肉毒杆菌神经毒素治疗磷酸二酯酶抑制剂难治性勃起功能障碍的安全性和有效性：一项随机对照试验的结果。
Safety and efficacy of botulinum neurotoxin in the treatment of erectile dysfunction refractory to phosphodiesterase inhibitors: Results of a randomized controlled trial.
机构信息
Andrology Department, Cairo University - Facuty of medicine, Cairo, Egypt.
Armed Forces College of Medicine, Cairo, Egypt.
出版信息
Andrology. 2022 Feb;10(2):254-261. doi: 10.1111/andr.13104. Epub 2021 Oct 7.
BACKGROUND
There has been recent interest in the use of botulinum neurotoxin (BoNT) in the field of Andrology, whereby it has been investigated in the treatment of penile retraction and premature ejaculation.
OBJECTIVES
To evaluate the safety and efficacy of intracavernosal BoNT-A injection in the treatment of patients with erectile dysfunction (ED) refractory to oral phosphodiesterase inhibitors (PDE5Is).
PATIENTS AND METHODS
A double-blind randomized placebo-controlled prospective comparative study conducted at one center and involved 70 patients with ED refractory to PDE5Is. At baseline, the following data were collected: erection hardness score (EHS), peak systolic velocity (PSV), end diastolic velocity (EDV), sexual health inventory for men (SHIM), and the sexual encounter profile 2&3 (SEP-2&3) questionnaires. Treatment group (n = 35) received a single ICI of 100 units of BoNT-A in 2 ml of saline and control group (n = 35) received a single ICI of 2 ml of saline. EHS, PSV, and EDV were assessed at 2 weeks post treatment. SHIM, SEP-2, SEP-3, and global assessment questionnaire (GAQ-Q1&Q2) were completed at 2-, 6-, and 12-weeks post treatment.
RESULTS
Two weeks post treatment, the treatment group showed a statistically significant improvement in the mean EHS, PSV, EDV, and GAQ-Q1 positive responders (p < 0.001) compared to the control group. At 6- and 12-weeks post treatment, the treatment group showed a statistically significant improvement in the SHIM scores, SEP-2, and GAQ-Q1&Q2 positive responders compared to the control group. At 6 weeks, where there was a 5-point improvement in the mean SHIM score of the treatment group (10±5.9 from 5.4±1.7 at baseline) versus no improvement in the placebo group, 18 patients in the treatment group (53%) were able to have an erection hard enough for vaginal penetration versus only one patient in the control group.
CONCLUSION
BoNT-A is safe and effective as a potential treatment for ED refractory to PDE5I therapy.
背景
肉毒杆菌神经毒素（BoNT）在男科领域的应用近来受到关注，其在治疗阴茎回缩和早泄方面已得到研究。
目的
评估阴茎内注射 BoNT-A 治疗对口服磷酸二酯酶抑制剂（PDE5Is）治疗抵抗的勃起功能障碍（ED）患者的安全性和疗效。
患者和方法
在一个中心进行的一项双盲随机安慰剂对照前瞻性比较研究，纳入了 70 例对 PDE5Is 治疗抵抗的 ED 患者。在基线时，收集了以下数据：勃起硬度评分（EHS）、收缩期峰值速度（PSV）、舒张末期速度（EDV）、男性健康问卷（SHIM）和性经历问卷 2&3（SEP-2&3）。治疗组（n=35）接受 100 单位 BoNT-A 加 2ml 生理盐水单次阴茎内注射，对照组（n=35）接受 2ml 生理盐水单次阴茎内注射。治疗后 2 周评估 EHS、PSV 和 EDV。治疗后 2、6 和 12 周完成 SHIM、SEP-2、SEP-3 和全球评估问卷 1&2（GAQ-Q1&Q2）。
结果
治疗后 2 周，与对照组相比，治疗组的平均 EHS、PSV、EDV 和 GAQ-Q1 阳性应答者均有统计学显著改善（p<0.001）。治疗后 6 和 12 周，与对照组相比，治疗组的 SHIM 评分、SEP-2 和 GAQ-Q1&Q2 阳性应答者均有统计学显著改善。在治疗组中，平均 SHIM 评分提高了 5 分（从基线时的 5.4±1.7 提高到 10±5.9），而安慰剂组无改善，在治疗组中有 18 例（53%）患者能够进行阴道插入的勃起，而对照组只有 1 例。
结论
BoNT-A 是安全有效的，可作为 PDE5I 治疗抵抗的 ED 的潜在治疗方法。
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