Lupo Mary P, Swetman Glenda, Waller William
Tulane Dermatology Department, Tulane University, New Orleans, LA 70124, USA.
J Drugs Dermatol. 2010 Sep;9(9):1097-100.
To determine if there is any effect on tolerance, adverse events or clinical outcome when lidocaine is added to large gel particle hyaluronic acid (LGP-HA).
Single-centered, double-blinded, randomized, with-in patient trial, comparing patient comfort when receiving LGP-HA injections versus injections of LGP-HA mixed with lidocaine hydrochloride 2% (LGP-HA + L). Results were determined through patient questionnaires, standardized Canfield photography and blinded physician assessors. Participants were followed for six months.
Eighteen females were enrolled and completed the study. The average pain rating was significantly less when LGP-HA + L was administered as reported by participants and blinded investigators. Average rating of bruising and redness were less with LGP-HA + L, but not significant. After six months, 100 percent of participants and 100 percent of the primary and secondary blinded investigators reported no difference in clinical outcome or longevity between the different treatments. There was no difference in adverse events.
This is the first trial to report a six-month follow-up in a split-face study comparing LGP-HA + L to LGP-HA alone. All participant and investigator reports found symmetry of the NLFs at six months, thus demonstrating that the addition of lidocaine to LGP-HA does not affect longevity. Administration of LGP-HA + L is associated with less patient discomfort than administration of LGP-HA alone.
确定在大颗粒透明质酸(LGP-HA)中添加利多卡因是否会对耐受性、不良事件或临床结果产生任何影响。
单中心、双盲、随机、自身对照试验,比较接受LGP-HA注射与注射LGP-HA混合2%盐酸利多卡因(LGP-HA + L)时患者的舒适度。通过患者问卷、标准化的Canfield摄影和盲法医生评估者来确定结果。对参与者进行了六个月的随访。
18名女性被纳入并完成了研究。据参与者和盲法研究者报告,给予LGP-HA + L时平均疼痛评分显著更低。LGP-HA + L组的瘀伤和发红平均评分更低,但不显著。六个月后,100%的参与者以及100%的主要和次要盲法研究者报告不同治疗之间在临床结果或维持时间上没有差异。不良事件方面也没有差异。
这是第一项在半脸研究中对LGP-HA + L与单独的LGP-HA进行六个月随访报告的试验。所有参与者和研究者报告均发现六个月时鼻唇沟的对称性,因此表明在LGP-HA中添加利多卡因不会影响维持时间。给予LGP-HA + L比单独给予LGP-HA会使患者不适更少。