副交感神经拮抗剂治疗摄护腺肥大病患之泌尿症状有效


  May 12, 2004 (旧金山) -- 根据美国泌尿科学会(American Urological Association,AUA),第99届年会发表的研究显示,常用于妇女尿失禁治疗的Tolterodine (Detrol LA)药物的长效缓释剂型,对男性因摄护腺肥大(benign prostatic hyperplasia,BPH),所造成的频尿现象,疗效也颇佳。
  
  美国纽约市哥伦比亚大学,医学院临床泌尿科助理教授Steven A. Kaplan医师在演讲中指出,以毒菌碱接受器拮抗剂(muscarinic receptor antagonists,MRA)治疗BPH男性患者的下泌尿道征候群(lower urinary tract symptoms, LUTS),可望成为临床可行的治疗方式;他表示,这些药物可以单独投予,也可以和alpha阻断剂或5-alpha还原脢抑制剂合并治疗;此外,这类药物可当作第一线用药,也可用于过去曾接受BPH症状治疗却无效的病患。
  
  Muscarinic receptor antagonists,又名副交感神经拮抗剂(anticholinergics);目前已广泛用于尿失禁治疗,但临床医师对于其在男性频尿及其它不适应症状(例如:LUTS等,较BPH轻微的症状)的治疗角色仍有存疑,因此,Kaplan医师及其团队试图了解,对于曾以alpha阻断剂治疗无效的男性LUTS族群而言,tolterodine的长效缓释剂型是否安全而有效。
  
  研究团队招募43名平均年龄为61.3岁(年龄分布50至83岁之间)的男性受试者;所有受试者皆有BPH及LUTS,而且都曾以alpha阻断剂治疗平均5.7个月;受试者接受Alpha阻断剂疗法后,分别因不同的原因而宣告失败,其中包括11名产生药物不适应反应,另32名则宣告无效。
  
  在为期6个月的测试中,每日投予4毫克tolterodine长效缓释剂型单独治疗,研究团队根据以下指标评量药物疗效,包括AUA Symptoms Score (AUASS),最高尿流速(peak flow rate)、残尿量(postvoid residual urine)等,同时也纪录了病患闭尿发生率及性功能影响。
  
  43名病患中,39 (91%)名完成整个为期6个月的测试;试验初期,病患平均AUASS为17.3,受试结束后则有效降低至11.2;最高尿流速则平均由每秒9.8毫升加速至每秒11.7毫升;残尿量则由97毫升减少至75毫升;另外,频尿情形则由每天9.8次,减少为6.3次;且夜间频尿情形,也由每晚4.1次减少至2.9次。
  
  Kaplan医师补充指出,另有4名患者(9%)由于不耐口渴而中断治疗;该症状为MRA已知的常见不适应症,受试期间,无病患发生闭尿反应,1名病患发生尿道感染。另外,受试之初,27名患者(63%)可正常勃起,测试结束后,可正常勃起的人数增加为29名(67%)。
  
  位于纽约康乃尔Weill医学院James J. Colt荣誉主席兼泌尿科教授,同时也是AUA前主席的E. Darracott Vaughan, Jr医师,检视该研究结果后表示,从过去经验而言,他们担心会使BPH病患发生闭尿现象,因此不敢投予副交感神经拮抗剂;然而,BPH的男性患者总是得面临频尿的问题,因此,副交感神经拮抗剂总是对特定族群有效。
  
  针对上述的患者,Vaughan医师建议合并使用副交感神经拮抗剂及alpha阻断剂或5-alpha还原脢抑制剂加以治疗。
  
  Vaughan进一步阐述,现有数据显示,副交感神经拮抗剂与闭尿发生率之间不尽相关,因此,使用副交感神经拮抗剂合并治疗,不仅未必有害,还可能很有帮助;虽然临床资料还很有限,但是基本的成效已经显现,至少可以说明,以副交感神经拮抗剂治疗因BPH而发生的频尿现象,对大多数病患而言应是安全的。

Anticholinergics Effective for

By Paula Moyer
Medscape Medical News

May 12, 2004 (San Francisco) — The extended-release formulation of tolterodine (Detrol LA), often used to treat overactive bladder in women, is also effective in men with urinary frequency due to benign prostatic hyperplasia (BPH), according to findings presented here at the 99th annual meeting of the American Urological Association (AUA).

"Treating men with BPH and lower urinary tract symptoms with muscarinic receptor antagonists may be a reasonable therapeutic option," Steven A. Kaplan, MD, said during his presentation. "These agents can either be used as monotherapy or in combination with alpha-blockers, 5-alpha-reductase inhibitors or both. They can be used either as first-line therapy or in patients in whom previous BPH treatments have failed." Dr. Kaplan is an assistant professor of clinical urology at Columbia University School of Medicine in New York City.

Muscarinic receptor antagonists, also called anticholinergics, has been widely used to treat overactive bladder, but physicians are uncertain about their potential role in treating frequency and other irritative symptoms in men with lower urinary tract symptoms (LUTS) secondary to BPH. Therefore, Dr. Kaplan and colleagues attempted to determine whether extended-release tolterodine would be safe and efficacious in men with LUTS for whom alpha-blocker therapy had failed.

The investigators recruited 43 consecutive men who were an average age of 61.3 years (range, 50-83 years). The men had BPH and LUTS and had been treated with alpha-blockers for an average of 5.7 months. Alpha-blocker therapy had been unsuccessful for a variety of reasons, including adverse events in 11 patients and lack of efficacy in 32 patients.

All patients received 4 mg of extended-release tolterodine once daily as monotherapy for six months. The investigators evaluated the drug's efficacy by the AUA Symptoms Score, peak flow rate, and postvoid residual urine. They also documented the incidence of urinary retention and patients' sexual function.

Of the 43 patients, 39 (91%) completed the six-month trial. At baseline the patents' mean symptoms score was 17.3; by the study's end it was 11.2. The peak flow rate averaged 9.8 mL/sec at baseline and it increased to an average of 11.7 mL/sec at six months. At baseline patients had an average postvoid residual urine volume of 97 mL; by the study's end it was an average of 75 mL. In addition, urination frequency decreased from an average of 9.8 voiding episodes daily to 6.3 episodes. Their nocturnal voiding episodes also decreased, from an average of 4.1 episodes per night to 2.9 nightly episodes.

Four men (9%) discontinued therapy because of intolerable dry mouth, a known adverse effect of muscarinic receptor antagonists, Dr. Kaplan said. No patients developed urinary retention, and one patient had a urinary tract infection. In this patient group, 27 (63%) had normal erectile function at baseline, as did 29 patients (67%) six months after starting treatment.

"Historically we have been told not to use anticholinergics in BPH for fear of obstruction-induced urinary retention," E. Darracott Vaughan, Jr., MD, told Medscape in an interview seeking outside comment. "However, men with BPH also have overactive bladder. Therefore, it may be that some men's urinary symptoms would respond to anticholinergics." In those cases, he recommends using anticholinergics in combination with an alpha-blocker or a 5-alpha-reductase inhibitor. Dr. Vaughan is chairman emeritus and James J. Colt professor of urology at Weill Medical College of Cornell in New York, and he is also a former president of the American Urological Association.

"The current data suggest that urinary retention with anticholinergics is not common. Therefore it is not detrimental, and is often helpful, to use the combination," Dr. Vaughan said. "There aren't a lot of randomized trials, but the proof of principle is there. Anticholinergics for BPH-related urinary frequency is safe for many patients."

AUA 99th Annual Meeting: Abstract 917. Presented May 10, 2004.

Reviewed by Gary D. Vogin, MD

    
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