Palm Melanie D, Misell Lisa M
J Drugs Dermatol. 2018 Jul 1;17(7):729-734.
The efficacy of various pre-medication strategies for comfort management during microfocused ultrasound with visualization (MFU-V) treatment has not been studied. The present objective was to compare 2 topical analgesics (lidocaine 4% and benzocaine 20%) formulated with a novel transdermal delivery system with compounded lidocaine 23%/tetracaine 7% (23/7) to mitigate discomfort during MFU-V treatment.
This was a randomized, double-blinded, split-face study. One hour before MFU-V, subjects (N=14 females) received 50 mg IM meperidine/25 mg IM promethazine/5 mg oral diazepam. Fifteen minutes before treatment, 1 side of the face was treated with 1 application of 4% lidocaine, followed by 1 application of 20% benzocaine; the contralateral side was treated with 2 applications of 23/7 (to maintain blinding). Numbness was assessed by blinded evaluator (scale: 1=completely numb to 4=not numb) pre-treatment. Subject pain scores (scale: 0=no pain to 10=worst pain) were collected post-treatment. Adverse events and subjective clinician measures were also assessed.
Mean subject pain scores for 23/7 and lidocaine 4%/benzocaine 20% were 5.6 and 5.7, respectively. Mean numbness scores were similar for 23/7 (2.5) and lidocaine 4%/benzocaine 20% (3.0). Clinicians rated both products as "very easy" to apply. For lidocaine 4%/benzocaine 20%, 7.1% of subjects required no pauses during treatment, vs 14.3% for 23/7. However, more subjects required 4+ pauses with 23/7 (21.4% vs 7.1%). Lidocaine 4%/benzocaine 20% was preferred by 78.5% of subjects; 35.7% rated lidocaine/benzocaine 20% 4% as "Very Effective" vs 7.1% for 23/7. No adverse events were reported.
Lidocaine 4% and benzocaine 20% formulations utilizing a novel transdermal delivery system perform similarly to compounded lidocaine 23%/tetracaine 7% for discomfort mitigation during MFU-V treatment. More subjects preferred lidocaine 4%/ benzocaine 20% and rated it as "very effective" vs the compounded product. Fewer treatment pauses due to patient discomfort when using the lidocaine 4%/benzocaine 20% may translate to time efficiency. J Drugs Dermatol. 2018;17(7):729-734.
尚未研究过在可视化微聚焦超声（MFU-V）治疗期间用于舒适度管理的各种预处理策略的疗效。当前的目的是比较两种用新型透皮给药系统配制的局部镇痛药（4%利多卡因和20%苯佐卡因）与复方23%利多卡因/7%丁卡因（23/7），以减轻MFU-V治疗期间的不适感。
这是一项随机、双盲、半脸研究。在MFU-V治疗前1小时，受试者（14名女性）接受50mg哌替啶肌内注射/25mg异丙嗪肌内注射/5mg地西泮口服。治疗前15分钟，一侧面部先涂抹一次4%利多卡因，随后再涂抹一次20%苯佐卡因；对侧面部涂抹两次23/7（以保持盲法）。由盲法评估者在治疗前评估麻木程度（评分：1=完全麻木至4=不麻木）。治疗后收集受试者的疼痛评分（评分：0=无疼痛至10=最剧烈疼痛）。还评估了不良事件和临床医生的主观评价。
23/7组和4%利多卡因/20%苯佐卡因组受试者的平均疼痛评分分别为5.6和5.7。23/7组（2.5）和4%利多卡因/20%苯佐卡因组（3.0）的平均麻木评分相似。临床医生将两种产品的涂抹难度均评为“非常容易”。对于4%利多卡因/20%苯佐卡因组，7.1%的受试者在治疗期间无需暂停，而23/7组为14.3%。然而，更多受试者在使用23/7时需要4次以上暂停（21.4%对7.1%）。78.5%的受试者更喜欢4%利多卡因/20%苯佐卡因；35.7%的受试者将4%利多卡因/20%苯佐卡因评为“非常有效”，而23/7组为7.1%。未报告不良事件。
在MFU-V治疗期间减轻不适感方面, 使用新型透皮给药系统的4%利多卡因和20%苯佐卡因制剂与复方23%利多卡因/7%丁卡因的效果相似。与复方产品相比，更多受试者更喜欢4%利多卡因/20%苯佐卡因，并将其评为“非常有效”。使用4%利多卡因/20%苯佐卡因时因患者不适导致的治疗暂停较少，这可能意味着时间效率更高。《药物皮肤病学杂志》。2018年；17(7):729 - 734。
