应用PLGA生物支架种植自体成纤维细胞进行阴茎增粗的临床研究

Clinical study on penis girth enhancement by biodegradable scaffold PLGA (Maxpol-T) cografting with autologous fibroblast cells

目的观察PLGA支架(Maxpol-T)种植自体成纤维细胞移植进行阴茎增粗的临床安全性和有效性。方法筛选知情同意下自愿参加临床研究的成年阴茎短小患者,局麻下获取阴囊真皮组织,分离、培养、鉴定、扩增成纤维细胞与Maxpol-T支架共培养后植入阴茎深筋膜下增粗阴茎。分别在手术后1,3,6个月随访,利用量尺和彩色超声比较手术前后阴茎周径变化,利用IIEF5评分表和副作用观察表评估其临床安全性,进行统计学分析。结果参加临床实验患者24名,完成临床实验22名(91.67%),平均年龄(31.1±8.4)岁。手术前阴茎疲软状态平均周径(8.18±0.83)cm,阴茎勃起状态平均周径(10.26±1.22)cm。手术后1,3,6个月后阴茎疲软状态平均周径分别为(11.79±1.18)cm,(12.20±1.24)cm,(12.19±1.27)cm,与术前相比差异具有统计学意义(P<0.001)。阴茎周径增加2cm以上的临床有效率为95.45%。术后6个月患者满意度调查结果非常满意68.18%,很满意27.27%,满意4.55%,与术前相比差异具有统计学意义(P<0.001)。2名患者术后切口乙/Ⅰ期愈合,其他患者甲/Ⅰ期愈合。所有患者手术前后IIEF5评估勃起功能无变化。结论利用生物可降解细胞支架(Maxpol-T)种植体自体成纤维细胞后,手术植入阴茎深筋膜下行阴茎增粗临床安全有效,临床有效率95.45%。手术后迟发性阴茎皮下少量积液发生率8.70%,可能与个别患者对PLGA过敏反应有关。

Objective To evaluate the efficacy and safety of tissue engineering surgery with PLGA Biodegradable Scaffold （Maxpol-T） cografting with autologous fibroblast cells（AFBC） on penis girth enhancement. Methods A total of 22 male patients received tissue engineering surgery AFBC graft. Fibroblast cells isolated from the skin of scrotum were seeded to Maxpol-T for coculture, and then they were transplanted under the deep fascia of penis. The post-operation penis girth enhancement was continuously observed for 6 months. Results The penis girth of patients was enlarged compared with that of pre-operation patients （P〈0.01）.There were no significant changes in penis girth of patients at 1st month, 3rd month and 6th month after operation between （P〉0.05）. No obvious changes in penis erection function pre- and post-operation were found by IIEF5 evaluation. Conclusion Penis girth of patients can be enhanced by biodegradable scaffold PLGA （Maxpol-T） cografting with autologous fibroblast cells.