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| 發表人 | 討論主題 | 發表時間 | 討論數 |
| 蒙恩 | 肉毒桿菌毒素用於處理下泌尿道疾病的最新系統回顧和標準化平均結果的統計比較 | 2014/5/29 下午 06:38:42 | 0 |
| 原 文 | 題 目 | An Updated Systematic Review and Statistical Comparison of Standardised Mean Outcomes for the Use of Botulinum Toxin in the Management of Lower Urinary Tract Disorders |
| 作 者 | Altaf Mangera *, Apostolos Apostolidis, Karl Eric Andersson, Prokar Dasgupta, Antonella Giannanton, Claus Roehrborn, Giacomo Novar, Christopher Chapple | |
| 出 處 | European Urology, Volume 65(5),2014, 981-990 | |
| 出版日期 | ||
| 評 論 |
A型肉毒桿菌毒素（Botulinum toxin A）已被准許用於神治療經性逼尿肌過度活動（NDO）和膀胱過動症（OAB），但它仍然未經許可用在其他下尿路症狀（LUTS），如男性非神經性良性前列腺肥大造成的下尿路症狀（LUTS/ BPE），膀胱疼痛症候群（BPS），和逼尿肌括約肌協同失調（DSD）等。此篇文章主要是比較在以上這些不同適應症中，使用A型肉毒桿菌毒素治療下尿路症狀的高證據等級（level of evidence, LE）之研究統計結果，以期做為臨床使用A型肉毒桿菌毒素治療下尿路症狀時的參考。作者針對已出版有關使用A型肉毒桿菌毒素治療下尿路症狀的研究做系統性的回顧，也對高證據等級及低證據等級的研究做統計性的比較。 在成年人神經性逼尿肌過度活動 ，使用A型肉毒桿菌毒素治療後，每日漏尿次數和導尿次數，最大膀胱容量（MCC），排尿反射容量，及最大逼尿肌壓（ MDP ）均有顯著的改善 。在膀胱過動症的病人 ， A型肉毒桿菌毒素顯著改善了病人排尿日記的各項參數，如每日排尿頻率，每日急尿的頻率，以及日間尿失禁次數。最大膀胱容量和最大逼尿肌壓等尿動力學參數亦顯著提高了58 ％和29％。而跟安慰劑比較起來，尿路感染的風險卻有顯著增加 ( 21 ％比7 ％）;間歇自我導尿的風險也從0 ％上升到12％。在男性有良性前列腺肥大合併下尿路症狀的病人，使用A型肉毒桿菌毒素治療後，無論在國際前列腺症狀評分，最大尿流率，或前列腺體積均無顯著改善。而在膀胱疼痛症候群（BPS）、逼尿肌括約肌協同失調（DSD）及兒童排尿障礙的研究上，目前沒有足夠的數據可進行統計分析。低證據等級的研究常高估了A型肉毒桿菌毒素治療在所有適應症中的效果，這些效果若是從高證據等級的研究中來看，只有少數參數有顯著差異。 結論： A型肉毒桿菌毒素顯著地改善了神經性逼尿肌過度活動和膀胱過動症的所有症狀及尿動力學參數。在低證據等級的研究中，A型肉毒桿菌毒素在治療尿路功能障礙的效果常是被高估了。 |
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| abstract |
Context Botulinum toxin A (BoNTA) has received regulatory approval for use in neurogenic detrusor overactivity (NDO) and overactive bladder (OAB), but it remains unlicensed in other lower urinary tract symptoms (LUTS) indications such as nonneurogenic LUTS in men with benign prostatic enlargement (LUTS/BPE), bladder pain syndrome (BPS), and detrusor sphincter dyssynergia (DSD). Objective To compare statistically the outcomes of high level of evidence (LE) studies with placebo using BoNTA for LUTS indications; NDO, OAB, LUTS/BPE, BPS and DSD. Evidence acquisition We conducted a systematic review of the published literature on PubMed, Scopus, and Embase reporting on BoNTA use in LUTS dysfunction. Statistical comparison was made between high LE studies with placebo and low LE studies. Evidence synthesis In adult NDO, there are significantly greater improvements with BoNTA in daily incontinence and catheterisation episodes (−63% and −18%, respectively; p < 0.01), and the urodynamic parameters of maximum cystometric capacity (MCC), reflex volume, and maximum detrusor pressure (MDP) (68%, 61%, and −42%, respectively; all p < 0.01). In OAB, BoNTA leads to significant improvements in bladder diary parameters such as daily frequency (−29%), daily urgency (−38%), and daily incontinence (−59%) (all p < 0.02). The urodynamic parameters of MCC and MDP improved by 58% (p = 0.04) and −29% (p = 0.002), respectively. The risk of urinary tract infection was significantly increased from placebo at 21% versus 7% (p < 0.001), respectively; the risk of intermittent self-catherisation increased from 0% to 12% (p < 0.001). Men with LUTS/BPE showed no significant improvements in International Prostate Symptom Score, maximum flow rate, or prostate volume. There were insufficient data for statistical analysis in DSD, BPS, and paediatric studies. Low LE studies were found to overestimate the effects of BoNTA in all indications, but differences from high LE studies were significant in only a few parameters. Conclusions BoNTA significantly improves all symptoms and urodynamic parameters in NDO and OAB. The effect of BoNTA in treating LUTS dysfunction appears to be overestimated in lower as opposed to higher LE studies. |
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