长期重复应用A型肉毒毒素面部除皱的疗效和安全性评价

Efficacy and safety of long-term repeated treatment of facial wrinkles with botulinum toxin A

目的 评价长期重复多次应用A型肉毒毒素（botulinum toxin A,BTXA）进行面部除皱的疗效和安全性.方法 对52例多次使用国产A型肉毒毒素注射面部除皱者进行了回顾性分析总结.每次注射除皱部位均包括额纹、鱼尾纹、眉间纹、鼻背横纹.于注射前和注射后1周、1个月、3个月及再次注射时,分别进行疗效和安全性评价.结果 每例均注射除皱共8次,每次注射后开始起效时间都在3～4 d,1个月左右是最佳表现时间.疗效评价1级为很好的比例依次是额纹100%、鱼尾纹97.1%、眉间纹99.8%、鼻背横纹99.0%,评价2级为好的比例依次是额纹0、鱼尾纹2.9%、眉间纹0.2%、鼻背横纹1.0%,评价为一般、较差、差这3个等级者为0.随着注射次数增多,疗效等级不断提高.平均疗效维持时间有所延长（r=0.256,P=0.02）,为（7.8±1.1）个月,呈正态分布.随着注射次数增加后,不良反应轻微,仅部分受注射者个别注射部位出现瘀斑、额部紧绷感、一定程度的表情僵化和鱼尾纹注射后下眼睑邻近部位皱纹加重.不良反应发生率随注射次数下降（r=0.850,P=0.01）.所有被注射者均未出现严重不良反应.结论 长期多次应用A型肉毒毒素除皱安全可靠,且疗效不受影响,因此可以多次使用.

Objective To evaluate the clinical efficacy and safety of long-term repeated treatment of facial wrinkles with application of botulinum toxin A （BTXA）. Methods A total of 52 patients had received 8 injections in seven years with BTXA against facial wrinkles, including forehead wrinkles, fishtail lines, glabellas wrinkles, and nasal dorsum transverse wrinkles. Besides day 1 （baseline） and day for the next injection （end-point）, follow-up visits were scheduled on 1 week, 1 month, and 3 months after every injection. The therapy effect and safety were evaluated. Results For all the patients, it began to take effect on day 3 or 4 after the treatment and best effect appeared on 1 month post-treatment. Patients＇ selfevaluation as grade 1 for the improvement of forehead wrinkles, fishtail lines, glabellas wrinkles and nasal dorsum transverse wrinkles, accounted for 100%, 97.1%, 99.8% and 99%, respectively. Correspondingly, cases as grade 2 accounted for 0, 2.9%, 0.2% and 1.0%. Grades 3 to 5 had not been reported. With the repetition of treatment, the efficiency increased. The average of effective duration was （7.8±1.1） months, which lasted longer with the injection times increased （r= 0.256, P= 0.02）. Adverse reactions observed in the previous several injections, including ecchymosis, feeling of tightness, rigid expression and severer wrinkles near the injected site, which were mild and the incidence rate decreased after the following injections （r= 0.850, P= 0.01）. Severe adverse effects, such as allergic reaction,headache, blepharoptosis and dysraphism of eyes had not happened in all the 52 patients. Conclusion Long-term repeated application of BTXA against facial wrinkles is safe and the efficacy is confirmed. The approach can be applied repeatedly to those who have indications and good tolerance.