【摘要】 1999年,以聚L-乳酸制作的一种新型填充剂"newfill"在欧洲获得认证许可并投放市场。接着,聚L-乳酸（商品名:sculptra）在1999年也在欧洲获得治疗皮肤皱纹、疤痕、皮肤老化等症状的认证。它是一种可注射的聚乳酸制剂,亦来源于α-羟基酸家族中一种可生物降解和生物相溶的合成聚合物,在2004年8月其获得美国食品和药物管理局快速评审后批准用于治疗人类免疫缺陷病毒相关的面部脂肪萎缩。目前已通过美国食品和药物管理局（FDA）批准,用于治疗包括脂肪萎缩、面部消瘦、皮下脂肪萎缩所致的面颊、眼和颞部下陷等病症的注射材料。研究表明,Sculptra可显著增加皮肤厚度和面部脂肪萎缩部位的组织量,使脂肪萎缩部位恢复原状。并且有较好的安全性。现我国上海信晟医疗制品有限公司生产的"美速得"注射用聚L-乳酸微球,由上海医药工业研究院研制,和Sculpra具有相同的材料、结构和成分,主要用于面部皮下脂肪和皮肤胶原蛋白流失的矫正,消除面部皱纹。现已通过中国药品和生物制品鉴定所的注册检验,报国家药监局注册。现正在进行临床阶段试验。目的探讨"美速得"聚L-乳酸微球治疗面部皱纹的临床效果。研究方法自2008年至2009年,从因面部皱纹而到我科就诊的患者中挑选20人。并随机分为两组,每组10人。试验组接受聚L-乳酸微球注射填充治疗,对照组接受脂肪注射填充治疗。行血常规、尿常规、肝肾功能及心电图检查,签治疗同意书。术前建立照片档案。术后于1周、2周、4周、16周、24周回访。对比两组的治疗效果和有无并发症,以及对比术前的血、尿试验及心电图观察安全性。结果术后回访,（1）10例试验组中1例脱失,第1周时治愈率100%,第2周时P=0.081>0.05,差异无统计学意义,未显效。第4周至第24周P均小于0.05,差异有统计学意义,有一定疗效。对照组第1周、4周、16周、24周P均小于0.05,按α=0.05水准拒绝H₀,接受H₁,差异有统计学意义,有疗效。两组在第16、24周组间疗效互相对比P均大于0.05,按α=0.05水准不拒绝H₀,差异无统计学意义,两种方法治疗结果无差别。（2）对照组及试验组于术后均出现红肿。对照组出现3例术后皮下淤血,试验组出现2例术后皮下淤血。两组术后红肿及淤血均于7-10天内痊愈。（3）对照组及试验组治疗后的血、尿试验及心电图均无异常变化。结论 "美速得"注射用聚L-乳酸微球对面部皱纹的修复有一定的效果。其并发症少,不良反应少。更多还原

【Abstract】 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-hydroxyacid 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.（1） In 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 toα=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 toα= 0.05 level not reject H₀,the two methods of treatment haven’t significant difference.（2） The 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.（3） the 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-1-lactic acid microspheres for the treatment of the facial wrinkles have effect,the few complications and no adverse reactions.更多还原