Hermabessiere J, Costa P, Andro M C
Centre République, Clermonl-Ferrand.
Prog Urol. 1995 Dec;5(6):985-91.
To evaluate the efficacy of intracavernous moxisylyle versus placebo in patients with erectile dysfunction of various origins. To assess the local tolerance and systemic safety of moxisylyte by self-administered injection.
Multicentre study, comprising two treatment phases: The first, double-blind phase, was conducted in two parallel groups of randomized patients, over a 1-month period (1 injection per week) in the investigator's office; the second phase was conducted under open conditions in the patient's home, over a period of 3 to 11 months. Self-administered injections (1 to 2 per week) were performed using a prefilled syringe containing 10 mg of moxisylyte.
Out of 307 patients evaluated during the first phase, the qualitative and quantitative superiority of erectile response induced by moxisylyte compared to placebo was confirmed (p < 0.0001). The stability of the response to moxisylyte was also confirmed on 4 injections, and the frequency of responses compatible with sexual intercourse ranged from 48% to 52% from one injection to another. This efficacy was also maintained during the open phase, as 92% of the 4,487 self-administered injections generated positive erectile responses. The quality of these responses was considered sufficient to allow sexual intercourse after 62% of injections. The local tolerance was considered to be excellent for more than 95% of injections, without any major adverse effects, and a very low risk of prolonged erection and fibrotic reaction. The systemic safety was also considered to be excellent for more than 98% of erections.
This study confirms the possibility of obtaining an erectile response by intracavernous injection of 10 mg of moxisylyte with a very low incidence of local and systemic adverse effects. It also tends to confirm the superior efficacy of moxisylyte by self-administered injections at home than by injection in the doctor's office.
评估海绵体内注射莫西赛利与安慰剂对不同病因勃起功能障碍患者的疗效。通过自我注射评估莫西赛利的局部耐受性和全身安全性。
多中心研究，包括两个治疗阶段：第一阶段为双盲阶段，将随机患者分为两个平行组，在研究者办公室进行为期1个月（每周注射1次）的研究；第二阶段在开放条件下于患者家中进行，为期3至11个月。使用预填充注射器进行自我注射（每周1至2次），注射器中含有10mg莫西赛利。
在第一阶段评估的307例患者中，证实莫西赛利诱导的勃起反应在质量和数量上优于安慰剂（p<0.0001）。在4次注射时也证实了对莫西赛利反应的稳定性，每次注射后与性交相容的反应频率在48%至52%之间。在开放阶段这种疗效也得以维持，4487次自我注射中有92%产生了阳性勃起反应。62%的注射后这些反应的质量被认为足以进行性交。超过95%的注射局部耐受性良好，无任何重大不良反应，阴茎异常勃起和纤维化反应风险极低。超过98%的勃起全身安全性也被认为良好。
本研究证实了海绵体内注射10mg莫西赛利获得勃起反应的可能性，局部和全身不良反应发生率极低。同时也倾向于证实在家中自我注射莫西赛利比在医生办公室注射疗效更佳。
