Clucas A, Verschoore M, Sorba V, Poncet M, Baker M, Czernielewski J
CIRD Galderma, Sophia Antipolis, France.
J Am Acad Dermatol. 1997 Jun;36(6 Pt 2):S116-8. doi: 10.1016/s0190-9622(97)70054-9.
Adapalene is a new naphthoic acid derivative developed for the topical treatment of acne vulgaris.
We describe the results of a combined safety analysis of two multicenter trials conducted in the U.S. and Europe in which adapalene 0.1% gel was compared with tretinoin 0.025% gel in the treatment of mild to moderate acne vulgaris.
A total of 591 acne patients were enrolled in these investigator-masked, randomized, controlled, parallel group studies. In the two studies, each patient was randomly assigned to receive topical adapalene 0.1% gel or tretinoin 0.025% gel once daily at bedtime, for 12 weeks. In addition to assessments of efficacy and facial skin tolerance, data on adverse events were recorded at each visit or at any other time the patient reported problems. We extracted data concerning adverse reactions (i.e., adverse events judged to be related to the study treatment) from both studies and combined the results to obtain a global comparison of safety of the two products.
A total of 15 of 296 patients (5.1%) reported 19 adverse reactions in the adapalene-treated groups, compared with 27 of 295 patients (9.1%) reporting 39 adverse reactions in the tretinoin-treated groups (p < 0.05). The number of patients discontinuing the study because of adverse events was approximately twice as low with adapalene (1.3% compared with 2.4%). Most adverse reactions for both products were related to skin irritation. No systemic adverse reactions were reported.
The results of these two multicenter clinical studies indicate that adapalene gel is better tolerated than tretinoin gel.
阿达帕林是一种新开发的萘甲酸衍生物，用于寻常痤疮的局部治疗。
我们描述了在美国和欧洲进行的两项多中心试验的联合安全性分析结果，该试验比较了0.1%阿达帕林凝胶与0.025%维甲酸凝胶治疗轻度至中度寻常痤疮的效果。
共有591名痤疮患者参加了这些研究者设盲、随机、对照、平行组研究。在这两项研究中，每位患者被随机分配，每晚睡前每日一次外用0.1%阿达帕林凝胶或0.025%维甲酸凝胶，为期12周。除了评估疗效和面部皮肤耐受性外，每次就诊或患者报告问题的任何其他时间都记录不良事件的数据。我们从两项研究中提取了有关不良反应（即判断为与研究治疗相关的不良事件）的数据，并合并结果以获得两种产品安全性的总体比较。
在阿达帕林治疗组中，296名患者中有15名（5.1%）报告了19例不良反应，而在维甲酸治疗组中，295名患者中有27名（9.1%）报告了39例不良反应（p<0.05）。因不良事件而停止研究的患者数量，使用阿达帕林的约为使用维甲酸的一半（分别为1.3%和2.4%）。两种产品的大多数不良反应都与皮肤刺激有关。未报告全身性不良反应。
这两项多中心临床研究的结果表明，阿达帕林凝胶的耐受性优于维甲酸凝胶。
