【摘要翻译】肉毒桿菌毒素對於前列腺肥大的治療是有效的
发布于 2003-10-16 · 浏览 529 · IP 广东广东
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肉毒桿菌毒素對於前列腺肥大的治療是有效的
作者：Laurie Barclay, MD
出處：WebMD醫學新聞
審閱：Gary D. Vogin, MD
2003年8月6日--根據一篇發表於8月號Urology的隨機化、安慰劑控制組研究之初步結果指出，將肉毒桿菌毒素（BT ；Botox）注射至前列腺，可以減少良性前列腺肥大(BPH) 的症狀及前列腺專一性抗原 ( PSA ) 含量，而且具有良好的耐受度。
羅馬Agostino Gemelli大學醫院的Giorgio Maria博士表示，研究人員注意到排尿障礙患者的尿道括約肌衰弱，可以藉由注射BT而緩解疼痛及症狀，近來已經證實在小鼠前列腺注射BT可以引起選擇性的神經切除及腺體萎縮。
三十名患有BPH且對於藥物無反應並拒絕手術的患者，給予4 ml的生理食鹽水溶液或200 U肉毒桿菌毒素A溶液於前列腺，無局部或全身性的併發症發生，平均追蹤期為19.6 ± 3.8個月。
在治療組中的13名患者及控制組的3名患者中，排尿障礙的症狀於二個月之後獲得改善（P = .0007），在 BT組中，症狀的評分下降65%，且血清PSA濃度字基準線降低了51%，控制組並未發生顯著的改變。
研究人員指出，我們發現BT注射對於BPH 的治療是具有良好效果的，因為它的耐受度佳，而且可以作為手術危險的患者之考慮療法，在BT治療普遍應用之前，還需要進一步的研究。
在伴隨的社論中，哥倫比亞大學泌尿科的Alexis E.Te博士將BT稱之為「值得引起注意和進一步研究的新方法」可是Te博士表示這項研究是初期的研究，僅針對少量患者進行短暫的追蹤研究，他表示還有其他需要注意的事項。
他表示，目前這種神經肌肉毒素只被食品與藥物管理局批准作為化妝品用途，它在尿道的應用還需要進一步研究，因為 BT容易取得且廣為應用，它可以輕易地施打，所以需要謹慎的檢驗以確保它不會造成生命威脅或產生神經毒性。
Botulinum Toxin Might Be Helpful in Benign Prostatic Hyperplasia
By Laurie Barclay, MD
Medscape Medical News
Aug. 6, 2003 — Botulinum toxin (BT; Botox) injected into the prostate reduced symptoms of benign prostatic hyperplasia (BPH) and prostate-specific antigen (PSA) levels and was well tolerated, according to the results of a randomized, placebo-controlled but preliminary trial published in the August issue of Urology.
"It has been noted that a weakening of the urethral sphincter muscle by BT injection is followed by pain relief and symptom improvement in patients with voiding dysfunction," write Giorgio Maria, MD, from University Hospital Agostino Gemelli in Rome, Italy, and colleagues. "Recently, it has been documented that BT injection into the rat prostate induces selective denervation and subsequent atrophy of the gland."
Thirty consecutive men with BPH who no longer responded favorably to medication and who refused surgery received 4 mL of saline solution or 200 U of botulinum toxin A solution injected into the prostate gland. There were no local complications or systemic adverse effects. Average follow-up was 19.6 ± 3.8 months.
Symptoms of voiding dysfunction improved after two months in 13 patients in the treated group and in three in the control group (P = .0007). In the BT group, the symptom score declined by 65% and the serum PSA concentration by 51% from baseline, whereas these values did not change significantly in the control group.
"We found BT injection into the prostate to be a promising approach to the treatment of BPH. It is well-tolerated and should be considered for patients who are at risk of surgery," the authors write. "Additional investigation of BT treatment is indicated before its general use can be advocated."
In an accompanying editorial, Alexis E. Te, MD, from the department of urology at Columbia University in New York City, calls this application of BT "a very novel approach deserving of interest and investigation." However, Dr. Te notes that this study was a preliminary investigation with a small number of patients and a short follow-up, and he addresses several additional concerns.
"Currently, this neuromuscular toxin is approved by the Food and Drug Administration only for cosmetic applications. Its application in the urinary tract is clearly investigational," Dr. Te writes. "Because BT is easily prescribed and widely available, its 'off label' urologic application can be easy to offer as one joins this 'fashionable Botox' trend in medical care. Therefore, it should be strongly emphasized that cautious examination of its application in the general community is warranted because it is still a neurotoxin with potential and significant life-threatening morbidities."
Urology. 2003;62:259-265
Reviewed by Gary D. Vogin, MD
作者：Laurie Barclay, MD
出處：WebMD醫學新聞
審閱：Gary D. Vogin, MD
2003年8月6日--根據一篇發表於8月號Urology的隨機化、安慰劑控制組研究之初步結果指出，將肉毒桿菌毒素（BT ；Botox）注射至前列腺，可以減少良性前列腺肥大(BPH) 的症狀及前列腺專一性抗原 ( PSA ) 含量，而且具有良好的耐受度。
羅馬Agostino Gemelli大學醫院的Giorgio Maria博士表示，研究人員注意到排尿障礙患者的尿道括約肌衰弱，可以藉由注射BT而緩解疼痛及症狀，近來已經證實在小鼠前列腺注射BT可以引起選擇性的神經切除及腺體萎縮。
三十名患有BPH且對於藥物無反應並拒絕手術的患者，給予4 ml的生理食鹽水溶液或200 U肉毒桿菌毒素A溶液於前列腺，無局部或全身性的併發症發生，平均追蹤期為19.6 ± 3.8個月。
在治療組中的13名患者及控制組的3名患者中，排尿障礙的症狀於二個月之後獲得改善（P = .0007），在 BT組中，症狀的評分下降65%，且血清PSA濃度字基準線降低了51%，控制組並未發生顯著的改變。
研究人員指出，我們發現BT注射對於BPH 的治療是具有良好效果的，因為它的耐受度佳，而且可以作為手術危險的患者之考慮療法，在BT治療普遍應用之前，還需要進一步的研究。
在伴隨的社論中，哥倫比亞大學泌尿科的Alexis E.Te博士將BT稱之為「值得引起注意和進一步研究的新方法」可是Te博士表示這項研究是初期的研究，僅針對少量患者進行短暫的追蹤研究，他表示還有其他需要注意的事項。
他表示，目前這種神經肌肉毒素只被食品與藥物管理局批准作為化妝品用途，它在尿道的應用還需要進一步研究，因為 BT容易取得且廣為應用，它可以輕易地施打，所以需要謹慎的檢驗以確保它不會造成生命威脅或產生神經毒性。
Botulinum Toxin Might Be Helpful in Benign Prostatic Hyperplasia
By Laurie Barclay, MD
Medscape Medical News
Aug. 6, 2003 — Botulinum toxin (BT; Botox) injected into the prostate reduced symptoms of benign prostatic hyperplasia (BPH) and prostate-specific antigen (PSA) levels and was well tolerated, according to the results of a randomized, placebo-controlled but preliminary trial published in the August issue of Urology.
"It has been noted that a weakening of the urethral sphincter muscle by BT injection is followed by pain relief and symptom improvement in patients with voiding dysfunction," write Giorgio Maria, MD, from University Hospital Agostino Gemelli in Rome, Italy, and colleagues. "Recently, it has been documented that BT injection into the rat prostate induces selective denervation and subsequent atrophy of the gland."
Thirty consecutive men with BPH who no longer responded favorably to medication and who refused surgery received 4 mL of saline solution or 200 U of botulinum toxin A solution injected into the prostate gland. There were no local complications or systemic adverse effects. Average follow-up was 19.6 ± 3.8 months.
Symptoms of voiding dysfunction improved after two months in 13 patients in the treated group and in three in the control group (P = .0007). In the BT group, the symptom score declined by 65% and the serum PSA concentration by 51% from baseline, whereas these values did not change significantly in the control group.
"We found BT injection into the prostate to be a promising approach to the treatment of BPH. It is well-tolerated and should be considered for patients who are at risk of surgery," the authors write. "Additional investigation of BT treatment is indicated before its general use can be advocated."
In an accompanying editorial, Alexis E. Te, MD, from the department of urology at Columbia University in New York City, calls this application of BT "a very novel approach deserving of interest and investigation." However, Dr. Te notes that this study was a preliminary investigation with a small number of patients and a short follow-up, and he addresses several additional concerns.
"Currently, this neuromuscular toxin is approved by the Food and Drug Administration only for cosmetic applications. Its application in the urinary tract is clearly investigational," Dr. Te writes. "Because BT is easily prescribed and widely available, its 'off label' urologic application can be easy to offer as one joins this 'fashionable Botox' trend in medical care. Therefore, it should be strongly emphasized that cautious examination of its application in the general community is warranted because it is still a neurotoxin with potential and significant life-threatening morbidities."
Urology. 2003;62:259-265
Reviewed by Gary D. Vogin, MD
最后编辑于 2004-06-20 · 浏览 529
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