国产可膨胀性阴茎假体的研制与临床应用

Development and Clinical Application of the Chinese-made Inflatable Penile Prosthesis

目的 :探讨国产可膨胀性阴茎假体的研制及治疗勃起功能障碍 (ED)的有效性与安全性。 方法 :根据我国男性生殖系统解剖生理特点 ,研制国产的可膨胀性阴茎假体 ,由改造的液泵阀、储液囊和一对可充液的圆柱体组成 ,用连接导管将其连接为一体。选择 4 5例器质性ED患者进行阴茎假体植入术。均采用阴茎阴囊切口进行手术 ,分别将圆柱体植入阴茎海绵体 ,液泵阀植入阴囊 ,储液囊植入耻骨后膀胱前间隙。 结果 :本组 4 5例未发生术中并发症 ;3例发生术后并发症 ,发生率为 6 .6 %,经术后处理未影响性交质量。 1 0～ 1 2个月后随访均可进行满意性交 ,性生活时间为 (2 0± 6 )min。 结论 :所研制的国产可膨胀性阴茎假体治疗严重器质性ED安全有效 ,机械故障发生率低。

Objective: To study the effect and safety of the Chinese-made inflatable penile prosthesis in the treatment of erectile dysfunction (ED). Methods: According to the anatomy and physiology of Chinese men, an inflatable penile prosthesis was developed in China, consisting of an innovated pump, a reservoir, and a pair of penile cylinders, which were connected by tubes to form a complete system. It was authorized to be used clinically by State Food and Drug Administration(SFDA). Forty-five cases of organic ED were selected for penile prosthesis implantation. Penoscrotal approach was used to implant the cylinders into the corpus cavernosum, the pump into the scrotum and the reservoir into the prevesical space. Results: Surgical problems and mechanical failures were not found in the subjects. Post-operative complications occurred in 3 cases( 6.6%), but did not affect the intercourse. Satisfactory intercourses were achieved 10～12 months later and the intercourse duration averaged about (20±6) min. Conclusion: The Chinese-developed inflatable penile prosthesis was safe and effective for patients with ED, with low rate of mechanical failures. Its long term effect has yet to be further studied.