loss of crust for the ethosome (3.5 days), in comparison with the times for the cream (6.4 days) and the drug-free vehicle (6.1 days), did not reach statistical significance. Approximately 30% of all episodes treated with the ethosome were clinically abortive; this compared with 10% of those treated with the cream or the drug-free vehicle. No adverse effects were reported, other than minor burning sensations at the application site that lasted a few seconds after application and were evenly distributed between the investigated preparations. This pilot study suggests the improved clinical efficacy of the new liposomal preparation in comparison with Zovirax cream in the treatment of recurrent herpes labialis.
在一项双臂、双盲、随机临床研究中，评估了一种新型脂质体载体（醇质体）中5%阿昔洛韦治疗复发性唇疱疹的疗效，并与市售5%阿昔洛韦乳膏（阿昔洛韦乳膏）和无药赋形剂进行比较。数据基于40名受试者的61次疱疹发作。在比较两种活性制剂的交叉组中，醇质体阿昔洛韦组（1.8天）皮损结痂时间显著短于乳膏组（3.5天）（P < 0.025）。痂皮脱落时间也显著缩短（4.2天对5.9天；P < 0.05）。在比较所有三种制剂的平行组中，醇质体阿昔洛韦组的结痂时间（1.6天）显著短于阿昔洛韦乳膏组（4.3天；P < 0.02）和无药赋形剂组（4.8天；P < 0.005）；在该组中，醇质体组痂皮脱落时间较短（3.5天），与乳膏组（6.4天）和无药赋形剂组（6.1天）相比，未达到统计学显著性。用醇质体治疗的所有发作中约30%在临床上呈顿挫型；相比之下，用乳膏或无药赋形剂治疗的为10%。除了用药部位有持续几秒钟的轻微烧灼感且在各研究制剂之间均匀分布外，未报告有不良反应。这项初步研究表明，与阿昔洛韦乳膏相比，这种新型脂质体制剂在治疗复发性唇疱疹方面具有更高的临床疗效。
