应用非动物源性稳定性透明质酸凝胶矫正鼻唇沟皱纹的研究
Study on stabilized hyaluronic acid-based gel of non-animal origin for the correction of nasolabial folds
摘要目的 评估非动物源性稳定性透明质酸凝胶(Restylane,瑞典Q-Med公司生产)注射治疗鼻唇沟皱纹的有效性和安全性.方法 鼻唇沟部皱纹严重程度分级在中度以上的患者接受非动物源性稳定性透明质酸凝胶的注射治疗(每侧<1.5 ml).随访时间6个月.分别由医生和患者本人根据皱纹严重程度分级标准进行评分.研究者记录不良事件.治疗前后进行常规实验室检查.结果 共86例患者接受鼻唇沟注射治疗(95%女性,平均年龄43岁).注射治疗6个月后,研究者和受试者分别评估,局部左右两侧鼻唇沟皱纹的评分均较注射前下降;面部整体美容效果的改善程度,均超过90%认为至少有某种程度的改善.在治疗6个月时,左右两侧鼻唇沟的应答率分别是81.4%和84.9%.治疗后6个月,32例(占受试者总数的37.2%)报告不良事件总数为52项,大多数被判断为注射部位反应.大多数不良反应为中度以下,并且可以自愈.没有全身反应.结论 非动物源性稳定性透明质酸凝胶纠正中国人的鼻唇沟皱纹疗效好,并且安全可靠.
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abstractsObjective To assess the safety and efficacy of hyaluronic acid-based gel of non-animal origin (NASHA~(TM) gel [Restylane~(R)]; Q-Med AB, Uppsala, Sweden)for correcting nasolabial folds in Chinese.Methods Patients with moderate or severe nasolabial fold(Wrinkle Severity Rating Scale, WSRS)were recruited to receive NASHA gel injection (< 1.5 ml). The patients were followed up for 6 months. The efficacy was assessed by physicians and patients, respectively. Adverse events(AEs)were recorded and laboratory tests were performed before and after operation. Results 86 patients were treated. 6 months after injection, improved esthetic results was assessed by patients and physicians independently. 52 AEs happened in 32 cases(37.2%).Most of them were local injection reaction and minor, which were recovered spontaneously. No systemic reaction was found. Conclusions NASHA gel can improve the nasolabial folds. It is very safe and tolerated.
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