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高育琳 Autologous myoblasts and fibroblasts versus collagen for treatment of stress urinary incontinence in women: a randomised controlled trial. 2007/8/9 下午 04:00:24 0
原 文 題  目 Autologous myoblasts and fibroblasts versus collagen for treatment of stress urinary incontinence in women: a randomised controlled trial.
作  者 Strasser H, Marksteiner R, Margreiter E, Pinggera GM, Mitterberger M, Frauscher F, Ulmer H, Fussenegger M, Kofler K and Bartsch G
出  處 Lancet. 2007 Jun 30;369(9580):2179-86.
出版日期
評 論 Sling procedure 是目前婦女泌尿科醫師的基本技法。但是不要忘了即使這個號稱30分鐘的OPD手術,仍是個危險性較高,會發生諸多併發症的手術。而這些併發症可能跑去尋求其他醫師的治療罷了。
之前的尿道填充物注射曾風行一時,例如adipose tissue, collagen等。因為長期的效果不佳,而被漸漸捨棄。以下的論文提出新的injection material及新的注射技術,希望讓這個技法鹹魚翻身。
由奧地利Innsbruck大學 Strasser等人,提出在經尿道超音波指引下,將autologus myoblast準確地注射於尿道rhabdosphincter及將autologus fibroblast 注射於黏膜下層,以重建尿道括約肌功能,達到治療尿失禁的目的。在術後12個月的追蹤,接受自體myoblast 及fibroblast注射的個案,90%(38/42)的病人仍是continent;反觀接受collagen注射的個案,只有9.5%(2/21)的病人是continent。這只是一個 randomized controlled trial (因為muscle biopsy的緣故,無法做 double blind design),尚需要更長期及多中心的觀察,若是這方法有效且長期耐用,將開啟婦女尿失禁治療的新紀元,亦是病人的福音。
abstract BACKGROUND: Preclinical studies have suggested that transurethral injections of autologous myoblasts can aid in regeneration of the rhabdosphincter, and fibroblasts in reconstruction of the urethral submucosa. We aimed to compare the effectiveness and tolerability of ultrasonography-guided injections of autologous cells with those of endoscopic injections of collagen for stress incontinence. METHODS: Between 2002 and 2004, we recruited 63 eligible women with urinary stress incontinence. 42 of these women were randomly assigned to receive transurethral ultrasonography-guided injections of autologous myoblasts and fibroblasts, and 21 to receive conventional endoscopic injections of collagen. The first primary outcome measure was an incontinence score (range 0-6) based on a 24-hour voiding diary, a 24-hour pad test, and a patient questionnaire. The other primary outcome measures were contractility of the rhabdosphincter and thickness of both the urethra and rhabdosphincter. Analysis was by intention to treat. This trial is registered with Controlled-Trials.com, number CCT-NAPN-16630. FINDINGS: At 12-months'' follow-up, 38 of the 42 women injected with autologous cells were completely continent, compared with two of the 21 patients given conventional treatment with collagen. The median incontinence score decreased from a baseline of 6.0 (IQR 6.0-6.0; where 6 represents complete incontinence), to 0 (0-0) for patients treated with autologous cells, and 6.0 (3.5-6.0) for patients treated with collagen (p<0.0001). Ultrasonographic measurements showed that the mean thickness of the rhabdosphincter increased from a baseline of 2.13 mm (SD 0.39) for all patients to 3.38 mm (0.26) for patients treated with autologous cells and 2.32 mm (0.44) for patients treated with collagen (p<0.0001). Contractility of the rhabdosphincter increased from a baseline of 0.58 mm (SD 0.32) to 1.56 mm (0.28) for patients treated with autologous cells and 0.67 mm (0.51) for controls (p<0.0001). The change in the thickness of the urethra after treatment was not significantly different between treatment groups. No adverse effects were recorded in any of the 63 patients. INTERPRETATION: Long-term postoperative results and data from multicentre trials with larger numbers of patients are needed to assess whether injection of autologous cells into the rhabdosphincter and the urethra could become a standard treatment for urinary incontinence.
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