Jain Ravi, Arias Gerardo Moreno, Naranjo Pablo, Murison Max, López Estebaranz Jose Luis, Fratila Alina, Prager Welf, Barona Carlos Guillén, Weidmann Michael, Dahan Serge, Cartier Hugues, Sattler Gerhard, Podda Maurizio
J Drugs Dermatol. 2018 Apr 1;17(4):413-418.
A variety of topical anesthetic creams are available to reduce pain associated with dermatological procedures. Pliaglis is a self-occluding eutectic mixture of lidocaine and tetracaine.
To evaluate the post-marketing safety profile of Pliaglis and efficacy in terms of pain reduction, product satisfaction, and daily practice use prior to pre-defined dermatological procedures.
A prospective, non-interventional study conducted at 44 sites in four European countries; 581 patients were treated prior to dermatological procedures such as pulsed-dye laser therapy, laser-assisted hair removal, non-ablative laser resurfacing, dermal filler injections, and vascular access. Efficacy was assessed by patients and investigators and included pain intensity (visual analogue scale [VAS]), satisfaction, and adequacy of pain relief. Safety was evaluated by adverse event (AE) reporting.
In 75% of the performed procedures, patients scored the pain experienced during the procedure as ≤30 mm on the VAS and most were very satisfied or satisfied with the pain reduction. The investigators assessed the product as providing adequate anesthesia in 97% of the performed procedures and were mostly very satisfied or satisfied with the convenience of use (79%) and tolerability (95%). Twenty-four AEs were reported in 18 (3%) patients.
Most patients experienced mild pain only as evident by the ≤ 30 mm VAS scores. Patients and investigators were aligned with regards to both product satisfaction and their opinion on adequacy of pain reduction. The AE frequency was low compared to previous studies, possibly relating to different ways of collecting AEs.
Pliaglis was well-tolerated and provided adequate pain reduction prior to dermatological procedures. www.clinicaltrials.gov (NCT01800474).
J Drugs Dermatol. 2018;17(4):413-418.
Partial study data have been presented at the Anti-Aging Medicine European Congress (AMEC), Paris; October, 24-25, 2014, and the European Academy of Dermatology and Venereology (EADV), Istanbul; October 2-6, 2013.
.有多种局部麻醉乳膏可用于减轻皮肤科手术相关的疼痛。Pliaglis是利多卡因和丁卡因的自封闭共熔混合物。
评估Pliaglis上市后的安全性概况，以及在预定的皮肤科手术前在减轻疼痛、产品满意度和日常使用方面的疗效。
在四个欧洲国家的44个地点进行了一项前瞻性、非干预性研究；581例患者在进行脉冲染料激光治疗、激光脱毛、非剥脱性激光换肤、真皮填充注射和血管通路等皮肤科手术前接受了治疗。疗效由患者和研究者评估，包括疼痛强度（视觉模拟量表[VAS]）、满意度和疼痛缓解的充分性。通过不良事件（AE）报告评估安全性。
在75%的手术中，患者将手术过程中经历的疼痛在VAS上评分为≤30mm，大多数患者对疼痛减轻非常满意或满意。研究者在97%的手术中评估该产品提供了充分的麻醉，并且大多对使用便利性（79%）和耐受性（95%）非常满意或满意。18例（3%）患者报告了24起不良事件。
如VAS评分≤30mm所示，大多数患者仅经历轻度疼痛。患者和研究者在产品满意度和对疼痛减轻充分性的看法上是一致的。与先前研究相比，不良事件发生率较低，这可能与收集不良事件的不同方式有关。
Pliaglis耐受性良好，在皮肤科手术前能提供充分的疼痛减轻。www.clinicaltrials.gov（NCT01800474）。
《药物皮肤病学杂志》。2018年；17(4):413 - 418。
部分研究数据已在巴黎举行的欧洲抗衰老医学大会（AMEC）上展示；2014年10月24 - 25日，以及在伊斯坦布尔举行的欧洲皮肤病与性病学会（EADV）上展示；2013年10月2 - 6日。
