Use Of Injectable "美速得" Poly-L-Lactic Acid Microspheres For The Treatment Of The Facial Wrinkles

Since 1999, the poly-L-lactic acid filler(PLA) has been marketed in Europe as Newfill. In the European Union, Sculptra received its CAE Mark in 1999. It is licensed to increase the volume of depressed areas, particularly to correct skin depressions such as skin creases, wrinkles, folds, and scars, and skin aging. It is a biocompatible, biodegradable, synthetic polymer from the alpha-hydroxy-acid family.In 2004, the U.S. Food and Drug Administration approved PLA under the name of Sculptra for the treatment of human immunodeficiency virus-related facial lipoatrophy.Now it as injection material approved for fat atrophy, facial wasting, subcutaneous fat atrophy due to cheek, eyes and temporal conditions by the U.S. Food and Drug Administration.The research shows that, Sculptra can significantly increase skin thickness and the face amount of fat tissue atrophy parts, It can makes fat atrophy restitution. And it has better security.Now the Shanghai XINSHENG Medical Products Co., Ltd. Production of"美速得"injected with poly L-lactic acid microspheres, was developed by the Shanghai Institute of Pharmaceutical Industry, it has the same material, structure and components with Sculptra, mainly for facial subcutaneous fat and skin collagen loss of correction, to eliminate facial wrinkles. It has been through the registration and inspection by China Drugs and Biological products identification Department Office. Now in clinical trial stage。[OBJECTIVE]:To explore the Clinical results of facial wrinkles that treatment by'(?)美速得"poly L-lactic acid microspheres.[METHODS]:From 2008 to 2009, We selected 20 paients in our centure who have Facial wrinkles. And they were randomly divided into two groups,each groups has 10 patients.Experimental group received poly-L-lactic acid microsphere treatment, the control group received fat treatment All patients with blood routine,urine routine,liver and kidney function,, ECG examination, and sign treatment consent. Preoperative establishment of photo docutment.Postoperation follow-up in 1 week,2 weeks,4 weeks,16 weeks and 24 weeks. Compared two groups of treatment Clinical results and complication, and the comparison of preoperative blood and urine tests and electrocardiogram.[RESULT] Postoperative follow-up.①In Experimental group, one case loss。The other patients cure rate was 100% in 1 week. In 2 weeks, P= 0.081> 0.05, the difference was not statistically significant. From 4 weeks to 24 weeks, P less than 0.05, the difference was statistically significant, there is a certain effect. Control group at 1 week,4 weeks,16 weeks,24 weeks, P<0.05, according to a= 0.05 level reject H0,, accept the H1, the difference was statistically significant. Between the two groups contrast in 16,24 weeks.p> 0.05, according to a= 0.05 level not reject H0,the two methods of treatment haven't significant difference.②The control group and experimental group were all redness. Control group had three cases of postoperative subcutaneous ecchymosis, experimental group 2 cases of subcutaneous ecchymosis. Postoperative swelling and ecchymosis were cured in 7 to 10 days.③the control group and experimental group after treatment haven't abnormal changes in blood and urine tests and ECG.[CONCLUSION] use of injectable "美速得" poly-l-lactic acid microspheres for the treatment of the facial wrinkles have effect,the few complications and no adverse reactions.