Maria Giorgio, Brisinda Giuseppe, Civello Ignazio Massimo, Bentivoglio Anna Rita, Sganga Gabriele, Albanese Alberto
Department of Surgery, Catholic School of Medicine, University Hospital Agostino Gemelli, Rome, Italy.
Urology. 2003 Aug;62(2):259-64; discussion 264-5. doi: 10.1016/s0090-4295(03)00477-1.
To evaluate the therapeutic role of botulinum toxin injection in men with benign prostatic hyperplasia.
Men with benign prostatic hyperplasia were enrolled in a randomized, placebo-controlled study. After a baseline evaluation, each participant received 4 mL of solution injected into the prostate gland. Patients in the control group received saline solution and patients in the treated group received 200 U of botulinum toxin A. The outcome of each group was evaluated by comparing the symptom scores, serum prostate-specific antigen concentration, prostate volume, postvoid residual urine volume, and peak urinary flow rates.
Thirty consecutive patients were enrolled. No local complications or systemic side effects were observed in any patient. After 2 months, 13 patients in the treated group and 3 in the control group had subjective symptomatic relief (P = 0.0007). In patients who received botulinum toxin, the symptom score was reduced by 65% compared with baseline values and the serum prostate-specific antigen concentration by 51% from baseline. In patients who received saline, the symptom score and serum prostate-specific antigen concentration were not significantly changed compared with the baseline values and 1-month values. Follow-up averaged 19.6 +/- 3.8 months.
Botulinum toxin injected into the prostate seems to be a promising approach for the treatment of benign prostatic hyperplasia. It is safe, effective, and well-tolerated. Furthermore, it is not related to the patient's willingness to complete treatment.
评估肉毒杆菌毒素注射对良性前列腺增生男性患者的治疗作用。
将良性前列腺增生男性患者纳入一项随机、安慰剂对照研究。在进行基线评估后，每位参与者接受4毫升溶液注入前列腺。对照组患者接受生理盐水溶液，治疗组患者接受200单位A型肉毒杆菌毒素。通过比较症状评分、血清前列腺特异性抗原浓度、前列腺体积、排尿后残余尿量和最大尿流率来评估每组的结果。
连续纳入30例患者。所有患者均未观察到局部并发症或全身副作用。2个月后，治疗组13例患者和对照组3例患者有主观症状缓解（P = 0.0007）。接受肉毒杆菌毒素治疗的患者，症状评分较基线值降低了65%，血清前列腺特异性抗原浓度较基线降低了51%。接受生理盐水治疗的患者，症状评分和血清前列腺特异性抗原浓度与基线值及1个月时的值相比无显著变化。随访平均为19.6 +/- 3.8个月。
向前列腺注射肉毒杆菌毒素似乎是治疗良性前列腺增生的一种有前景的方法。它安全、有效且耐受性良好。此外，它与患者完成治疗的意愿无关。
