異量分子聚合物系統NASHA/Dx對應力性尿失禁有助益


  Aug. 24, 2004 -根據八月號泌尿科學誌(Urology)刊載的一項開放、預測性臨床試驗結果顯示,對應力性尿失禁而言,將非動物穩定型透明質子酸hyaluronic acid /(NASHA/Dx)異量分子聚合物藉著引導器具植入,是一種安全且有效的侵入式治療方法。
  
  荷蘭馬斯垂克醫院大學Philip Van Kerrebroeck及同僚指出,NASHA/Dx異量分子聚合物是唯一被U.S食品及藥品管理部門核准用於孩童膀胱切開術內視鏡檢查治療SUI的血管注射劑,這項產品同時也取得歐洲許可,用於治療SUI,一個新的引導性器具-Implacer -它已經被發展為不需要外科設備或膀胱檢驗鏡的引導,即可改善及可再生的,及標準化地通過尿道的 NASHA/Dx異量分子聚合物注射劑;此器具由被置入及注視尿道的支架所組成,(例如膨脹尿道的周長,因而弄平長度的褶層),允許利用四個大約在2、4、8及10點鐘位置的注射器去注射植入管。
  
  在此多中心的試驗研究中,42位罹患SUI,而之前未曾接受侵入性治療的女性患者,被給予Implacer 4 x 1.0 mL或4 x 0.7 Ml的 NASHA/Dx 異量分子聚合物治療;在60%的患者中只有一個需要注射手術,療效參數為咳嗽引起的露尿壓力 (CILPP)、由於誘發試驗而引起的漏尿、在24小時內尿失禁的次數及患者膀胱狀況的感知度,評估六點尺度,全部計量為基線及1、3、6及治療之後的12個月,患者對Implacer治療的耐受性相當好,也沒有副作用報告發生。
  
  研究人員確定CILPP資料是沒有根據也不可靠的,治療之後,在20下跳耀動作之後的中位數漏尿量,或是3個月治療之後強烈咳嗽,從基礎點36 g (範圍在 0.0 - 300.0) 降至5.5 g (範圍在0.0 - 98.0) 及12個月治療後降至7.0 g (範圍在0.0 - 98.0) (P < .0001),3個月及12個月治療後,42位患者中有32位(76%)漏尿狀況獲得改善。
  
  在12個月後,24小時內尿失禁的中位數次數從基礎點1.9 (範圍在 0.0 - 24.0之間)降至0.4 (範圍在 0.0 - 24.0之間) (P < .0001);在3個月及12個月的治療後,29位患者(69%)在6項患者感知尺度中,至少有一項參數獲得改善。
  
  此試驗限制包括,缺少主要療效評估CILPP從基礎線開始的改變之有效及可靠的數據,且因各試驗中心不一致的測量法、遺漏的數值或驗證的難度,也是研究的侷限所在。
  
  研究人員指出,這項試驗得到一個新的方法,即利用Implacer 的NASHA/Dx 異量分子聚合物,對不曾使用過侵入式治療的SUI患者而言,是有效而耐受性高的治療方法,且至少可持續改善12個月;另外,不需要外科設備且已建立的安全形象,更進一步的支持此新的SUI治療。
  
  NASHA/Dx 異量分子聚合物系統的製造商Q-Med AB贊助此研究。

NASHA/Dx Copolymer System Help

By Laurie Barclay, MD
Medscape Medical News

Aug. 24, 2004 — Non-animal-stabilized hyaluronic acid/dextranomer (NASHA/Dx) copolymer placed by a guiding instrument (the Implacer) is a safe and effective invasive treatment for stress urinary incontinence (SUI), according to the results of an open, prospective trial published in the August issue of Urology.

"NASHA/Dx copolymer is the only injectable agent approved by the U.S. Food and Drug Administration for endoscopic treatment of vesicoureteral reflux in children and has also gained European approval for the treatment of SUI," write Philip Van Kerrebroeck, from University Hospital Maastricht, the Netherlands, and colleagues. "A new guiding instrument — the Implacer — has been developed to facilitate reproducible and standardized transurethral injection of NASHA/Dx copolymer, without the need for surgical facilities or cystoscopic guidance. This device made up of a holder that is placed into, and fixates, the urethra (ie, distends the urethral circumference, thus smoothing out the longitudinal folds), allowing use of four syringes to inject implants at approximately the 2, 4, 8, and 10-o'clock positions."

In this multicenter study, 42 female patients with SUI with no previous invasive treatment received 4 x 1.0 mL or 4 x 0.7 mL of NASHA/Dx copolymer using the Implacer. Only one injection procedure was required in 60% of patients. Efficacy parameters were cough-induced leak point pressure (CILPP), urine leakage by provocation test, number of incontinence episodes in 24 hours, and patient perception of bladder condition, rated on a six-point scale, all measured at baseline and one, three, six, and 12 months after treatment. Treatment with the Implacer was well tolerated, and there were no reported complications.

The investigators determined that the CILPP data were neither valid nor reliable. After treatment, median urine leakage after 20 "jumping jacks" or vigorous coughs declined from 36 g (range 0.0 – 300.0) at baseline to 5.5 g (range, 0.0 – 98.0) at three months and 7.0 g (range, 0.0 – 98.0) at 12 months (P < .0001). Urine leakage at three and 12 months improved in 32 (76%) of the 42 patients.

The median number of incontinence episodes in 24 hours declined from 1.9 (range, 0.0 – 24.0) at baseline to 0.4 (range, 0.0 – 24.0) at 12 months (P < .0001). At both three and 12 months, 29 patients (69%) had at least one category of improvement on the six-point patient perception scale.

Study limitations include lack of valid and reliable data for the primary end point of change from baseline in CILPP, because of inconsistent measurement among the centers and values missing or difficult to verify.

"The results of the present study indicate that a novel system, NASHA/Dx copolymer using the Implacer, is an effective and well-tolerated treatment for patients with SUI who have not undergone invasive therapy, with improvement sustained for at least 12 months," the authors write. "The lack of a requirement for surgical facilities and the established safety profile of NASHA/Dx copolymer further support the use of this new SUI treatment."

Q-Med AB, the maker of the NASHA/Dx copolymer system, supported this study.

Urology. 2004;64:276-281

Reviewed by Gary D. Vogin, MD

    
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