Brisinda Giuseppe, Cadeddu Federica, Vanella Serafino, Mazzeo Pasquale, Marniga Gaia, Maria Giorgio
Department of Surgery, Catholic University Hospital "Agostino Gemelli," Rome, Italy.
Urology. 2009 Jan;73(1):90-4. doi: 10.1016/j.urology.2008.08.475. Epub 2008 Nov 8.
To present a comprehensive experience with intraprostatic botulinum toxin (BT) injection in men with symptomatic benign prostatic hyperplasia (BPH).
In this open-label study using an outpatient setting, 77 men with BPH received 200 intraprostatic BT A units (Botox) using an ultrasound-guided transperineal approach. We evaluated the American Urological Association (AUA) score, serum prostate-specific antigen (PSA), prostatic volume, residual volume, and peak urinary flow rates. The primary endpoint was symptomatic improvement after treatment, as measured by means of AUA score and peak urinary flow rates. The secondary endpoint was the evaluation of prostatic volume, serum PSA, and residual urinary volume.
No significant local effects occurred. At their 1-month evaluation, 41 patients had subjective symptomatic relief. Compared with baseline values, AUA score was reduced from 24.1 +/- 4.6 to 12.6 +/- 2.9 (P = .00001), and serum PSA from 6.2 +/- 1.7 to 4.8 +/- 1.0 ng/mL (P = .03). At the same time, prostatic volume and residual urine volume were reduced by 12.7% and 12.8%, respectively, and mean peak urinary flow rate increased (P = .01). At 2 months' evaluation, 55 patients had subjective symptomatic relief. AUA score was reduced by 63.9% (P = .00001) compared with baseline values. In the same patients, serum PSA, prostatic volume, and residual urine volume were reduced by 51.6% (P = .00001), 42.8% (P = .00001), and 55.9% (P = .002), respectively, and mean peak urinary flow rate increased significantly.
Intraprostatic BT seems to be a promising approach to the treatment of BPH. It is safe, effective, well-tolerated, and not related to the patient's willingness to complete treatment.
介绍对有症状的良性前列腺增生（BPH）男性患者进行前列腺内注射肉毒杆菌毒素（BT）的全面经验。
在这项使用门诊环境的开放标签研究中，77例BPH男性患者采用超声引导经会阴途径接受了200单位前列腺内BT A（保妥适）注射。我们评估了美国泌尿外科学会（AUA）评分、血清前列腺特异性抗原（PSA）、前列腺体积、残余尿量和最大尿流率。主要终点是治疗后症状改善情况，通过AUA评分和最大尿流率来衡量。次要终点是评估前列腺体积、血清PSA和残余尿量。
未出现明显局部效应。在1个月评估时，41例患者有主观症状缓解。与基线值相比，AUA评分从24.1±4.6降至12.6±2.9（P = 0.00001），血清PSA从6.2±1.7降至4.8±1.0 ng/mL（P = 0.03）。同时，前列腺体积和残余尿量分别减少了12.7%和12.8%，平均最大尿流率增加（P = 0.01）。在2个月评估时，55例患者有主观症状缓解。与基线值相比，AUA评分降低了63.9%（P = 0.00001）。在同一批患者中，血清PSA、前列腺体积和残余尿量分别降低了51.6%（P = 0.00001）、42.8%（P = 0.00001）和55.9%（P = 0.002），平均最大尿流率显著增加。
前列腺内注射BT似乎是一种有前景的BPH治疗方法。它安全、有效、耐受性良好，且与患者完成治疗的意愿无关。
