Giuliano Francois, Joussain Charles, Denys Pierre
Neuro-Uro-Andrology R.Poincare academic hospital, Garches, France; Faculty of Medicine, U1179 Inserm / Versailles Saint Quentin University, Montigny le Bretonneux, Paris Saclay, France.
Neuro-Uro-Andrology R.Poincare academic hospital, Garches, France; Faculty of Medicine, U1179 Inserm / Versailles Saint Quentin University, Montigny le Bretonneux, Paris Saclay, France.
J Sex Med. 2022 Jan;19(1):83-89. doi: 10.1016/j.jsxm.2021.10.011. Epub 2021 Dec 20.
Some evidence suggests that intracavernosal botulinum toxin A (BTX-A IC) injections administered in addition to phosphodiesterase type 5 inhibitors (PDE5-Is) or prostaglandin E1 intracavernosal injections (PGE1 ICI) could effectively treat erectile dysfunction (ED) in non-responders, or insufficient responders to these pharmacologic treatments.
To determine the long-term effectiveness and safety of combined treatment involving a single injection of BTX-A IC as an add on therapy to PDE5-Is or PGE1-ICI for the treatment of ED of different etiologies.
A retrospective, uncontrolled, single center study was conducted. Data from 123 consecutive patients with ED who were insufficient responders to PDE5-Is or PGE1-ICI and who received onabotulinumtoxinA 100 U, abobotulinumtoxinA 250 U or 500 U IC as an add on to their current pharmacologic treatment were analyzed. All analyses were exploratory. Qualitative data were compared using the Fisher's exact test. Univariate and multivariate analysis were performed using logistic regression with Odds Ratios (OR). Only variables with P < .05 in the univariate analysis were selected for multivariate analysis.
The minimally clinically important difference (relative to baseline severity of ED) in the International Index of Erectile Function-Erectile function domain (IIEF-EF) score was achieved in 50% of patients at 34 (27-42) days and in 41% at 5.9 (3.9 - 8.1) months following BTX-A IC in combination with PDE5-Is or PGE1 ICI. The severity of ED influenced response to BTX-A IC according to the multivariate analysis (OR = 0.3, IC(95%]) = (0.16 - 0.56). Neither being post prostatectomy nor the type of BTX-A affected the response. Effectiveness tended to decrease more over time with abobotulinumtoxinA 250 U than 500 U. The only side-effects were mild penile pain on injection (n = 1) and mild penile pain for 3 days following injection (n = 1); no systemic effects were reported.
BTX-A IC (all types) administered as an add on to registered pharmacologic treatments improved erectile function for at least 6 months in 41% of patients with ED of varying etiologies, and was safe.
STRENGTHS & LIMITATIONS: A relatively large cohort of patients with ED was included, with a long follow-up period, however the study was retrospective, and uncontrolled.
This study provides preliminary evidence that BTX-A IC administered as an add-on therapy for ED that is insufficiently responsive to standard therapy is effective for at least 6 months, and is safe. Randomized clinical trials are now needed to fully confirm these results. Giuliano F, Joussain C, Denys P, Long Term Effectiveness and Safety of Intracavernosal Botulinum Toxin A as an Add-on Therapy to Phosphosdiesterase Type 5 Inhibitors or Prostaglandin E1 Injections for Erectile Dysfunction. J Sex Med 2022;19:83-89.
一些证据表明，除5型磷酸二酯酶抑制剂（PDE5-Is）或前列腺素E1海绵体内注射（PGE1 ICI）外，联合海绵体内注射A型肉毒毒素（BTX-A IC）可有效治疗对这些药物治疗无反应或反应不足的勃起功能障碍（ED）患者。
确定单次注射BTX-A IC作为PDE5-Is或PGE1-ICI的附加疗法联合治疗不同病因ED的长期有效性和安全性。
进行了一项回顾性、非对照、单中心研究。分析了123例连续的ED患者的数据，这些患者对PDE5-Is或PGE1-ICI反应不足，并接受了100 U的A型肉毒杆菌毒素、250 U或500 U的阿柏型肉毒杆菌毒素IC作为当前药物治疗的附加治疗。所有分析均为探索性。使用Fisher精确检验比较定性数据。使用比值比（OR）的逻辑回归进行单变量和多变量分析。单变量分析中P < 0.05的变量才被选入多变量分析。
在BTX-A IC联合PDE5-Is或PGE1 ICI治疗后，50%的患者在34（27 - 42）天达到勃起功能国际指数-勃起功能领域（IIEF-EF）评分的最小临床重要差异（相对于ED的基线严重程度），41%的患者在5.9（3.9 - 8.1）个月达到。多变量分析显示，ED的严重程度影响对BTX-A IC的反应（OR = 0.3，95%置信区间[CI] = [0.16 - 0.56]）。前列腺切除术后状态和BTX-A的类型均不影响反应。与500 U阿柏型肉毒杆菌毒素相比，250 U阿柏型肉毒杆菌毒素随时间推移有效性下降趋势更明显。仅出现1例注射时轻度阴茎疼痛和1例注射后3天轻度阴茎疼痛的副作用；未报告全身影响。
作为已注册药物治疗的附加治疗，所有类型的BTX-A IC可使41%不同病因的ED患者勃起功能改善至少6个月，且安全。
纳入了相对较大队列的ED患者，随访期长，但该研究为回顾性且非对照研究。
本研究提供了初步证据，即作为对标准治疗反应不足的ED的附加疗法，BTX-A IC至少6个月有效且安全。现需要随机临床试验来充分证实这些结果。朱利亚诺F、朱桑C、德尼斯P，海绵体内注射A型肉毒毒素作为5型磷酸二酯酶抑制剂或前列腺素E1注射治疗勃起功能障碍的附加疗法的长期有效性和安全性。《性医学杂志》2022；19：83 - 89。
