注射医用胶原显效持续时间的观察

Clinical effective durations after intracutaneous injection of a medical collagenous production

目的 探讨由牛真皮提取的高纯度医用注射性胶原充填剂肤美达的（长春博泰医药生物技术有限责任公司）临床显效持续时间.方法 选择30例60侧中、重度鼻唇沟皱纹受试者进行临床观察实验.其中中度鼻唇沟皱纹49侧,重度鼻唇沟皱纹11侧,受试者平均年龄（41.80±8.03）岁.受试者每侧鼻唇沟皮内注射医用胶原1 ml,于注射后即刻及第7、30、90、150、360天随访,照相并分析图像资料,统计有效率.结果 即刻到第150天的随访率为100%,第360天的随访率为93.3%;各随访时间点的总有效率分别为：100.0%、100.0%、96.7%、90.0%、83.3%及44.6%.2例受试者在注射后7 d和90 d随访时有嘴唇干裂伴疱疹,其他各随访时间点未见受试者胶原注射区皮肤有红肿、硬结、渗液、破溃等异常表现.结论 使用注射性胶原充填剂临床显效持续时间较长,充填皱纹效果满意.

Objective To study the clinical effective durations of a medical injected collagenous products, a high-purity medical injectable collagen filling agents extracted from bovine leather （Fumeida Produced by Changchun Botai Pharmaceutical Biotechnology Co, Ltd）. Methods 30 subjects （60 sides） with moderate to severe nasolabial fold wrinkles were selected to perform a clinical observation, in which 49 sides with moderate and 11 sides with severe labial fold wrinkles, and the average age of subjects were （41. 80 ± 8. 03） years. 1 ml of medical collagen was injected into the subjects wrinkle on each side by surgeons. The follow-up was made immediately, 7, 30, 90, 150 and 360 days after injection. The photograph was taken, and the image data and the validity were analyzed. Results The follow-up rate of immediate to 150 days after injection was 100 %, and 93. 3 % after 350 days. At the each follow-up points, the total effective rates were as follows： 100. 0 %, 100. 0 % , 96. 7 %, 90. 0 %, 83. 3 % and 44. 6 % .respectively. There were dry lips with herpes simplex in two cases of subjects at 7 d and 90 d after injection, no redness, induration, exudate, ulceration or other abnormal performance on collagen injection zone in the other subjects at each follow-up time point. Conclusion In this study, there is the longer clinical effective duration of injected collagen used in filling wrinkles with satisfactory results.