CAJ | 학술논문

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.
목적 관찰PLGA지가(Maxpol-T)충식자체성섬유세포이식진행음경증조적림상안전성화유효성.방법 사선지정동의하자원삼가림상연구적성년음경단소환자,국마하획취음낭진피조직,분리、배양、감정、확증성섬유세포여Maxpol-T지가공배양후식입음경심근막하증조음경.분별재수술후1,3,6개월수방,이용량척화채색초성비교수술전후음경주경변화,이용IIEF5평분표화부작용관찰표평고기림상안전성,진행통계학분석.결과 삼가림상실험환자24명,완성림상실험22명(91.67%),평균년령(31.1±8.4)세.수술전음경피연상태평균주경(8.18±0.83)cm, 음경발기상태평균주경(10.26±1.22)cm.수술후1,3,6개월후음경피연상태평균주경분별위(11.79±1.18)cm,(12.20±1.24)cm,(12.19±1.27)cm,여술전상비차이구유통계학의의(P<0.001).음경주경증가2cm이상적림상유효솔위95.45%.술후6개월환자만의도조사결과비상만의68.18%,흔만의27.27%,만의4.55%,여술전상비차이구유통계학의의(P<0.001).2명환자술후절구을,I기유합,기타환자갑,I기유합.소유환자수술전후IIEF5평고발기공능무변화.결론 이용생물가강해세포지가(Maxpol-T)충식체자체성섬유세포후,수술식입음경심근막하행음경증조림상안전유효,림상유효솔95.45%.수술후지발성음경피하소량적액발생솔8.70%,가능여개별환자대PLGA과민반응유관.
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>O.05).No obvious changes in penis erection function pre-and post-operation were found byⅡEF5 evaluation.Conclusion Penis girth of patients Can be enhanced by biodegradable scaffold PLGA(Maxpol-T)cografting with autologous fibroblast cells.