论文部分内容阅读
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 observe the clinical safety and efficacy of Maxpol-T implanted autologous fibroblasts for penile thickening. METHODS: Scrotal dermis was obtained under local anesthesia in patients with short adult penis, who voluntarily participated in the clinical study under the informed consent. The sclera dermis was obtained under local anesthesia. The fibroblasts were isolated, cultured, identified, expanded and co-cultured with Maxpol-T scaffold Thick penis. The patients were followed up at 1, 3, and 6 months after operation respectively. The changes of penile circumference before and after surgery were compared by measuring scale and color sonography. The clinical safety was assessed by IIEF5 score table and side effect observation table. Statistical analysis was performed. Results Twenty-four patients participated in the clinical trial, completing 22 clinical trials (91.67%) and mean age (31.1 ± 8.4) years. Preoperative penile weakness average circumference (8.18 ± 0.83) cm, penile erection average circumference (10.26 ± 1.22) cm. The average circumferences of weakness of the penis were (11.79 ± 1.18) cm, (12.20 ± 1.24) cm and (12.19 ± 1.27) cm respectively at 1, 3 and 6 months after operation, which were significantly different from those before operation P <0.001). Penile circumference increased more than 2cm clinical effective rate was 95.45%. Six months after surgery, the results of satisfaction survey were very satisfied with 68.18%, very satisfied with 27.27% and satisfied with 4.55%, which was statistically significant compared with that before operation (P <0.001). Two patients underwent incision B / Ⅰ healing, other patients with a / Ⅰ heal. All patients had no change in erectile function assessed by IIEF5 before and after surgery. Conclusion Maxpol-T implanted autologous fibroblasts were safe and effective in the surgical implantation of penile deep fascia with penile thickening. The clinical effective rate was 95.45%. Postoperative delayed subcutaneous penile effusion rate of 8.70%, may be associated with individual patients with PLGA allergic reactions.